Female Genital Fistula, Urinary Incontinence
Conditions
Brief summary
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.
Interventions
BEHAVIORALMulti-component reintegration intervention
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Mama, LLC
Mulago Hospital, Uganda
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing surgery for female genital fistula * Age 18 or above, or emancipated minor per Ugandan law
Exclusion criteria
* No further criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Planned Intervention Sessions That Were Delivered | 6 weeks | Number of planned intervention session over the total number of planned interention sessions |
| Number of Participants Reporting to be Satisfied or Very Satisfied About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants. | 6 weeks | Number of participants reporting to be satisfied or very satisfied about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Reintegration Score | Baseline and 6 months | Mean change in reintegration score from pre-intervention (baseline) to post (6 months) on the post-fistula repair reintegration instrument (range 0-100, higher indicating better) |
| Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants. | 6 weeks | Number of participants reporting to be satisfied or very satisfied about their experience with the physiotherapy component of the intervention on a five-point Likert scale at six weeks over the total number of intervention participants. |
| Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants | 6 weeks | Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants |
| Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants | 6 weeks | Number of participants reporting to be satisfied or very satisfied about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants. |
| Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants. | 6 weeks | Number of participants reporting to be satisfied or very satisfied about their experience participating in the psychosocial counseling component of the intervention on a five-point Likert scale at six weeks over the total number of participants. |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multi-component Reintegration Intervention 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.
Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Multi-component Reintegration Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 34.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Participants Reporting to be Satisfied or Very Satisfied About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Number of participants reporting to be satisfied or very satisfied about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-component Reintegration Intervention | Number of Participants Reporting to be Satisfied or Very Satisfied About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants. | 12 Participants |
Primary
Percentage of Planned Intervention Sessions That Were Delivered
Number of planned intervention session over the total number of planned interention sessions
Time frame: 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Multi-component Reintegration Intervention | Percentage of Planned Intervention Sessions That Were Delivered | 96.2 percentage of planned sessions |
Secondary
Change in Reintegration Score
Mean change in reintegration score from pre-intervention (baseline) to post (6 months) on the post-fistula repair reintegration instrument (range 0-100, higher indicating better)
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Multi-component Reintegration Intervention | Change in Reintegration Score | 30.5 scores on a scale |
Secondary
Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.
Number of participants reporting to be satisfied or very satisfied about their experience participating in the psychosocial counseling component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-component Reintegration Intervention | Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants. | 12 Participants |
Secondary
Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-component Reintegration Intervention | Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants | 12 Participants |
Secondary
Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
Number of participants reporting to be satisfied or very satisfied about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-component Reintegration Intervention | Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants | 12 Participants |
Secondary
Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
Number of participants reporting to be satisfied or very satisfied about their experience with the physiotherapy component of the intervention on a five-point Likert scale at six weeks over the total number of intervention participants.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Multi-component Reintegration Intervention | Number of Participants Reporting to be Satisfied or Very Satisfied About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants. | 12 Participants |