Quality of Life Clinical Trial
Official title:
Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence: a Randomized Controlled Trial
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.
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:
1. Whether study involves humans/animals or both : Humans
2. Population/ participants: Patients with pelvic organ prolapse who are planned for
vaginal prolapse surgery in BPKIHS (BP Koirala Institute of Health and Sciences).
3. Type of study design: a randomized controlled trial
(e) Expected sample size: 54 Sample size calculation: Previous study done by Control groups:
Patient undergoing vaginal prolapse surgery only without mid urethral sling. There will be
small incision in the suprapubic region that mimics the TVT incision.
(f) Probable duration of study: one and half year (g) Setting: BPKIHS, Department of
Obstetrics and Gynecology (h) Parameter/Variables to be applied/ measured: Age, BMI, POPQ
(Pelvic organ prolapse quantification) stage, menopause, ESST (Empty supine stress test).
(i) Outcome measures: LUTS score, UDI-6 score, SUI (stress urinary incontinence), Voiding
dysfunction, dyspareunia, satisfaction, Complications like bladder injury, hemorrhage.
(j) Rationale for statistical methods to be employed: attached (k) Ethical clearance: Study
will be started after getting clearance from the IRC (Institutional review committee) of
BPKIHS .
(l) Permission to use copyright questionnaire/Proforma: Pre designed Proforma and
questionnaire will be used to collect the data. The internationally valid questionnaire in
English will be validated in Nepali language first and then it will be used.
(m) Maintain the confidentiality of subject: The confidentiality of the patients will be
maintained throughout the research.
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