Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger

May 28, 2009 updated by: Ascher-Walsh, Charles, M.D.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women who underwent surgery for repair of vesciovaginal fistula in Niamey, Niger

Description

Inclusion Criteria:

  • Women who underwent surgery for repair or vesicovaginal fistula

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vesicovaginal fistula repair
Women undergoing repair of vesicovaginal fistula
Other: Questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Access to healthcare
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Comprehension of pre-operative counselling
Time Frame: 1 year
1 year
Post-operative goals of women undergoing repair of vesicovaginal fistula
Time Frame: 1 yr
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascher-Walsh, Charles, M.D.

Investigators

  • Study Director: Charles Ascher-Walsh, MD, MS, Mt Sinai School of Medicine, Dept Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

June 1, 2009

Last Update Submitted That Met QC Criteria

May 28, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSD08-00564

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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