Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

Vaginal Fistula Clinical Trial

Official title:

Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428830
• Other study ID #: A65783
• Status: Completed
• Phase: N/A
• First received: September 2, 2011
• Last updated: January 15, 2015
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: January 2015
• Source: EngenderHealth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: World Health Organization
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Vaginal Fistula

Intervention

Procedure:
• 7-day catheterization following fistula repair surgery
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
• 14 day catheterization
This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.

Locations

Country	Name	City	State
Congo, The Democratic Republic o	Hôpital Saint Joseph	Kinshasa
Ethiopia	Gondar University Hospital	Gondar
Guinea	L'Hôpital Préfectoral de Kissidougou	Kissidougou
Kenya	Kenyatta National Hospital	Nairobi
Niger	Maternité Centrale de Zinder	Zinder
Nigeria	National Obstetric Fistula Centre	Abakaliki
Sierra Leone	Aberdeen Women's Centre	Freetown
Uganda	Kagando Hospital	Kasese District

Sponsors (3)

Lead Sponsor	Collaborator
EngenderHealth	United States Agency for International Development (USAID), World Health Organization

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Ethiopia,  Guinea,  Kenya,  Niger,  Nigeria,  Sierra Leone,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.		3 months	Yes
Secondary	Repair breakdown one week following catheter removal		14 days or 21 days post-repair	Yes
Secondary	Intermittent catheterization due to urinary retention		7 or 14 days post repair	Yes
Secondary	Prolonged hospitalization		14 or 21 days post-repair	No
Secondary	Catheter blockage		14 or 21 days post repair	Yes
Secondary	Self-reported residual incontinence		3 months	Yes
Secondary	The occurrence of septic or febrile episodes		14 or 21 days post-repair	Yes