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. 2017 Jul 25;2017(7):CD003881. doi: 10.1002/14651858.CD003881.pub4

Dmochowski 2004.

Methods RCT (multicentre). 253 total, 237 women randomised. Results presented for 168 women at 12 months follow up for primary effectiveness. Adverse events for 253 patients.
Participants Included: women diagnosed with urodynamic SUI confirmed by clinical urodynamic evaluation. Mean age for both groups 61 years. All patients had failed previous incontinence treatment, 46% failing at least one surgery.
Interventions A: Uryx™ is an injectable solution of ethylene vinyl alcohol copolymer (EVOH) dissolved in dimethyl sulphoxide (DMSO) carrier. Upon contact with an aqueous environment, such as the submucosal tissues of the urethra, the DMSO solvent diffuses away, resulting in precipitation of the polymer, which forms a cohesive spongy mass creating a bulking effect. Uryx™ hand‐injected through a fine 25 g needle.
 B: Contigen™ is cross‐linked bovine collagen.
Maximum of 3 treatments in 90 days allowed,
Outcomes Mean total volume injected per patient. A: 4.7 cc; B: 7.2 cc. Efficacy was assessed at 12 months following last treatment using pad weight and Stamey test. I‐QOL also used.
Notes No description of participant characteristics (age, parity, BMI).
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear
Other bias Unclear risk Funded by Genyx medical, Inc. manufacturer of Uryx™