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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 weeks3 visits

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.

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%

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