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

Launched by UNIVERSITY OF NEW MEXICO · Mar 24, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two types of treatments for women who have been struggling with overactive bladder (OAB), a condition that causes sudden urges to urinate. The study is comparing the effectiveness of a treatment called percutaneous tibial nerve stimulation (PTNS) and another called transcutaneous electrical nerve stimulation (TENS). Both treatments aim to improve the quality of life for women who have already tried other options, like medication and lifestyle changes, without success.

To participate in this study, you need to be a woman aged 18 or older, have OAB or related urinary incontinence symptoms, and have already tried at least one type of medication or conservative therapy without improvement. If you join the trial, you will receive treatment over a three-month period and complete some questionnaires to help the researchers understand how each treatment affects your daily life. It’s important to know that some people, like those with certain medical conditions or those currently pregnant, may not be eligible to participate.

Gender

FEMALE

Eligibility criteria

• 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 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