ClinicalTrials.gg
Sign In
CompletedNCT04676568Updated Dec 21, 2020

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

An interventional study of Extravesical VVF repair in Vesico Vaginal Fistula, sponsored by Armed Forces Institute of Urology, Rawalpindi. Completed at 1 site in Pakistan. Open to female participants. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Armed Forces Institute of Urology, Rawalpindi · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jul 2019, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Sex
Female
01

Study summary

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

02

Conditions studied

  • Vesico Vaginal Fistula
03

In context

Lead sponsor

Armed Forces Institute of Urology, Rawalpindi is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients with Vesicovaginal fistula

Exclusion criteria

Exclusion Criteria:

  • uretrovaginal fistula
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    extravesical VVF repair

    Procedure: Extravesical VVF repair

  • Active comparator
    Transvesical VVF repair

    Procedure: Extravesical VVF repair

Interventions

  • ProcedureExtravesical VVF repair

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

    Also known as: Transvesical VVF repair

06

What researchers measure

Primary outcomes

  1. operative time

    total time taken for surgery

    Time frame: 3 months

  2. complications

    bladder spasms, bleeding

    Time frame: 3 months

  3. recurrence

    patients who have recurrenec of symptoms

    Time frame: 3 months

07

Study locations

1 site
  • Armed Forces Institute of Urology
    Rawalpindi, Punjab 46000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Jul 2020, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2020
First posted
Dec 21, 2020
StartActual
Jul 1, 2019
Primary completionActual
Jul 1, 2020
CompletionActual
Jul 1, 2020
Last update
Dec 21, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04676568
Lead sponsor
Armed Forces Institute of Urology, Rawalpindi
Responsible party
Adnan Ali (Consultant Surgeon, Armed Forces Institute of Urology, Rawalpindi) — Principal investigator
First posted
Dec 21, 2020
Start date
Jul 1, 2019
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020
Last update
Dec 21, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Vesicovaginal Fistula

Other studies from this sponsor

Armed Forces Institute of Urology, Rawalpindi

Start the discussion