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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Stress Urinary Incontinence; Vaginal Hysterectomy
• Intervention / Treatment: Device: Retro pubic sling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: vaginal hysterectomy
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress urinary incontinence	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.	3 months
stress urinary incontinence	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The main two questionnaires used in this study are BFLUTS-SF and UDI-6. BFLUTS-SF has five different section; BFLUTS- FS: frequency symptoms and score ranges from 0-15, VS: voiding symptoms and score is from 0-12 IS: irritable bladder symptoms and score is from 0-20. . sex: sexual symptoms and score is from 0-6. QoL: quality of life due to bladder symptoms and score is from 0-18.; UDI-6 score: quality of life due to bladder symptoms. Score range from 0-18. Severity increases as score increases in each section. High score denotes patient are highly affected due to bladder problems.; Complications are noted hemorrhage, bladder injury, prolonged catheterization, urinary retention, need of mesh removal Remote complications: mesh erosion, Dyspareunia, pelvic pain, these complications will be noted. For pelvic pain visual analogue scale will be used, score having 1-10; 0, being least to 10 being the maximum.	3 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	The main two questionnaires used in this study are BFLUTS-SF and UDI-6. BFLUTS-SF has five different section; BFLUTS- FS: frequency symptoms and score ranges from 0-15, VS: voiding symptoms and score is from 0-12 IS: irritable bladder symptoms and score is from 0-20. . sex: sexual symptoms and score is from 0-6. QoL: quality of life due to bladder symptoms and score is from 0-18.; UDI-6 score: quality of life due to bladder symptoms. Score range from 0-18. Severity increases as score increases in each section. High score denotes patient are highly affected due to bladder problems.; Complications are noted hemorrhage, bladder injury, prolonged catheterization, urinary retention, need of mesh removal Remote complications: mesh erosion, Dyspareunia, pelvic pain, these complications will be noted. For pelvic pain visual analogue scale will be used, score having 1-10; 0, being least to 10 being the maximum.	6 months

Collaborators and Investigators

• Sponsor: B.P. Koirala Institute of Health Sciences
• Investigators: Study Chair: Mohan ch Regmi, Professor, BPKIHS

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Urination Disorders; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Urinary Incontinence; Prolapse; Urinary Incontinence, Stress; Uterine Prolapse
• Other Study ID Numbers: IRC/1536/019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes