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

Not Applicable

Terminated

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: Trans Obturator Tape Procedure (TOT); Procedure: Cystocele Repair

• Registration Number: NCT06044987
• Lead Sponsor: Al-Mustafa University College

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?

1. What are the effects of the tested Interventions on the degree of pelvic organ prolapse?

2. 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?

3. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (TOT alone)	Trans Obturator Tape Procedure (TOT)	49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure
Group II (TOT+ Cystocele Repair)	Trans Obturator Tape Procedure (TOT)	49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair.
Group II (TOT+ Cystocele Repair)	Cystocele Repair	49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair.

Primary Outcome Measures

Name	Time	Method
Degree of Pelvic organ Prolapse (POP-Q)	At baseline, and at 9 months	Assessed using the pelvic organ prolapse quantification system, in which it classified into: 1. Stage 0: No prolapse is observed; 2. Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen; 3. Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen; 4. Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm; 5. 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.	At baseline, and at 9 months	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

Name	Time	Method
Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.	At baseline, and after 9 months	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.

Trial Locations

Locations (1)

Al-Sadr Teaching Hospital; 🇮🇶 Al 'Amārah, Maysan, Iraq