Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)
Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.