An RCT of early discharge with a catheter Vs late discharge after catheter removal following urogenital fistula repair among women in Mulago Hospital,
Not Applicable
- Conditions
- Urological and Genital DiseasesSurgeryFemale urogenital Fistula
- Registration Number
- PACTR201306000556261
- Lead Sponsor
- Makerere- Karolinska collaboration sponsored by sida
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
women with urogenital fistula,
following surgery irrespective of route, fistula 1cm or more from external urethra orifice,
surgeon has confirmed closure by negative dye test,
fistula still closed by day 3-5,
if consented and
stable will be randomized and included in the study
Exclusion Criteria
women with both urogenital and recto-vaginal fistula,
extensive fibrosis,
fistula within 1cm from external urethra orifice,
bladder length of less than 5cm (small capacity bladder),
leakage after repair up to 3 days,
fistula following malignancy,
fistulas following infection,
very sick patient after surgery or during surgery,
those with overt infection
women who come from far (transport cost more than 40,000 Uganda shillings
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fistula closure rates
- Secondary Outcome Measures
Name Time Method rates of complications: catheter blockage, post repair urethral incontinence, infections leading to readmission, acceptabilty of catheter, quality of life change in relationshipships following treatment among the 2 groups