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ToT and Estrogen in Postmenopausal Females

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03295487
Enrollment
210
Registered
2017-09-28
Start date
2017-03-01
Completion date
2020-11-30
Last updated
2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Disorder, Stress Urinary Incontinence

Keywords

post menopausal stress incontinence, local estrogen

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.

Detailed description

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

Interventions

PROCEDURETVT-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

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
49 Years to 65 Years
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 .

Design outcomes

Primary

MeasureTime frameDescription
outcome of the surgeryimmediately after surgeryclinical and urodynamic test improvment of the stress incontinence

Secondary

MeasureTime frameDescription
nocturia ,immediatly after surgerysymptom and sign from the patients
frequency,immediatly after surgerysymptom and sign from the patients
denovo urgencyimmediatly after surgerysymptom and sign from the patients
nocturia3 months after surgerysymptom and sign from the patients
frequency3 months after surgerysymptom and sign from the patients

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026