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Outcomes of Women After Obstetric Fistula Repair

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ClinicalTrials.gov Identifier: NCT02685878
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Jennifer Tang, MD, MSCR, University of North Carolina, Chapel Hill

Brief Summary:

The purpose of this study is to describe the long-term surgical success, quality of life, prevalence of depression, fertility rates, and pregnancy outcomes of patients who have undergone obstetric fistula repair.

This will be a study involving up to 300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.

Patients who underwent obstetric fistula repair between January 1, 2012 and July 31, 2014 will be identified from an existing database of fistula patients. They will then be contacted and invited to participate in the study. Consented patients will complete a 1-hour pad weight to evaluate urinary continence, a demographic questionnaire, an incontinence-related quality of life metric, and a depression metric. The data will be analyzed and then disseminated to stakeholders.


Condition or disease
Fistula HIV

Detailed Description:

Eligible participants will be identified from an existing, secure database. Participants will be contacted and traced. They will then be invited to participate in the study. If a participant agrees to participate in the study, they will undergo informed consent by trained study staff, using IRB-approved informed consent forms. They will then undergo a 1-hour pad weight, complete demographic data, complete an incontinence-related quality of life metric, and complete a depression metric.

1-hour pad weight: Use of the 1-hour pad weights have been recommended as an objective measure of treatment outcome for anti-incontinence procedures. After a woman has agreed to enroll in the study and has given written consent, she will be asked to complete a 1-hour pad weight. Pad weights will be measured through having participants sit on a pre-weighed pad for exactly one hour and re-weighing the same pad. The weight of the pad before and after will be recorded and the difference between the two will be used as the pad weight. The pad weight represents the degree of urinary leakage a woman is experiencing. In continent populations, this weight is <1.5 grams. The research assistant will use a calibrated portable scale and stopwatch to ensure accurate recording of these weights. During this time, the remainder of the survey will be conducted.

Demographic Data: Demographic data for each participant will be collected at the time of enrollment and after a written consent has been obtained. This includes information about the patient's age, place of residence, HIV status, education attainment, living arrangement, number of pregnancies and living children, and symptoms of urinary or fecal leakage.

Incontinence-related Quality of Life Metric: To assess OF repair success and continence, participants will be asked about any leakage symptoms with the Kings' Health Questionnaire.

Depression Metric:The 9-question Patient Health Questionnaire (PHQ-9) will be used to assess repaired OF participants for depression.


Study Type : Observational
Actual Enrollment : 297 participants
Time Perspective: Prospective
Official Title: Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas




Primary Outcome Measures :
  1. The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated. [ Time Frame: 1 hour ]
    To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.


Secondary Outcome Measures :
  1. Depression after obstetric fistula repair [ Time Frame: 1-3 years after obstetric fistula repair ]
    The PHQ-9 will be administered and women who score a 10 or greater will be considered to have major depression.


Other Outcome Measures:
  1. Number of fertile women able to achieve pregnancy after fistula repair [ Time Frame: 1-3 years after obstetric fistula repair ]
    The number of women with any pregnancy since repair divided by the number of married, fecund women.

  2. Quality of life of women after fistula repair [ Time Frame: 1-3 years after obstetric fistula repair ]
    The number of women with a score over 0 in the each of the following domains of the King's Health Questionnaire: general health, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, and sleep/energy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 women 1-3 years after they have undergone obstetric fistula repair at the Fistula Care Center in Lilongwe, Malawi.
Criteria

Inclusion Criteria:

  1. Study participants who have had an obstetric fistula repair performed at the Fistula Care Center between January 1, 2012 and July 31, 2014
  2. Women that currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba will be traced.
  3. Ability to speak Chichewa or English fluently
  4. Current age 18 years or above

Exclusion Criteria:

  1. Participants who did not have an obstetric fistula repair
  2. Participants who have deceased since their obstetric fistula repair
  3. Participants who do not currently reside within the districts of Lilongwe, Dedza, Kasungu, Salima, Dowa, Ntcheu, Nkhotakota, Mchinji, Ntchisi, and Mzimba

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685878


Locations
Malawi
UNC Project
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Jennifer Tang, MD University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jennifer Tang, MD, MSCR, Assistant Professor, OBGYN-Global Health, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02685878     History of Changes
Other Study ID Numbers: UNCPM 21502
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jennifer Tang, MD, MSCR, University of North Carolina, Chapel Hill:
urinary continence
prevalence of depression
reproductive outcomes
quality of life
HIV status
obstetric fistula

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical