Health Condition 1: N393- Stress incontinence (female) (male)
Conditions
Interventions
Intervention1: Autologous Fascia Lata: Retropubic Autologous Fascia Lata Sling Surgery(for lifetime) for stress urinary incontinence
Control Intervention1: Synthetic Vaginal Tape: Retropubic Synthetic
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Patients with SUI or stress predominant mixed UI with 1.Failure of conservative management 2.A positive cough stress test when bladder volume at 300 ml or more
Exclusion criteria
Exclusion criteria: 1.Pelvic organ prolapse requiring surgical intervention 2.Previous incontinence surgery or pelvic operation 3.Evidence or suspicious of malignancies 4.History of neurogenic bladder 5.Uncontrolled diabetes mellitus (DM), neurological disease, and prominent mixed incontinence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate cure rate and improvement in symptoms of patients post-procedure using cough stress test and ICIQ-UI SF questionnaire Timepoint: 1 week 6 weeks 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of painTimepoint: At 8th and 24th hour of procedure ;Length of operative time (incision to closure) Timepoint: From incision to closure ;Intraoperative complications of each procedure in terms of bleeding, bladder and urethral injuryTimepoint: At the time of operation;Postoperative complications in terms of urinary retention (post-voiding residual urine) and graft site complicationsTimepoint: 3 months;Duration of hospital stayTimepoint: Immediately post procedure;Assessing the improvement in symptoms including quality of life and sexual function post-surgery by Bladder diary, International Consultation on Incontinence Questionnaire- Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) score and Kings Health Questionnaire (KHQ)Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Richa Vatsa
AIIMS New Delhi
Outcome results
None listed