Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M 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.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2023-04-01
- Completion
- 2023-04-15
Outcome
Met primary endpoint
paper There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). PMID 39101958 ↗
paper the addition of a β-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo. PMID 39101958 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirabegron | Other / unclassified | 50 mg | — |