Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women (NCT06508944) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Vaginal 17β-Estradiol on the Urinary Storage Symptoms in Postmenopausal Women
Thailand86 participantsStarted 2024-04-08
Plain-language 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 it aims to answer are:
* What is the efficacy of vaginal 17β-estradiol treatment compared to placebo in alleviating storage symptoms of LUTS?
* How does vaginal 17β-estradiol treatment affect the urethral maturation index and vaginal pH compared to placebo?
* What impact does vaginal 17β-estradiol treatment have on overall quality of life and patients' perception of global improvement (PGI)?
Participants in the trial will undergo the following procedures:
* Screening procedures at the first visit to exclude correctable causes of LUTS and to complete a bladder diary.
* Visit the clinic at 1-2 weeks for a review of the bladder diary and a check-up. Participants will receive the assigned dosage of vaginal 17β-estradiol or placebo: one vaginal tablet daily for two weeks, followed by one vaginal tablet twice a week for 10 weeks.
* The third and fourth visits (at 4 and 12 weeks after treatment) will involve: completion of bladder diaries, questionnaires, vaginal pH testing, collection of urethral maturation index (UMI), observation of intervention's side effects and monitoring of LUTS symptoms.
Who can participate
SexFEMALE
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Inclusion criteria
✓. Presenting with storage phase symptom score more than/equal to 1 evaluated by the ICIQ-FLUTS questionnaire in these items
✓. 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 criteria
✕. 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
✕
What they're measuring
1
Storage symptom improvement
Timeframe: The patients were monitored closely for 1 and 3 months after treatment.
. 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