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
Date
2015Author
Mark A, Barone
Mariana, Widmer
Steven, Arrowsmith
Joseph, Ruminjo
Armando, Seuc
Evelyn, Landry
Thierno Hamidou, Barry
Dantani, Danladi
Lucien, Djangnikpo
Tagie, Gbawuru-Mansaray
Issoufa, Harou
Alyona, Lewis
Mulu, Muleta
Dolorès, Nembunzu
Robert, Olupot
Ileogben, Sunday-Adeoye
Weston Khisa, Wakasiaka
Sihem, Landoulsi
Alexandre, Delamou
Lilian, Were
Vera, Frajzyngier
Karen, Beattie
A Metin, Gülmezoglu
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Show full item recordAbstract
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.