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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: Trans Obturator Tape Procedure (TOT)
* Procedure: Cystocele Repair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (TOT alone)<br>49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure | Procedure: Trans Obturator Tape Procedure (TOT)<br>* Done under Spinal anesthesia in the dorsal lithotomy position.<br>|
| Experimental: Group II (TOT+ Cystocele Repair)<br>49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair. | Procedure: Trans Obturator Tape Procedure (TOT)<br>* Done under Spinal anesthesia in the dorsal lithotomy position.<br>Procedure: Cystocele Repair<br>* Done under Spinal anesthesia in the dorsal lithotomy position..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At baseline, and at 9 months | 
| 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 | At baseline, and at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At baseline, and after 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Cystocele, Trans Obturator Tape, Pelvic Organ Prolapse