BERKELEY, CA (UroToday Inc.) - Corcos and colleagues from Canada attempt to answer this question by performing a multicenter, randomized non-inferiority study comparing the efficacy, satisfaction, and complications in women undergoing collagen injection or surgery to treat stress urinary incontinence (SUI). Their findings were published in the May 2005 edition of Urology

Overall 133 women with mixed or pure SUI were recruited from 6 centers. History and physical examination was performed and included urodynamics studies. Patients with bladder neck hypermobility were included in the study. Patients excluded were those with a history of interstitial cystitis, neurogenic bladder, previous collagen injection or pelvic radiation. Patients completed the Rand Medical Outcomes Study 36-item Health Survey and the Incontinence Impact Questionnaire and Beck Inventory, which is a depression index questionnaire. Follow-up was performed at 1, 3, 6, and 12 months. Patients were randomized to receive a surgical procedure for SUI (Burch procedure, sling procedure, transvaginal endoscopic bladder neck suspension) or collagen injection. Collagen injection was performed via intraurethral injection at the 3, 6, and 9 o'clock positions, and they could receive up to 3 injections with 1-month intervals before being considered a failure. The primary endpoint was defined as a negative 24-hour pad test at 1 year.

66 patients were randomized to receive collagen and 67 to receive surgery. 15 patients, 2 randomized to collagen and 13 to surgery, refused to participate and 5 patients were lost to follows up. The 54 patients undergoing surgery had the following: 29 pubovaginal fascial sling, 19 retropubic bladder neck suspension, and 6 transvaginal endoscopic bladder neck suspensions. The collagen groups had a mean of 2.9 injections per patient with a mean 9.7 ml of collagen used.

The baseline demographics and SF-36 and IIQ scores were similar in the two groups. Using the intent to treat analysis, the rate of success was similar in the two groups with surgery being 55.2% and collagen 51.5%. The difference was greater when analyzed on a per protocol analysis with those undergoing surgery having 63% success rate and those with collagen having a 50.0% success rare.

32.8% of those receiving collagen were not satisfied compared to 20.4 % of those in the surgery group. Yet quality of life at 1 month was much worse by all measured variables in the surgery group. At 12 months, there was no significant difference in the quality of life between the two groups. The total number of side effects was greater in the surgery groups (84 versus 36). After surgery 63% of women had at least one side effect, while 36% had such effects after collagen. The most common complications were transient difficulty voiding, complete retention, urinary tract infection and transient hematuria.

The authors concluded that although surgery is the primary treatment of choice for SUI, collagen had similar results with decreased side effects and complication profile. Therefore it may be a reasonable first line option in the treatment of SUI.

Urology 2005; 65: 898-903