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After discussing this study with the investigators, it was decided to consider it a retrospective study rather than a clinical trial. Since we could not delete this record, we chose the termination status instead.
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| Name | Class |
|---|---|
| Al-Sadr Teaching Hospital | OTHER_GOV |
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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?
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (TOT alone) | Active Comparator | 49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure |
|
| Group II (TOT+ Cystocele Repair) | Experimental | 49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans Obturator Tape Procedure (TOT) | Procedure | Done under Spinal anesthesia in the dorsal lithotomy position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Pelvic organ Prolapse (POP-Q) | Assessed using the pelvic organ prolapse quantification system, in which it classified into:
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hayder Adnan Fawzi, Ph.D | Al-Mustafa University College | Study Chair |
| Thaer Saleh Sabor Al-Omary, Ph.D | Al-Sadr Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Sadr Teaching Hospital | Amarah | Maysan Governorate | 62001 | Iraq |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D052858 | Cystocele |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Cystocele Repair | Procedure | Done under Spinal anesthesia in the dorsal lithotomy position.. |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |