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1
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Wang X, Chen JDZ. Therapeutic potential and mechanisms of sacral nerve stimulation for gastrointestinal diseases. J Transl Int Med 2023; 11:115-127. [PMID: 37408571 PMCID: PMC10318922 DOI: 10.2478/jtim-2023-0086] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 07/07/2023] Open
Abstract
Background The aim of this systemtic review is to introduce clinical applications (especially emerging) and potential mechanisms of sacral nerve stimulation (SNS) for treating various gastrointestinal diseases. Materials and Methods PubMed and Web of Science were searched for studies published on SNS and its clinical applications in fecal incontinence (limited to systematic review and meta-analysis of clinical studies), constipation (limited to reviews and randomized control clinical studies), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) and upper gastrointestinal motility disorders. The relevant studies were pooled, and their findings were summarized and discussed. Results SNS is an approved method for treating fecal incontinence. Systematic review and meta-analysis demonstrated high efficacy of the SNS therapy for fecal incontinence. Increased anal sphincter pressure and improvement in rectal sensation were reported as major mechanisms involved in the SNS therapy. SNS has also been proposed for treating constipation, but the therapy has been shown ineffective. There is a lack in SNS methodological optimization and mechanistic research. A few basic and clinical studies have reported the potential of SNS for treating visceral pain in IBS. SNS seemed capable of improving mucosal barrier functions. Several case reports are available in the literature on the treatment of IBD with SNS. Several laboratory studies suggested therapeutic potential of a special method of SNS for IBD. Cholinergic anti-inflammatory mechanisms were reported. Due to a recently reported spinal afferent and vagal efferent pathway of SNS, a few preclinical studies reported the potential of SNS for upper gastrointestinal motility disorders. However, no clinical studies have been performed. Conclusions SNS for fecal incontinence is a well-established clinical therapy. However, the current method of SNS is ineffective for treating constipation. Further methodological development and randomized clinical trials are needed to explore potential applications of SNS for IBS and IBD.
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Affiliation(s)
- Ximeng Wang
- Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD21228, USA
| | - Jiande DZ Chen
- Department of Internal Medicine, University of Michigan School of Medicine, Ann ArborMI48109, USA
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Sharifi-Rad L, Ladi-Seyedian SS, Alimadadi H, Yousefi A. Non-retentive faecal incontinence in children: Conventional therapy alone or combined electrical stimulation. J Paediatr Child Health 2022; 58:2225-2229. [PMID: 36052750 DOI: 10.1111/jpc.16194] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2022] [Revised: 08/16/2022] [Accepted: 08/16/2022] [Indexed: 11/30/2022]
Abstract
AIMS To compare the effects of functional electrical stimulation (FES) with conventional therapy and conventional therapy alone on improvement of faecal incontinence (FI) symptoms in a number of children with functional non-retentive FI. METHODS Data of 28 children with FI were accepted for this retrospective study. The case group (n = 14) underwent FES + conventional therapy and the control group (n = 14) received conventional therapy only. Data of children with faecal retention, inflammatory, anatomic, metabolic and neurological disorders were excluded. Children were assessed with a paediatric FI score questionnaire, and a bowel habit diary both before treatment sessions, after they ended, and after 6 months. A FI quality of life questionnaire was completed before and after treatment for all children. RESULTS Full response to the treatment (100% reduction in FI episodes) was significantly observed in 8/14 (57.1%) of children in the case group compared to 2/14 (14.2%) of children in the control group after the ending of treatment sessions (P = 0.005). The baseline mean ± SD of FI episodes per week was 3.7 ± 2.1 among both groups which significantly decreased after the ending of treatment sessions in the case group compared to the control group (1.4 ± 2.1 vs 3 ± 2.7; P = 0.05). Mean ± SD of FI score was significantly reduced in the case group compared to the controls after the ending of treatment sessions (3.9 ± 4.5 vs 8 ± 4.7; P = 0.02) and maintained after 6 months (P = 0.05). CONCLUSIONS Functional electrical stimulation is a safe, effective, non-invasive, inexpensive, reproducible and easy-to-use modality for treatment of functional non-retentive faecal incintinence in children.
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Affiliation(s)
- Lida Sharifi-Rad
- Department of Physical Therapy, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran
| | - Seyedeh-Sanam Ladi-Seyedian
- Pediatric Gastroenterology and Hepatology Research Center, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran
| | - Hosein Alimadadi
- Pediatric Gastroenterology and Hepatology Research Center, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.,Department of Pediatrics, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran
| | - Azizollah Yousefi
- Pediatric Growth and Developmental Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran
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Ali MK, Saha S, Milkova N, Liu L, Sharma K, Huizinga JD, Chen JH. Modulation of the autonomic nervous system by one session of spinal low-level laser therapy in patients with chronic colonic motility dysfunction. Front Neurosci 2022; 16:882602. [PMID: 36117615 PMCID: PMC9477245 DOI: 10.3389/fnins.2022.882602] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2022] [Accepted: 08/04/2022] [Indexed: 11/30/2022] Open
Abstract
Patients with a defecation disorder may not evoke a normal defecation reflex, or the reflex may be excessive, as a dysfunction of the spinal autonomic nervous system. Treatment with various forms of lumbar and sacral neuromodulation have shown symptom improvement, but potential changes in autonomic functioning are rarely studied. Here we evaluate the effects on autonomic function of a single session of low-level laser therapy (LLLT) on the lumbar and sacral spine in 41 patients with chronic gastrointestinal motor dysfunction. The LLLT protocol used red LED light at a wavelength of 660 nm for 10 min and infrared LED light at a wavelength of 840 nm for 10 min, followed by infrared laser light at a wavelength of 825 nm for 10 min. Effects on the autonomic nervous system were assessed by measuring heart rate variability (HRV) changes. Respiratory Sinus Arrhythmia (RSA) and Root Mean Square of Successive Differences (RMSSD) were used to quantify parasympathetic reactivity; the Baevsky’s Stress Index (SI) reflected sympathetic activity while the ratios SI/RSA and SI/RMSSD were used to show shifts in autonomic dominance. The results indicate that lumbar and sacral neuromodulation using light arrays reduced, whereas stimulation by the laser probes significantly increased parasympathetic activity. The light arrays increased whereas the laser probes significantly decreased sympathetic activity (SI). The entire protocol shifted the autonomic balance toward parasympathetic activity. The comparison of actual vs. sham neuromodulation proved that the change in HRV parameters was due to actual light stimulation and not due to the arrays and probe touching the skin. In conclusion, a single session of LLLT markedly affects autonomic nervous system activity reflected in changes in HRV which is only possible by generating activity in the spinal autonomic nerves. These results warrant a study into the effects of LLLT on restoring autonomic dysfunction in chronic refractory colonic motility disorders.
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Affiliation(s)
- M. Khawar Ali
- Faculty of Engineering, School of Biomedical Engineering, McMaster University, Hamilton, ON, Canada
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
| | - Shrayasee Saha
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
| | - Natalija Milkova
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
| | - Lijun Liu
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
| | - Kartik Sharma
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
| | - Jan D. Huizinga
- Faculty of Engineering, School of Biomedical Engineering, McMaster University, Hamilton, ON, Canada
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
- *Correspondence: Jan D. Huizinga,
| | - Ji-Hong Chen
- Division of Gastroenterology, Department of Medicine, Faculty of Health Sciences, Farncombe Family Digestive Health Research Institute, Hamilton, ON, Canada
- *Correspondence: Jan D. Huizinga,
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Meyer I, Richter HE. Accidental Bowel Leakage/Fecal Incontinence: Evidence-Based Management. Obstet Gynecol Clin North Am 2021; 48:467-485. [PMID: 34416932 DOI: 10.1016/j.ogc.2021.05.003] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.
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Affiliation(s)
- Isuzu Meyer
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA.
| | - Holly E Richter
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA
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5
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Zhang SH, Chen Y. Progress in research of sacral nerve stimulation. Shijie Huaren Xiaohua Zazhi 2020; 28:1266-1271. [DOI: 10.11569/wcjd.v28.i24.1266] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Sacral nerve stimulation (SNS) is well-known as a minimally invasive treatment. Originally, it was mainly used to treat urinary system diseases such as urge urinary incontinence. Gradually, it is used to treat digestive system diseases such as fecal incontinence and chronic constipation. SNS is a method in which electrical pulse signals are sent out through pulse generators to stimulate the sacral nerve directly or indirectly, thus modulating the nerve reflex of the bladder, urethra, anus, colon, and rectum and improving abnormal nerve regulation to achieve the therapeutic effect. The regulation of the sacral nerve is often carried out by inserting electrodes into the sacral spinal canal S2-4 (mostly S3), and the symptoms are improved by complex regulation of spinal reflex and supraspinal reflex. However, the exact mechanism is still unclear. Many studies have shown that SNS plays a key role in the treatment of many diseases of the urinary system and digestive system. This paper reviews the progress in the research of SNS.
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Affiliation(s)
- Shu-Hui Zhang
- Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou 256603, Shandong Province, China
| | - Yan Chen
- Department of Gastroenterology, Binzhou Medical University Hospital, Binzhou 256603, Shandong Province, China
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Leo CA, Leeuwenburgh M, Orlando A, Corr A, Scott SM, Murphy J, Knowles CH, Vaizey CJ, Giordano P. Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two-centre retrospective clinical audit. Colorectal Dis 2020; 22:2161-2169. [PMID: 32686233 DOI: 10.1111/codi.15277] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/10/2020] [Accepted: 05/30/2020] [Indexed: 02/08/2023]
Abstract
AIM The SphinKeeper™ artificial bowel sphincter implant is a relatively new surgical technique for the treatment of refractory faecal incontinence. This study presents the first experience in two UK tertiary centres. METHOD This is a retrospective audit of prospectively collected clinical data in relation to technique, safety, feasibility and short-term effectiveness from patients undergoing surgery from January 2016 to April 2019. Baseline data, intra-operative and postoperative complications, symptoms [using St Mark's incontinence score (SMIS)] and radiological outcomes were analysed. RESULTS Twenty-seven patients [18 women, median age 57 years (range 27-87)] underwent SphinKeeper. In 30% of the patients, the firing device jammed and not all prostheses were delivered. There were no intra-operative complications and all patients were discharged the same or the following day. SMIS significantly improved from baseline [median -6 points (range -12 to +3); P < 0.00016] with 14/27 (51.9%) patients achieving a 50% reduction in the SMIS score. On postoperative imaging, a median of seven prostheses (range 0-10) were identified with a median of five (range 0-10) optimally placed. There was no relationship between number of well-sited prostheses on postoperative imaging and categorical success based on 50% reduction in SMIS (χ2 test, P = 0.79). CONCLUSION SphinKeeper appears to be a safe procedure for faecal incontinence. Overall, about 50% patients achieved a meaningful improvement in symptoms. However, clinical benefit was unrelated to the rate of misplaced/migrated implants. This has implications for confidence in proof of mechanism and also the need for technical refinement.
