Mp65-05 Polyacrylamide Hydrogel (Bulkamid®) in the Treatment of Female Stress Urinary Incontinence: Three Year Follow Up Outcomes.

Abstract

METHODS: ISD was created in female NHPs by cutting and then cauterizing the pudendal innervation to the urinary sphincter complex. Chronic fibrotic, muscle poor ISD developed within 6 months post-surgery. Partial bone marrow transplantation with autologous Lenti-GFP bone marrow cells (BMCs) was performed and NHPs (n¼6/ experimental condition) were then given sphincter injections of Lenti-Mcherry-labeled 5 million autologous skMPCs, or SDF-1a. Tissues were removed 6 months later and analyzed for sphincter content of muscle, collagen, BMCs, skMPCs and SDF-1a. RESULTS: When compared to previously studied NHPs with acute ISD (Badra et al, J Urol. 2013;190(5):1938), there was less expression of BMCs and SDF-1a in the urinary sphincter complexes of NHPs with chronic ISD (p<0.05). This correlated with reduced effectiveness of skMPCs to restore sphincter muscle, innervation and vascularization in chronic vs. almost complete restoration in acute ISD (p<0.05). That injection of SDF-1a restores sphincter structure and function in chronic ISD further supports a role of the SDF-1a pathway in sphincter regeneration. CONCLUSIONS: The underlying reason(s) by which SDF-1a can, but skMPC cannot, stimulate sphincter regeneration in chronic ISD remains unclear, but could be related to the reduced capacity of skMPCs to stimulate SDF-1a mediated cell homing to the sphincter complex in chronic ISD. Providing SDF-1a to a fibrotic urinary sphincter may represent a novel approach to treat chronic ISD.

Reconstruction of Urethral Sphincter With Polyacrylamide Hydrogel

“…Three studies present shorter follow-up data of standard PAHG injection with a timeline similar to our study 20,21,23 . However, comparison continues to be limited by differing definitions of subjective and objective outcomes, methods of data collection, and varying sample sizes.…”

“…However, comparison continues to be limited by differing definitions of subjective and objective outcomes, methods of data collection, and varying sample sizes. Pai et al 23 offer a retrospective study of 212 women and report 82.8% subjective improvement (defined as subjective cure or significant improvement) at 3-month follow, which was stable over the 5-year study. Umberto et al 21 demonstrated a 1-month subjective success rate of 89.1%, which declined to 59.7% at 3 months, 72% at 6 months, and 74.4% at 1 year.…”

Long-term complications of bulking agents in the treatment of stress urinary incontinence: Results of a national survey

“…22 Currently no migration of the material has been reported at 2 years follow-up 23,24 ; however, pain and erosion were reported at 25 months in one study. 25 Pai and Al-Singary 13 referenced Bulkamid as nonmigratory and non-degradable even after 10 years as it has previously been used in breast surgery and as a soft tissue filler in plastic surgery. In a case report, Bulkamid was shown to form a periurethral abscess causing pain 6 weeks post-injection 26 ; similarly, Zuidex has been shown to cause a paraurethral abscess.…”

“…Pai and Al-Singary 13 followed up 256 patients injected with Bulkamid for a minimum of 3 years, with a median follow-up of 38 months. Only short-term complications affecting seven patients were described, with 18 patients undergoing a second injection to achieve desired symptomatic control.…”