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

NCT05309993 | Terminated FDA Device

• 1 other identifier: 20-003
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder; Overactive Bladder Syndrome; Urinary Urge Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Keywords

overactive bladder; urinary frequency; urinary urgency; urge incontinence; electrical stimulation; TENS; PTNS; nerve stimulation; bladder treatment

Outcome Measures

Primary Outcomes (1)

• Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life (HRQOL) score

  Change in OAB-q HRQOL score from baseline to 12 weeks, score range 0 to 100, higher scores indicating higher quality of life (higher scores good)

  12 weeks

Secondary Outcomes (8)

• Overactive bladder questionnaire (OAB-q) Symptom Bother subscale score

  6 weeks, 12 weeks

• Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life

  6 weeks

• Number of urinary incontinence episodes

  6 weeks, 12 weeks

• Number of voids per day

  6 weeks, 12 weeks

• Number of voids per night

  6 weeks, 12 weeks

Study Arms (2)

Posterior Tibial Nerve Stimulation (PTNS)

ACTIVE COMPARATOR

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.

Device: PTNS

Home transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

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.

Device: TENS

Interventions

PTNS DEVICE

See arm description

Also known as: Posterior Tibial Nerve Stimulation

Posterior Tibial Nerve Stimulation (PTNS)

TENS DEVICE

See arm description

Also known as: transcutaneous electrical nerve stimulation

Home transcutaneous electrical nerve stimulation (TENS)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females are entered in this trial as they are population most affected by overactive bladder (OAB) and served by the investigators
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Related Publications (29)

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MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Kate V Meriwether, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: April 4, 2022
• Study Start: June 30, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)