NCT04907032: PTNS-M

Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)

Completed Phase 4 Results posted Last updated 20 July 2023

What this trial tests

Phase 4 trial testing Mirabegron 50 MG in Overactive Bladder in 54 participants. Completed in 15 April 2023.

Timeline

1 October 2021

Primary endpoint
1 April 2023

15 April 2023

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 October 2021
Primary completion	1 April 2023
Estimated completion	15 April 2023
Sites	1 location across United States

Drugs / interventions tested

• Mirabegron 50 MG — full drug profile →
• Posterior Tibial Nerve Stimulation (PTNS)

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →

Sponsor

University of Alabama at Birmingham

Who can join

18 and older, female only, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Number of UUI Episodes Over a 3-day Voiding Diary Pre- vs. Post-treatment. This Includes a Baseline Measure Pre-trial and a Pos-trial Measure in 12 Weeks Primary · 3 day voiding diary will be filled out prior to the 12 week PTNS trial and voiding diary will be filled out immediately after the 12 week PTNS trial

change in the number of urgency urinary incontinence episodes as measures by a 3-day voiding diary pre- vs. post-treatment. This includes a baseline measure pre-trial and then a post-trial measure in 12 weeks and then you calculate the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test.

Group	Value	95% CI
Posterior Tibial Nerve Stimulation With Mirabegron	9.4	± 3.9
Posterior Tibial Nerve Stimulation Plus Placebo	5.3	± 5.4

Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) Secondary · 12 weeks

This is a quality of life measure using a validated questionnaire called the Urinary Distress Index Scale with a range from 0-100 with higher scores meaning worse urinary distress such as urinary incontinence and leakage and bother with the life stresses related to urinary incontinence. Will include a baseline measure pre-trial and then a post-trial measure (post-trial). This includes a pre-trial measure (baseline) and a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test.

Group	Value	95% CI
Posterior Tibial Nerve Stimulation With Mirabegron	23.6	± 12.9
Posterior Tibial Nerve Stimulation Plus Placebo	16.3	± 14.0

Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Incontinence Impact Questionnaire Short Form (IIQ-7) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure in 12 Weeks) Secondary · pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact.

The IIQ-7 (Incontinence Impact Questionnaire) is a measure of distress caused by urge urinary incontinence and overactive bladder in the patient. This scale is a scale of 0-100 with 0 being minimal impact and 100 being worse impact and distress. This includes a baseline pre-trial measure and a post-trial measure at 12 weeks. This includes a pre-trial measure (baseline) and then a post-trial measure and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test.

Group	Value	95% CI
Posterior Tibial Nerve Stimulation With Mirabegron	29.7	± 17.4
Posterior Tibial Nerve Stimulation Plus Placebo	20.2	± 17.6

Change in UUI (Urge Urinary Incontinence)/OAB (Overactive Bladder) Quality of Life as Measured by the Overactive Bladder Questionnaire-Short Form (OAB-q SF) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure) Secondary · pre trial measurements as described and then 12 weeks later post-trial measurements as described.

This is the change in Quality of life measure for urge urinary incontinence for the OABq SF scale and it is a 0-100 scale where 0 equals minimum symptoms and 100 equals maximal symptoms. Lower scores indicate better quality of life and higher scores indicate worse quality of life. This includes a pre-trial measure and a post-trial measure at 12 weeks and then a calculation of the difference. The difference between the two measures (baseline vs. post-trial) was then compared with a sample t test.

Group	Value	95% CI
Posterior Tibial Nerve Stimulation With Mirabegron	53.6	± 30.0
Posterior Tibial Nerve Stimulation Plus Placebo	33.3	± 35.7

Adverse events — posted to ClinicalTrials.gov

Time frame: During the study, each patient (all 54) were monitored for adverse events from baseline (start of the study) to 12 weeks (the end of the study for each patient.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Posterior Tibial Nerve Stimulation With Mirabegron

Serious: 0/27 (0%)

Deaths: 0/27

Posterior Tibial Nerve Stimulation Plus Placebo

Serious: 0/27 (0%)

Deaths: 0/27

Other adverse events (2 terms — click to expand)

Reaction	System	Posterior Tibial Nerve Sti…	Posterior Tibial Nerve Sti…
Urinary Tract Infection	General disorders	—	—
transient leg swelling from PTNS	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04907032 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.
   Stanley RF, Meyer I, Blanchard CT, Richter HE. · · 2024 · cited 2× · PMID 39101958 · DOI 10.1007/s00192-024-05835-y