Study design, materials and methods
We performed a prospective study of women with POFRI and persistent 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. Preoperative evaluation included Waaldijk fistula classification, bladder capacity, urethral length, vaginal length and others. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF), Questionnaire for Urinary Incontinence Diagnosis (QUID), and pad weight testing were done at baseline, discharge (2-3 days) and 3 months postoperatively. The primary outcome, Patient Global Impression of Improvement (PGI-I), was collected at discharge (2-3 days post-procedure) and 3 months post injection.
Results
In January 2025, Cohort 1 (n=11) underwent cystoscopic Bulkamid injection, and in June 2025, Cohort 2 (n=17) underwent periurethral Bulkamid injection without cystoscopy. Cohort 1 patients were older (36 vs 29 yrs, p=0.217) with shorter urethras (2.7 vs 3.4 cm, p=0.042). Cystoscopic injection was “moderate “or “difficult” in 10/11 cases and visual coaptation was “moderate” or “poor” in 7/11. Periurethral injection was “easy” in 16/17 cases. The injected volume was similar (2.4 vs 2.5 cc). The primary outcome was met by 8/11 (72.7%) of Cohort 1 at discharge, and 2/5 (40%) at 3 months, and by 10/16 (62.5%) of Cohort 2 at discharge and 6/10 (60%) at 6 months. Combined, 18/27 (66.7%) patients were noted to have “success” at discharge and 8/15 (53.3%) at 3 months. At 3-months, Cohorts 1 and 2 both demonstrated significant reductions in mean QUID scores (p<0.001) and mean ICIQ-UI-SF scores (p=0.011) Two patients, one from each cohort, developed recurrent vaginal fistulas, both successfully repaired.
Interpretation of results
Bulkamid injection was associated with clinically meaningful early improvement in stress urinary incontinence symptoms, with approximately two-thirds of POFRI patients reporting improvement shortly after treatment and over half maintaining improvement at three months. Both cystoscopic and periurethral approaches demonstrated similar symptom improvements despite technical challenges encountered with cystoscopic injections. The periurethral technique appeared technically simpler while achieving comparable short-term outcomes, suggesting it may represent a practical approach in low-resource settings where cystoscopy may be limited.