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Affiliation(s)
- C A Leo
- Imperial College London, London, UK.,Sir Alan Park's Physiology Unit, St Mark's Hospital Academic Institute, Harrow, UK
| | | | - A Orlando
- Imperial College London, London, UK.,Sir Alan Park's Physiology Unit, St Mark's Hospital Academic Institute, Harrow, UK
| | - A Corr
- Sir Alan Park's Physiology Unit, St Mark's Hospital Academic Institute, Harrow, UK
| | - S M Scott
- National Bowel Research Centre and GI Physiology Unit, Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Queen Mary University of London, London, UK.,Royal London Hospital, London, UK
| | - J Murphy
- Imperial College London, London, UK
| | - C H Knowles
- National Bowel Research Centre and GI Physiology Unit, Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Queen Mary University of London, London, UK.,Royal London Hospital, London, UK
| | - C J Vaizey
- Sir Alan Park's Physiology Unit, St Mark's Hospital Academic Institute, Harrow, UK
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Leo CA, Thomas GP, Bradshaw E, Karki S, Hodgkinson JD, Murphy J, Vaizey CJ. Long-term outcome of sacral nerve stimulation for faecal incontinence. Colorectal Dis 2020; 22:2191-2198. [PMID: 32954658 DOI: 10.1111/codi.15369] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2020] [Accepted: 09/06/2020] [Indexed: 12/11/2022]
Abstract
AIM Sacral nerve stimulation (SNS) is a minimally invasive treatment for faecal incontinence (FI). We report our experience of patients who have undergone SNS for FI with a minimum of 5 years' follow-up. This is a single centre prospective observational study with the aim to assess the long-term function of SNS. METHOD All patients implanted with SNS were identified from our prospective database. The date of implantation, first and last clinic follow-up, surgical complications and St Mark's incontinence scores were abstracted and analysed. RESULTS From 1996 to 2014, 381 patients were considered for SNS. Of these, 256 patients met the study inclusion criteria. Median age at implantation was 52 years (range 18-81). The ratio of women to men was 205:51. Indications were urge FI (25%), passive FI (17.9%) and mixed FI (57%). The median of the incontinence score at baseline was 19/24 and this improved to 7/24 at the 6-month follow-up. Of the total cohort, 235 patients received a medium-term follow-up (median 110 months, range 12-270) with a median continence score of 10/24 which was also confirmed at the telephone long-term follow-up on 185 patients (132 months, range 60-276). CONCLUSION This study demonstrates that SNS is an effective treatment in the long term. SNS results in an improvement of validated scores for approximately 60% of patients; however, there is a significant reduction of efficacy over time due to underlying causes.
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Affiliation(s)
- C A Leo
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK.,Imperial College London, London, UK.,Northwick Park Hospital, London North West NHS Trust, Harrow, UK
| | - G P Thomas
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK
| | - E Bradshaw
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK
| | - S Karki
- Northwick Park Hospital, London North West NHS Trust, Harrow, UK
| | - J D Hodgkinson
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK.,Imperial College London, London, UK
| | - J Murphy
- Imperial College London, London, UK
| | - C J Vaizey
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Northwest London University NHS Trust, Harrow, UK.,Imperial College London, London, UK
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Artus A, Tabchouri N, Iskander O, Michot N, Muller O, Giger-Pabst U, Bourlier P, Bourbao-Tournois C, Kraemer-Bucur A, Lecomte T, Salamé E, Ouaissi M. Long term outcome of anastomotic leakage in patients undergoing low anterior resection for rectal cancer. BMC Cancer 2020; 20:780. [PMID: 32819329 PMCID: PMC7439541 DOI: 10.1186/s12885-020-07109-4] [Citation(s) in RCA: 17] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/17/2019] [Accepted: 06/23/2020] [Indexed: 12/15/2022] Open
Abstract
Background The influence of anastomotic leakage (AL) on local recurrence rates and survival in rectal cancer remains controversial. The aim of this study was to analyze the effect of asymptomatic anastomotic leakage (AAL) and symptomatic anastomotic leakage (SAL) on short- and long-term outcome after curative rectal cancer resection. Methods All patients who underwent surgical resection of non-metastatic rectal cancer with curative intent from January 2005 to December 2017 were retrospectively analyzed. Short-term morbidity, long-term functional and oncological outcomes were compared between patients with SAL, AAL and without AL (WAL). Results Overall, 200 patients were included and AL was observed in 39 (19.5%) patients (10 AAL and 29 SAL) with a median follow-up of 38.5 months. Rectal cancer location and preoperative neoadjuvant treatment was similar between the three groups. Postoperative 30-day mortality rate was nil. The permanent stoma rate was higher in patients with SAL or AAL compared to WAL patients (44.8 and 30% vs 9.3%, p < 0.001). The mean wexner continence grading scale was significantly different between AAL (11,4 ± 3,8), SAL (10,3 ± 0,6) and WAL (6,4 ± 4,7) groups (p = 0.049). The 3 and 5-year overall and disease-free survival rates were similar between the 3 groups (86.6% /84% vs 100%/100% vs 76%/70 and 82.9%/77% vs 100%/100% vs 94.7%/88.3% for patients with SAL, AAL, and WAL, p = 0.480 and p = 0.527). Conclusion The permanent stoma rate was significant higher in patients with SAL or AAL compared to WAL patients. AL did not impair long-term oncological outcome.
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Affiliation(s)
- Alice Artus
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Nicolas Tabchouri
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Othman Iskander
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Nicolas Michot
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Olivier Muller
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Urs Giger-Pabst
- Department of General-, Visceral- and Transplant Surgery, University of Münster, Münster, Germany
| | - Pascal Bourlier
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Céline Bourbao-Tournois
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Aurore Kraemer-Bucur
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Thierry Lecomte
- Department of Hepatogastroenterology and Digestive Oncology, Tours, France
| | - Ephrem Salamé
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France
| | - Mehdi Ouaissi
- Department of Digestive, Oncological, Endocrine, Hepato-Biliary, Pancreatic and Liver Transplant Surgery, Trousseau Hospital, Chambray les Tours, Avenue de la République, Chambray les Tours, France.
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Gevelinger MM, Jaworski EM, Speranza JR, Sanderson DJ. Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation. Neuromodulation 2020; 23:1158-1163. [PMID: 32803836 DOI: 10.1111/ner.13249] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/27/2020] [Revised: 06/01/2020] [Accepted: 07/06/2020] [Indexed: 11/26/2022]
Abstract
OBJECTIVE To evaluate changes in self-reported depression after treatment of fecal incontinence (FI) with sacral neuromodulation. MATERIALS AND METHODS This is a subanalysis of data collected from March 2016 to October 2017 for an Institutional Review Board-approved retrospective cohort study. Demographic information, medical history, psychiatric comorbidities, and the Patient-Reported Outcomes Measurement Information System item bank t-scores were extracted from the electronic medical record. The differences in t-scores were compared with a two-sided paired t-test, and a p value <0.05 was considered statistically significant. RESULTS Of the cohort (n = 24), most were Caucasian (88%), female (92%), nonsmokers (92%). Median age was 63.5 years (interquartile range 57.5-71.0 years) and median body mass index was 27.7 kg/m2 (range 18.3-42.9 kg/m2 ). A significant decrease in mean depression t-scores occurred after implantation of a sacral neuromodulation device, -4.5 (95% confidence interval [CI]: -8.7, -0.2, p = 0.04). Self-reported pain interference (p = 0.37) and physical function (p = 0.47) scores were similar following implantation. Individuals with comorbid anxiety reported the greatest improvement in depression (-6.5, 95% CI: -11.8, -1.1, p = 0.02). CONCLUSIONS Treatment of FI with sacral neuromodulation was associated with improvement in self-reported depression with the greatest improvement in those with anxiety. Further prospective research is needed to corroborate these findings.
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Affiliation(s)
- Matthew M Gevelinger
- Department of Obstetrics and Gynecology, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
| | | | - Jenny R Speranza
- Department of Surgery, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
| | - Derrick J Sanderson
- Department of Obstetrics and Gynecology, School of Medicine and Dentistry, University of Rochester, Rochester, NY, USA
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Ezra E, Siilin AMH, Gulobovic M, Graf JWR. Patterns of tined lead migration in sacral nerve modulation. Int J Colorectal Dis 2020; 35:1163-1166. [PMID: 32144532 PMCID: PMC7245592 DOI: 10.1007/s00384-020-03530-0] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/05/2020] [Indexed: 02/04/2023]
Abstract
AIM Lead migration is a common cause of loss of efficacy in sacral nerve modulation. Our aim was to systematically study the migration pattern of tined leads in sacral nerve modulation. Our hypothesis was that tined leads may promote forward migration because of their configuration. METHOD Consecutive patients treated with sacral nerve modulation with a tined lead electrode, who had experienced loss of efficacy and had radiographs both at baseline and after loss of efficacy between 2005 and 2016 were eligible for inclusion. RESULTS Twenty-five patients out of 70 with loss of efficacy were studied. Lead migration was measured as percent electrode movement in relation to sacral cortex at lateral projection. All had some degree of lead migration, ranging from 35% backward to 74% forward migration. Sixteen (64%) had forward migration while nine (36%) had backward migration. In seven patients (28%), loss of efficacy was associated with an episode of perceived mechanical strain on the electrode. Fifty percent (4/8) who associated their loss of efficacy with an adverse event had forward migration of the electrode. CONCLUSIONS Forward lead migration with concomitant loss of efficacy seems to be a common event in patients with tined leads, hence supporting our hypothesis. The retrospective design and that some of the patients with loss of efficacy could not be included because of incomplete data, which is a limitation to the study. Further studies are needed to confirm to what extent the direction and magnitude of the migration relate to loss of efficacy.
