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Bayrak O, Mock S, Dmochowski RR. Injectable treatments for female stress urinary incontinence. World J Clin Urol 2014; 3:209-217. [DOI: 10.5410/wjcu.v3.i3.209] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/09/2014] [Revised: 05/13/2014] [Accepted: 07/15/2014] [Indexed: 02/06/2023] Open
Abstract
The use of injectable agents for the treatment of stress urinary incontinence (SUI) is an option for female patients who are unwilling to undergo surgery, or have concurrent conditions or diseases that render surgical treatment unsuitable. To be effective for SUI, an injectable agent must be nonimmunogenic, hypoallergenic, biocompatible, permanent, nonerosive, nonmigratory and painless. It must also heal with minimal fibrosis, possess a long-term bulking effect, and be easily stored and handled. Glutaraldehyde cross-linked bovine collagen (Contigen), silicone polymers (Macroplastique), Durasphere, calcium hydroxyapatite (Coaptite), polyacrylamide hydrogel (Aquamid, Bulkamid), Permacol, and stem cell therapy have been used as injectable agents. Patients must be informed that treatment with injectable agents is not as effective as surgical treatment, and that such agents might necessitate additional and repeated administrations in order to achieve the desired therapeutic effect.
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Hegde A, Smith AL, Aguilar VC, Davila GW. Three-dimensional endovaginal ultrasound examination following injection of Macroplastique for stress urinary incontinence: outcomes based on location and periurethral distribution of the bulking agent. Int Urogynecol J 2012; 24:1151-9. [DOI: 10.1007/s00192-012-1983-9] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2012] [Accepted: 10/20/2012] [Indexed: 10/27/2022]
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Elzayat EA, Karsenty G, Bismar TA, Corcos J. Volume changes and histological response to injected dextranomer/hyaluronic acid copolymer (Zuidex) and collagen (Contigen) in rats. Int Urogynecol J 2007; 19:247-52. [PMID: 17639343 DOI: 10.1007/s00192-007-0414-9] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/07/2007] [Accepted: 06/08/2007] [Indexed: 10/23/2022]
Abstract
The objective of this study was to investigate the stability in terms of volume changes and local tissue reactions of dextranomer (Dx)/hyaluronic acid (HA) and collagen implants. A total of 57 rats were included in this study: the control group (nine rats), collagen-injected group (24 rats), and Dx/HA copolymer-injected group (24 rats). Under anesthesia, 0.35 ml of bulking agents was injected subcutaneously in the abdominal area. At 1, 6, and12 months, eight animals of the two implant groups and three animals of the control group were killed. The area of the injected material and surrounding tissue were carefully resected for histopathological examination. Mean volume changes in the Dx/HA copolymer group were 0.56 +/- 0.12, 0.43 +/- 0.08, and 0.28 +/- 0.02 ml at 1, 6, and 12 months, respectively. Mean volume changes in the collagen group were 0.25 +/- 0.03, 0.21 +/- 0.08, and 0.21 +/- 0.01 at 1, 6, and 12 months, respectively. The degree of tissue reaction and fibrosis are more pronounced in the Dx/HA copolymer group at each measurement period after injection.
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Affiliation(s)
- Ehab A Elzayat
- Urology Department, Jewish General Hospital, McGill University, 3755 Côte Sainte-Catherine, Montreal, Quebec, Canada H3T 1E2
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Mayer R, Lightfoot M, Jung I. Preliminary evaluation of calcium hydroxylapatite as a transurethral bulking agent for stress urinary incontinence. Urology 2001; 57:434-8. [PMID: 11248613 DOI: 10.1016/s0090-4295(00)01098-0] [Citation(s) in RCA: 82] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/21/2022]
Abstract
OBJECTIVES To evaluate the potential of calcium hydroxylapatite particles as a bulking material for the treatment of stress incontinence. METHODS Ten women (mean age 68 years, range 60 to 82) with stress incontinence associated with intrinsic sphincter deficiency and limited hypermobility were treated with one (3 patients) or two (7 patients) injections of calcium hydroxylapatite particles and were followed up for 1 year subsequent to the last injection. RESULTS The mean total volume injected was 3.9 mL. No significant safety issues were identified with regard to local pain, infection, induration, or obstruction. Seven women reported substantial improvement using many fewer pads or none at all (3 patients) at 1 year, 2 women reported fewer pads, and 1 patient reported no change. The daily mean pad use declined from 2.59 to 1.64 and the mean 24-hour pad weight declined by more than 90% (104.9 versus 1.5 g). The mean Valsalva leak point pressure (VLPP) increased from 39 to 46 cm H(2)O at 12 months, with 2 patients dry on testing. CONCLUSIONS The results of this small initial study suggest that calcium hydroxylapatite particles have potential as a bulking agent for the treatment of stress incontinence.
