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To compare the subjective and objective outcomes of TVT-O procedure alone versus the same procedure followed by the use of premarin vaginal cream for 3 months in postmenopausal female with genuine stress incontinence.
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery |
|
| Group B | Active Comparator | post menopausal female with genuine stress incontinence treated by TVT-O only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVT-O | Procedure | transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A |
|
| Measure | Description | Time Frame |
|---|---|---|
| outcome of the surgery | clinical and urodynamic test improvment of the stress incontinence | immediately after surgery |
| outcome of the surgery | clinical and urodynamic test improvment of the stress incontinence | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| nocturia , | symptom and sign from the patients | immediatly after surgery |
| frequency, | symptom and sign from the patients | immediatly after surgery |
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Inclusion Criteria:
-menopause patients included in group A should have: no history of breast cancer, ovarian cancer or uterine cancer No history of blood clots or thromboembolism No history of heart disease or stroke No history liver disease. Endometrial thickness less than 5mm Have a normal mammogram
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Ainiy Hospital | Cairo | 11562 | Egypt |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| denovo urgency | symptom and sign from the patients | immediatly after surgery |
| denovo urgency | symptom and sign from the patients | 3 months after surgery |
| nocturia | symptom and sign from the patients | 3 months after surgery |
| frequency | symptom and sign from the patients | 3 months after surgery |
| 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 |