Posterior Tibial Nerve Stimulation (PTNS) Plus Mirabegron to Treat Refractory OAB Symptoms (PTNS-M Study)
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Mirabegron 50 MG; Posterior Tibial Nerve Stimulation (PTNS)
Intervention description: Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo; Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo
Intervention MeSH terms: Mirabegron
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: 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.
    

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