ToT and Estrogen in Postmenopausal Females

Study Overview
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Brief Summary
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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.

Detailed Description
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a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female

Official Title
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The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.

Conditions
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Stress Urinary Incontinence, Postmenopausal Disorder

Intervention / Treatment
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* Procedure: TVT-O


Participation Criteria
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Eligibility Criteria
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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: presence of urge or mixed incontinence .

Ages Eligible for Study
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Minimum Age: 49 Years
Maximum Age: 65 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 A<br>post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery | Procedure: TVT-O<br>* 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<br>* Other names: local vaginal estrogen cream;|
| Active Comparator: Group B<br>post menopausal female with genuine stress incontinence treated by TVT-O only | Procedure: TVT-O<br>* 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<br>* Other names: local vaginal estrogen cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nocturia , | symptom and sign from the patients | immediatly after surgery | 
| frequency, | symptom and sign from the patients | immediatly after surgery | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post menopausal stress incontinence, local estrogen