Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.
Study Details
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?
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What are the effects of the tested Interventions on the degree of pelvic organ prolapse?
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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?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I (TOT alone) 49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure |
Procedure: Trans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
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| Experimental: Group II (TOT+ Cystocele Repair) 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)
Done under Spinal anesthesia in the dorsal lithotomy position.
Procedure: Cystocele Repair
Done under Spinal anesthesia in the dorsal lithotomy position..
|
Outcome Measures
Primary Outcome Measures
- 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: 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. [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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients.
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Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele.
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Had not undergone a previous SUI surgery.
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BMI less than 35 kg/m2
Exclusion Criteria:
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Patients out of the age limit.
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Patients refused to participate in the study.
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Severe comorbid disease (heart failure HYHA class II and above, etc.).
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Patients with a previous surgical history of transvaginal mesh.
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Patients suffering detrusor overactivity.
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Patients diagnosed with the female genital system or urinary bladder Malignancies.
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Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Al-Sadr Teaching Hospital | Al 'AmÄrah | Maysan | Iraq | 62001 |
Sponsors and Collaborators
- Al-Mustafa University College
- Al-Sadr Teaching Hospital
Investigators
- Study Chair: Hayder Adnan Fawzi, Ph.D, Al-Mustafa University College
- Principal Investigator: Thaer Saleh Sabor Al-Omary, Ph.D, Al-Sadr Teaching Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A-202301