Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence
Primary Purpose
Stress Urinary Incontinence, Vaginal Hysterectomy, Quality of Life
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Retro pubic sling
Sponsored by
About this trial
This is an interventional prevention trial for Stress Urinary Incontinence
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
vagianl prolapse surgery accompanied with TVT sling
vaginal prolapse surgery not accompanied with sling
Arm Description
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.
patients will undergo vaginal hysterectomy with McCall's culdoplasty and anterior repair with or without posterior repair according to the need.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04251923
First Posted
January 15, 2020
Last Updated
January 30, 2020
Sponsor
B.P. Koirala Institute of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04251923
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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:
Whether study involves humans/animals or both : Humans
Population/ participants: Patients with pelvic organ prolapse who are planned for vaginal prolapse surgery in BPKIHS (BP Koirala Institute of Health and Sciences).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Vaginal Hysterectomy, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
those who will be filling questionnaires before and after the surgery are masked
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vagianl prolapse surgery accompanied with TVT sling
Arm Type
Experimental
Arm Description
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.
Arm Title
vaginal prolapse surgery not accompanied with sling
Arm Type
No Intervention
Arm Description
patients will undergo vaginal hysterectomy with McCall's culdoplasty and anterior repair with or without posterior repair according to the need.
Intervention Type
Device
Intervention Name(s)
Retro pubic sling
Other Intervention Name(s)
vaginal hysterectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stress urinary incontinence
Description
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.
Time Frame
3 months
Title
stress urinary incontinence
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
3 months
Title
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
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
all female patients
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
baburam Dixit (Thapa), MD/MS
Phone
977-9842352481
Email
baburamdixit@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohan Ch Regmi, Professor
Phone
977-9852044055
Email
mohanchallo@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohan ch Regmi, Professor
Organizational Affiliation
BPKIHS
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence
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