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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
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Urinary Incontinence

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 15, 2020
    Last Updated
    January 30, 2020
    Sponsor
    B.P. Koirala Institute of Health Sciences
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    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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