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

NCT01428830 | Completed DMC

• 1 other identifier: A65783
• Study Type: interventional
• Target: 524
• Locations: 8 countries
• Sites: 8

Brief 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

Keywords

fistula; catheter; surgery; obstetrics; gynecology; urology

Outcome Measures

Primary Outcomes (1)

• Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.

  3 months

Secondary Outcomes (6)

• Repair breakdown one week following catheter removal

  14 days or 21 days post-repair

• Intermittent catheterization due to urinary retention

  7 or 14 days post repair

• Prolonged hospitalization

  14 or 21 days post-repair

• Catheter blockage

  14 or 21 days post repair

• Self-reported residual incontinence

  3 months

Study Arms (2)

7-day catheterization

EXPERIMENTAL

Procedure: 7-day catheterization following fistula repair surgery

14-day catheterization

ACTIVE COMPARATOR

Procedure: 14 day catheterization

Interventions

7-day catheterization following fistula repair surgery PROCEDURE

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

7-day catheterization

14 day catheterization PROCEDURE

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

14-day catheterization

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• EngenderHealth: lead
• World Health Organization: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (8)

Hôpital Saint Joseph

Kinshasa, Democratic Republic of the Congo

Location

Gondar University Hospital

Gonder, Ethiopia

Location

L'Hôpital Préfectoral de Kissidougou

Kissidougou, Guinea

Location

Kenyatta National Hospital

Nairobi, Kenya

Location

National Obstetric Fistula Centre

Abakaliki, Nigeria

Location

Maternité Centrale de Zinder

Zinder, Niger

Location

Aberdeen Women's Centre

Freetown, Sierra Leone

Location

Kagando Hospital

Kasese District, Uganda

Location

Related Publications (2)

• Barone MA, Widmer M, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Barry TH, Danladi D, Djangnikpo L, Gbawuru-Mansaray T, Harou I, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Landoulsi S, Delamou A, Were L, Frajzyngier V, Beattie K, Gulmezoglu AM. Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial. Lancet. 2015 Jul 4;386(9988):56-62. doi: 10.1016/S0140-6736(14)62337-0. Epub 2015 Apr 21.

  PMID: 25911172 DERIVED

• 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, Gulmezoglu 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.

  PMID: 22433581 DERIVED

MeSH Terms

Conditions

Vaginal Fistula; Fistula

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Mark A Barone, DVM, MS

  EngenderHealth

  PRINCIPAL INVESTIGATOR

• Mariana Widmer

  World Health Organization

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 5, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

UG (1); SI (1); DE (1); NI (1); NG (1); KE (1); GU (1); ET (1)