PERIURETHRAL IMPLANTATION OF GLUTARALDEHYDE CROSS-LINKED COLLAGEN (CONTIGEN(R)) IN WOMEN WITH TYPE-I OR III STRESS-INCONTINENCE - QUANTITATIVE OUTCOME MEASURES

Objective To evaluate the effectiveness of periurethral collagen (Cont igen (R)) implantation as a treatment for stress incontinence, using q uantitative measures of urine loss and the patients' subjective respon se. Patients and methods Twelve women, age range 46-87 years, had vide o urodynamic testing-confirming Type I or III stress urinary incontine nce and were eligible for periurethral collagen implant, Eleven had ha d at least one anti-incontinence operation. One woman was withdrawn fr om the study because of a severe subcutaneous skin reaction 21 days af ter the skin-test and one patient declined follow-up. Ten patients had up to two implants each, introduced 3-5 months apart under local anae sthetic (5 mL collagen per implant), All patients underwent 10 h pad t ests (with 2-hourly pad changes) at baseline and 8 week after collagen implant. The following quantitative measures of incontinence severity and voiding function were studied: urine loss during the 10 h test, n umber of wet pads, weight of urine in the wettest pad, maximum voided volume, residual volume on ultrasound, maximum now rate and urinary no w curve pattern, Blind to the quantitative results, patients were aske d to categorize their outcome as cured, improved and failed. Results T here was a significant decrease in urine loss (P = 0.007), number of w et pads (P = 0.05) and weight of the wettest pad (g) (P = 0.03) from b aseline to 8 weeks after the second collagen implant. There was no sig nificant difference at any point in maximum voided volume, maximum uri nary now rate and residual volume after voiding measured on ultrasound . Objectively, two women appeared cued (< 5 g urine loss on 10 h pad t est); subjectively, both reported themselves as improved !not cured); one subject stated she was cured and on pad test had 11g urine loss: t wo women stated there was no change pet urine loss decreased markedly by > 60% from 434 g to 123 g and 533 g to 199 g. The remaining six sta ted they were improved although, objectively, their urine loss after t he collagen implant remained high (mean 132 g, range 87-185). Conclusi on These results show a significant reduction in urine loss at 8 weeks after the second collagen implant and an objective cure rate of 18%, There was little relationship between the objective measure of success and the self-report, Of interest is the fact that no obstructive chan ges occurred in the voided amount, the flow curve and the residual vol ume after voiding.