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

Primary Purpose

Vesico Vaginal Fistula

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Extravesical VVF repair
Sponsored by
Armed Forces Institute of Urology, Rawalpindi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vesico Vaginal Fistula

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients with Vesicovaginal fistula

Exclusion Criteria:

  • uretrovaginal fistula

Sites / Locations

  • Armed Forces Institute of Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

extravesical VVF repair

Transvesical VVF repair

Arm Description

Outcomes

Primary Outcome Measures

operative time
total time taken for surgery
complications
bladder spasms, bleeding
recurrence
patients who have recurrenec of symptoms

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
December 16, 2020
Sponsor
Armed Forces Institute of Urology, Rawalpindi
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1. Study Identification

Unique Protocol Identification Number
NCT04676568
Brief Title
Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula
Official Title
A One Year Interventional Study in Patients With Vesicovaginal Fistula
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Forces Institute of Urology, Rawalpindi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vesico Vaginal Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extravesical VVF repair
Arm Type
Active Comparator
Arm Title
Transvesical VVF repair
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Extravesical VVF repair
Other Intervention Name(s)
Transvesical VVF repair
Intervention Description
Both standard transvesical and extravesical approach for VVF repair will be utilised
Primary Outcome Measure Information:
Title
operative time
Description
total time taken for surgery
Time Frame
3 months
Title
complications
Description
bladder spasms, bleeding
Time Frame
3 months
Title
recurrence
Description
patients who have recurrenec of symptoms
Time Frame
3 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients with Vesicovaginal fistula Exclusion Criteria: uretrovaginal fistula
Facility Information:
Facility Name
Armed Forces Institute of Urology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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