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

NCT01428830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2015-01-19

No results posted yet for this study

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.

Conditions

  • Vaginal Fistula

Interventions

PROCEDURE

7-day catheterization following fistula repair surgery

This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.

PROCEDURE

14 day catheterization

This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • EngenderHealth

    lead OTHER

Principal Investigators

  • Mark A Barone, DVM, MS · EngenderHealth

  • Mariana Widmer · World Health Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

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

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01428830 on ClinicalTrials.gov