ToT and Estrogen in Postmenopausal Females

NCT ID: NCT03295487

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-11-30

Brief Summary

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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

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

Conditions

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Stress Urinary Incontinence Postmenopausal Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

TVT-O

Intervention Type PROCEDURE

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

Group B

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

Group Type ACTIVE_COMPARATOR

TVT-O

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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local vaginal estrogen cream

Eligibility Criteria

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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 .
Minimum Eligible Age

49 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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sarah mohamed hassan

lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr El Ainiy Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Saramohamed7880

Identifier Type: -

Identifier Source: org_study_id

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