Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence
NCT04251923 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2020-02-05
Summary
Prevalence of pelvic organ prolapsed is high in Nepal. After prolapse surgery many patients are affected with incontinence. Incontinence has physical, social and mental effect to the individual. This study is designed to know the role for mid urethral sling during vaginal prolapse surgery to decrease the rate of incontinence after the surgery.
Conditions
- Stress Urinary Incontinence
- Vaginal Hysterectomy
- Quality of Life
Interventions
- DEVICE
-
Retro pubic sling
patient after hysterectomy will undergo retropubic sling surgery in the same setting. Retropubic sling will be inserted vaginally in the retropubic area following standard protocol.
Sponsors & Collaborators
-
B.P. Koirala Institute of Health Sciences
lead OTHER
Principal Investigators
-
Mohan ch Regmi, Professor · BPKIHS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-31
- Primary Completion
- 2021-06-30
- Completion
- 2021-07-31
- FDA Device
- Yes
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