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Affiliation(s)
- Emmanuel Ezra
- Department of Surgical Sciences, Uppsala University, Akademiska Sjukhuset, 75 185 Uppsala, Sweden
| | - A. M. Helene Siilin
- Department of Surgical Sciences, Uppsala University, Akademiska Sjukhuset, 75 185 Uppsala, Sweden
| | - Milan Gulobovic
- Department Section of Radiology, Uppsala University, Akademiska Sjukhuset, 75 185 Uppsala, Sweden
| | - J. Wilhelm R. Graf
- Department of Surgical Sciences, Uppsala University, Akademiska Sjukhuset, 75 185 Uppsala, Sweden
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11
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Sarveazad A, Babahajian A, Amini N, Shamseddin J, Yousefifard M. Posterior Tibial Nerve Stimulation in Fecal Incontinence: A Systematic Review and Meta-Analysis. Basic Clin Neurosci 2019; 10:419-431. [PMID: 32284831 PMCID: PMC7149953 DOI: 10.32598/bcn.9.10.290] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/29/2018] [Revised: 05/15/2018] [Accepted: 09/28/2018] [Indexed: 12/14/2022] Open
Abstract
INTRODUCTION The present systematic review and meta-analysis aims to investigate the role of Posterior Tibial Nerve Stimulation (PTNS) in the control of Fecal Incontinence (FI). METHODS Two independent reviewers extensively searched in the electronic databases of Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, CINAHL, and Scopus for the studies published until the end of 2016. Only randomized clinical trials were included. The studied outcomes included FI episodes, FI score, resting pressure, squeezing pressure, and maximum tolerable pressure. The data were reported as Standardized Mean Differences (SMD) with 95% confidence interval. RESULTS Five articles were included in the present study (249 patients under treatment with PTNS and 239 in the sham group). Analyses showed that PTNS led to a significant decrease in the number of FI episodes (SMD=-0.38; 95% CI: -0.67-0.10; P=0.009). Yet, it did not have an effect on FI score (SMD=0.13; 95% CI: -0.49-0.75; P=0.68), resting pressure (SMD=0.12; 95% CI: -0.14-0.37; P=0.67), squeezing pressure (SMD=-0.27; 95% CI: -1.03-0.50; P=0.50), and maximum tolerable pressure (SMD=-0.10; 95% CI: -0.40-0.24; P=0.52). CONCLUSION Based on the results, it seems that the prescription of PTNS alone cannot significantly improve FI.
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Affiliation(s)
- Arash Sarveazad
- Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran
| | - Asrin Babahajian
- Liver and Digestive Research Center, Kurdistan University of Medical Sciences, Sanandaj, Iran
| | - Naser Amini
- Cellular and Molecular Research Center, Iran University of Medical Sciences, Tehran, Iran
| | - Jebreil Shamseddin
- Molecular Medicine Research Center, Hormozgan Health Institute, Department of Parasitology, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran
| | - Mahmoud Yousefifard
- Physiology Research Center, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
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12
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Ludmir EB, Kachnic LA, Czito BG. Evolution and Management of Treatment-Related Toxicity in Anal Cancer. Surg Oncol Clin N Am 2018; 26:91-113. [PMID: 27889040 DOI: 10.1016/j.soc.2016.07.004] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Over the past several decades, clinical trials have demonstrated improved disease-related outcomes in the definitive treatment of anal cancer. Although treatment with radiation and concurrent chemotherapy results in high rates of cure, significant acute and late toxicities are seen. This review focuses on the evolution of treatment-related toxicity for anal cancer. Management of these adverse effects is reviewed, as are future directions in anal cancer treatment and their impact on toxicity.
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Affiliation(s)
- Ethan B Ludmir
- Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler St, Unit 1422, Houston, TX 77030, USA
| | - Lisa A Kachnic
- Department of Radiation Oncology, Vanderbilt University Medical Center, 2220 Pierce Avenue, Suite B1034, Nashville, TN 37232, USA
| | - Brian G Czito
- Department of Radiation Oncology, Duke University Medical Center, Box 3085, Durham, NC 27710, USA.
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13
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Epidemiology, Pathophysiology and Management of Fecal Incontinence in the Older Woman. CURRENT GERIATRICS REPORTS 2017. [DOI: 10.1007/s13670-017-0201-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
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14
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Percutaneous tibial nerve stimulation (pTNS): success rate and the role of rectal capacity. Int J Colorectal Dis 2017; 32:789-796. [PMID: 28391449 DOI: 10.1007/s00384-017-2804-x] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 03/23/2017] [Indexed: 02/04/2023]
Abstract
PURPOSE Percutaneous tibial nerve stimulation (pTNS) was originally developed to treat urinary incontinence. Recently, some case series have also documented its success in the treatment of fecal incontinence. Nevertheless, the mechanism underlying this effect remains unknown but may be related to changes in rectal capacity. The aim of this study was to investigate the success of pTNS for the treatment of fecal urge incontinence and assess the influence of rectal capacity on treatment efficacy. METHODS All patients undergoing pTNS for fecal incontinence between July 2009 and March 2014 were enrolled in a prospective, observational study consisting of a therapeutic regimen that lasted 9 months. Therapy success was defined as a reduction in the CCI (Cleveland Clinic incontinence) score of ≥50% and patient-reported success. Furthermore, quality of life (Rockwood's scale) and changes in anorectal physiology were recorded. RESULTS Fifty-seven patients with fecal urge incontinence were eligible, nine of whom were excluded. The success rate was 72.5%. Incontinence events and urge symptoms were significantly reduced after 3 months and at the end of therapy. The median CCI score decreased from 12 to 4 (P < 0.0001), and the quality of life was significantly improved. However, rectal capacity was not significantly related to treatment success before or after therapy. No adverse events were observed. CONCLUSIONS These results demonstrate that pTNS can improve the symptoms and quality of life of patients with fecal urge incontinence. However, the study fails to demonstrate a correlation between treatment success and changes in rectal capacity.
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Abelson JS, Spiegel JD, Yeo HL, Mao J, Sun T, Sedrakyan A, Milsom JW, Garrett KA. Evaluation of Trends in the Use of InterStim for Fecal Incontinence. Surg Innov 2017; 24:133-138. [PMID: 28132584 DOI: 10.1177/1553350616689750] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
BACKGROUND Fecal incontinence (FI) represents a large source of morbidity and is a challenging clinical problem to manage. InterStim was approved to treat FI in 2011. Little is known about its adoption. We sought to characterize patterns of use of Interstim since Food and Drug Administration approval for FI. METHODS The New York State SPARCS database was used to evaluate InterStim use for FI from 2011 to 2014. The primary endpoint was the number of successful implantations of InterStim. Secondary endpoints included device removal, median time to removal of device, 90-day infection rates, and percentage of procedures performed by surgeon specialty and geographic location. RESULTS A total of 369 patients with FI underwent "Stage 1" of InterStim from 2011 to 2014. A total of 302 patients underwent "Stage 2," yielding a trial period failure rate of 18.2%. The majority of patients who underwent successful implantation were female (87.7%) and White (78.8%). Twenty-nine patients underwent device removal after a median duration of 147 days. Estimated risk of removal at median follow-up of 2 years was 11.8%. Colorectal surgeons comprised 51.1% of all providers followed by gynecologic (24.4%) and urologic surgeons (17.8%). A total of 71.7% of providers performed <5 procedures, while 3 of the highest volume providers performed 50.7% of all procedures. CONCLUSIONS InterStim for FI has been used by a wide variety of providers in New York State although only a few high-volume providers have performed the majority of procedures. White, female patients with Medicare are the most common recipients of InterStim. Further work must be done to develop strategies for improving access to this technology and to determine whether volume relates to outcomes.
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Affiliation(s)
- Jonathan S Abelson
- 1 Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
| | - Joshua D Spiegel
- 2 University of Tennessee Health Science Center, Memphis, TN, USA
| | - Heather L Yeo
- 1 Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA.,3 Department of Healthcare Policy and Research, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
| | - Jialin Mao
- 3 Department of Healthcare Policy and Research, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
| | - Tianyi Sun
- 3 Department of Healthcare Policy and Research, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
| | - Art Sedrakyan
- 3 Department of Healthcare Policy and Research, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
| | - Jeffrey W Milsom
- 1 Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
| | - Kelly A Garrett
- 1 Department of Surgery, New York-Presbyterian Hospital, Weill Cornell Medicine, New York, NY, USA
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16
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Abstract
Fecal incontinence is a highly prevalent and distressing condition that has a negative impact on quality of life. The etiology is often multifactorial, and the evaluation and treatment of this condition can be hindered by a lack of understanding of the mechanisms and currently available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.
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Affiliation(s)
- Isuzu Meyer
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA.
| | - Holly E Richter
- Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, 1700 6th Avenue South, Suite 10382, Birmingham, AL 35233, USA
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17
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Bielefeldt K. Adverse events of sacral neuromodulation for fecal incontinence reported to the federal drug administration. World J Gastrointest Pharmacol Ther 2016; 7:294-305. [PMID: 27158546 PMCID: PMC4848253 DOI: 10.4292/wjgpt.v7.i2.294] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/19/2015] [Revised: 02/23/2016] [Accepted: 03/16/2016] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the nature and severity of AE related to sacral neurostimulation (SNS).
METHODS: Based on Pubmed and Embase searches, we identified published trials and case series of SNS for fecal incontinence (FI) and extracted data on adverse events, requiring an active intervention. Those problems were operationally defined as infection, device removal explant or need for lead and/or generator replacement. In addition, we analyzed the Manufacturer and User Device Experience registry of the Federal Drug Administration for the months of August - October of 2015. Events were included if the report specifically mentioned gastrointestinal (GI), bowel and FI as indication and if the narrative did not focus on bladder symptoms. The classification, reporter, the date of the recorded complaint, time between initial implant and report, the type of AE, steps taken and outcome were extracted from the report. In cases of device removal or replacement, we looked for confirmatory comments by healthcare providers or the manufacturer.
RESULTS: Published studies reported adverse events and reoperation rates for 1954 patients, followed for 27 (1-117) mo. Reoperation rates were 18.6% (14.2-23.9) with device explants accounting for 10.0% (7.8-12.7) of secondary surgeries; rates of device replacement or explant or pocket site and electrode revisions increased with longer follow up. During the period examined, the FDA received 1684 reports of AE related to SNS with FI or GI listed as indication. A total of 652 reports met the inclusion criteria, with 52.7% specifically listing FI. Lack or loss of benefit (48.9%), pain or dysesthesia (27.8%) and complication at the generator implantation site (8.7%) were most commonly listed. Complaints led to secondary surgeries in 29.7% of the AE. Reoperations were performed to explant (38.2%) or replace (46.5%) the device or a lead, or revise the generator pocket (14.6%). Conservative management changes mostly involved changes in stimulation parameters (44.5%), which successfully addressed concerns in 35.2% of cases that included information about treatment results.
