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Completed

NCT Number: NCT03295487

ToT and Estrogen 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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Postmenopausal Disorder Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

49 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kasr El Ainiy Hospital

Cairo, 11562, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

TVT-O

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

Other names: local vaginal estrogen cream

Primary outcomes

  1. outcome of the surgery

    Time frame: immediately after surgery

    clinical and urodynamic test improvment of the stress incontinence

  2. outcome of the surgery

    Time frame: 3 months after surgery

    clinical and urodynamic test improvment of the stress incontinence

Secondary outcomes

  1. nocturia ,

    Time frame: immediatly after surgery

    symptom and sign from the patients

  2. frequency,

    Time frame: immediatly after surgery

    symptom and sign from the patients

  3. denovo urgency

    Time frame: immediatly after surgery

    symptom and sign from the patients

  4. denovo urgency

    Time frame: 3 months after surgery

    symptom and sign from the patients

  5. nocturia

    Time frame: 3 months after surgery

    symptom and sign from the patients

  6. frequency

    Time frame: 3 months after surgery

    symptom and sign from the patients

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2017
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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