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NCT06135311 · ClinicalTrials.gov registry record · NA
Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children
A NA study of Nocturnal Enuresis and Bedwetting, sponsored by Albany Medical College.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06135311: Recruiting NA study of Nocturnal Enuresis and Bedwetting, sponsored by Albany Medical College.
NCT06135311 is a NA study of Nocturnal Enuresis and Bedwetting that is actively recruiting participants, run by Albany Medical College. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06135311, a NA study of Nocturnal Enuresis and Bedwetting, is actively recruiting participants, sponsored by Albany Medical College.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Children referred to pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail will next be offered therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study.The patients will be randomized into two groups of 35 patients each.Group 1 will be the high pulse width set at 260us. Group 2 will be the low pulse width set at 50us. The patients will be provided with a TENS unit and electrode pads and caretakers instructed on how to use the apparatus. The child's TENS unit will be set at a pulse width determined by randomization, frequency of 10Hz, and an intensity to be determined in the office based upon when the child feels sensitive to the TENS unit. The child will be randomized and will place the electrodes along the posterior tibial nerve on the medial ankle each night before bed time for 30 minutes for a total of 30 days. Diaries including nighttime incontinence episodes and a "wet sheet" scale (dry, damp, wet, soaked) will be recorded, along with any adverse reactions to the TENS unit. Patients will be followed up after one month of TENS with evaluation including the Bowel \& Bladder Questionnaire (BBQ), a validated tool for measuring symptoms in children with voiding dysfunction \[6\]; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment. The data will be collected at different time points (baseline and after 1 month of treatment) for each group by itself and the groups compared against each other using statistical analysis.
Primary Outcome
Percent of wet nights per month compared in each TENS arm and baseline wet nights
Conditions Studied
Interventions
- DEVICE Pulse Width 260us
- DEVICE Pulse Width 50us
Study Locations (1)
New York
- Albany Medical College - Albany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-10-24 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT06135311 shows while recruiting
NCT06135311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Nocturnal Enuresis appearing as the primary indexed condition, and to 2 interventions - of which Pulse Width 260us is the first listed.
NCT06135311 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06135311 about?
NCT06135311 is a clinical study titled "Optimal Pulse Width Used in Transcutaneous Electrical Nerve Stimulation for Treating Nocturnal Enuresis in Children". Children referred to pediatric urology clinic for primary nocturnal enuresis will be screened for enrollment. Patients who fail will next be offered therapy with a bedwetting alarm device or a TENS unit as an alternative, and those who chose TENS therapy will be included in the study.The patients wi...
What is the current status of trial NCT06135311?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2023-10-24. Estimated completion is 2026-12-31.
What conditions does trial NCT06135311 study?
This clinical trial studies the following conditions: Nocturnal Enuresis, Bedwetting.
What interventions are being tested in trial NCT06135311?
The interventions under investigation include: Pulse Width 260us (DEVICE), Pulse Width 50us (DEVICE).
Who is sponsoring clinical trial NCT06135311?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06135311 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06135311's enrollment target sits among peer trials
70 1104th of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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