PURPOSE: Bulkamid is a new bulking agent for the treatment of SUI which is injected into the urethral submucosa using a specifically designed device.
We evaluate the safety and efficacy of Bulkamid vs. Contigen in the treatment of SUI or stress predominant mixed UI.
MATERIALS AND METHODS: This was a single-masked, randomized, prospective, 33-center, 2-arm parallel study of Bulkamid vs. Contigen with follow-up to 1 year. At baseline, patients underwent physical exam, completed QoL questionnaires and bladder diaries, and underwent bladder testing. After randomization, patients could receive up to 3 injections at 1-month intervals. Patients were assessed at 3, 6, 9 and 12 months after bulking and completed bladder diaries, QoL questionnaires, pad weight testing and VLPP (at last visit). Subjective and objective incontinence outcomes and adverse events were compared.
RESULTS: 345 women were randomized: 229 to Bulkamid and 116 to Contigen. A ≥50% reduction in leakage and incontinence episodes was seen in 53.2% of Bulkamid and 55.4% of Contigen patients at 12 months. At 12 months 47.2% of Bulkamid and 50% of Contigen patients reported zero stressincontinence episodes and 77.1% of Bulkamid and 70% of Collagen patients considered themselves cured or improved. Major adverse events were rare in both groups.
CONCLUSION: Bulkamid is not inferior to Contigen and has a favorable and persistent effect on SUI with a low risk of serious adverse events. Bulkamid is a new, simple office-based bulking system that shows promise as a treatment for women suffering from SUI, particularly since Contigen is no longer commercially available.
Written by:
Sokol ER, Karram MM, Dmochowski R. Are you the author?
Department of Obstetrics and Gynecology, Stanford University, Stanford California; Department of Obstetrics and Gynecology, The Christ Hospital, Cincinnati, Ohio; Department of Urology, Vanderbilt University, Nashville, Tennessee.
Reference: J Urol. 2014 Apr 2. pii: S0022-5347(14)03211-X.
doi: 10.1016/j.juro.2014.03.109
PubMed Abstract
PMID: 24704117
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