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ToT and Estrogen in Postmenopausal Females

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295487
Recruitment Status : Unknown
Verified September 2017 by sarah mohamed hassan, Kasr El Aini Hospital.
Recruitment status was:  Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
sarah mohamed hassan, Kasr El Aini Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Postmenopausal Disorder Procedure: TVT-O Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Value of Local Estrogen After TVT_O anti_incontinence Surgery in Postmenopausal Females.
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

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 Name: 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 Name: local vaginal estrogen cream




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295487


Locations
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Egypt
Kasr El Ainiy Hospital Recruiting
Cairo, Egypt, 11562
Contact: sarah M Hassan, Lecturer    01003733671    saramohamed7880@yahoo.com   
Sponsors and Collaborators
Kasr El Aini Hospital
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Responsible Party: sarah mohamed hassan, lecturer of obstetrics and gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03295487    
Other Study ID Numbers: Saramohamed7880
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

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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
Keywords provided by sarah mohamed hassan, Kasr El Aini Hospital:
post menopausal stress incontinence
local estrogen
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs