TERMINATED

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

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Conditions

Overactive BladderOveractive Bladder SyndromeUrinary Urge IncontinenceUrinary Bladder, OveractiveUrinary Incontinence, Urgeurinary frequencyurinary urgencyurge incontinenceelectrical stimulationTENSPTNSnerve stimulationbladder treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-06-30
Study Completion:2025-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05309993

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female Subjects ≥18 years of age
  2. * OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms and more bother from UUI than stress urinary incontinence
  3. * 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
  4. * Willing to complete study questionnaires
  5. * Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that arm
  6. * No contraindication to undergoing PTNS or TENS therapy
  1. * Age \< 18 years
  2. * Presence of urinary fistula
  3. * Male genital anatomy
  4. * 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
  5. * Current Bladder stones
  6. * Bladder cancer or suspected bladder cancer
  7. * Gross Hematuria
  8. * Pregnancy or planning to become pregnant during the study
  9. * Cognitive impairment
  10. * Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson's disease, spina bifida, spinal cord lesions, etc.
  11. * Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (ankle/leg)
  12. * Uncontrolled diabetes
  13. * Diabetes with peripheral nerve involvement
  14. * Current use of anticoagulants (excluding aspirin)
  15. * Current use of anticholinergics or use within the last 4 weeks
  16. * Current use of botox bladder injections or bladder botox injection within the last year (12 months)
  17. * Current use of sacral neuromodulation therapy or currently implanted sacral neuromodulation device or leads
  18. * Bladder outlet obstruction
  19. * Urinary retention or gastric retention
  20. * Painful Bladder Syndrome/Interstitial Cystitis
  21. * Unable to be contacted for follow up by telephone
  22. * Inability to speak/read/understand English or Spanish

Contacts and Locations

Principal Investigator

Kate V Meriwether, MD
PRINCIPAL_INVESTIGATOR
University of New Mexico

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of New Mexico

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-30
Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-06-30
Study Completion Date2025-08-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Overactive Bladder
  • Overactive Bladder Syndrome
  • Urinary Urge Incontinence
  • Urinary Bladder, Overactive
  • Urinary Incontinence, Urge