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NCT05221021 · ClinicalTrials.gov registry record · Phase 4
Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome
A Phase 4 study of Overactive Bladder Syndrome, sponsored by Walter Reed National Military Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 152
- Enrollment target
- 1
- Study location
NCT05221021: Recruiting Phase 4 study of Overactive Bladder Syndrome, sponsored by Walter Reed National Military Medical Center.
NCT05221021 is a Phase 4 study of Overactive Bladder Syndrome that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 152 participants, above the 108-participant average among 11 other Overactive Bladder Syndrome trials with a reported enrollment target (41% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05221021, a Phase 4 study of Overactive Bladder Syndrome, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 152 participants
- Enrollment target
- 1
- Study location
Study Summary
A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral Mirabegron with a placebo vaginal cream for 12 weeks.
Primary Outcome
Primary Aim: Compare changes in the six-item OAB-q short form (SF) symptom bother scores from baseline to 12 weeks post treatment in postmenopausal women who receive either vaginal estradiol or Mirabegron. We will also compare 12-weeks post treatment OAB-q SF symptom bother scores after single therapy trials with patients who desire combined therapy for another 12 weeks. The OAB-q SF symptom bother questionnaire is based on six individual questions a 6-point scale ranging from 1 or "not at all"
Conditions Studied
Interventions
- DRUG Vaginal estrogen
- DRUG Mirabegron 50 MG [Myrbetriq]
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 4 |
What NCT05221021 shows while recruiting
NCT05221021 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 108-participant average among 11 other Overactive Bladder Syndrome trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Overactive Bladder Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Vaginal estrogen is the first listed.
NCT05221021 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05221021 about?
NCT05221021 is a clinical study titled "Vaginal Estradiol vs Oral Beta-3 Agonist for Overactive Bladder Syndrome". A single site, double-blinded, randomized controlled trial for postmenopausal women with urinary frequency, urgency, nocturia with or without urgency urinary incontinence symptoms. Patient's will be randomized between 0.01% vaginal estradiol cream with placebo oral pill or daily 50 milligrams oral M...
What is the current status of trial NCT05221021?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 152 participants. The study started on 2022-10-01. Estimated completion is 2027-01-30.
What conditions does trial NCT05221021 study?
This clinical trial studies the following conditions: Overactive Bladder Syndrome.
What interventions are being tested in trial NCT05221021?
The interventions under investigation include: Vaginal estrogen (DRUG), Mirabegron 50 MG [Myrbetriq] (DRUG).
Who is sponsoring clinical trial NCT05221021?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05221021 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Overactive Bladder Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05221021's enrollment target sits among peer trials
152 3rd of 11 higher than 9 of 11 other Overactive Bladder Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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