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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00911014
Other study ID # HSD08-00564
Secondary ID
Status Completed
Phase N/A
First received May 28, 2009
Last updated May 28, 2009
Start date September 2005
Est. completion date January 2006

Study information

Verified date May 2009
Source Ascher-Walsh, Charles, M.D.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Women who underwent surgery for repair or vesicovaginal fistula

Exclusion Criteria:

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Mount SInai School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Ascher-Walsh, Charles, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Access to healthcare 1 year No
Secondary Comprehension of pre-operative counselling 1 year No
Secondary Post-operative goals of women undergoing repair of vesicovaginal fistula 1 yr No
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