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Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Trans Obturator Tape Procedure (TOT)
Cystocele Repair
Sponsored by
Al-Mustafa University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Urinary Incontinence, Stress, Cystocele, Trans Obturator Tape, Pelvic Organ Prolapse

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female patients. Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele. Had not undergone a previous SUI surgery. BMI less than 35 kg/m2 Exclusion Criteria: Patients out of the age limit. Patients refused to participate in the study. Severe comorbid disease (heart failure HYHA class II and above, etc.). Patients with a previous surgical history of transvaginal mesh. Patients suffering detrusor overactivity. Patients diagnosed with the female genital system or urinary bladder Malignancies. Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.

Sites / Locations

  • Al-Sadr Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group I (TOT alone)

Group II (TOT+ Cystocele Repair)

Arm Description

49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure

49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair.

Outcomes

Primary Outcome Measures

Degree of Pelvic organ Prolapse (POP-Q)
Assessed using the pelvic organ prolapse quantification system, in which it classified into: Stage 0: No prolapse is observed Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL
Frequency, severity, and effect of urine incontinence on quality of life.
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from "0 to 21", with higher values indicating more severe illness

Secondary Outcome Measures

Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.
Assessed using the King Health Questionnaire (KHQ). It contains ten patient-rated domains. Each score value from 0% (best outcome) to 100% (worst outcome), except for Q10 from "0 to 30" with 30 being the worst.

Full Information

First Posted
September 13, 2023
Last Updated
September 20, 2023
Sponsor
Al-Mustafa University College
Collaborators
Al-Sadr Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06044987
Brief Title
Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.
Official Title
The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Mustafa University College
Collaborators
Al-Sadr Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. The main questions to answer are: 1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic Organ Prolapse Quantification (POP-Q) System? What are the effects of the tested Interventions on the degree of pelvic organ prolapse? What are the effects of the tested Interventions on the frequency, severity, and effect of Stress urinary incontinence on the quality of life of the patients? What are the effects of the tested Interventions on the impact of lower urinary tract symptoms on the quality of the patient's life? Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups Group I: (n=49) offered TOT alone Group II: (n=49) offered concurrent TOT and Cystocele Repair Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their impact on SUI and quality of life was measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Urinary Incontinence, Stress, Cystocele, Trans Obturator Tape, Pelvic Organ Prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (TOT alone)
Arm Type
Active Comparator
Arm Description
49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure
Arm Title
Group II (TOT+ Cystocele Repair)
Arm Type
Experimental
Arm Description
49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair.
Intervention Type
Procedure
Intervention Name(s)
Trans Obturator Tape Procedure (TOT)
Intervention Description
Done under Spinal anesthesia in the dorsal lithotomy position.
Intervention Type
Procedure
Intervention Name(s)
Cystocele Repair
Intervention Description
Done under Spinal anesthesia in the dorsal lithotomy position..
Primary Outcome Measure Information:
Title
Degree of Pelvic organ Prolapse (POP-Q)
Description
Assessed using the pelvic organ prolapse quantification system, in which it classified into: Stage 0: No prolapse is observed Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL
Time Frame
At baseline, and at 9 months
Title
Frequency, severity, and effect of urine incontinence on quality of life.
Description
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from "0 to 21", with higher values indicating more severe illness
Time Frame
At baseline, and at 9 months
Secondary Outcome Measure Information:
Title
Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.
Description
Assessed using the King Health Questionnaire (KHQ). It contains ten patient-rated domains. Each score value from 0% (best outcome) to 100% (worst outcome), except for Q10 from "0 to 30" with 30 being the worst.
Time Frame
At baseline, and after 9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients. Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele. Had not undergone a previous SUI surgery. BMI less than 35 kg/m2 Exclusion Criteria: Patients out of the age limit. Patients refused to participate in the study. Severe comorbid disease (heart failure HYHA class II and above, etc.). Patients with a previous surgical history of transvaginal mesh. Patients suffering detrusor overactivity. Patients diagnosed with the female genital system or urinary bladder Malignancies. Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayder Adnan Fawzi, Ph.D
Organizational Affiliation
Al-Mustafa University College
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thaer Saleh Sabor Al-Omary, Ph.D
Organizational Affiliation
Al-Sadr Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Sadr Teaching Hospital
City
Al 'Amārah
State/Province
Maysan
ZIP/Postal Code
62001
Country
Iraq

12. IPD Sharing Statement

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Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.

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