Injectable treatments for female stress urinary incontinence

Table 1 Level of evidence and grade of recommendation for injectable agents (b)

Evidence summary	LE
Periurethral injection of bulking agent may provide short-term improvement in symptoms (3 mo), but not cure, in women with SUI	2a
Repeat injections to achieve therapeutic effect are often required	2a
Bulking agents are less effective than colposuspension or autologous sling for cure of SUI	2a
Adverse effect rates are lower compared to open surgery	2a
There is no evidence that one type of bulking agent is better than another type	1b
Transperineal route of injection may be associated with a higher risk of urinary retention compared to the transurethral route	2b
Recommendations	GR
Do not offer bulking agents to women who are seeking a permanent cure for stress urinary incontinence	A

LE: Level of evidence; GR: Grade of recommendation; SUI: Stress urinary incontinence.

Table 2 The clinical trials on injectable treatments for female stress urinary incontinence

Ref.	Bulking agents	Number of patients	Assessment methods	Outcomes
Lightner et al[56]	Durasphere vs Collagen	n = 61 (Durasphere) n = 68 (Collagen)	SUIS Standardized pad test	At the one year follow up, the Durasphere group achieved improvement in one Stamey grade or more in 80.3% of patients compared to 69.1% of patients in the Collagen group (P = 0.162)
Chrouser et al[58]	Durasphere vs Contigen	n = 43 (Durasphere) n = 43 (Contigen)	Patient satisfaction and continence were subjectively evaluated via telephone interview	Success rateswere reported in 33% of Durasphere group and 19% in Contigen at 24 mo; at 36 mo, 21% in Durasphere, 9% in Contigen No significant difference was observed in time to failure between the injection groups (P = 0.25)
Bano et al[73]	Permacol vs Macroplastique	n = 25 (Permacol) n = 25 (Macroplastique)	1-h pad test SUIS KCQ	At 6 mo, 62.5% in the Permacol group were dry vs 37.5% in the Macroplastique group but no statistical analysis was reported
Hurtado et al[13]	Tegress	n = 19	Physical exam Urodynamic findings Complications	A 58% of the patients had a complication related to the procedure with 37% experiencing urethral erosion 10.5% of the patients reported at least a 50% subjective improvement
Mayer et al[67]	Coaptite vs Collagen	n = 131 (Coaptite) n = 100 (Collagen)	SUIS	Improvement of one or more Stamey grade was showed 63.4% in Coaptite group and 57% in the Collagen group, at 12 mo follow-up (P = 0.34) More patients in the Coaptite group required only one injection (38%) compared with the Collagen group (26.1%) (P = 0.03)
Ghoniem et al[53]	Macroplastique vs Contigen	n = 122 (Macroplastique) n = 125 (Contigen)	SUIS 1-h pad test Urinary Incontinence QoL Scale scores	After 12 mo, improved 1 or more Stamey grade and dry/cure rates were determined in 61.5% and 36.9% of patients treated with Macroplastique, vs 48% and 24.8% of patients treated with Contigen, respectively (P < 0.05)
Toozs-Hobson et al[70]	Bulkamid	n = 135	24-h pad weighting test 3-d micturition diary ICIQ score QoL score VAS score	There was durability of success with 64% of women cure/improved, which was not significantly different compared with the 12 mo data
Sokol et al[71]	Bulkamid vs Contigen	n = 229 (Bulkamid) n = 116 (Contigen)	Bladder diaries QoL questionnaire Pad weight testing VLPP	47.2% of Bulkamid patients and 50% of Contigen patients reported no SUI episodes 77.1% of Bulkamid patients and 70% of Collagen patients reported improvement or cure

SUIS: Stamey urinary incontinence scale; KCQ: Kings college hospital quality of health questionnaire; QoL: Quality of life; SUI: Stress urinary incontinence; ICIQ: International consultation on incontinence questionnaire; VAS: Visual analogue scale; VLPP: Valsalva leak point pressure.