CONCLUSION: With reoperation rates around 20%, physicians need to fully disclose the high likelihood of complications and secondary interventions and exhaust non-invasive treatments, including transcutaneous stimulation paradigms.
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18
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Mirbagheri N, Sivakumaran Y, Nassar N, Gladman MA. Systematic review of the impact of sacral neuromodulation on clinical symptoms and gastrointestinal physiology. ANZ J Surg 2015; 86:232-6. [PMID: 26245170 PMCID: PMC5054906 DOI: 10.1111/ans.13257] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 06/09/2015] [Indexed: 12/13/2022]
Abstract
Background Sacral neuromodulation (SNM) has emerged as a treatment option for faecal incontinence (FI). However, its objective effect on symptoms and anorectal function is inconsistently described. This study aimed to systematically review the impact of SNM on clinical symptoms and gastrointestinal physiology in patients with FI, including factors that may predict treatment outcome. Methods An electronic search of MEDLINE (1946–2014)/EMBASE database was performed in accordance with PRISMA guidelines. Articles that reported the relevant outcome measures following SNM were included. Clinical outcomes evaluated included: frequency of FI episodes, FI severity score and success rates. Its impact on anorectal and gastrointestinal physiology was also evaluated. Results Of 554 citations identified, data were extracted from 81 eligible studies. Meta‐analysis of the data was precluded due to lack of a comparison group in most studies. After permanent SNM, ‘perfect’ continence was noted in 13–88% of patients. Most studies reported a reduction in weekly FI episodes (median difference of the mean −7.0 (range: −24.8 to −2.7)) and Wexner scores (median difference of the mean −9 (−14.9 to −6)). A trend towards improved resting and squeeze anal pressures and a reduction in rectal sensory volumes were noted. Studies failed to identify any consistent impact on other physiological parameters or clinicophysiological factors associated with success. Conclusion SNM improves clinical symptoms and reduces number of incontinence episodes and severity scores in patients with FI, in part by improving anorectal physiological function. However, intervention studies with standardized outcome measures and physiological techniques are required to robustly assess the physiological impact of SNM.
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Affiliation(s)
- Naseem Mirbagheri
- Academic Colorectal Unit, Sydney Medical School - Concord, The University of Sydney, Sydney, New South Wales, Australia.,Sydney Colorectal + Pelvic Floor Centre, Concord Private Hospital, Sydney, New South Wales, Australia
| | - Yogeesan Sivakumaran
- Academic Colorectal Unit, Sydney Medical School - Concord, The University of Sydney, Sydney, New South Wales, Australia
| | - Natasha Nassar
- Academic Colorectal Unit, Sydney Medical School - Concord, The University of Sydney, Sydney, New South Wales, Australia.,Clinical and Population Perinatal Health Research, Kolling Institute of Medical Research, The University of Sydney, Sydney, New South Wales, Australia
| | - Marc A Gladman
- Academic Colorectal Unit, Sydney Medical School - Concord, The University of Sydney, Sydney, New South Wales, Australia.,Sydney Colorectal + Pelvic Floor Centre, Concord Private Hospital, Sydney, New South Wales, Australia
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19
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Devane LA, Evers J, Jones JF, Ronan O'Connell P. A review of sacral nerve stimulation parameters used in the treatment of faecal incontinence. Surgeon 2015; 13:156-62. [DOI: 10.1016/j.surge.2014.11.002] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/22/2014] [Revised: 11/05/2014] [Accepted: 11/13/2014] [Indexed: 01/27/2023]
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20
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Meyer I, Richter HE. Evolving Surgical Treatment Approaches for Fecal Incontinence in Women. CURRENT OBSTETRICS AND GYNECOLOGY REPORTS 2015. [DOI: 10.1007/s13669-015-0116-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
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21
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Maeda Y, O'Connell PR, Lehur PA, Matzel KE, Laurberg S. Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement. Colorectal Dis 2015; 17:O74-87. [PMID: 25603960 DOI: 10.1111/codi.12905] [Citation(s) in RCA: 67] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/08/2014] [Accepted: 10/29/2014] [Indexed: 12/14/2022]
Abstract
AIM In Europe during the last decade sacral nerve stimulation (SNS) or sacral neuromodulation (SNM) has been used to treat faecal incontinence (FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/SNM for FI and constipation. METHOD A systematic literature search of SNS for FI and constipation was conducted using PubMed. A set of questions derived from the search and expert opinion were answered on-line on two occasions by an international panel of specialists from Europe. A 1-day face-to-face meeting of the experts finalized the discussion. RESULTS Three hundred and ninety-three articles were identified from the literature search, of which 147 fulfilled the inclusion criteria. Twenty-two specialists in FI and constipation from Europe participated. Agreement was achieved on 43 (86%) of 50 domains including the set-up of service, patient selection, baseline investigations, operative technique and programming of the device. The median of agreement was 95% (35-100%). CONCLUSION Consensus was achieved on the majority of domains of SNS/SNM for FI and constipation. This should serve as a benchmark for safe and quality practice of SNS/SNM in Europe.
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Affiliation(s)
- Y Maeda
- Sir Alan Parks Physiology Unit, St Mark's Hospital, Harrow, UK
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22
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Shridhar R, Shibata D, Chan E, Thomas CR. Anal cancer: current standards in care and recent changes in practice. CA Cancer J Clin 2015; 65:139-62. [PMID: 25582527 DOI: 10.3322/caac.21259] [Citation(s) in RCA: 61] [Impact Index Per Article: 6.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/29/2023] Open
Abstract
Answer questions and earn CME/CNE The management of squamous cell carcinomas of the anal canal has evolved from surgery as first-line treatment to curative chemoradiation, with surgery reserved for salvage. Significant progress has been made in understanding how to most effectively deliver chemotherapy and reduce toxicity through advancements in radiation delivery. The purpose of this article is to review the multimodality approach to the diagnosis and management of anal cancer based on a review of the published data and in light of available guidelines.
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Affiliation(s)
- Ravi Shridhar
- Associate Professor, Department of Radiation Oncology, Moffitt Cancer Center, Tampa, FL
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23
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24
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Madbouly KM, Hussein AM. Temporary sacral nerve stimulation in patients with fecal incontinence owing to rectal hyposensitivity: A prospective, double-blind study. Surgery 2015; 157:56-63. [DOI: 10.1016/j.surg.2014.06.003] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/06/2014] [Accepted: 06/09/2014] [Indexed: 12/30/2022]
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25
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Carrington EV, Evers J, Grossi U, Dinning PG, Scott SM, O'Connell PR, Jones JFX, Knowles CH. A systematic review of sacral nerve stimulation mechanisms in the treatment of fecal incontinence and constipation. Neurogastroenterol Motil 2014; 26:1222-37. [PMID: 25167953 DOI: 10.1111/nmo.12388] [Citation(s) in RCA: 132] [Impact Index Per Article: 12.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/13/2014] [Accepted: 06/04/2014] [Indexed: 12/23/2022]
Abstract
BACKGROUND Sacral nerve stimulation (SNS) is now well established as a treatment for fecal incontinence (FI) resistant to conservative measures and may also have utility in the management of chronic constipation; however, mechanism of action is not fully understood. End organ effects of SNS have been studied in both clinical and experimental settings, but interpretation is difficult due to the multitude of techniques used and heterogeneity of reported findings. The aim of this study was to systematically review available evidence on the mechanisms of SNS in the treatment of FI and constipation. METHODS Two systematic reviews of the literature (performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses framework) were performed to identify manuscripts pertaining to (a) clinical and (b) physiological effects of SNS during the management of hindgut dysfunction. KEY RESULTS The clinical literature search revealed 161 articles, of which 53 were deemed suitable for analysis. The experimental literature search revealed 43 articles, of which nine were deemed suitable for analysis. These studies reported results of investigative techniques examining changes in cortical, gastrointestinal, colonic, rectal, and anal function. CONCLUSIONS & INFERENCES The initial hypothesis that the mechanism of SNS was primarily peripheral motor neurostimulation is not supported by the majority of recent studies. Due to the large body of evidence demonstrating effects outside of the anorectum, it appears likely that the influence of SNS on anorectal function occurs at a pelvic afferent or central level.
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Affiliation(s)
- E V Carrington
- National Centre for Bowel Research and Surgical Innovation (NCRBSI) and The Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine and Dentistry, London, UK; Biomedical Science Section, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland
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26
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Lee YY. What's New in the Toolbox for Constipation and Fecal Incontinence? Front Med (Lausanne) 2014; 1:5. [PMID: 25705618 PMCID: PMC4335388 DOI: 10.3389/fmed.2014.00005] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/01/2014] [Accepted: 03/13/2014] [Indexed: 12/11/2022] Open
Abstract
Constipation and fecal incontinence (FI) are common complaints predominantly affecting the elderly and women. They are associated with significant morbidity and high healthcare costs. The causes are often multi-factorial and overlapping. With the advent of new technologies, we have a better understanding of their underlying pathophysiology which may involve disruption at any levels along the gut-brain-microbiota axis. Initial approach to management should always be the exclusion of secondary causes. Mild symptoms can be approached with conservative measures that may include dietary modifications, exercise, and medications. New prokinetics (e.g., prucalopride) and secretagogues (e.g., lubiprostone and linaclotide) are effective and safe in constipation. Biofeedback is the treatment of choice for dyssynergic defecation. Refractory constipation may respond to neuromodulation therapy with colectomy as the last resort especially for slow-transit constipation of neuropathic origin. Likewise, in refractory FI, less invasive approach can be tried first before progressing to more invasive surgical approach. Injectable bulking agents, sacral nerve stimulation, and SECCA procedure have modest efficacy but safe and less invasive. Surgery has equivocal efficacy but there are promising new techniques including dynamic graciloplasty, artificial bowel sphincter, and magnetic anal sphincter. Despite being challenging, there are no short of alternatives in our toolbox for the management of constipation and FI.
