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ToT and Estrogen in Postmenopausal Females

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03295487
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
28.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2017
Anticipated Primary Completion Date :
Sep 30, 2017
Anticipated Study Completion Date :
Sep 30, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. outcome of the surgery [immediately after surgery]

      clinical and urodynamic test improvment of the stress incontinence

    2. outcome of the surgery [3 months after surgery]

      clinical and urodynamic test improvment of the stress incontinence

    Secondary Outcome Measures

    1. nocturia , [immediatly after surgery]

      symptom and sign from the patients

    2. frequency, [immediatly after surgery]

      symptom and sign from the patients

    3. denovo urgency [immediatly after surgery]

      symptom and sign from the patients

    4. denovo urgency [3 months after surgery]

      symptom and sign from the patients

    5. nocturia [3 months after surgery]

      symptom and sign from the patients

    6. frequency [3 months after surgery]

      symptom and sign from the patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    49 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr El Ainiy Hospital Cairo Egypt 11562

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Sep 28, 2017
    Last Update Posted:
    Sep 28, 2017
    Last Verified:
    Sep 1, 2017
    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, lecturer of obstetrics and gynecology, Kasr El Aini Hospital
    post menopausal stress incontinence
    local estrogen
    Additional relevant MeSH terms:
    Urinary Incontinence
    Urinary Incontinence, Stress
    Estrogens

    Study Results

    No Results Posted as of Sep 28, 2017