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NCT03295487 Clinical Trial

ToT and Estrogen in Postmenopausal Females

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03295487
Other study ID # Saramohamed7880
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date March 1, 2017
Est. completion date November 30, 2020

Study information
Verified date October 2022
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date November 30, 2020
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 49 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Egypt Kasr El Ainiy Hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary outcome of the surgery clinical and urodynamic test improvment of the stress incontinence immediately after surgery
Primary outcome of the surgery clinical and urodynamic test improvment of the stress incontinence 3 months after surgery
Secondary nocturia , symptom and sign from the patients immediatly after surgery
Secondary frequency, symptom and sign from the patients immediatly after surgery
Secondary denovo urgency symptom and sign from the patients immediatly after surgery
Secondary denovo urgency symptom and sign from the patients 3 months after surgery
Secondary nocturia symptom and sign from the patients 3 months after surgery
Secondary frequency symptom and sign from the patients 3 months after surgery
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