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

Sponsor

Ascher-Walsh, Charles, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT00911014

Collaborator

(none)

Enrollment

Location

Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vesicovaginal Fistula Delivery of Healthcare	Other: Questionnaire

Study Design

Study Type:

Observational

Actual Enrollment :

58 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jan 1, 2006

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Access to healthcare [1 year]

Secondary Outcome Measures

Comprehension of pre-operative counselling [1 year]
Post-operative goals of women undergoing repair of vesicovaginal fistula [1 yr]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Women who underwent surgery for repair or vesicovaginal fistula

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00911014

Other Study ID Numbers:

HSD08-00564

First Posted:

Jun 1, 2009

Last Update Posted:

Jun 1, 2009

Last Verified:

May 1, 2009

Additional relevant MeSH terms:

Vesicovaginal Fistula

Fistula

Study Results

No Results Posted as of Jun 1, 2009