Outcomes of Women After Obstetric Fistula Repair

HIV Clinical Trial

Official title:

Physical, Psychological, and Reproductive Outcomes of Women After Obstetric Fistula Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685878
• Other study ID #: UNCPM 21502
• Status: Completed
• Start date: September 2015
• Est. completion date: November 5, 2018

Study information

• Verified date: November 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: November 5, 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• HIV

Locations

Country	Name	City	State
Malawi	UNC Project	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of fertile women able to achieve pregnancy after fistula repair	The number of women with any pregnancy since repair divided by the number of married, fecund women.	1-3 years after obstetric fistula repair
Other	Quality of life of women after 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.	1-3 years after obstetric fistula repair
Primary	The prevalence of participants with a 1-hour pad weight over 1.5 grams (marker of incontinence) will be be calculated.	To assess OF repair success and continence, patients will complete a 1-hour pad weight, which correlates to urinary incontinence.	1 hour
Secondary	Depression 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.	1-3 years after obstetric fistula repair