ToT and Estrogen in Postmenopausal Females

NCT03295487 — Phase 2 / Phase 3, Completed, 210 participants, Kasr El Aini Hospital

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

Registry	NCT03295487
Status	Completed
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	210 (Actual)
Sponsor	Kasr El Aini Hospital (Other)
Conditions	Stress Urinary Incontinence, Postmenopausal Disorder
Interventions	TVT-O (Procedure)
Dates	start 2017-03-01, primary completion 2020-11-30, completion 2020-11-30, first posted 2017-09-28, last updated 2022-10-25
Locations	1 site in Egypt

-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.

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+Detailed description

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

+Arms and interventions

Arm	Type	Interventions	Description
Group A	Active comparator	Procedure: TVT-O	post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
Group B	Active comparator	Procedure: TVT-O	post menopausal female with genuine stress incontinence treated by TVT-O only

TVT-O (Procedure), also known as local vaginal estrogen cream: 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

+Outcome measures

Primary outcomes

outcome of the surgery [immediately after surgery]: clinical and urodynamic test improvment of the stress incontinence
outcome of the surgery [3 months after surgery]: clinical and urodynamic test improvment of the stress incontinence

Secondary outcomes

nocturia , [immediatly after surgery]: symptom and sign from the patients
frequency, [immediatly after surgery]: symptom and sign from the patients
denovo urgency [immediatly after surgery]: symptom and sign from the patients
denovo urgency [3 months after surgery]: symptom and sign from the patients
nocturia [3 months after surgery]: symptom and sign from the patients
frequency [3 months after surgery]: symptom and sign from the patients

+Eligibility

Sex: Female, ages: 49 Years to 65 Years

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 .

+Locations (1)

Facility	City	Country	Status
Kasr El Ainiy Hospital	Cairo	Egypt

My Notes

Public

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