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Affiliation(s)
- Yeong Yeh Lee
- School of Medical Sciences, Universiti Sains Malaysia , Kota Bharu , Malaysia ; Section of Gastroenterology and Hepatology, Department of Medicine, Medical College of Georgia, Georgia Regents University , Augusta, GA , USA
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27
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Bouguen G, Ropert A, Lainé F, Pequin P, Morcet J, Bretagne JF, Siproudhis L. Effects of transcutaneous tibial nerve stimulation on anorectal physiology in fecal incontinence: a double-blind placebo-controlled cross-over evaluation. Neurogastroenterol Motil 2014; 26:247-54. [PMID: 24304363 DOI: 10.1111/nmo.12256] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2013] [Accepted: 10/05/2013] [Indexed: 02/08/2023]
Abstract
BACKGROUND Transcutaneous electrical tibial nerve stimulation (TENS) is of growing interest for the treatment of fecal incontinence (FI), but its mechanism of action remains uninvestigated. We aimed to further assess the anorectal response to TENS in a dynamic model. METHODS We performed a placebo-controlled, randomized, double-blinded crossover study in 19 patients suffering from FI to assess the effects of TENS on anorectal function. Anorectal physiology and perception were recorded through two sequences of rectal isobaric distension using an electronic barostat device to measure anal and rectal pressures, rectal volumes, and perception scores. KEY RESULTS Maximal rectal pressure and volume variation were affected by TENS, with higher mean maximal rectal pressure (5.33 and 4.06 mmHg in the active and sham TENS respectively, p < 0.0001) and lower volume variation (11.45 and 14.7 mL in the active and sham stimulation respectively, p < 0.05). Rectal compliance was not modified by active TENS. Pressure of the upper anal canal was significantly lower with raised isobaric distension in sequences assigned to active TENS. CONCLUSIONS & INFERENCES Acute TENS modified anorectal physiology by strengthening the myogenic response to distension rather than increasing muscle relaxation and related rectal compliance in patients with FI.
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Affiliation(s)
- G Bouguen
- Service des Maladie de l'Appareil Digestif, Centre Hospitalier Pontchaillou et Université de Rennes 1, Rennes, France; INSERM U991, Université de Rennes 1, Rennes, France
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28
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Richardson ML, Balise RR, Comiter CV. Chronic sacral nerve stimulation as a novel treatment for stress urinary incontinence-A rat model. Neurourol Urodyn 2013; 34:270-3. [DOI: 10.1002/nau.22550] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/20/2013] [Accepted: 11/25/2013] [Indexed: 12/20/2022]
Affiliation(s)
- Monica L. Richardson
- Female Pelvic Medicine and Reconstructive Surgery; Department of Urology and Ob/Gyn, Stanford University School of Medicine; Palo Alto California
| | - Raymond R. Balise
- Department of Health and Research Policy; Stanford University; Palo Alto California
| | - Craig V. Comiter
- Department of Urology; Stanford University School of Medicine; Palo Alto California
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29
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Chiarioni G, Palsson OS, Asteria CR, Whitehead WE. Neuromodulation for fecal incontinence: an effective surgical intervention. World J Gastroenterol 2013; 19:7048-7054. [PMID: 24222947 PMCID: PMC3819539 DOI: 10.3748/wjg.v19.i41.7048] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/27/2013] [Revised: 08/16/2013] [Accepted: 08/28/2013] [Indexed: 02/06/2023] Open
Abstract
Fecal incontinence is a disabling symptom with medical and social implications, including fear, embarrassment, isolation and even depression. Most patients live in seclusion and have to plan their life around the symptom, with secondary impairment of their quality of life. Conservative management and biofeedback therapy are reported to benefit a good percentage of those affected. However, surgery must be considered in the non-responder population. Recently, sacral nerve electrostimulation, lately named neuromodulation, has been reported to benefit patients with fecal incontinence in randomized controlled trials more than placebo stimulation and conservative management, by some unknown mechanism. Neuromodulation is a minimally invasive procedure with a low rate of adverse events and apparently favorable cost-efficacy profile. This review is intended to expand knowledge about this effective intervention among the non-surgically skilled community who deals with this disabled group of patients.
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30
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Moya P, Arroyo A, Lacueva J, Candela F, Soriano-Irigaray L, López A, Gómez MA, Galindo I, Calpena R. Sacral nerve stimulation in the treatment of severe faecal incontinence: long-term clinical, manometric and quality of life results. Tech Coloproctol 2013; 18:179-85. [PMID: 23624794 DOI: 10.1007/s10151-013-1022-y] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2012] [Accepted: 04/18/2013] [Indexed: 12/15/2022]
Abstract
BACKGROUND Faecal incontinence (FI) is a complex and multifactorial health problem. Treatment has to be individualised, analysing the aetiology and gravity in every case. Sacral nerve stimulation (SNS) has been shown to effectively improve treatment of FI. METHODS Fifty patients with severe FI treated with SNS between March 2002 and December 2010 were analysed. Preoperative assessment included physical examination, anorectal manometry and anal endosonography. Anal continence was evaluated using the Wexner continence grading system. Quality of life was evaluated using the Fecal Incontinence Quality of life Scale (FIQLS). Follow-up appointments were scheduled at 1, 6 and 12 months and annually thereafter. Wexner score, FIQLS and the ability to defer defecation were assessed at each visit. RESULTS Fifty patients underwent a permanent implant. The overall mean follow-up period was 55.52 ± 31.84 months. After 6 months, SNS significantly improved FI and positively impacted quality of life, as evidence by significant improvements in all 4 scales of the FIQLS. Anorectal manometry showed a trend towards an increase in maximum resting pressure and maximum pressure. After the first assessment at 6 months, Wexner score and FIQLS remained stable. Ability to defer defecation was also maintained. During follow-up, 3 patients (6 %) experienced implant site pain and episodes of extremity pain and paresthesias that were refractory to medical management and required device explantation. The implant site infection rate was 2 %. CONCLUSIONS Analysis of our long-term results confirms the safety and effectiveness of SNS in the management of patients with FI.
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Affiliation(s)
- P Moya
- Department of Surgery, University General Hospital of Elche, Elche, Alicante, Spain,
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31
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Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. The effect of sacral nerve stimulation on distal colonic motility in patients with faecal incontinence. Br J Surg 2013; 100:959-68. [PMID: 23536312 DOI: 10.1002/bjs.9114] [Citation(s) in RCA: 90] [Impact Index Per Article: 7.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/06/2013] [Indexed: 02/06/2023]
Abstract
BACKGROUND Sacral nerve stimulation (SNS) is an effective treatment for neurogenic faecal incontinence (FI). However, the clinical improvement that patients experience cannot be explained adequately by changes in anorectal function. The aim of this study was to examine the effect of SNS on colonic propagating sequences (PSs) in patients with FI in whom urgency and incontinence was the predominant symptom. METHODS In patients with FI a high-resolution fibre-optic manometry catheter, containing 90 sensors spaced at 1-cm intervals, was positioned colonoscopically and clipped to the caecum. A unipolar or quadripolar tined electrode was implanted into the S3 sacral nerve foramen. Colonic manometry was evaluated in a double-blind randomized crossover trial, using true suprasensory stimulation or sham stimulation. Each stimulation period, lasting 2 h, was preceded by a 2-h basal manometric recording. RESULTS All 11 patients studied showed a colonic response to SNS. In ten patients there was a significant increase in the frequency of retrograde PSs throughout the colon during true stimulation compared with sham stimulation (P = 0·014). In one outlier, with baseline retrograde PS frequency nine times that of the nearest patient, a reduction in retrograde PS frequency was recorded. Compared with sham stimulation, SNS had no effect on the frequency of antegrade PSs or high-amplitude PSs. CONCLUSION SNS modulates colonic motility in patients with faecal urge incontinence. These data suggest that SNS may improve continence and urgency through alteration of colonic motility, particularly by increasing retrograde PSs in the left colon.
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Affiliation(s)
- V Patton
- Department of Anorectal Physiology, St George Hospital, Sydney, Australia
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Abstract
OBJECTIVE Stimulation of the pudendal nerve or the anal sphincter could provide therapeutic options for fecal incontinence with little involvement of other organs. The goal of this project was to assess the effects of pudendal nerve and anal sphincter stimulation on bladder and anal pressures. DESIGN Ten virgin female Sprague Dawley rats were randomly allocated to control (n = 2), perianal stimulation (n = 4), and pudendal nerve stimulation (n = 4) groups. A monopolar electrode was hooked to the pudendal nerve or placed on the anal sphincter. Aballoon catheter was inserted into the anus to measure anal pressure, and a catheter was inserted into the bladder via the urethra to measure bladder pressure. Bladder and anal pressures were measured with different electrical stimulation parameters and different timing of electrical stimulation relative to spontaneous anal sphincter contractions. RESULTS Increasing stimulation current had the most dramatic effect on both anal and bladder pressures. An immediate increase in anal pressure was observed when stimulating either the anal sphincter or the pudendal nerve at stimulation values of 1 mA or 2 mA. No increase in anal pressure was observed for lower current values. Bladder pressure increased at high current during anal sphincter stimulation, but not as much as during pudendal nerve stimulation. Increased bladder pressure during anal sphincter stimulation was due to contraction of the abdominal muscles. CONCLUSION Electrical stimulation caused an increase in anal pressures with bladder involvement only at high current. These initial results suggest that electrical stimulation can increase anal sphincter pressure, enhancing continence control.
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Worsøe J, Fassov J, Schlageter V, Rijkhoff NJM, Laurberg S, Krogh K. Turning off sacral nerve stimulation does not affect gastric and small intestinal motility in patients treated for faecal incontinence. Colorectal Dis 2012; 14:e713-20. [PMID: 22738022 DOI: 10.1111/j.1463-1318.2012.03148.x] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
AIM Sacral nerve stimulation (SNS) reduces symptoms in up to 80% of patients with faecal incontinence (FI). Its effects are not limited to the distal colon and the pelvic floor. Accordingly, spinal or supraspinal neuromodulation have been suggested as part of the mode of action. The effect of SNS on gastric and small-intestinal motility was studied. METHOD Using the magnet tracking system, MTS-1, a small magnetic pill was tracked twice through the upper gastrointestinal tract of eight patients with FI successfully treated with SNS. Following a randomized double-blind crossover design, the stimulator was either left active or was turned off for 1 week before investigations with MTS-1. RESULTS The median (range) frequency of gastric con-tractions was 3.05 (2.83-3.40) per min during SNS and 3.04 (2.79?-3.76) per min without (P=NS). The median (range) frequency of contractions in the small intestine during the first 2h after pyloric passage was 10.005 (9.68-10.70) per min during SNS and 10.09 (9.79-10.29) per min without SNS (P=NS). The median (range) velocity of the magnetic pill during the first 2h in the small intestine was 1.6 (1.2-2.8) cm/min during SNS and 1.7 (0.8-3.7) cm/min without SNS (P=NS). Small-intestinal propagation mainly occurred during very fast movements (>15cm/min), accounting for 51% (42-60%) of the distance 3% (2-4%) of the time during SNS and for 53% (18-73%) of the distance 3% (1-8%) of the time without SNS (P=NS). CONCLUSION Turning off SNS for 1week did not affect gastric or small-intestinal motility patterns.
