Prophylactic Autologous Slings at the Time of Obstetric Fistula Repair: A Randomized Clinical Trial.

OBJECTIVE

To compare prophylactic slings for women with obstetric fistulas at high risk of residual incontinence.

METHODS

This was a multiple-site randomized controlled trial comparing autologous fascia slings to pubococcygeal (PC) slings at time of fistula repair. Women with a Goh type 3 or 4 vesicovaginal fistula (distal edge of the fistula is ≤2.5 cm from the external urethral orifice) with no prior repair were randomized to receive either a rectus fascia sling or a PC sling while undergoing fistula repair. Interviews were performed before surgery and at follow-up 1 to 6 months later including the Michigan Incontinence Symptom Index and the Incontinence Quality of Life Tool. Pad weights were also collected at this time. Safety analysis was performed after 10 participants were enrolled in each arm.

RESULTS

Eleven participants randomized to a PC sling and 10 to a rectus sling. There was 1 repair breakdown in the PC group and 3 in the rectus group. There was no significant difference noted in pad weights or quality of life scores between groups. Quality of life and Michigan Incontinence Symptom Index scores improved significantly for both groups after surgery. The study was terminated at safety analysis due to the number of breakdowns and difficulty of follow-up at 1 site.

CONCLUSIONS

There was no superiority between slings. Randomization proved problematic given the vast heterogeneity between fistula injuries. There is a need for an innovative anti-incontinence technique.ClinicalTrials.gov identifier: NCT03236922 https://www.clinicaltrials.gov/ct2/show/NCT03236922?cond=vesico-vaginal+fistula&rank=2.