Periurethral implantation of glutaraldehyde cross-linked collagen (Contigen) in women with type I or III stress incontinence: quantitative outcome measures.

OBJECTIVE

To evaluate the effectiveness of periurethral collagen (Contigen) implantation as a treatment for stress incontinence, using quantitative measures of urine loss and the patients' subjective response.

PATIENTS AND METHODS

Twelve women, age range 46-87 years, had video urodynamic testing--confirming Type I or III stress urinary incontinence and were eligible for periurethral collagen implant. Eleven had had at least one anti-incontinence operation. One woman was withdrawn from the study because of a severe subcutaneous skin reaction 21 days after the skin-test and one patient declined follow-up. Ten patients had up to two implants each, introduced 3-5 months apart under local anaesthetic (5 mL collagen per implant). All patients underwent 10 h pad tests (with 2-hourly pad changes) at baseline and 8 weeks after collagen implant. The following quantitative measures of incontinence severity and voiding function were studied: urine loss during the 10 h test, number of wet pads, weight of urine in the wettest pad, maximum voided volume, residual volume on ultrasound, maximum flow rate and urinary flow curve pattern. Blind to the quantitative results, patients were asked to categorize their outcome as cured, improved and failed.

RESULTS

There was a significant decrease in urine loss (P = 0.007), number of wet pads (P = 0.05) and weight of the wettest pad (g) (P = 0.03) from baseline to 8 weeks after the second collagen implant. There was no significant difference at any point in maximum voided volume, maximum urinary flow rate and residual volume after voiding measured on ultrasound. Objectively, two women appeared cured (< 5 g urine loss on 10 h pad test); subjectively, both reported themselves as improved (not cured); one subject stated she was cured and on pad test had 11 g urine loss; two women stated there was no change yet urine loss decreased markedly by > 60% from 434 g to 123 g and 533 g to 199 g. The remaining six stated they were improved although, objectively, their urine loss after the collagen implant remained high (mean 132 g, range 87-185).

CONCLUSION

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 changes occurred in the voided amount, the flow curve and the residual volume after voiding.