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Affiliation(s)
- J Worsøe
- Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark.
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Ratto C, Litta F, Parello A, Donisi L, De Simone V, Zaccone G. Sacral nerve stimulation in faecal incontinence associated with an anal sphincter lesion: a systematic review. Colorectal Dis 2012; 14:e297-304. [PMID: 22356165 DOI: 10.1111/j.1463-1318.2012.03003.x] [Citation(s) in RCA: 54] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
AIM The long-term results of sphincteroplasty for faecal incontinence due to an anal sphincter lesion have been disappointing. Initially sacral nerve stimulation was used only in faecal incontinence of neurogenic origin but subsequently the indications have been extended to other conditions. The aim of this review was to evaluate sacral nerve stimulation for incontinence in the presence of a sphincter defect. METHOD The MEDLINE, Embase and Cochrane Library databases for the period between 1995 and 2011 were searched for studies in English, with no limitations concerning the study size or the length of follow-up. The major endpoints were clinical efficacy, changes in anorectal manometry and quality of life. RESULTS Ten reports (119 patients) satisfied the inclusion criteria. The quality of the studies was low (nine were retrospective, one was prospective). All reported a lesion of the external anal and/or internal anal sphincter on endoanal ultrasound. A definitive implant was performed on 106 (89%) of the 119 patients who underwent a peripheral nerve evaluation test. The weighted average number of incontinent episodes per week decreased from 12.1 to 2.3, the weighted average Cleveland Clinic Score decreased from 16.5 to 3.8, and the ability to defer defaecation, when evaluated, increased significantly. The features at anorectal manometry did not change. The quality of life improved significantly in almost all studies. CONCLUSION Sacral nerve stimulation could be a therapeutic option for faecal incontinence in patients with an anal sphincter lesion. However, the quality of the published studies is low. A randomized clinical trial comparing sacral nerve stimulation with other classical surgical procedures at long-term follow-up, although beset with difficulties, should be conducted.
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Affiliation(s)
- C Ratto
- Department of Surgical Sciences, Catholic University, Rome, Italy.
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Dinning PG, Hunt LM, Arkwright JW, Patton V, Szczesniak MM, Wiklendt L, Davidson JB, Lubowski DZ, Cook IJ. Pancolonic motor response to subsensory and suprasensory sacral nerve stimulation in patients with slow-transit constipation. Br J Surg 2012; 99:1002-10. [PMID: 22556131 DOI: 10.1002/bjs.8760] [Citation(s) in RCA: 61] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 03/07/2012] [Indexed: 11/06/2022]
Abstract
BACKGROUND Sacral nerve stimulation (SNS) is emerging as a potential treatment for patients with constipation. Although SNS can elicit an increase in colonic propagating sequences (PSs), the optimal stimulus parameters for this response remain unknown. This study evaluated the colonic motor response to subsensory and suprasensory SNS in patients with slow-transit constipation. METHODS Patients with confirmed slow-transit constipation were studied. Either a water-perfused manometry catheter or a high-resolution fibre-optic manometry catheter was positioned colonoscopically to the caecum. A temporary electrode was implanted transcutaneously in the S3 sacral nerve foramen. In the fasted state, three conditions were evaluated in a double-blind randomized fashion: sham, subsensory and suprasensory stimulation. Each 2-h treatment period was preceded by a 2-h basal period. The delta (Δ) value was calculated as the frequency of the event during stimulation minus that during the basal period. RESULTS Nine patients had readings taken with a water-perfused catheter and six with a fibre-optic catheter. Compared with sham stimulation, suprasensory stimulation caused a significant increase in the frequency of PSs (mean(s.d.) Δ value - 1·1(7·2) versus 6·1(4·0) PSs per 2 h; P = 0·004). No motor response was recorded in response to subsensory stimulation compared with sham stimulation. Compared with subsensory stimulation, stimulation at suprasensory levels caused a significant increase in the frequency of PSs (P = 0·006). CONCLUSION In patients with slow-transit constipation, suprasensory SNS increased the frequency of colonic PSs, whereas subsensory SNS stimulation did not. This has implications for the design of therapeutic trials and the clinical application of the device.
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Affiliation(s)
- P G Dinning
- Department of Human Physiology, Flinders University, Bedford Park, South Australia.
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Lansen-Koch SMP, Govaert B, Oerlemans D, Melenhorst J, Vles H, Cornips E, Weil EHJ, van Heurn E, Baeten CGMI, van Gemert WG. Sacral nerve modulation for defaecation and micturition disorders in patients with spina bifida. Colorectal Dis 2012; 14:508-14. [PMID: 21689346 DOI: 10.1111/j.1463-1318.2011.02678.x] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023]
Abstract
AIM Sacral nerve modulation is a well accepted method for the treatment of defaecation disorders and voiding dysfunction. Results of sacral nerve modulation in patients with spinal cord lesions are not well assessed, but preliminary results look poor. Therefore, the purpose of this study was to assess the effectiveness of sacral nerve modulation for defaecation disorders and voiding dysfunction in patients with spina bifida. METHOD Consecutive patients with spina bifida suffering from a myelomeningocele and combined faecal and urinary functional disorders that were eligible for peripheral nerve evaluation (PNE) were studied. A permanent sacral nerve modulation implantation was performed after successful PNE. RESULTS Ten patients (four female) were included in this study with a median age of 26.4 (range 11.1-41.0) years. In two the PNE was not possible. The median faecal incontinence days (6.0 vs 3.5) and episodes (8.5 vs 3.5) per 21 days decreased significantly during the 3-week period of PNE (P = 0.033). Only 3/10 (30%) patients had a more than 50% improvement and proceeded to a permanent sacral nerve modulation implantation. In one patient it was not possible to perform the permanent implant. CONCLUSION Preliminary results of sacral nerve modulation in a subgroup of spina bifida patients with combined faecal and urinary functional disorders look promising, but long-term results in larger patient groups need to be studied.
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Affiliation(s)
- S M P Lansen-Koch
- Department of Colorectal Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands
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Worsøe J, Fynne L, Laurberg S, Krogh K, Rijkhoff NJM. Electrical stimulation of the dorsal clitoral nerve reduces incontinence episodes in idiopathic faecal incontinent patients: a pilot study. Colorectal Dis 2012; 14:349-55. [PMID: 21689288 DOI: 10.1111/j.1463-1318.2011.02586.x] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
AIM Faecal incontinence (FI) has a significant impact on quality of life. This study investigates whether stimulation of the dorsal genital nerve (DGN) improves FI symptoms. METHOD Ten female patients suffering from idiopathic FI (median age 60 years) were included in the study. Stimulation was applied twice daily for 3 weeks at the maximal tolerable stimulation amplitude (pulse width, 200 μs; pulse rate, 20 Hz). Patients kept a 3-week bowel diary prior to stimulation, during stimulation and after the final stimulation. FI severity scores, FI Severity Visual-Analogue Score (VAS), FI Quality of Life Score (FIQL), sphincter function and rectal volume tolerance were assessed at baseline, immediately after stimulation and 3 weeks after stimulation. RESULTS Nine patients completed the study. The Wexner score (P=0.027) and the St Mark's score (P=0.035) improved after stimulation in seven and six of the patients and improvement was maintained 3 weeks after stimulation (P=0.048 and P=0.049, respectively). The number of incontinent episodes was reduced in seven out of nine patients (P=0.025). Improvement was maintained for 3 weeks after stimulation (P=0.017). Subjective assessments of FI severity using the VAS score and the FIQl score did not improve during stimulation. Sphincter function and rectal volume tolerability were unaffected. CONCLUSION DGN stimulation reduced the number of FI episodes in most patients suffering from idiopathic FI. Sphincter function and rectal volume tolerability were not affected. DGN stimulation may represent a new treatment for idiopathic FI.
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Affiliation(s)
- J Worsøe
- Department of Surgery P, Aarhus University Hospital, Aarhus, Denmark.
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Schwandner T, Hemmelmann C, Heimerl T, Kierer W, Kolbert G, Vonthein R, Weinel R, Hirschburger M, Ziegler A, Padberg W. Triple-target treatment versus low-frequency electrostimulation for anal incontinence: a randomized, controlled trial. DEUTSCHES ARZTEBLATT INTERNATIONAL 2011; 108:653-60. [PMID: 22013492 DOI: 10.3238/arztebl.2011.0653] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 02/24/2011] [Accepted: 07/20/2011] [Indexed: 11/27/2022]
Abstract
BACKGROUND In the nonsurgical treatment of anal incontinence, the combination of amplitude-modulated medium-frequency stimulation and electromyographic biofeedback (EMG-BF), known as triple-target treatment (3T), is superior to EMG-BF alone. The aim of this trial is to compare 3T with the standard treatment, low-frequency stimulation (LFS). METHODS 80 patients with anal incontinence of Grade I or higher who presented to physicians or centers specialized in coloproctology were enrolled in this multicenter randomized trial with blinded observer. The trial had an open parallel-group design. Randomization was performed centrally by telephone. The primary endpoint was the Cleveland Clinic Score (CCS) after self-training at home with either 3T or LFS in two 20-minute sessions per day for 6 months. The secondary endpoints included the proportion of patients regaining continence, and the patients' quality of life (QoL). On completion of the trial as planned, the results were evaluated with an intention-to-treat analysis. STUDY REGISTRATION DRKS00000138 (http://register.germanctr.de). RESULTS 39 patients were randomized to 3T, and 41 to LFS. After 6 months of treatment, the CCS (mean ± standard deviation) was 3.1 ± 4.2 in the 3T group and 9.6 ± 3.9 in the LFS group. The median improvement in the CCS at 6 months compared to baseline was 7 points greater in the 3T group than in the LFS group (95% CI: 5-9, p<0.001). Anal continence was regained by 54% of the 3T patients, but none of the LFS patients (95% CI for the difference: 37.18% - 69.91%, p<0.001). QoL scores were higher in all dimensions in the 3T group than in the LFS group. No major adverse effects occurred in either group. CONCLUSION 3T is superior to LFS in the treatment of anal incontinence. The available evidence suggests that the success of 3T is based on the combined effect of biofeedback and medium-frequency stimulation. LFS of the type applied in this trial has no effect. 3T should be used in routine clinical practice instead of LFS.
