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

Vesico Vaginal Fistula Clinical Trial

Official title:

A One Year Interventional Study in Patients With Vesicovaginal Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676568
• Other study ID #: AFIU
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2020
• Source: Armed Forces Institute of Urology, Rawalpindi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients with Vesicovaginal fistula

Exclusion Criteria:

• uretrovaginal fistula

Related Conditions & MeSH terms

• Fistula
• Vaginal Fistula
• Vesico Vaginal Fistula
• Vesicovaginal Fistula

Intervention

Procedure:
• Extravesical VVF repair
Both standard transvesical and extravesical approach for VVF repair will be utilised

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Urology	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Institute of Urology, Rawalpindi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	total time taken for surgery	3 months
Primary	complications	bladder spasms, bleeding	3 months
Primary	recurrence	patients who have recurrenec of symptoms	3 months