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.
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.