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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
World Health Organization
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
EngenderHealth
ClinicalTrials.gov Identifier:
NCT01428830
First received: September 2, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Vaginal Fistula
Procedure: 7-day catheterization following fistula repair surgery
Procedure: 14 day catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery

Resource links provided by NLM:


Further study details as provided by EngenderHealth:

Primary Outcome Measures:
  • Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Repair breakdown one week following catheter removal [ Time Frame: 14 days or 21 days post-repair ] [ Designated as safety issue: Yes ]
  • Intermittent catheterization due to urinary retention [ Time Frame: 7 or 14 days post repair ] [ Designated as safety issue: Yes ]
  • Prolonged hospitalization [ Time Frame: 14 or 21 days post-repair ] [ Designated as safety issue: No ]
  • Catheter blockage [ Time Frame: 14 or 21 days post repair ] [ Designated as safety issue: Yes ]
  • Self-reported residual incontinence [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • The occurrence of septic or febrile episodes [ Time Frame: 14 or 21 days post-repair ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 507
Study Start Date: January 2012
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7-day catheterization Procedure: 7-day catheterization following fistula repair surgery
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
Active Comparator: 14-day catheterization Procedure: 14 day catheterization
This group will have an indwelling urethral catheter for 14 days following 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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428830

Locations
Congo, The Democratic Republic of the
Hôpital Saint Joseph
Kinshasa, Congo, The Democratic Republic of the
Ethiopia
Gondar University Hospital
Gondar, Ethiopia
Guinea
L'Hôpital Préfectoral de Kissidougou
Kissidougou, Guinea
Kenya
Kenyatta National Hospital
Nairobi, Kenya
Nigeria
National Obstetric Fistula Centre
Abakaliki, Nigeria
Niger
Maternité Centrale de Zinder
Zinder, Niger
Sierra Leone
Aberdeen Women's Centre
Freetown, Sierra Leone
Uganda
Kagando Hospital
Kasese District, Uganda
Sponsors and Collaborators
EngenderHealth
World Health Organization
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Mark A Barone, DVM, MS EngenderHealth
Study Director: Mariana Widmer World Health Organization
  More Information

No publications provided by EngenderHealth

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EngenderHealth
ClinicalTrials.gov Identifier: NCT01428830     History of Changes
Other Study ID Numbers: A65783
Study First Received: September 2, 2011
Last Updated: May 23, 2013
Health Authority: United Nations: World Health Organization

Keywords provided by EngenderHealth:
fistula
catheter
surgery
obstetrics
gynecology
urology

Additional relevant MeSH terms:
Fistula
Vaginal Fistula
Genital Diseases, Female
Pathological Conditions, Anatomical
Vaginal Diseases

ClinicalTrials.gov processed this record on October 22, 2014