Vesico Vaginal FistulaNCT03029130
Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures
A study testing Catheter extension in people with Vesico Vaginal Fistula, run by Evangel VVF Centre.
Trial summary
This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. 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?
- Catheter extension
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Mar 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
- Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test
Who cannot join
- HIV infection,
- concomitant bladder stone(s),
- one or more ureters outside of the bladder,
- urethrovaginal fistula,
- multiple fistulas (more than one),
- dye leak / fistulous leak present at end of surgical procedure,
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- radiation-induced fistula,
- fistula caused by cancer or infection (such as lymphogranuloma venereum),
- continence procedures being performed (such as pubovaginal sling),
- rectovaginal fistula,
- pregnancy,
- fistula breakdown of greater than 2cm identified on postoperative dye test.
About this study
Official title: Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial
This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.
Read the detailed description
At present, there is no standard of care nor consensus for the proper management of repaired vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter removal. In the past, extension of time with catheterization has been tried, with patients becoming fully healed by the time of catheter removal. However, some patients who are discharged with a fistulous leak later return at follow up completely dry, with a closed and healed fistula. This study will compare, in a prospective, randomized manner, extension of catheterization vs no intervention, to see if in such patients extending catheterization will improve their likelihood of complete fistula healing.
- Conditions
- Vesico Vaginal Fistula
- Being tested
- Catheter extension
- Keywords
- vesicovaginal fistula, urinary catheter, catheter extension
- Medical subject headings
- Vesicovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter extensionDevice
Foley transurethral catheter placed to allow continuous drainage of urine.
| Study group | Role | What they receive |
|---|---|---|
| Catheter Extension | Experimental | Patients in this arm will have a foley catheter re-passed, to remain in situ for an additional 14 days, after which time the catheter will be removed and the patient discharged to return for follow up exam at 3 months postop. Receives: Device: Catheter extension |
| Discharge | No intervention | Patients in this arm will be discharged, to return for follow up exam at 3 months postop. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula closure
Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak
Measured: 3 months post-repair
Secondary outcomes (3)
Urinary continence
Patient is completely continent of urine with no reported OR demonstrable leakage of dye on inspection.
Measured: 3 months post-repair
Closure and continence at hospital discharge
Rates of fistula closure and complete urinary continence at the time of hospital discharge
Measured: Date of discharge (7-28 days post-repair)
Complications
Rates of complications or urinary tract infections during hospitalization
Measured: Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
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
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evangel VVF Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Shephard, Evangel VVF Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029130
- Sponsor's protocol ID
- EvangelWFC
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 24 Jan 2017
- 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 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03029130
- Acronym / sponsor ID
- EvangelWFC
- Conditions
- Vesico Vaginal Fistula
- Keywords
- vesicovaginal fistula, urinary catheter, catheter extension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Evangel VVF CentreUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.
Detailed description
At present, there is no standard of care nor consensus for the proper management of repaired vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter removal. In the past, extension of time with catheterization has been tried, with patients becoming fully healed by the time of catheter removal. However, some patients who are discharged with a fistulous leak later return at follow up completely dry, with a closed and healed fistula. This study will compare, in a prospective, randomized manner, extension of catheterization vs no intervention, to see if in such patients extending catheterization will improve their likelihood of complete fistula healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter Extension | Experimental | Device: Catheter extensionPatients in this arm will have a foley catheter re-passed, to remain in situ for an additional 14 days, after which time the catheter will be removed and the patient discharged to return for follow up exam at 3 months postop. |
| Discharge | No intervention | –Patients in this arm will be discharged, to return for follow up exam at 3 months postop. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test
Key exclusion criteria (12 listed)
- HIV infection,
- concomitant bladder stone(s),
- one or more ureters outside of the bladder,
- urethrovaginal fistula,
- multiple fistulas (more than one),
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 |
|---|---|---|
| Catheter extensionFoley transurethral catheter placed to allow continuous drainage of urine. | Device | Catheter Extension |
Primary outcome
Fistula closure
Time frame: 3 months post-repair
Successful closure of the fistula, as defined by patient self-reporting no urinary leakage AND a negative dye test proving no fistulous leak
3 secondary outcomes
Urinary continence
Time frame: 3 months post-repair
Closure and continence at hospital discharge
Time frame: Date of discharge (7-28 days post-repair)
Complications
Time frame: Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter extension in people with Vesico Vaginal Fistula, run by Evangel VVF Centre.
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 12 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: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Fistula closure (time frame: 3 months post-repair). 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 24 Jan 2017.