- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295487
ToT and Estrogen in Postmenopausal Females
October 21, 2022 updated by: sarah mohamed hassan, Kasr El Aini Hospital
The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
Study Type
Interventional
Enrollment (Actual)
210
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 11562
- Kasr El Ainiy Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
49 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
|
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
Other Names:
|
Active Comparator: Group B
post menopausal female with genuine stress incontinence treated by TVT-O only
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
outcome of the surgery
Time Frame: immediately after surgery
|
clinical and urodynamic test improvment of the stress incontinence
|
immediately after surgery
|
outcome of the surgery
Time Frame: 3 months after surgery
|
clinical and urodynamic test improvment of the stress incontinence
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3 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
nocturia ,
Time Frame: immediatly after surgery
|
symptom and sign from the patients
|
immediatly after surgery
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frequency,
Time Frame: immediatly after surgery
|
symptom and sign from the patients
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immediatly after surgery
|
denovo urgency
Time Frame: immediatly after surgery
|
symptom and sign from the patients
|
immediatly after surgery
|
denovo urgency
Time Frame: 3 months after surgery
|
symptom and sign from the patients
|
3 months after surgery
|
nocturia
Time Frame: 3 months after surgery
|
symptom and sign from the patients
|
3 months after surgery
|
frequency
Time Frame: 3 months after surgery
|
symptom and sign from the patients
|
3 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
September 20, 2017
First Submitted That Met QC Criteria
September 22, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 21, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Saramohamed7880
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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