ToT and Estrogen in Postmenopausal Females

Overview

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 Title of Study: “The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2020

Detailed Description

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

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Group A
    • post menopausal female with genuine stress incontinence treated by TVT-O and local estrogen cream for 3 months after surgery
  • Active Comparator: Group B
    • post menopausal female with genuine stress incontinence treated by TVT-O only

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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 .

Gender Eligibility: Female

Minimum Age: 49 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kasr El Aini Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: sarah mohamed hassan, lecturer of obstetrics and gynecology – Kasr El Aini Hospital

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