Injectable collagen for type 3 female stress incontinence: the first 50 Australian patients.

OBJECTIVE

To assess the safety, efficacy and durability of injectable glutaraldehyde cross-linked (GAX) collagen in the treatment of type 3 female stress incontinence.

DESIGN AND SETTING

A prospective study of incontinent women attending a private practice for clinical and urodynamic assessment.

PATIENTS

Fifty women who had had an average of 1.8 previous operations for stress urinary incontinence took part in the study. Each had been diagnosed as having type 3 genuine stress incontinence (poor or nonfunctioning urethral sphincter mechanism in the presence of a bladder neck which is well supported, usually by scar tissue from previous surgery). Subject to a negative skin test for allergy, each patient underwent the implantation of GAX collagen (Contigen), a biocompatible product causing no foreign body reaction.

INTERVENTIONS

The implant was performed by a short day-only procedure involving cystoscopically controlled periurethral (71%) or transurethral (29%) injection of Contigen. The aim was to achieve closure of the urethra at the bladder neck and increase resistance to urine loss. Top-up injections were used as required. The follow-up period ranged from one to 21 months (mean, 11 months).

RESULTS

Of these first 50 female patients, 41 (82%) were successfully treated. Twenty-one (42%) were no longer incontinent; 20 (40%) desired no further treatment because their condition was improved; seven (14%) did not respond to treatment and two patients were awaiting top-up injections. The average number of injections given was 1.9 and the average volume injected was 14.4 mL. There were no allergic reactions or infections. Side effects were temporary and of a minor nature.

CONCLUSIONS

Injectable GAX collagen appears to be a safe and effective treatment for type 3 stress urinary incontinence. Its durability awaits further follow-up.