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

This study has been completed.
Sponsor:
Information provided by:
Ascher-Walsh, Charles, M.D.
ClinicalTrials.gov Identifier:
NCT00911014
First received: May 28, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Vesicovaginal Fistula
Delivery of Healthcare
Other: Questionnaire

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Access to Healthcare, Patient Comprehension and Future Plans of Women Undergoing Surgery for a Vesicovaginal Fistula in Niamey, Niger

Resource links provided by NLM:


Further study details as provided by Ascher-Walsh, Charles, M.D.:

Primary Outcome Measures:
  • Access to healthcare [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comprehension of pre-operative counselling [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Post-operative goals of women undergoing repair of vesicovaginal fistula [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: September 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Women who underwent surgery for repair or vesicovaginal fistula

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911014

Locations
United States, New York
Mount SInai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Ascher-Walsh, Charles, M.D.
Investigators
Study Director: Charles Ascher-Walsh, MD, MS Mt Sinai School of Medicine, Dept Obstetrics and Gynecology
  More Information

Publications:
Responsible Party: Charles Ascher-Walsh, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00911014     History of Changes
Other Study ID Numbers: HSD08-00564
Study First Received: May 28, 2009
Last Updated: May 28, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fistula
Vesicovaginal Fistula
Pathological Conditions, Anatomical
Urinary Bladder Fistula
Urinary Fistula
Urogenital Abnormalities
Urinary Bladder Diseases
Urologic Diseases
Vaginal Fistula

ClinicalTrials.gov processed this record on August 27, 2014