ToT and Estrogen in Postmenopausal Females

October 21, 2022 updated by: sarah mohamed hassan, Kasr El Aini Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr El Ainiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

49 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
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
Other Names:
  • local vaginal estrogen cream
Active Comparator: Group B
post menopausal female with genuine stress incontinence treated by TVT-O only
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
Other Names:
  • local vaginal estrogen cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
outcome of the surgery
Time Frame: immediately after surgery
clinical and urodynamic test improvment of the stress incontinence
immediately after surgery
outcome of the surgery
Time Frame: 3 months after surgery
clinical and urodynamic test improvment of the stress incontinence
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nocturia ,
Time Frame: immediatly after surgery
symptom and sign from the patients
immediatly after surgery
frequency,
Time Frame: immediatly after surgery
symptom and sign from the patients
immediatly after surgery
denovo urgency
Time Frame: immediatly after surgery
symptom and sign from the patients
immediatly after surgery
denovo urgency
Time Frame: 3 months after surgery
symptom and sign from the patients
3 months after surgery
nocturia
Time Frame: 3 months after surgery
symptom and sign from the patients
3 months after surgery
frequency
Time Frame: 3 months after surgery
symptom and sign from the patients
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

September 20, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Saramohamed7880

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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