Vaginal FistulaNCT01428830
Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
A study testing 7-day catheterization following fistula repair surgery and 14 day catheterization in people with Vaginal Fistula, run by EngenderHealth at 8 sites in 8 countries.
Trial summary
This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginal Fistula
- What is being tested?
- 7-day catheterization following fistula repair surgery and 14 day catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jan 2012to Aug 2013
- 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
- Have a "simple" fistula, as determined at the end of fistula repair surgery (irrespective of the number of prior repair attempts and the cause of the fistula, with the exceptions noted under the exclusion criteria below)
- Have a closed fistula at completion of surgery
- Have a closed fistula 7 days after surgery (i.e. at the time of randomization)
- Understand study procedures and requirements
- Agree to return to the facility for one follow-up visit three month after the date of surgery
- Provide informed consent to participate in the study or in the case of non-emancipated minors, both consent to the study and receive proxy consent to participate in the study
- Have no contraindications precluding their participation.
Who cannot join
- Have a fistula that is determined to be "not simple" (i.e. intermediate or complex)
- Have a fistula that is radiation-induced, associated with cancer or due to lymphogranuloma venereum (These cases will be excluded because the healing process is very different from fistula resulting from other causes. We expect there to be few cases of these fistulas at the study sites)
- Have a fistula that is not closed immediately after surgery or 7 days after surgery (i.e. at the time of randomization)
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Democratic Republic of the Congo1 site
Hôpital Saint Joseph
Kinshasa
About this study
This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.
Read the detailed description
A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity (by freeing available bed space and increasing availability of nursing staff), lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery.
This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test, a routine practice in fistula repair services. t. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization (defined as a stay at the facility beyond one week following initial catheter removal related to an adverse event), catheter blockage, and self-reported residual incontinence. This study will be conducted among 507 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 16-18 months at each site.
- Conditions
- Vaginal Fistula
- Being tested
- 7-day catheterization following fistula repair surgery, 14 day catheterization
- Keywords
- fistula, catheter, surgery, obstetrics, gynecology, urology
- Medical subject headings
- Vaginal Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day catheterization following fistula repair surgeryProcedure or surgery
This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
14 day catheterizationProcedure or surgery
This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.
| Study group | Role | What they receive |
|---|---|---|
| 7-day catheterization | Experimental | Not described Receives: Procedure: 7-day catheterization following fistula repair surgery |
| 14-day catheterization | Active comparator | Not described Receives: Procedure: 14 day catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.
Measured: 3 months
Secondary outcomes (6)
Repair breakdown one week following catheter removal
Measured: 14 days or 21 days post-repair
Intermittent catheterization due to urinary retention
Measured: 7 or 14 days post repair
Prolonged hospitalization
Measured: 14 or 21 days post-repair
Catheter blockage
Measured: 14 or 21 days post repair
Self-reported residual incontinence
Measured: 3 months
The occurrence of septic or febrile episodes
Measured: 14 or 21 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 posted5 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- EngenderHealth
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Mark A Barone, DVM, MS, Principal investigator, EngenderHealthMariana Widmer, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428830
- Sponsor's protocol ID
- A65783
- Status last verified
- Jan 2015
- First submitted
- 2 Sep 2011
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barone MA, Widmer M, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Barry TH, Danladi D, Djangnikpo L, Gbawuru-Mansaray T, Harou I, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Landoulsi S, Delamou A, Were L, Frajzyngier V, Beattie K, Gulmezoglu AM. Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial. Lancet. 2015 Jul 4;386(9988):56-62. doi: 10.1016/S0140-6736(14)62337-0. Epub 2015 Apr 21.
PubMed 25911172Barone MA, Frajzyngier V, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Beattie K, Barry TH, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Widmer M, Gulmezoglu AM. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial. BMC Womens Health. 2012 Mar 20;12:5. doi: 10.1186/1472-6874-12-5.
PubMed 22433581
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority of Short-term Catheterization Following Fistula Repair Surgery
- ClinicalTrials.gov ID
- NCT01428830
- Acronym / sponsor ID
- A65783
- Conditions
- Vaginal Fistula
- Keywords
- fistula, catheter, surgery, obstetrics, gynecology, urology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- EngenderHealthUniversity, hospital or other
- Collaborators
- World Health Organization, United States Agency for International Development (USAID)
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Sep 2011 (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 facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown three months following urinary fistula repair surgery. The study will be conducted among 507 women with simple fistula presenting at 8 study sites in Sub-Saharan Africa for fistula repair surgery.