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Affiliation(s)
- R Mayer
- Department of Urology, University of Rochester, Rochester, New York 14642, USA
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Abstract
BACKGROUND The treatment of faecal incontinence secondary to internal anal sphincter dysfunction is unsatisfactory. The aim of the study was to evaluate the efficacy of anal glutaraldehyde cross-linked (GAX) collagen injections in patients with a surgically incorrectable disorder. METHODS Seventeen patients were studied: nine had idiopathic faecal incontinence, three had incontinence following haemorrhoidectomy, two following internal sphincterotomy, two following an internal sphincter defect from obstetric injury and one following treatment for fistula in ano. All patients were refractory to conservative treatment and were unsuitable for surgical repair. All had anorectal physiology and endoanal ultrasonography before and after GAX collagen injections. RESULTS All patients tolerated the injection without side-effects. All patients had an intact external anal sphincter. Following injection, 11 patients showed marked symptomatic improvement. One patient reported symptomatic improvement but remained in clinical grade 3, and two reported minimal improvement. There was no improvement in three patients, but one of these had a repeat injection and showed significant improvement subsequently. CONCLUSION Injection of GAX collagen in the anal canal is a simple and well tolerated method of treating faecal incontinence due to internal sphincter dysfunction. Early results suggest it provides an easy and reliable alternative to the currently available methods that are often unsuccessful and at best unpredictable.
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Affiliation(s)
- D Kumar
- Department of Surgery, St George's Hospital, London, UK
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Duckett JR. The use of periurethral injectables in the treatment of genuine stress incontinence. BRITISH JOURNAL OF OBSTETRICS AND GYNAECOLOGY 1998; 105:390-6. [PMID: 9609263 DOI: 10.1111/j.1471-0528.1998.tb10121.x] [Citation(s) in RCA: 25] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Affiliation(s)
- J R Duckett
- Department of Obstetrics and Gynaecology, Heartlands Hospital, Bordesley Green East, Birmingham
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Monga AK, Stanton SL. Urodynamics: prediction, outcome and analysis of mechanism for cure of stress incontinence by periurethral collagen. BRITISH JOURNAL OF OBSTETRICS AND GYNAECOLOGY 1997; 104:158-62. [PMID: 9070131 DOI: 10.1111/j.1471-0528.1997.tb11037.x] [Citation(s) in RCA: 41] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To assess the role of urodynamics in the prediction and assessment of outcome and analysis of the mechanism of cure for stress incontinence using periurethral collagen as our treatment model. DESIGN Prospective longitudinal study. SETTING A teaching hospital tertiary referral centre. PATIENTS Sixty women with genuine stress incontinence. RESULTS The objective cure rate was 54% (n = 54) at 12 months. Subtracted cystometry, urethral electrical conductivity and bladder neck excursion measurements did not predict cure. A low pre-injection maximum urethral closure pressure adversely affects outcome (31 cmH2O (success) vs 19 cmH2O (failure), P = 0.004); all women with a maximum urethral closure pressure > 39 cmH2O were rendered dry. Urethral pressure profilometry can analyse mechanism of cure. Total profile length, stress maximum urethral closure pressure, stress functional urethral length and pressure transmission ratio in the first quarter of urethral length were increased in successful cases (P < 0.05), and rest maximum urethral and maximum urethral closure pressures, area under rest profile and pressure transmission ratio in the second quarter of urethral length were increased in failed cases (P < 0.02). CONCLUSIONS In successful cases the increased area and pressure transmission ratio in the first quarter of the functional urethral length suggest that collagen placement occurs at the bladder neck or proximal urethra. Cure appears to be due to prevention of bladder neck opening during stress and not obstruction. In addition the cephalad elongation of the urethra caused by collagen probably accounts for the increased abdominal pressure transmission in the first quarter of the urethra. In failures, there is an increased length and increased area to peak pressure suggesting collagen is deposited more distally. This study confirms the role of certain urethral pressure profilometry variables in the prediction and analysis of mechanism of cure.
