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

September 2, 2011
May 23, 2013
January 2012
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01428830 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Repair breakdown one week following catheter removal [ Time Frame: One week ] [ Designated as safety issue: Yes ]
  • Intermittent catheterization due to urinary retention the occurrence of septic or febrile episodes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Prolonged hospitalization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Catheter blockage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Self-reported residual incontinence [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
Non-inferiority of Short-term 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 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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vaginal Fistula
  • 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.
  • Experimental: 7-day catheterization
    Intervention: Procedure: 7-day catheterization following fistula repair surgery
  • Active Comparator: 14-day catheterization
    Intervention: Procedure: 14 day catheterization
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, Gülmezoglu 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
507
Not Provided
June 2013   (final data collection date for primary outcome measure)

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)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sierra Leone,   Ethiopia,   Congo, The Democratic Republic of the,   Uganda,   Kenya,   Guinea,   Niger,   Nigeria
 
NCT01428830
A65783
Yes
EngenderHealth
EngenderHealth
  • World Health Organization
  • United States Agency for International Development (USAID)
Principal Investigator: Mark A Barone, DVM, MS EngenderHealth
Study Director: Mariana Widmer World Health Organization
EngenderHealth
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP