Comparison of Combination Therapy vs Single Agent Therapy for Treatment of Urge Incontinence.
Condition: Urinary Urge Incontinence
MeSH terms: Urinary Incontinence, Urge
Intervention: Oxybutynin extended release; Posterior Tibial Nerve Stimulation; Placebo
Intervention description: 5mg tablet taken by mouth daily for 6 weeks; In office therapy administered for 30 minutes once every week for a total of 6 weeks; Tablet taken by mouth daily for 6 weeks
Intervention MeSH terms: Oxybutynin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Urge Incontinence; Posterior Tibial Nerve Stimulation; PTNS; Neuromodulation; Oxybutynin; Anticholinergic Medication

Summary:

      This is a randomized double-blind placebo-controlled clinical trial of posterior tibial nerve
      stimulation (PTNS) plus extended release oxybutynin versus PTNS alone (placebo pills) in
      women undergoing treatment of urgency urinary incontinence (UUI).

      The investigators hypothesize that combination therapy with PTNS and anticholinergic
      medication will result in a significant incremental improvement in UUI symptoms over that
      achieved with PTNS alone. In addition, the investigators hypothesize that the addition of
      anticholinergics to PTNS will result in a greater improvement in patients' perception of
      treatment response, symptom distress, and quality of life than PTNS alone.

      Specific Aim 1: To compare the change, from baseline, in mean number of UUI episodes per day
      using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus
      placebo in women undergoing treatment for UUI.

      Specific Aim 2: To compare the change, from baseline, in a 24hr pad weight between PTNS plus
      anticholinergic medication versus PTNS plus placebo.

      Specific Aim 3: To compare subjective treatment response, symptoms distress, and quality of
      life between PTNS plus anticholinergic medication versus PTNS plus placebo utilizing the
      Patient Global Impression of Improvement (PGI-I) and the Overactive Bladder Questionnaire
      Short Form (OABq-SF).

      An interim analysis will be conducted by an independent entity after 50 participants have
      completed the study protocol. A Data Safety Monitoring Board is not utilized because the
      study utilizes FDA approved treatments for urgency urinary incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients

          -  > 18 years of age

          -  > 3 UUI episodes on a 3-day bladder diary

          -  Urge predominant ( > 50% of total incontinence episodes) urinary incontinence based on
             a three-day bladder diary

          -  Existing insurance coverage of PTNS therapy.

          -  Ability to undergo weekly PTNS treatments in clinic for 6 week period of time and
             complete all study related items

          -  Not on an anticholinergic or beta agonist medication or, if they are, willing to
             undergone a three week washout period prior to randomization

        Exclusion Criteria:

          -  Any previous PTNS therapy, intra-detrusor botulinum toxin injections, or implanted
             sacral neuromodulation

          -  Contraindication to anticholinergic therapy (narrow-angle glaucoma or gastric
             retention) or PTNS therapy (implanted pacemaker/defibrillator or peripheral
             neuropathy)

          -  Symptomatic urinary tract infection that has not resolved prior to randomization

          -  Surgical treatment for stress urinary incontinence or pelvic organ prolapse
             recommended or planned at time of enrollment

          -  Surgically altered detrusor muscle

          -  Known diagnosis or history of neurogenic bladder, post void residual volume >150ml,
             bladder malignancy, interstitial cystitis/painful bladder syndrome, or pelvic
             radiation

          -  Surgery for pelvic organ prolapse or stress urinary incontinence within the previous 3
             months

          -  Pregnancy, lactation, or planned pregnancy during study period