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Affiliation(s)
- Thilo Schwandner
- Klinik für Allgemein-, Viszeral-, Thorax- und Transplantationschirurgie, Fachbereich Medizin, Justus-Liebig-Universität Giessen
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Abstract
BACKGROUND The indications for sacral nerve stimulation are increasing, but the mechanism remains poorly understood. OBJECTIVE This study aimed to examine the effect of sacral nerve stimulation on rectal compliance and rectal sensory function. DESIGN This was a prospective study. SETTINGS This study took place at a university teaching hospital. PATIENTS Twenty-three consecutive consenting patients (22 female; median age, 49 y) undergoing temporary sacral nerve stimulation for fecal incontinence were prospectively studied. Clinical response was assessed by the use of bowel diaries and Wexner scores. MAIN OUTCOME MEASURES Anal manometry, rectal compliance, volume and pressure thresholds to rectal distension (barostat), and rectal Doppler mucosal blood flow were measured before and at the end of stimulation. RESULTS Sixteen patients (70%) had a favorable clinical response. Median anal squeeze pressures increased with stimulation from 40 (range, 6-156) cmH2O to 64 (range, 16-243) cmH2O. Median rectal compliance did not significantly change with stimulation (prestimulation: 11.5 (range, 7.9-21.8) mL/mmHg, poststimulation: 12.4 (range, 6.2-22) mL/mmHg, P = .941). Rectal wall pressures associated with urge (baseline: 15.4 (range, 11-26.7) mmHg, poststimulation: 19 (range, 11.1-42.7) mmHg, P = .054) and maximal tolerated thresholds (baseline: 21.6 (8.5-31.9) mmHg, poststimulation: 27.1 (14.3-43.3) mmHg, P = .023) significantly increased after stimulation. Rectal Doppler mucosal blood flow did not significantly change with stimulation (baseline: 125.8 (69.9-346.8), poststimulation: 112.4 (50.2-404.1), P = .735). Changes in anal resting pressure and rectal wall pressures with stimulation were evident only in responders; however, changes in anal squeeze pressures were evident in both responders and nonresponders. LIMITATIONS The study reports results following short-term stimulation in a small but homogenous group of patients. A larger long-term study will follow. CONCLUSION Temporary sacral nerve stimulation does not change rectal compliance, but is associated with significant changes to the pressure thresholds of rectal distension. This, together with the observation that outcome is not related to sphincter integrity, supports the hypothesis of an afferent-mediated mechanism of action.
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Abstract
BACKGROUND AND OBJECTIVE Sacral nerve stimulation is effective in the treatment of urinary incontinence and is currently under Food and Drug Administration review in the United States for fecal incontinence. Previous reports have focused primarily on short-term results of sacral nerve stimulation for fecal incontinence. The present study reports the long-term effectiveness and safety of sacral nerve stimulation for fecal incontinence in a large prospective multicenter study. DESIGN AND METHODS Patients with fecal incontinent episodes more than twice per week were offered participation in this multicentered prospective trial. Patients showing ≥ 50% improvement during test stimulation were offered chronic implantation of the InterStim Therapy system (Medtronic; Minneapolis, MN). The aims of the current report were to provide 3-year follow-up data on patients from that study who underwent sacral nerve stimulation and were monitored under the rigors of an Food and Drug Administration-approved investigational protocol. RESULTS One hundred thirty-three patients underwent test stimulation with a 90% success rate, of whom 120 (110 females) with a mean age of 60.5 years and a mean duration of fecal incontinence of 7 years received chronic implantation. Mean length of follow-up was 3.1 (range, 0.2-6.1) years, with 83 patients completing all or part of the 3-year follow-up assessment. At 3 years follow-up, 86% of patients (P < .0001) reported ≥ 50% reduction in the number of incontinent episodes per week compared with baseline and the number of incontinent episodes per week decreased from a mean of 9.4 at baseline to 1.7. Perfect continence was achieved in 40% of subjects. The therapy also improved the fecal incontinence severity index. Sacral nerve stimulation had a positive impact on the quality of life, as evidenced by significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument at 12, 24, and 36 months of follow-up. The most common device- or therapy-related adverse events through the mean 36 months of follow-up included implant site pain (28%), paresthesia (15%), change in the sensation of stimulation (12%), and infection (10%). There were no reported unanticipated adverse device effects associated with sacral nerve stimulation therapy. CONCLUSIONS Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with fecal incontinence. These data support long-term safety and effectiveness to 36 months.
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Hollingshead JRF, Dudding TC, Vaizey CJ. Sacral nerve stimulation for faecal incontinence: results from a single centre over a 10-year period. Colorectal Dis 2011; 13:1030-4. [PMID: 20718837 DOI: 10.1111/j.1463-1318.2010.02383.x] [Citation(s) in RCA: 55] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
AIM Sacral nerve stimulation (SNS) is considered a first-line surgical treatment option for faecal incontinence. There is little information on long-term results. The results of SNS for faecal incontinence performed at a single centre over a 10-year period are reported. METHOD A cohort analysis of consecutive patients treated with SNS for faecal incontinence over a 10-year period was carried out. Data were collected prospectively using bowel habit diaries and St Mark's and Cleveland Clinic incontinence scores. Treatment success was defined as a >50% reduction in episodes of faecal incontinence compared with baseline. RESULTS Temporary SNS was performed in 118 patients, and 91 (77%) were considered suitable for chronic stimulation. The median period of follow up was 22 (1-138) months. Seventy patients were followed for 1 year with success in 63 (90%). Of 18 patients followed for 5 years, 15 (83%) reported continued success, 11 (61%) maintained full efficacy, 4 (22%) reported some loss, and 3 (17%) reported complete loss. Three patients with a 10-year follow up had no loss in efficacy. Overall, complete loss of efficacy was observed in 14 (16%) patients at a median of 11.5 months following implantation. A further 5 (6%) patients showed deterioration with time. In 9 (47%), no reason for the deterioration in symptoms could be identified. CONCLUSIONS SNS can be effective for up to 10 years. Some patients experience deterioration in symptoms over time. The reasons for this are often not evident.
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Dudding TC, Hollingshead JR, Nicholls RJ, Vaizey CJ. Sacral nerve stimulation for faecal incontinence: optimizing outcome and managing complications. Colorectal Dis 2011; 13:e196-202. [PMID: 21689329 DOI: 10.1111/j.1463-1318.2011.02646.x] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
AIM A knowledge of the principles of neurostimulation is essential to achieve optimal efficacy and minimize adverse effects. The aim of this article was to review the current evidence regarding device programming in the management of patients having sacral nerve stimulation (SNS) for faecal incontinence. METHOD A Medline search was performed including the keywords and/or MeSH headings of sacral nerve stimulation, neuromodulation, artificial pacemaker, faecal incontinence, programming, adverse effects and complications. Further studies were identified by cross-referencing from relevant articles and by appraisal of recent peer-reviewed conference abstracts and proceedings. RESULTS Neurostimulator programming is an important component of SNS. Efficacy can be improved or restored with reprogramming. Adverse stimulation is often reversible, and nonstimulation-related complications are correctable. A total loss of efficacy can be explained in over one-half of patients. CONCLUSION An improved outcome of SNS can be achieved by selecting the best possible stimulation parameters individualized to each patient. Further research into the optimal settings is needed.
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Affiliation(s)
- T C Dudding
- Physiology Unit, St Mark's Hospital, Harrow, Middlesex, UK
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Damgaard M, Thomsen FG, Sørensen M, Fuglsang S, Madsen JL. The influence of sacral nerve stimulation on gastrointestinal motor function in patients with fecal incontinence. Neurogastroenterol Motil 2011; 23:556-e207. [PMID: 21385289 DOI: 10.1111/j.1365-2982.2011.01683.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/25/2023]
Abstract
BACKGROUND Sacral nerve stimulation (SNS) is a well-established treatment for fecal incontinence of various etiologies. However, the mechanism of action remains unclear. The aim of the present study was to determine whether SNS affects gastric emptying, small intestinal transit or colonic transit times. METHODS Seven patients with a permanently implanted sacral nerve stimulator participated in a double-blind randomized cross-over study. The patients were allocated to stimulation ON or OFF for two 7-day periods separated by at least 1week. On days 4-7 of each 7-day period, the patients were examined by gamma camera imaging to measure gastric emptying, small intestinal transit and colonic transit parameters of a radiolabeled, 1600 kJ mixed solid and liquid meal ingested on day 4. KEY RESULTS Sacral nerve stimulation did not change gastric retention at 15 min, gastric mean emptying time, gastric half emptying time, small intestinal mean transit time or colonic geometric center after 24, 48 and 72 h. CONCLUSIONS & INFERENCES Sacral nerve stimulation does not induce major changes in the propulsive capacity of the gastrointestinal tract in patients successfully treated for fecal incontinence with permanent sacral nerve stimulator.
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Affiliation(s)
- M Damgaard
- Department of Clinical Physiology and Nuclear Medicine, Hvidovre Hospital, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
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Khedr EM, Alkady EAM, El-Hammady DH, Khalifa FAM, bin-Humam S. Repetitive Lumbosacral Nerve Magnetic Stimulation Improves Bladder Dysfunction Due to Lumbosacral Nerve Injury. Neurorehabil Neural Repair 2011; 25:570-6. [DOI: 10.1177/1545968311400091] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Background. Rapid rate magnetic stimulation of human sacral nerve roots can reduce stress incontinence. Objective. To test stimulation for urgency incontinence due to lumbosacral plexopathy. Methods. The authors studied patients with intractable neurogenic urinary dysfunction due to lumbosacral nerve injuries. Eligible patients were randomized to receive either real or sham repetitive lumbosacral magnetic stimulation (rLMS; 15 Hz with a total of 1500 pulses/session) for 10 sessions. Evaluation was performed before starting treatment, immediately after the 5th and 10th treatment session, and 1 month later, using rating scales to score urinary dysfunction and a visual analogue scale (VAS) to assess lower back pain. Posterior tibial nerve F-wave and H-reflexes were tested before and after treatment. Results. Both treatment and control groups were comparable for baseline characters and sphincteric disturbances. The mean number of voids and incontinence per 24 hours was significantly reduced in patients who received rLMS. The improvement was maintained 1 month after the end of treatment. Patients receiving real-rLMS also reported an improvement in VAS ratings. Improvement in F-wave and H-reflex latencies after real stimulation ( P = .002 and P = .036, respectively) was found as well. Conclusion. rLMS at 15 Hz may improve urinary dysfunction secondary to lumbosacral nerve injury. Further trials can determine the profile of patients who may benefit and optimal stimulation parameters.
