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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    54
  • sponsor
    University of Alabama at Birmingham
Updated on 15 December 2021
mirabegron
incontinence
percutaneous tibial nerve stimulation
Accepts healthy volunteers

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.

Description

Specific Aims:

Introduction/Background: Urgency Urinary Incontinence (UUI) remains a challenging clinical problem for urogynecologists as they treat women and seek to find better therapies. There is a wealth of literature addressing individual therapies for first, second, and third line treatments for UUI. There are three main third line treatment options for UUI including percutaneous tibial nerve stimulation (PTNS), sacral neuromodulation, and intradetrusor botox. At the current time, there are limited studies that have looked at a combination of second and third-line therapy therapies for UUI. While some anticholinergic medications have been studied in combination with percutaneous tibial nerve stimulation (PTNS) such as solifenacin, tolterodine, and trospium, there is limited data on the combination of mirabegron, a beta-3 agonist, and PTNS for treatment of refractory UUI. The studies that looked at anticholinergic medications in combination with PTNS revealed improvement in UUI compared to PTNS plus placebo. However, there are patients who do not tolerate anticholinergic medications well because of side effects. A relatively new finding as reported by the American Urogynecologic Society (AUGS) about avoiding anticholinergic medications in women greater than age 70 secondary to increased risk for cognitive impairment, dementia, and Alzheimer's disease is further impetus to conduct this trial [1]. The rationale for studying mirabegron in combination with PTNS versus PTNS plus placebo is important as mirabegron does not have the significant side effect profile that anticholinergic medications have and better tolerated in the older population. Therefore, more research should be performed to evaluate the effect of the combination of mirabegron and PTNS for refractory UUI. The purpose of this study is to evaluate the combination of PTNS and mirabegron and compare that to PTNS plus placebo in the treatment of refractory UUI.

Hypothesis: Combination therapy of PTNS and mirabegron, a beta-3 agonist, will contribute to greater improvement in the number of urgency urinary incontinence episodes as measured by a 3-day bladder diary compared to PTNS plus placebo in women.

Method: This is a randomized clinical trial comparing the efficacy of combination therapy with PTNS plus mirabegron to PTNS plus placebo in women with refractory urgency urinary incontinence.

Primary Aim: The primary aim of this study is to compare the efficacy of combined treatment of PTNS and mirabegron versus PTNS plus placebo on change in the number of UUI episodes at 12 weeks.

Secondary Aims:

  • Comparing urinary symptom specific distress and quality of life over a 12-week course of PTNS.
  • Comparing the side effect/adverse event profile of combined treatment of PTNS and mirabegron versus PTNS plus placebo over a 12-week course of PTNS
  • Comparing the treatment efficacy and adverse events of combined treatment of PTNS and mirabegron versus PTNS plus placebo in women > 70 years of age as a sub analysis within the study

Details
Condition Overactive Bladder
Treatment Mirabegron 50 MG, Posterior Tibial Nerve Stimulation (PTNS)
Clinical Study IdentifierNCT04907032
SponsorUniversity of Alabama at Birmingham
Last Modified on15 December 2021

Eligibility

Yes No Not Sure

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
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