TENS treatment for bedwetting in children
Optimal Frequency Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
This study is testing whether using a TENS unit at different settings can help children aged 5-18 who struggle with bedwetting after trying other methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Albany Medical College Academic / other |
| Locations | 1 site (Albany, New York) |
| Trial ID | NCT04313192 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves children aged 5-18 years who experience primary nocturnal enuresis and have not responded to behavioral modifications. Participants will be randomized into three groups, each receiving a different frequency setting (2 Hz, 10 Hz, or 150 Hz) on a TENS unit to be used nightly. The study aims to evaluate the effectiveness of TENS therapy as an alternative treatment for bedwetting. Caretakers will be instructed on the proper use of the TENS unit and electrode placement.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 who experience bedwetting more than once a week and have failed behavioral modification treatments.
Not a fit: Patients with daytime incontinence, those who have recently tried pharmacologic treatments, or those with other urologic or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive alternative for children struggling with bedwetting.
How similar studies have performed: While TENS therapy for bedwetting is a novel approach, similar neuromodulation techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Presenting with nocturnal enuresis (more than 1x a week) 2. Failed Behavioral modification treatment (limiting evening drinking, double voiding prior to bedtime, bowel habits, social anxiety factors) 3. Ability to provide informed consent and assent and complete study requirements Exclusion Criteria: 1. Patients who have previously tried pharmacologic treatment for nocturnal enuresis, neuromodulation or other alternative therapy for urologic disorders within the past 30 days 2. Daytime incontinence symptoms 3. Known "high volume" voiders (determined from history) 4. Bedwetting episodes on the average of less than two times per week, 5. Medications predisposing to incontinence (eg, Lithium for bipolar disorder) 6. Other known voiding or neurologic disorders (eg, overactive bladder, myelomeningocele, interstitial cystitis, etc) 7. Secondary etiologies for nocturnal enuresis (eg, cystitis, obstructive sleep apnea, urinary fistulae, heart disease) 8. Any contraindications to usage of a TENS unit (pacemaker or other implantable device, lymphedema, pregnancy, malignancy,bleeding or clotting disorders, unhealthy tissue, seizure disorders, impaired cognition) 9. Any history of heart disease or complications
Where this trial is running
Albany, New York
- Albany Medical College — Albany, New York, United States (Recruiting)
Study contacts
- Principal investigator: Adam Howe, MD — Albany Medical College
- Study coordinator: Brenda Romeo, CCRC
- Email: amcurologyreseach@amc.edu
- Phone: 518-262-8579
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.