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Affiliation(s)
- Eman M. Khedr
- Department of Neurology, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt
| | - Eman A. M. Alkady
- Rheumatology and Rehabilitation, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt
| | - Dina H. El-Hammady
- Rheumatology and Rehabilitation, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt
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Findlay JM, Maxwell-Armstrong C. Posterior tibial nerve stimulation and faecal incontinence: a review. Int J Colorectal Dis 2011; 26:265-73. [PMID: 21069357 DOI: 10.1007/s00384-010-1085-4] [Citation(s) in RCA: 42] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 10/27/2010] [Indexed: 02/04/2023]
Abstract
PURPOSE Faecal incontinence is a common and important multifactorial disorder with a range of treatment options. Over the last two decades, neuromodulation via sacral nerve stimulators has been shown to be effective for both faecal and urinary incontinence, although associated with complications. Peripheral neuromodulation, via the posterior tibial nerve, is widely used in urinary incontinence; however, its use in faecal incontinence, whilst evolving is limited to eight small heterogeneous studies. REVIEW These eight studies are discussed in the context of the methodology and underlying neurophysiology of peripheral neuromodulation, as are thus far unanswered questions. The eight studies include a total of 129 patients with faecal incontinence (of variable aetiology), all of whom had failed conservative management. One study was prospective and controlled, six were uncontrolled and one was retrospective and uncontrolled. Five different neuromodulatory protocols were used over six different study periods. Outcome measures varied, but short term primary endpoint success ranged from 30.0% to 83.3%. The limitations to this early evidence, whilst encouraging, are significant, and it remains to be seen whether this novel treatment modality represents the minimally invasive, well-tolerated, cost-effective and flexible panacea hoped for this common and debilitating disease. Three upcoming multicentre placebo-controlled trials will better be able to delineate its role.
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Affiliation(s)
- John M Findlay
- Department of General Surgery, Royal Berkshire Hospital, Reading RG1 5AN, UK.
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Abstract
AIM Sacral nerve stimulation (SNS) has become an established option in the management of defaecatory disorders. There are many data on the end-organ effects of SNS, but limited consensus on its mechanism of action. The objective of this review was to determine the effect of sacral nerve stimulation (SNS) on anorectal function. METHOD Systematic literature review of the effect of sacral nerve stimulation (SNS) on anorectal function. RESULTS There was significant heterogeneity of data pertaining to the effects of SNS on anorectal function, with no consistent change in physiological measures identified. Most data supported a mixed mechanism of action on anal motor and rectal sensory functioning. CONCLUSION To date, conflicting data exist on the mechanism of action of SNS as determined by end-organ changes in anorectal physiology. Nevertheless, the data as they stand best support a mixed mechanism of action on anal motor and rectal sensory functions.
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Affiliation(s)
- E V Carrington
- Academic Surgical Unit, Centre for Digestive Diseases, Blizard Institute of Cellular and Molecular Science, Barts and the London School of Medicine and Dentistry, Queen Mary University London, London, UK
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Neuromodulation for constipation: sacral and transcutaneous stimulation. Best Pract Res Clin Gastroenterol 2011; 25:181-91. [PMID: 21382589 DOI: 10.1016/j.bpg.2010.12.008] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/16/2010] [Revised: 12/10/2010] [Accepted: 12/16/2010] [Indexed: 01/31/2023]
Abstract
Constipation is a frequently occurring digestive ailment that is usually treated conservatively. Neuromodulation is altering function of an organ by altering neural activity. This paper reviews methods of neuromodulation used to treat constipation. This includes direct stimulation of sacral nerves and stimulation across the skin. Direct stimulation of sacral nerves is the most well developed method and is presented in detail. It is generally accepted that the mechanism of action is modulation rather than stimulation so it is called sacral neuromodulation (SNM). SNM involves percutaneous placement of an electrode in the third sacral foramen and implanting a stimulating device under the skin in the buttocks. SNM is founded on the physiological principle that activity in one neural pathway modulates pre-existing activity in another through synaptic interaction. The mechanism of action in constipation may be neuromodulation of the extrinsic neural control of the large bowel or modulation of reflexes inhibiting large bowel function. Limited evidence is available to assess the outcome of SNM in constipation. Results in the medium term seem promising for selected patients with idiopathic slow and normal transit constipation not responding to optimal conservative treatment. Adverse events include electrode migration and infection. The availability of a testing phase provides a predictor of treatment outcome. In addition, transcutaneous stimulation using sticky pad electrodes over the lumbosacral region or acupuncture points has been reported to improve constipation symptoms. In general, the level of evidence is low and further studies are needed.
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van Wunnik BP, Govaert B, Leong R, Nieman FH, Baeten CG. Patient experience and satisfaction with sacral neuromodulation: results of a single-center sample survey. Dis Colon Rectum 2011; 54:95-100. [PMID: 21160319 DOI: 10.1007/dcr.0b013e3181f46810] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
PURPOSE Sacral neuromodulation is a well researched and successful treatment for functional bowel disorders. Indications have expanded throughout the years and various studies have been published on clinical efficacy or on technique improvement. The main goal of this retrospective study was to systematically evaluate daily experiences with this treatment and measure the long-term satisfaction of sacral neuromodulation therapy for functional bowel disorders. METHODS After institutional review board approval a new, self-designed postal questionnaire was sent to all patients in our center who were being treated with sacral neuromodulation. Only patients with a minimal follow-up of 1 year were included in the survey. Implantation years range from 2000 to 2007. RESULTS A total of 174 patients received the questionnaire regarding patient satisfaction and experience with sacral neuromodulation therapy. The response rate after reminder letter was 71.8% (n = 125) including 114 (91.2%) females. Patient satisfaction was high: 81 patients (65.3%) reported their results as very satisfying, 30 patients (24.2%) were moderately satisfied, and 13 patients (10.4%) were not satisfied. Analysis showed that patient satisfaction can be explained by both patient perception of present bowel function and their evaluation of the quality of daily life. No significant relationship was found with patient demographics, self-ascribed (co)morbidity, behavioral habits, or therapy duration. A total of 47 patients (38.2%) reported having some concerns regarding the future with sacral neuromodulation treatment. Twenty-eight patients (23.1%) reported a temporary loss of effect at any time during sacral neuromodulation therapy. Pain at the implantation site was reported by 65 patients (52.4%). CONCLUSIONS This study shows that patients treated with sacral neuromodulation, in general, are very satisfied. The main problems mentioned by patients are pain, loss of efficacy, and general concerns.
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Affiliation(s)
- Bart P van Wunnik
- Department of Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.
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Poor outcome of sphincter repair: an evacuation problem? Tech Coloproctol 2010; 15:23-9. [PMID: 21052760 DOI: 10.1007/s10151-010-0652-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/07/2009] [Accepted: 03/26/2010] [Indexed: 10/18/2022]
Abstract
INTRODUCTION Colorectal transport in idiopathic fecal incontinence has scarcely been studied, and it remains to be investigated in patients with fecal incontinence and anal sphincter lesion. The aim of the present study was to compare colorectal transport during defecation in patients with idiopathic fecal incontinence and patients with fecal incontinence due to anal sphincter lesions with transport in healthy volunteers. METHOD Five women with idiopathic fecal incontinence (median age 72 years, range: 58-78 years) and five women with an obstetric sphincter lesion (median age 42 years, range: 28-63 years), four of whom had had previous anal sphincter repair, were compared with nine healthy female volunteers (median age 53 years, range 32-57 years). Colorectal scintigraphy was performed to assess colorectal emptying at defecation as well as segmental antegrade and retrograde transport during defecation. Segmental colorectal transit times were determined using radio-opaque markers. RESULTS Median colorectal emptying time at defecation was significantly lower in the sphincter lesion group compared with the healthy volunteers (P = 0.009). At defecation, median antegrade transport time from the ascending colon was significantly lower in the sphincter lesion group than in the healthy group (P = 0.02). The median segmental transit time from the rectosigmoid colon was higher in the group with a sphincter lesion than in the healthy group (P = 0.05). There were no statistically significant differences between the group with idiopathic fecal incontinence and the healthy volunteers. CONCLUSION Patients with fecal incontinence due to sphincter lesions, but not those with idiopathic fecal incontinence, have reduced transport from the cecum/ascending colon and from the rectosigmoid colon at defecation.
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Naldini G, Martellucci J, Moraldi L, Balestri R, Rossi M. Treatment of slow-transit constipation with sacral nerve modulation. Colorectal Dis 2010; 12:1149-1152. [PMID: 19843118 DOI: 10.1111/j.1463-1318.2009.02067.x] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
AIM Constipation is common and a selection of the best treatment is difficult, especially for slow-transit constipation (STC). The aim of the study was to assess the effect of sacral nerve modulation (SNM) on STC. METHOD A retrospective analysis of patients with STC, treated with SNM was undertaken. All were evaluated by cinedefecography, colon transit-time, Cleveland Clinic Constipation Score (CCS), SF-36 Quality of Life (QoL) and a bowel diary. Initially, all patients underwent a temporary implant for 4 weeks. The criteria of success were disappearance of necessity for laxatives or enema requirement, and improvement in QoL. RESULTS Fifteen patients with STC were treated from March 2003 to May 2006. Nine (60%) underwent permanent implantation. After SNM, the mean improvement of Wexner Constipation Score (CCS) and QoL was 10 and 6.2 respectively. There were no complications. The mean follow-up period was 42 months. CONCLUSION Sacral nerve modulation seems to be a useful option for STC.
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Affiliation(s)
- G Naldini
- General Surgery IV, Hospital of Pisa, Pisa, Italy
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