ToT and Estrogen in Postmenopausal Females
Overview
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.
Full Title of Study: “The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 30, 2020
Detailed Description
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
Interventions
- Procedure: TVT-O
- 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
Arms, Groups and Cohorts
- Active Comparator: Group A
- post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
- Active Comparator: Group B
- post menopausal female with genuine stress incontinence treated by TVT-O only
Clinical Trial Outcome Measures
Primary Measures
- outcome of the surgery
- Time Frame: immediately after surgery
- clinical and urodynamic test improvment of the stress incontinence
- outcome of the surgery
- Time Frame: 3 months after surgery
- clinical and urodynamic test improvment of the stress incontinence
Secondary Measures
- nocturia ,
- Time Frame: immediatly after surgery
- symptom and sign from the patients
- frequency,
- Time Frame: immediatly after surgery
- symptom and sign from the patients
- denovo urgency
- Time Frame: immediatly after surgery
- symptom and sign from the patients
- denovo urgency
- Time Frame: 3 months after surgery
- symptom and sign from the patients
- nocturia
- Time Frame: 3 months after surgery
- symptom and sign from the patients
- frequency
- Time Frame: 3 months after surgery
- symptom and sign from the patients
Participating in This Clinical Trial
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 .
Gender Eligibility: Female
Minimum Age: 49 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Kasr El Aini Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: sarah mohamed hassan, lecturer of obstetrics and gynecology – Kasr El Aini Hospital
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