Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula

December 16, 2020 updated by: Adnan Ali, Armed Forces Institute of Urology, Rawalpindi

A One Year Interventional Study in Patients With Vesicovaginal Fistula

In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Armed Forces Institute of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • all patients with Vesicovaginal fistula

Exclusion Criteria:

  • uretrovaginal fistula

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: extravesical VVF repair
Procedure: Extravesical VVF repair
Both standard transvesical and extravesical approach for VVF repair will be utilised
Other Names:
  • Transvesical VVF repair
Active Comparator: Transvesical VVF repair
Procedure: Extravesical VVF repair
Both standard transvesical and extravesical approach for VVF repair will be utilised
Other Names:
  • Transvesical VVF repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: 3 months
total time taken for surgery
3 months
complications
Time Frame: 3 months
bladder spasms, bleeding
3 months
recurrence
Time Frame: 3 months
patients who have recurrenec of symptoms
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Institute of Urology, Rawalpindi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

December 16, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFIU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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