NCT04676568

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

December 16, 2020

Last Update Submit

December 16, 2020

Conditions

Vesico Vaginal Fistula

Outcome Measures

Primary Outcomes (3)

  • operative time

    total time taken for surgery

    3 months

  • complications

    bladder spasms, bleeding

    3 months

  • recurrence

    patients who have recurrenec of symptoms

    3 months

Study Arms (2)

extravesical VVF repair

ACTIVE COMPARATOR
Procedure: Extravesical VVF repair

Transvesical VVF repair

ACTIVE COMPARATOR
Procedure: Extravesical VVF repair

Interventions

Extravesical VVF repairPROCEDURE

Both standard transvesical and extravesical approach for VVF repair will be utilised

Also known as: Transvesical VVF repair
Transvesical VVF repairextravesical VVF repair

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all patients with Vesicovaginal fistula

You may not qualify if:

  • uretrovaginal fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Urology

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Vesicovaginal Fistula

Condition Hierarchy (Ancestors)

Vaginal FistulaVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder FistulaUrinary FistulaUrogenital AbnormalitiesUrinary Bladder DiseasesUrologic DiseasesGenital DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 21, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)