Vesicovaginal FistulaNCT00911014
Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger
An observational study of Vesicovaginal Fistula and Delivery of Healthcare, run by Ascher-Walsh, Charles, M.D. at 1 site in United States.
Trial summary
Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vesicovaginal Fistula, Delivery of Healthcare
- What is being tested?
- Questionnaire
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jan 2006
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women who underwent surgery for repair of vesciovaginal fistula in Niamey, Niger
Who may be able to join
- Women who underwent surgery for repair or vesicovaginal fistula
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount SInai School of Medicine
New York, New York, 10029
About this study
Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire.
- Conditions
- Vesicovaginal Fistula, Delivery of Healthcare
- Being tested
- Questionnaire
- Medical subject headings
- Vesicovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
From September 2005 to January 2006, 58 women who underwent surgery for vesicovaginal fistula at the National Hospital Fistula Center in Niamey, Niger were interviewed post-operatively using a questionnaire developed to investigate demographic, social, economic, and cultural factors that may affect formation of fistula. Also included in this questionnaire was evaluation of access to health care as well as patient understanding of counseling regarding their surgery and post-operative instructions, in particular information about future fertility and fistula development.
| Study group | Role | What they receive |
|---|---|---|
| Vesicovaginal fistula repair | Women undergoing repair of vesicovaginal fistula Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to healthcare
Measured: 1 year
Secondary outcomes (2)
Comprehension of pre-operative counselling
Measured: 1 year
Post-operative goals of women undergoing repair of vesicovaginal fistula
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startSep 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vesicovaginal 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascher-Walsh, Charles, M.D.
- Investigators
- Charles Ascher-Walsh, MD, MS, Study director, Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911014
- Sponsor's protocol ID
- HSD08-00564
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 1 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meyer L, Ascher-Walsh CJ, Norman R, Idrissa A, Herbert H, Kimso O, Wilkinson J. Commonalities among women who experienced vesicovaginal fistulae as a result of obstetric trauma in Niger: results from a survey given at the National Hospital Fistula Center, Niamey, Niger. Am J Obstet Gynecol. 2007 Jul;197(1):90.e1-4. doi: 10.1016/j.ajog.2007.03.071.
PubMed 17618772
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger
- ClinicalTrials.gov ID
- NCT00911014
- Acronym / sponsor ID
- HSD08-00564
- Conditions
- Vesicovaginal Fistula, Delivery of Healthcare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ascher-Walsh, Charles, M.D.
- Study start
- Sep 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 1 Jun 2009 (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.
Evaluate access to healthcare, comprehension of pre-operative counseling and post-operative goals of women treated for vesicovaginal fistula in Niger through use of a questionnaire.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vesicovaginal fistula repair | – | Other: QuestionnaireWomen undergoing repair of vesicovaginal fistula |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who underwent surgery for repair of vesciovaginal fistula in Niamey, Niger
Key inclusion criteria (1 listed)
- Women who underwent surgery for repair or vesicovaginal fistula
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| QuestionnaireFrom September 2005 to January 2006, 58 women who underwent surgery for vesicovaginal fistula at the National Hospital Fistula Center in Niamey, Niger were interviewed post-operatively using a questionnaire developed to investigate demographic, social, economic, and cultural factors that may affect formation of fistula. Also included in this questionnaire was evaluation of access to health care as well as patient understanding of counseling regarding their surgery and post-operative instructions, in particular information about future fertility and fistula development. | Other | Vesicovaginal fistula repair |
Primary outcome
Access to healthcare
Time frame: 1 year
2 secondary outcomes
Comprehension of pre-operative counselling
Time frame: 1 year
Post-operative goals of women undergoing repair of vesicovaginal fistula
Time frame: 1 yr
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 1 Jun 2009.
- Background: PubMed 17618772Meyer L, Ascher-Walsh CJ, Norman R, Idrissa A, Herbert H, Kimso O, Wilkinson J. Commonalities among women who experienced vesicovaginal fistulae as a result of obstetric trauma in Niger: results from a survey given at the National Hospital Fistula Center, Niamey, Niger. Am J Obstet Gynecol. 2007 Jul;197(1):90.e1-4. doi: 10.1016/j.ajog.2007.03.071.
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.
Charles Ascher-Walsh, MD, MS study director
Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vesicovaginal Fistula and Delivery of Healthcare, run by Ascher-Walsh, Charles, M.D. at 1 site in United States.
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 1 Jun 2009. 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 United States. 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?
Access to healthcare (time frame: 1 year). 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 NCT00911014, which also lists 1 linked publication.
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 1 Jun 2009.