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Open Access Study protocol

Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

Mark A Barone1*, Vera Frajzyngier1, Steven Arrowsmith12, Joseph Ruminjo1, Armando Seuc3, Evelyn Landry1, Karen Beattie1, Thierno Hamidou Barry4, Alyona Lewis5, Mulu Muleta6, Dolorès Nembunzu7, Robert Olupot8, Ileogben Sunday-Adeoye9, Weston Khisa Wakasiaka10, Mariana Widmer3 and A Metin Gülmezoglu3

Author Affiliations

1 Fistula Care Project, EngenderHealth, 440 Ninth Avenue, 13th Floor, New York, NY 10001, USA

2 Fistula Consulting LLC, 452 Union Ave. SE, Grand Rapids, MI 49503, USA

3 World Health Organization, Department of Reproductive Health and Research, 1211 Geneva 27, Geneva, Switzerland

4 L'Hôpital Préfectoral de Kissidougou, Kissidougou, Guinea

5 Aberdeen Women's Centre, PO Box 416, Freetown, Sierra Leone

6 Gondar University Hospital, Fistula Unit, PO Box 196, Gondar, Ethiopia

7 Hôpital Saint Joseph, 15ème Rue, Boulevard Lumumba, Limete Résidentiel, Kinshasa, Democratic Republic of Congo

8 Kagando Hospital, Kasese District, Uganda

9 National Obstetric Fistula Centre Abakaliki, 1 Water Works Street, Abakaliki, Ebonyi State, Nigeria

10 Kenyatta National Hospital, PO Box 20723-00202, Nairobi, Kenya

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BMC Women's Health 2012, 12:5  doi:10.1186/1472-6874-12-5

Published: 20 March 2012

Abstract

Background

A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service.

Methods/Design

This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site.

Discussion

If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia.

Trial registration

ClinicalTrials.gov Identifier NCT01428830.

Keywords:
Vaginal fistula; Catheter; Non-inferiority randomized controlled trial; Surgery