Vesico Vaginal FistulaNCT04676568
Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula
A study testing Extravesical VVF repair in people with Vesico Vaginal Fistula, run by Armed Forces Institute of Urology, Rawalpindi at 1 site in Pakistan.
Trial summary
In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vesico Vaginal Fistula
- What is being tested?
- Extravesical VVF repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients with Vesicovaginal fistula
Who cannot join
- uretrovaginal fistula
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Urology
Rawalpindi, Punjab Province, 46000
About this study
Official title: 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.
- Conditions
- Vesico Vaginal Fistula
- Being tested
- Extravesical VVF repair
- Medical subject headings
- Vesicovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extravesical VVF repairProcedure or surgery
Also called Transvesical VVF repair
Both standard transvesical and extravesical approach for VVF repair will be utilised
| Study group | Role | What they receive |
|---|---|---|
| extravesical VVF repair | Active comparator | Not described Receives: Procedure: Extravesical VVF repair |
| Transvesical VVF repair | Active comparator | Not described Receives: Procedure: Extravesical VVF repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
total time taken for surgery
Measured: 3 months
complications
bladder spasms, bleeding
Measured: 3 months
recurrence
patients who have recurrenec of symptoms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jul 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesico Vaginal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Urology, Rawalpindi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adnan Ali, Armed Forces Institute of Urology, Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676568
- Sponsor's protocol ID
- AFIU
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A One Year Interventional Study in Patients With Vesicovaginal Fistula
- ClinicalTrials.gov ID
- NCT04676568
- Acronym / sponsor ID
- AFIU
- Conditions
- Vesico Vaginal Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Armed Forces Institute of Urology, RawalpindiUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extravesical VVF repair | Active comparator | Procedure: Extravesical VVF repair |
| Transvesical VVF repair | Active comparator | Procedure: Extravesical VVF repair |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with Vesicovaginal fistula
Key exclusion criteria (1 listed)
- uretrovaginal fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extravesical VVF repairAlso: Transvesical VVF repairBoth standard transvesical and extravesical approach for VVF repair will be utilised | Procedure or surgery | Transvesical VVF repair, extravesical VVF repair |
Primary outcome
operative time
Time frame: 3 months
total time taken for surgery
complications
Time frame: 3 months
bladder spasms, bleeding
recurrence
Time frame: 3 months
patients who have recurrenec of symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extravesical VVF repair in people with Vesico Vaginal Fistula, run by Armed Forces Institute of Urology, Rawalpindi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2020.