Restoring Continence After Devastating Post-Obstetric Fistula Repair Incontinence: A Pilot Study Comparing...

Post-obstetric fistula repair incontinence (POFRI) refers to persistent urinary leakage after successful fistula closure. This study evaluated Bulkamid for POFRI using two techniques: cystoscopic-guided injections versus periurethral injections without cystoscopy.

We performed a prospective study of women with POFRI and persistent stress urinary incontinence (SUI) treated with Bulkamid at the Freedom from Fistula unit in Tamatave, Madagascar. Cohort 1 underwent cystoscopic Bulkamid injection; Cohort 2 underwent periurethral Bulkamid injection without cystoscopy. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), Questionnaire for Urinary Incontinence Diagnosis (QUID), and pad weight testing were obtained at baseline, discharge, and 3 months postoperatively. The primary outcome, Patient Global Impression of Improvement (PGI-I), was collected at discharge and 3-month follow-up.

In January 2025, Cohort 1 (n = 11) underwent cystoscopic injection, and in June 2025, Cohort 2 (n = 17) underwent periurethral injection. The primary outcome was met by 8/11 (72.7%) patients in Cohort 1 at discharge and 2/5 (40%) at 3 months. In Cohort 2, 11/17 (64.7%) patients met the primary outcome at discharge and 6/10 (60%) at 3 months. Combined, 19/28 (67.9%) patients achieved "success" at discharge and 8/15 (53.3%) at 3 months. At 3 months, both cohorts demonstrated significant reductions in mean QUID (p < 0.001) and ICIQ-UI-SF scores (p = 0.011). Two patients developed recurrent vaginal fistulas, both successfully repaired.

Bulkamid provided promising short-term outcomes for SUI in women with POFRI. Both cystoscopic and periurethral approaches were effective, the periurethral technique was simpler and avoided cystoscopy. Larger studies with longer follow-up are needed.