INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder (NCT05309993) | Clinical Trial Compass
TerminatedNot Applicable
INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder
Stopped: Inadequate recruitment with expiration of funding and futility of enrollment
United States27 participantsStarted 2022-06-30
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 perip…
What they're measuring
1
Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life (HRQOL) score