Comparing TENS and PTNS for treating overactive bladder
INvestigation of TENS Efficacy Versus Posterior Tibial Nerve Stimulation for Overactive Bladder
This study is testing whether a new electrical nerve treatment is just as good as a different nerve treatment for helping women with overactive bladder feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT05309993 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) compared to percutaneous tibial nerve stimulation (PTNS) in improving the quality of life for women suffering from idiopathic overactive bladder (OAB) and urgency urinary incontinence (UUI). The study will involve a non-masked, non-inferiority randomized controlled trial design, where participants will be informed of their treatment assignment. Eligible women will have previously failed first- and second-line treatments and will undergo a thorough evaluation to confirm their diagnosis before enrollment. The study will assess the outcomes over a series of office visits to monitor the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with overactive bladder or urgency urinary incontinence who have not responded to conservative or pharmacologic treatments.
Not a fit: Patients with urinary fistulas, male genital anatomy, or those under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-surgical treatment option that significantly improves the quality of life for women with overactive bladder.
How similar studies have performed: Other studies have shown promising results with similar electrical stimulation approaches for treating overactive bladder, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Albuquerque, New Mexico
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Kate V Meriwether, MD — University of New Mexico
- Study coordinator: Kate V Meriwether, MD
- Email: meriwet2@salud.unm.edu
- Phone: 5052495967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.