Detailed description
A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity (by freeing available bed space and increasing availability of nursing staff), lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery.
This facility-based, multi-center randomized controlled trial (RCT) will test the non-inferiority of short-term (7 day) urethral catheterization compared to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test, a routine practice in fistula repair services. t. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization (defined as a stay at the facility beyond one week following initial catheter removal related to an adverse event), catheter blockage, and self-reported residual incontinence. This study will be conducted among 507 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 16-18 months at each site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7-day catheterization | Experimental | Procedure: 7-day catheterization following fistula repair surgery |
| 14-day catheterization | Active comparator | Procedure: 14 day catheterization |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have a "simple" fistula, as determined at the end of fistula repair surgery (irrespective of the number of prior repair attempts and the cause of the fistula, with the exceptions noted under the exclusion criteria below)
- Have a closed fistula at completion of surgery
- Have a closed fistula 7 days after surgery (i.e. at the time of randomization)
- Understand study procedures and requirements
- Agree to return to the facility for one follow-up visit three month after the date of surgery
Key exclusion criteria (3 listed)
- Have a fistula that is determined to be "not simple" (i.e. intermediate or complex)
- Have a fistula that is radiation-induced, associated with cancer or due to lymphogranuloma venereum (These cases will be excluded because the healing process is very different from fistula resulting from other causes. We expect there to be few cases of these fistulas at the study sites)
- Have a fistula that is not closed immediately after surgery or 7 days after surgery (i.e. at the time of randomization)
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 |
|---|---|---|
| 7-day catheterization following fistula repair surgeryThis group will have an indwelling urethral catheter for 7 days following fistula repair surgery. | Procedure or surgery | 7-day catheterization |
| 14 day catheterizationThis group will have an indwelling urethral catheter for 14 days following fistula repair surgery. | Procedure or surgery | 14-day catheterization |
Primary outcome
Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test.
Time frame: 3 months
6 secondary outcomes
Repair breakdown one week following catheter removal
Time frame: 14 days or 21 days post-repair
Intermittent catheterization due to urinary retention
Time frame: 7 or 14 days post repair
Prolonged hospitalization
Time frame: 14 or 21 days post-repair
Catheter blockage
Time frame: 14 or 21 days post repair
Self-reported residual incontinence
Time frame: 3 months
The occurrence of septic or febrile episodes
Time frame: 14 or 21 days post-repair
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 19 Jan 2015.
- Derived from this study: PubMed 25911172Barone MA, Widmer M, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Barry TH, Danladi D, Djangnikpo L, Gbawuru-Mansaray T, Harou I, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Landoulsi S, Delamou A, Were L, Frajzyngier V, Beattie K, Gulmezoglu AM. Breakdown of simple female genital fistula repair after 7 day versus 14 day postoperative bladder catheterisation: a randomised, controlled, open-label, non-inferiority trial. Lancet. 2015 Jul 4;386(9988):56-62. doi: 10.1016/S0140-6736(14)62337-0. Epub 2015 Apr 21.
- Derived from this study: PubMed 22433581Barone MA, Frajzyngier V, Arrowsmith S, Ruminjo J, Seuc A, Landry E, Beattie K, Barry TH, Lewis A, Muleta M, Nembunzu D, Olupot R, Sunday-Adeoye I, Wakasiaka WK, Widmer M, Gulmezoglu AM. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial. BMC Womens Health. 2012 Mar 20;12:5. doi: 10.1186/1472-6874-12-5.
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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.
Mark A Barone, DVM, MS principal investigator
EngenderHealth
Mariana Widmer study director
World Health Organization
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7-day catheterization following fistula repair surgery and 14 day catheterization in people with Vaginal Fistula, run by EngenderHealth at 8 sites in 8 countries.
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 7 inclusion and 3 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 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Democratic Republic of the Congo, Ethiopia, Guinea, Kenya, Nigeria and 3 more countries. 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?
Fistula repair breakdown three months following fistula repair surgery as assessed by a urinary dye test. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428830, which also lists 2 linked publications.
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 19 Jan 2015.