Injectable treatments for female 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.