Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 56
- Primary Endpoint
- stress urinary incontinence
Study Overview
Brief 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.
Detailed Description
Aim: To de termine the effect of mid urethral sling in reducing postoperative incontinence after vaginal prolapse surgery.
General Objectives: To compare the risk of de novo postoperative incontinence between prolapsed surgery with mid urethral sling versus no sling.
Specific Objectives: to compare the change in score of BFLUTS-SF (Bristol Female lower urinary tract symptoms- sexual function) and UDI-6 (Urinary distress inventory-6) pre and post surgery between the two groups.
Research Hypothesis: The use of mid urethral sling after vaginal prolapse surgery has role in reduction of postoperative incontinence.
Materials & Methods:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
those who will be filling questionnaires before and after the surgery are masked
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical POP-Q stage 3 or more
- •Must have cell phone
Exclusion Criteria
- •Patient with POPQ stage less than stage 3
- •Patient not giving consent
- •Patient with previous pelvic and spine surgery
- •Patient having positive cough stress test on examination
Arms & Interventions
vagianl prolapse surgery accompanied with TVT sling
patients will undergo vaginal hysterectomy with McCall's culdoplasty and anterior repair with or without posterior repair according to the need. Patient who falls in Group will undergo mid urethral sling with tension free vaginal tape (TVT) using TVT mid urethral sling.
Intervention: Retro pubic sling (Device)
vaginal prolapse surgery not accompanied with sling
patients will undergo vaginal hysterectomy with McCall's culdoplasty and anterior repair with or without posterior repair according to the need.
Outcomes
Primary Outcomes
stress urinary incontinence
Time Frame: 6 months
The primary outcome of the study will be the presence of stress urinary incontinence in post operative at 6 months follow up. During follow up patient will be asked about the urinary incontinence on coughing, sneezing, heavy work and will examined in comfortably full bladder and cough stress test will be done to confirm the diagnosis of stress urinary incontinence.
Stress urinary incontinence
Time Frame: 3 months
The primary outcome of the study will be the presence of stress urinary incontinence in post operative at 3 months follow up. During follow up patient will be asked about the urinary incontinence on coughing, sneezing, heavy work and will examined in comfortably full bladder and cough stress test will be done to confirm the diagnosis of stress urinary incontinence.
Secondary Outcomes
- 1) BFLUTS-FS (frequency symptoms), VS(voiding symptoms), IS (Irritable symptoms), Sex symptoms , QoL (Quality of life) score 2) UDI-6 (Urinary distress inventory-6) score 3) Complications during surgery 4) Dyspareunia 5) Pelvic pain(6 months)
- 1) BFLUTS-FS (frequency symptoms), VS(voiding symptoms), IS (Irritable symptoms), Sex symptoms , QoL (Quality of life) score 2) UDI-6 (Urinary distress inventory-6) score 3) Complications during surgery 4) Dyspareunia 5) Pelvic pain(3 months)
Investigators
Baburam Dixit Thapa
Assistant Professor, Obstetrics and Gynecology
B.P. Koirala Institute of Health Sciences