24704117
OBJECTIVE	Bulkamid is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device .
OBJECTIVE	We evaluated the safety and efficacy of Bulkamid vs Contigen collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence .
METHODS	This was a single-blind , randomized , prospective , 33-center , 2-arm parallel study of hydrogel vs collagen gel with followup to 1year .
METHODS	At baseline patients underwent physical examination and bladder testing , and completed quality of life questionnaires and bladder diaries .
METHODS	After randomization patients could receive up to 3 injections at 1-month intervals .
METHODS	Patients were assessed 3 , 6 , 9 and 12 months after bulking .
METHODS	They completed bladder diaries and quality of life questionnaires , and pad weight was tested .
METHODS	Atthe last visit Valsalva leak point pressure was measured .
METHODS	Subjective and objective incontinence outcomes and adverse events were compared .
RESULTS	Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel .
RESULTS	At 12 months a 50 % or greater decrease in leakage and incontinence episodes was seen in 53.2 % and 55.4 % of patients who received hydrogel and collagen gel , respectively .
RESULTS	At 12 months 47.2 % of patients with hydrogel and 50 % with collagen gel reported zero stress incontinence episodes , and 77.1 % and 70 % , respectively , considered themselves cured or improved .
RESULTS	Major adverse events were rare in each group .
CONCLUSIONS	Bulkamid is not inferior to Contigen .
CONCLUSIONS	It has a favorable , persistent effect on stress urinary incontinence with a low risk of serious adverse events .
CONCLUSIONS	Bulkamid is a new , simple , office based bulking system that shows promise asatreatment in women with stress urinary incontinence , particularly since Contigen is no longer commercially available .

