Clinical trial NCT04251923: Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence
Official title: Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Stress Urinary Incontinence
Vaginal Hysterectomy
Quality of Life
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: If patient gives consent and falls on selection criteria (inclusion and exclusion), she will be enrolled for randomization. Written informed consent will be taken. Computer generated simple randomization will be done.filled. POP-Q, Occult SUI and ESST will be checked and noted. This will be done by one of the researcher. Surgery will be performed by one of the researcher. Both Group I and Group II 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 I will undergo midurethral sling with tension free vaginal tape (TVT).

Patient will be followed up at 3 and 6 months. The primary outcome of the study will be the difference in SUI. Secondary outcomes will be BFLUTS AND udi-6 SCORE, voiding dysfunction, dyspareunia, patient satisfaction and complications during surgery.
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stress urinary incontinence
timeFrame: 3 months
measure: stress urinary incontinence
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: BPKIHS
name: Mohan ch Regmi, Professor
role: STUDY_CHAIR
References: