Clinical trial NCT01428830: Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
Official title: Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Fistula
Keywords: fistula
catheter
surgery
obstetrics
gynecology
urology
Lead sponsor: EngenderHealth
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: United States Agency for International Development (USAID)
First posted: 2011-09-05
Enrollment: 524
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.

Detailed description: A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. 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 (by freeing available bed space and increasing availability of nursing staff), 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 facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test, a routine practice in fistula repair services. t. 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 (defined as a stay at the facility beyond one week following initial catheter removal related to an adverse event), catheter blockage, and self-reported residual incontinence. This study will be conducted among 507 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 16-18 months at each site.

Eligibility criteria: Inclusion Criteria:

* Have a "simple" fistula, as determined at the end of fistula repair surgery (irrespective of the number of prior repair attempts and the cause of the fistula, with the exceptions noted under the exclusion criteria below)
* Have a closed fistula at completion of surgery
* Have a closed fistula 7 days after surgery (i.e. at the time of randomization)
* Understand study procedures and requirements
* Agree to return to the facility for one follow-up visit three month after the date of surgery
* Provide informed consent to participate in the study or in the case of non-emancipated minors, both consent to the study and receive proxy consent to participate in the study
* Have no contraindications precluding their participation.

Exclusion Criteria:

* Have a fistula that is determined to be "not simple" (i.e. intermediate or complex)
* Have a fistula that is radiation-induced, associated with cancer or due to lymphogranuloma venereum (These cases will be excluded because the healing process is very different from fistula resulting from other causes. We expect there to be few cases of these fistulas at the study sites)
* Have a fistula that is not closed immediately after surgery or 7 days after surgery (i.e. at the time of randomization)

Primary outcomes:
measure: Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.
timeFrame: 3 months
Secondary outcomes:
measure: Repair breakdown one week following catheter removal
timeFrame: 14 days or 21 days post-repair
measure: Intermittent catheterization due to urinary retention
timeFrame: 7 or 14 days post repair
measure: Prolonged hospitalization
timeFrame: 14 or 21 days post-repair
measure: Catheter blockage
timeFrame: 14 or 21 days post repair
measure: Self-reported residual incontinence
timeFrame: 3 months
measure: The occurrence of septic or febrile episodes
timeFrame: 14 or 21 days post-repair
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Hôpital Saint Joseph
city: Gondar
country: Ethiopia
facility: Gondar University Hospital
city: Kissidougou
country: Guinea
facility: L'Hôpital Préfectoral de Kissidougou
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
city: Abakaliki
country: Nigeria
facility: National Obstetric Fistula Centre
city: Zinder
country: Niger
facility: Maternité Centrale de Zinder
city: Freetown
country: Sierra Leone
facility: Aberdeen Women's Centre
city: Kasese District
country: Uganda
facility: Kagando Hospital
Study officials:
affiliation: EngenderHealth
name: Mark A Barone, DVM, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: World Health Organization
name: Mariana Widmer
role: STUDY_DIRECTOR
References:
citation: Barone MA, Widmer M, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Barry TH, Danladi D, Djangnikpo L, Gbawuru-Mansaray T, Harou I, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Landoulsi S, Delamou A, Were L, Frajzyngier V, Beattie K, Gulmezoglu AM. Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial. Lancet. 2015 Jul 4;386(9988):56-62. doi: 10.1016/S0140-6736(14)62337-0. Epub 2015 Apr 21.
citation: Barone MA, Frajzyngier V, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Beattie K, Barry TH, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Widmer M, Gulmezoglu AM. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial. BMC Womens Health. 2012 Mar 20;12:5. doi: 10.1186/1472-6874-12-5.