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NCT04907032 · ClinicalTrials.gov registry record · Phase 4
Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT04907032 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 54 participants.
The verdict
NCT04907032, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
Abstract Introduction: Urgency Urinary Incontinence (UUI) is a common condition with a prevalence of 9-31% in women in the United States. Despite current treatments, a high number of women have symptoms refractory to first- and second-line treatment approaches. Aims: The primary aim of this randomized controlled trial is to compare the efficacy of percutaneous tibial nerve stimulation (PTNS) and mirabegron treatment versus PTNS with placebo on change in the number of UUI episodes over a 12-week treatment course. Secondary aims include comparing the efficacy of combined treatment of PTNS and mirabegron versus PTNS with placebo on improvement in urinary incontinence symptom specific distress and quality of life related to UUI over a 12-week course of PTNS. Methods: A total of 54 consented participants will be recruited and randomized with 27 patients in the PTNS with mirabegron (daily 50 mg dose for the 12-week course) group and 27 patients in the PTNS with placebo group. Demographics and baseline data will be analyzed by student's t-test and chi-squared test or Fischer's Exact test as appropriate. Hypothesis: We anticipate that combination therapy will prove superior to monotherapy for reducing the number of UUI episodes over a 12-week treatment course.
Interventions
- DRUG Mirabegron 50 MG
- DEVICE Posterior Tibial Nerve Stimulation (PTNS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2023-04-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04907032
The ClinicalTrials.gov registry entry for NCT04907032 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mirabegron 50 MG is the first listed.
NCT04907032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04907032 about?
NCT04907032 is a clinical study titled "Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)". Abstract Introduction: Urgency Urinary Incontinence (UUI) is a common condition with a prevalence of 9-31% in women in the United States. Despite current treatments, a high number of women have symptoms refractory to first- and second-line treatment approaches. Aims: The primary aim of this random...
What is the current status of trial NCT04907032?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2021-10-01. Estimated completion is 2023-04-15.
What interventions are being tested in trial NCT04907032?
The interventions under investigation include: Mirabegron 50 MG (DRUG), Posterior Tibial Nerve Stimulation (PTNS) (DEVICE).
Who is sponsoring clinical trial NCT04907032?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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