INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this research is to perform a non-masked, non-inferiority randomized controlled trial to assess the quality of life (QOL) of women with idiopathic overactive bladder (OAB) before and after treatment with percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) of tibial nerve. The target population is patients with OAB who previously failed first- and second-line treatments and desire non-surgical management.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Mexico
University of New Mexico
RECRUITING
Albuquerque
Contact Information
Primary
Kate V Meriwether, MD
meriwet2@salud.unm.edu
5052495967
Backup
Karen Taylor, MS
kataylor@salud.unm.edu
5059678428
Time Frame
Start Date: 2022-06-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 130
Treatments
Active_comparator: Posterior Tibial Nerve Stimulation (PTNS)
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.
Experimental: Home transcutaneous electrical nerve stimulation (TENS)
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.
Related Therapeutic Areas
Sponsors
Leads: University of New Mexico

This content was sourced from clinicaltrials.gov