Breakdown of simple female genital fi stula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial

Abstract

Summary Background Duration of bladder catheterisation after female genital fi stula repair varies widely. We aimed to establish whether 7 day bladder catheterisation was non-inferior to 14 days in terms of incidence of fi stula repair breakdown in women with simple fi stula. Methods In this randomised, controlled, open-label, non-inferiority trial, we enrolled patients at eight hospitals in the Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Niger, Nigeria, Sierra Leone, and Uganda. Consenting patients were eligible if they had a simple fi stula that was closed after surgery and remained closed 7 days after surgery, understood study procedures and requirements, and agreed to return for follow-up 3 months after surgery. We excluded women if their fi stula was not simple or was radiation-induced, associated with cancer, or due to lymphogranuloma venereum; if they were pregnant; or if they had multiple fi stula. A research assistant at each site randomly allocated participants 1:1 (randomly varying block sizes of 4–6; stratifi ed by country) to 7 day or 14 day bladder catheterisation (via a random allocation sequence computer generated centrally by WHO). Outcome assessors were not masked to treatment assignment. The primary outcome was fi stula repair breakdown, on the basis of dye test results, any time between 8 days after catheter removal and 3 months after surgery. The non-inferiority margin was 10%, assessed in the per-protocol population. This trial is registered with ClinicalTrials.gov, number NCT01428830. Findings We randomly allocated 524 participants between March 7, 2012, and May 6, 2013; 261 in the 7 day group and 263 in the 14 day group. In the per-protocol analysis, ten (4%) of 250 patients had repair breakdown in the 7 day group (95% CI 2–8) compared with eight (3%) of 251 (2–6) in the 14 day group (risk diff erence 0·8% [95% CI –2·8 to 4·5]), meeting the criteria for non-inferiority. Interpretation 7 day bladder catheterisation after repair of simple fi stula is non-inferior to 14 day catheterisation and could be used for management of women after repair of simple fi stula with no evidence of a signifi cantly increased risk of repair breakdown, urinary retention, or residual incontinence up to 3 months after surgery.