Phase 4 N=54 Randomized Treatment

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

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT04907032 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: 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 — 9.4; 5.3 UUI episodes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Mirabegron 50 MG (Drug); Posterior Tibial Nerve Stimulation (PTNS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	9.4; 5.3	—
SECONDARY Change in Symptom Distress as Measured by the Urinary Distress Index (UDI-6) Questionnaire Pre- (Baseline Measure) vs. Post-treatment (Post-trial Measure)	23.6; 16.3	—
SECONDARY 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)	29.7; 20.2	—
SECONDARY 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)	53.6; 33.3	—

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.

Eligibility Criteria

Inclusion Criteria

Female patients > 18 years old at UAB facilities with refractory urgency urinary incontinence that have failed first line and second line treatments
Ability to consent
Ability to complete all study related items and interviews

Exclusion Criteria

Patients with a history of any known or determined urinary retention or urinary tract obstruction
PVR > 150 ml in clinic prior to the start of PTNS
History of bladder augmentation surgery
Patients who are pregnant or who have the suspicion of pregnancy
Uncontrolled hypertension
Hypersensitivity to mirabegron
Superficial and/or deep skin infection where PTNS intervention is required
Spinal cord injury or clinically significant neurological disorders known to affect urgency urinary incontinence
Bleeding diathesis
Failure of previous third line treatment options such as sacral neuromodulation, PTNS, or Botox
Pacemaker, implantable defibrillator
Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs
Coagulopathy
Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS needles or surface electrodes would be placed
Metal implant in foot/toes near TENS electrode location
Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS needles or surface electrodes would be placed
Currently pregnant or planning to become pregnant during the course of the study
Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential
Unable or unwilling to complete the 3-day bladder diary
Visual impairment prohibiting reading the paper diary
Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions
Unable to speak, read, or write in English

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04907032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.