ToT and Estrogen in Postmenopausal Females

Kasr El Aini Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postmenopausal Disorder; Stress Urinary Incontinence

Treatments: Procedure: TVT-O

Study type: Interventional

Funder types: Other

Identifiers

NCT03295487

Saramohamed7880

Details and patient eligibility

About

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 description

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

Enrollment: 210 patients

Sex: Female

Ages: 49 to 65 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Group A

Active Comparator group

Description:

post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery

Treatment:

Procedure: TVT-O

Group B

Active Comparator group

Description:

post menopausal female with genuine stress incontinence treated by TVT-O only

Treatment:

Procedure: TVT-O