Fistula Reintegration Pilot

University of California San Francisco (UCSF)

Status: Completed

Conditions: Female Genital Fistula; Urinary Incontinence

Treatments: Behavioral: Multi-component reintegration intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04748653

P0527552

R00HD086232 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing surgery for female genital fistula
• Age 18 or above, or emancipated minor per Ugandan law

Exclusion criteria

• No further criteria

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Multi-component reintegration intervention

Experimental group

Description:

There is one arm for the feasibility and acceptability study - all intervention participants will receive the intervention: health education, psychosocial counseling, physiotherapy, and economic investment.

Treatment:

Behavioral: Multi-component reintegration intervention