Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.
NCT ID: NCT06044987
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
98 participants
INTERVENTIONAL
2021-09-01
2022-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I (TOT alone)
49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure
Trans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
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.
Trans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
Cystocele Repair
Done under Spinal anesthesia in the dorsal lithotomy position..
Interventions
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Trans Obturator Tape Procedure (TOT)
Done under Spinal anesthesia in the dorsal lithotomy position.
Cystocele Repair
Done under Spinal anesthesia in the dorsal lithotomy position..
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
60 Years
FEMALE
No
Sponsors
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Al-Sadr Teaching Hospital
OTHER_GOV
Al-Mustafa University College
OTHER
Responsible Party
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Hayder Adnan Fawzi
Assistant Prof.
Principal Investigators
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Hayder Adnan Fawzi, Ph.D
Role: STUDY_CHAIR
Al-Mustafa University College
Thaer Saleh Sabor Al-Omary, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Al-Sadr Teaching Hospital
Locations
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Al-Sadr Teaching Hospital
Amarah, Maysan, Iraq
Countries
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Other Identifiers
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A-202301
Identifier Type: -
Identifier Source: org_study_id
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