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

Phase 4
Waitlist Available
Led By Russell F Stanley, DO
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing a combination of electrical nerve stimulation and a bladder-relaxing drug in women who have not found relief from standard treatments for urgency urinary incontinence. The goal is to see if this combination is more effective in reducing incontinence episodes and improving quality of life.

Eligible Conditions
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact.
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-trial 0-100 scale measurement and then 12 weeks later post-trial measurement 0-100 with higher scores meaning worse impact. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)
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)
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)

Side effects data

From 2023 Phase 4 trial • 54 Patients • NCT04907032
11%
transient leg swelling from PTNS
11%
Urinary Tract Infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Posterior Tibial Nerve Stimulation Plus Placebo
Posterior Tibial Nerve Stimulation With Mirabegron

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Posterior Tibial Nerve Stimulation with MirabegronExperimental Treatment2 Interventions
One arm of the study will receive PTNS combined with mirabegron. In the PTNS with mirabegron arm, the patient will take a 50 mg dose daily for 12 weeks of the trial. This arm of the study will have 27 patients randomized to this arm of the study. The percutaneous approach entails insertion of a 36-gauge needle electrode at a 60 degree angle approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. A portable electrical stimulator delivers an adjustable current in the range of 0.5-9 mA. The generators commonly are set for a pulse frequency of 20 Hz with a goal of creating a motor and/or sensory response in the foot. The stimulation sessions last for 30 min once per week for 12 continuous weeks.
Group II: Posterior Tibial Nerve Stimulation Plus PlaceboPlacebo Group1 Intervention
The other arm of the study will receive PTNS with placebo. In the PTNS with placebo arm, the patient will receive a placebo daily during the 12-week trial. PTNS will be performed as described: The percutaneous approach entails insertion of a 36-gauge needle electrode at a 60 degree angle approximately 5 cm or 3 finger breadths cephalad to the medial malleolus and posterior to the tibia. A portable electrical stimulator delivers an adjustable current in the range of 0.5-9 mA. The generators commonly are set for a pulse frequency of 20 Hz with a goal of creating a motor and/or sensory response in the foot. The stimulation sessions last for 30 min once per week for 12 continuous weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron 50 MG
2022
Completed Phase 4
~100
Posterior Tibial Nerve Stimulation (PTNS)
2021
Completed Phase 4
~60

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,319 Total Patients Enrolled
Russell F Stanley, DOPrincipal InvestigatorUniversity of Alabama at Birmingham
~13 spots leftby Dec 2025