INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder (INTENSE)
Overactive Bladder, Overactive Bladder Syndrome, Urinary Urge Incontinence
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, urinary frequency, urinary urgency, urge incontinence, electrical stimulation, TENS, PTNS, nerve stimulation, bladder treatment
Eligibility Criteria
Inclusion Criteria:
- Female Subjects ≥18 years of age
- OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms and more bother from UUI than stress urinary incontinence
- Failed trial of conservative therapy (including bladder training, fluid modification, diet modification, caffeine restriction, or pelvic floor training) -Failed trial of at least one pharmacologic treatment (anticholinergics, β3- adrenoceptor agonist) either due to inability to take the medication, adverse reaction to medication, or no improvement on medication
- Willing to complete study questionnaires
- Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that arm
- No contraindication to undergoing PTNS or TENS therapy
Exclusion Criteria:
- Age < 18 years
- Presence of urinary fistula
- Male genital anatomy
- Undergoing evaluation or treatment of recurrent (2 or more infections in the last 6 months or 3 or more infections in the last 12 months) or current urinary tract infection
- Current Bladder stones
- Bladder cancer or suspected bladder cancer
- Gross Hematuria
- Pregnancy or planning to become pregnant during the study
- Cognitive impairment
- Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson's disease, spina bifida, spinal cord lesions, etc.
- Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (ankle/leg)
- Uncontrolled diabetes
- Diabetes with peripheral nerve involvement
- Current use of anticoagulants (excluding aspirin)
- Current use of anticholinergics or use within the last 4 weeks
- Current use of botox bladder injections or bladder botox injection within the last year (12 months)
- Current use of sacral neuromodulation therapy or currently implanted sacral neuromodulation device or leads
- Bladder outlet obstruction
- Urinary retention or gastric retention
- Painful Bladder Syndrome/Interstitial Cystitis
- Unable to be contacted for follow up by telephone
- Inability to speak/read/understand English or Spanish
Sites / Locations
- University of New MexicoRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Posterior Tibial Nerve Stimulation (PTNS)
Home transcutaneous electrical nerve stimulation (TENS)
Women randomized to the PTNS will be scheduled for sessions once weekly for 30 minutes, for 12 weeks total. The patient sits reclined with their legs elevated on a foot rest. After alcohol swab, a 34 gauge needle is inserted percutaneously 5 cm cephalad to the medial malleolus of the right or left ankle (patient's choice) at a 60 degree angle. A surface electrode is placed on the medial ipsilateral heel. The needle and electrode are connected to a low voltage (9V) electrical stimulator. Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 μsec is increased until flexion of the big toe or fanning of all toes visualized, or until the woman reports a tingling sensation across the heel or sole of the foot. The current is then set to the highest level of tolerable to the patient (0-10 mA) and then she undergoes therapy for 30 minutes.
Women randomized to the TENS group will be asked to purchase a TENS 7000 device (estimated cost $30) and will administer self-treatment at home, daily for 20 minutes, for 12 weeks total. TENS treatment will be performed as follows (adapted from the most common setting from a s systematic review of TENS for OAB): - Surface electrodes, 2 x 2 in diameter, will be placed 5 cm cephalad to the medial malleolus of the right or left ankle (patient's choice). The second surface electrode is placed on the medial aspect of the ipsilateral calcaneus. The electrodes are connected to the TENS device with pre-set settings. Women will complete 20-minute daily TENS treatment for 12 weeks total.