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Affiliation(s)
- A K Monga
- Urogynaecology Unit, St George's Hospital, London, UK
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Herschorn S, Radomski SB. Collagen injections for genuine stress urinary incontinence: patient selection and durability. Int Urogynecol J 1997; 8:18-24. [PMID: 9260092 DOI: 10.1007/bf01920289] [Citation(s) in RCA: 63] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
The questions of patient selection parameters and durability of response in the use of collagen injections for genuine stress incontinence are addressed. A total of 181 women with a mean age of 64 years (range 26-94) underwent collagen injections for urethral incompetence. Treatment outcome was determined by a change in individual incontinence grades before and after injection. Of the 181 women 42 (23%) are cured, 94 (52%) are improved and 45 (25%) failed. Follow-up in the successful patients, either cured or improved, was a mean of 21 months (range 4-69) after their last collagen injection. No difference in outcome was seen in relation to patient age or pretreatment grade of incontinence. Of the 30 patients with bladder instability, 18 (60%) had a favorable outcome. No significant difference in outcome was seen in patients with or without hypermobility (P = 0.2889). Patients with type III incontinence required the largest amount of collagen for a successful outcome. The persistence of continence in 78 patients who were cured for at least 2 months were plotted on a Kaplan-Meier survival curve. The probability of remaining dry without additional collagen was 72% at 1 year, 57% at 2 years and 45% at 3 years. It was concluded that, collagen injection into the urethra is a safe and well-tolerated procedure. Pretreatment bladder instability may be an adverse factor. Patients with or without hypermobility had equal benefit. Long-term durability was seen. If deterioration occurred repeat collagen injections restored success. The current literature is reviewed and the use of collagen relative to other treatments is discussed.
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Affiliation(s)
- S Herschorn
- Division of Urology, Sunnybrook Health Science Center, University of Toronto, Canada
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Herschorn S, Steele DJ, Radomski SB. Followup of Intraurethral Collagen for Female Stress Urinary Incontinence. J Urol 1996. [DOI: 10.1016/s0022-5347(01)65575-7] [Citation(s) in RCA: 72] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Affiliation(s)
- Sender Herschorn
- Division of Urology, Department of Surgery, University of Toronto, Sunnybrook Health Science Centre, Toronto, Ontario, Canada
| | - Deborah J. Steele
- Division of Urology, Department of Surgery, University of Toronto, Sunnybrook Health Science Centre, Toronto, Ontario, Canada
| | - Sidney B. Radomski
- Division of Urology, Department of Surgery, University of Toronto, Sunnybrook Health Science Centre, Toronto, Ontario, Canada
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Winters JC, Appell R. PERIURETHRAL INJECTION OF COLLAGEN IN THE TREATMENT OF INTRINSIC SPHINCTERIC DEFICIENCY IN THE FEMALE PATIENT. Urol Clin North Am 1995. [DOI: 10.1016/s0094-0143(21)00537-1] [Citation(s) in RCA: 38] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
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Monga AK, Robinson D, Stanton SL. Periurethral collagen injections for genuine stress incontinence: a 2-year follow-up. BRITISH JOURNAL OF UROLOGY 1995; 76:156-60. [PMID: 7663903 DOI: 10.1111/j.1464-410x.1995.tb07664.x] [Citation(s) in RCA: 129] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
Abstract
OBJECTIVE To assess the short- and medium-term efficacy of periurethral collagen injection in women with urethral sphincter incompetence and to determine if urodynamic variables can elucidate the mechanism of action. PATIENTS AND METHODS Sixty women (mean age 64 years, range 20-90) with genuine stress incontinence received periurethral collagen injections under local anaesthesia; 55 had undergone previous continence surgery. A total of three injection sessions were allowed. Subjective and urodynamic assessments were obtained at 1, 3, 6, 12 and 24 months after injection to evaluate success and long-term effects of collagen. RESULTS Subjective success rates were 86% at 3 months, 77% at 12 months and 68% at 24 months. Objective cure rates were 61% at 3 months, 54% at 12 months and 48% at 24 months. Low urethral pressures and decreased bladder neck mobility did not affect the outcome. Collagen injections significantly increased stress maximum urethral closure pressures and functional urethral length; increase in the latter and clinical assessment of bulking at the time of injection appeared to predict medium-term success. There were some minor early complications and none in the medium-term. CONCLUSIONS Periurethral collagen injections continued to be effective at the 2-year follow-up, although there was a time-dependent decline. In comparison with more complicated procedures used in patients with previous failed continence surgery, periurethral collagen injection is a simple, acceptable, day case procedure which improves the quality of life in physically fit or frail patients, with few complications.
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Abstract
Urinary incontinence is a common problem that affects millions of elderly men and women and their caregivers. Evaluation of incontinence is easy and inexpensive and does not require hospitalization. A basic evaluation consists of history taking (including a review of drug use), physical examination, and appropriate laboratory testing. Urodynamic evaluation may also be necessary. Treatment may consist of behavior modification techniques (eg, Kegel exercises, biofeedback, bladder retraining), use of a mechanical device or pharmacologic agent, or surgery. Should medical and surgical methods fail, alternatives are available to ensure patients' well-being and comfort.
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Affiliation(s)
- N Baum
- Department of Urology, Touro Infirmary, New Orleans
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