Back to resultsToT and Estrogen in Postmenopausal Females
Primary Purpose
Stress Urinary Incontinence, Postmenopausal Disorder
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
TVT-O
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring post menopausal stress incontinence, local estrogen
Eligibility Criteria
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 .
Sites / Locations
- Kasr El Ainiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
post menopausal female with genuine stress incontinence treated by TVT-O only
Outcomes
Primary Outcome Measures
outcome of the surgery
clinical and urodynamic test improvment of the stress incontinence
outcome of the surgery
clinical and urodynamic test improvment of the stress incontinence
Secondary Outcome Measures
nocturia ,
symptom and sign from the patients
frequency,
symptom and sign from the patients
denovo urgency
symptom and sign from the patients
denovo urgency
symptom and sign from the patients
nocturia
symptom and sign from the patients
frequency
symptom and sign from the patients
Full Information
NCT ID
NCT03295487
First Posted
September 20, 2017
Last Updated
October 21, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03295487
Brief Title
ToT and Estrogen in Postmenopausal Females
Official Title
The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
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
5. Study Description
Brief Summary
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
a randomized controlled trial comparing the effect of using local estrogen cream after tot in postmenopausal female
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Postmenopausal Disorder
Keywords
post menopausal stress incontinence, local estrogen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
post menopausal female with genuine stress incontinence treated by TVT-O only
Intervention Type
Procedure
Intervention Name(s)
TVT-O
Other Intervention Name(s)
local vaginal estrogen cream
Intervention Description
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
Primary Outcome Measure Information:
Title
outcome of the surgery
Description
clinical and urodynamic test improvment of the stress incontinence
Time Frame
immediately after surgery
Title
outcome of the surgery
Description
clinical and urodynamic test improvment of the stress incontinence
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
nocturia ,
Description
symptom and sign from the patients
Time Frame
immediatly after surgery
Title
frequency,
Description
symptom and sign from the patients
Time Frame
immediatly after surgery
Title
denovo urgency
Description
symptom and sign from the patients
Time Frame
immediatly after surgery
Title
denovo urgency
Description
symptom and sign from the patients
Time Frame
3 months after surgery
Title
nocturia
Description
symptom and sign from the patients
Time Frame
3 months after surgery
Title
frequency
Description
symptom and sign from the patients
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
ToT and Estrogen in Postmenopausal Females
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