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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Overactive Bladder
Intervention / Treatment

-

Contacts and Locations

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of New Mexico,

Kate V Meriwether, MD, PRINCIPAL_INVESTIGATOR, University of New Mexico

Study Record Dates

2026-12-31