NCT00911014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
Last Updated

June 1, 2009

Status Verified

May 1, 2009

Enrollment Period

4 months

First QC Date

May 28, 2009

Last Update Submit

May 28, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Access to healthcare

    1 year

Secondary Outcomes (2)

  • Comprehension of pre-operative counselling

    1 year

  • Post-operative goals of women undergoing repair of vesicovaginal fistula

    1 yr

Study Arms (1)

Vesicovaginal fistula repair

Women undergoing repair of vesicovaginal fistula

Other: Questionnaire

Interventions

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.

Vesicovaginal fistula repair

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Women who underwent surgery for repair or vesicovaginal fistula

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount SInai School of Medicine

New York, New York, 10029, United States

Location

Related 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. doi: 10.1016/j.ajog.2007.03.071.

    PMID: 17618772BACKGROUND

MeSH Terms

Conditions

Vesicovaginal Fistula

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vaginal FistulaVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder FistulaUrinary FistulaUrogenital AbnormalitiesUrinary Bladder DiseasesUrologic DiseasesGenital DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Charles Ascher-Walsh, MD, MS

    Mt Sinai School of Medicine, Dept Obstetrics and Gynecology

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

September 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

June 1, 2009

Record last verified: 2009-05

Locations