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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01428830
• Date of registration: 02/09/2011
• Prospective Registration: Yes
• Primary sponsor: EngenderHealth
• Public title: Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
• Scientific title: Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
• Date of first enrolment: January 2012
• Target sample size: 524
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01428830
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

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

Contacts

• Name: Mark A Barone, DVM, MS
• Affiliation: EngenderHealth

• Name: Mariana Widmer
• Affiliation: World Health Organization

Key inclusion & exclusion 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)



Age minimum: N/A
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Vaginal Fistula

Intervention(s)

Procedure: 14 day catheterization

Procedure: 7-day catheterization following fistula repair surgery

Primary Outcome(s)

Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. [Time Frame: 3 months]

Secondary Outcome(s)

Repair breakdown one week following catheter removal [Time Frame: 14 days or 21 days post-repair]

Self-reported residual incontinence [Time Frame: 3 months]

Catheter blockage [Time Frame: 14 or 21 days post repair]

The occurrence of septic or febrile episodes [Time Frame: 14 or 21 days post-repair]

Intermittent catheterization due to urinary retention [Time Frame: 7 or 14 days post repair]

Prolonged hospitalization [Time Frame: 14 or 21 days post-repair]

Secondary ID(s)

A65783

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

World Health Organization

United States Agency for International Development (USAID)