Status:
COMPLETED
Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women
Lead Sponsor:
Mahidol University
Conditions:
Lower Urinary Tract Symptoms
Female Genitourinary Disease
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate whether vaginal 17β-estradiol effectively treats storage symptoms of lower urinary tract symptoms (LUTS) and enhances quality of life. The main questions...
Detailed Description
I. First Visit and Recruitment Participants will be recruited from the urogynecology clinic, menopause clinic, and urology clinic using hospital and public advertisement. An information sheet in Thai...
Eligibility Criteria
Inclusion
- Presenting with storage phase symptom score more than/equal to 1 evaluated by the ICIQ-FLUTS questionnaire in these items
- Item 2a) nocturia and/or
- Item 3a) urgency and/or
- Item 5a) daytime frequency and/or
- Item 9a) UUI and/or
- Item 11a) SUI
- Being natural or surgical menopause for more than 1 year
- Absence of urinary tract infection or other identifiable cause
- Not using hormone replacement therapy or any route of estrogen within 4 weeks
- Never undergone onabotulinumtoxinA therapy, percutaneous tibial nerve stimulation (PTNS), or neuromodulation for overactive bladder (OAB) treatment
- Willing to adhere to the research protocol and actively participate in the scheduled follow-up appointments as delineated within the framework of this study
Exclusion
- Contraindication for estrogen therapy: undiagnosed abnormal vaginal bleeding, previous thromboembolic event, breast cancer, gynecologic/genitourinary malignancy, active liver disease
- Pelvic organ prolapse of anterior compartment stage III and IV
- Immunocompromised patient or taking immunosuppressant drug
- History of antibiotics drug use within the past 7 days
- History of bladder outlet obstruction
- History of using anti-muscarinics, beta3-adrenoceptor agonists, vaginal energy-based devices (laser and radiofrequency) or electromagnetic energy-based therapies within the past 2 weeks
- History of documented positive urine culture in the past 6 weeks
- Have an allergic reaction to study's drug
- Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study
Key Trial Info
Start Date :
April 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06508944
Start Date
April 8 2024
End Date
October 31 2024
Last Update
April 20 2025
Active Locations (1)
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1
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, Thailand, 10400