Using electrical stimulation to treat bedwetting in children
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation (TENS) for Treating Nocturnal Enuresis in Children
This study is testing if a new electrical stimulation treatment can help children aged 5-17 who struggle with bedwetting after other methods haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Albany Medical College Academic / other |
| Locations | 1 site (Albany, New York) |
| Trial ID | NCT06135311 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves children aged 5-17 who are experiencing primary nocturnal enuresis and have not responded to behavioral modifications. Participants will be randomized into two groups to receive transcutaneous electrical nerve stimulation (TENS) with different pulse widths: one group at 260 microseconds and the other at 50 microseconds. The TENS unit will be applied nightly for 30 minutes over a period of 30 days, with caregivers instructed on its use. The effectiveness of the treatment will be monitored through diaries documenting nighttime incontinence.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-17 with nocturnal enuresis who have failed initial behavioral modification treatments.
Not a fit: Patients with daytime incontinence, those who have recently tried other treatments for bedwetting, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide an effective non-pharmacological treatment option for children suffering from bedwetting.
How similar studies have performed: While the use of TENS for nocturnal enuresis 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) during the 30 day period prior to randomization 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: romeob@amc.edu
- Phone: 518-262-3349
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.