Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stress Urinary Incontinence Vaginal Hysterectomy Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

those who will be filling questionnaires before and after the surgery are masked

Study Groups

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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.

Group Type EXPERIMENTAL

Retro pubic sling

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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vaginal hysterectomy

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No