Rigi10™ Malleable Penile Prosthesis
Also Known As
Polyacrylamide Hydrogel (PAHG), Urethral Bulking Agent (UBA), Bulkamid® Urethral Bulking System
Definition
Bulkamid is a permanently implanted, non-resorbable, injectable, transparent polyacrylamide hydrogel (PAHG) used as a urethral bulking agent for the treatment of stress urinary incontinence (SUI) in adult women.1 It consists of cross-linked polyacrylamide (2.5% w/w) and water (97.5% w/w), which is supplied sterile in 1 mL pre-filled syringes.2 Bulkamid works by adding volume to the urethral wall through injections into the urethral submucosa, creating a cushioning effect that helps prevent urine leakage during physical activities.3 The hydrogel maintains its volume over time without causing reactions in the surrounding tissue, providing a long-lasting treatment option for women with SUI.4
Clinical Context
Bulkamid Urethral Bulking System is indicated for urethral injection for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.1
Patient selection criteria typically include women with demonstrated SUI who have failed conservative treatments.2 The procedure is particularly suitable for women seeking a minimally invasive alternative to surgery, those with comorbidities that increase surgical risks, or patients who have failed previous anti-incontinence surgeries.3
The surgical implantation process involves injecting the hydrogel into the urethral submucosa using a specifically designed device under cystoscopic guidance.4 Typically, 3-4 injections are administered circumferentially around the urethra to create a cushioning effect that helps prevent urine leakage.5 The procedure can be performed under local anesthesia, usually takes approximately 10-15 minutes, and patients can typically resume normal activities within 24 hours.6
Clinical studies have demonstrated treatment success rates ranging from 46-60% at various follow-up intervals from less than 1 year to 7-8 years post-treatment.7 Approximately 60% of patients may require a second injection to achieve optimal results.8 Adverse events are generally infrequent and include urinary tract infection (5%), transient acute urinary retention (5%), and hematuria.9 No cases of erosion or migration of the product have been reported in long-term studies.10