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NCT04313192 · ClinicalTrials.gov registry record · NA
TENS Treatment for Bedwetting
A NA study, sponsored by Albany Medical College.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
NCT04313192 is a NA study that has completed, run by Albany Medical College. The registered enrollment target is 125 participants.
The verdict
NCT04313192, a NA study, has completed, sponsored by Albany Medical College.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
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 three groups of 30 patients each. Group 1 will be the long frequency set at 2 Hz (hertz). Group 2 will be the moderate frequency set at 10 Hz. Group 3 will be the short frequency set 150 Hz. 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 frequency determined by randomization, pulse width of 260 seconds, 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 15 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 Pediatric Urinary Incontinence Questionnaire, a validated tool for measuring quality of life in children with bladder dysfunction; this questionnaire will be filled out prior to starting TENS treatment in order to compare the effect of treatment on QOL. 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.
Interventions
- DEVICE pulse rate of 2 Hz
- DEVICE pulse rate of 10 Hz
- DEVICE pulse rate of 150 Hz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2020-01-20 |
| Est. Completion | 2024-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04313192
The ClinicalTrials.gov registry entry for NCT04313192 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albany Medical College, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which pulse rate of 2 Hz is the first listed.
NCT04313192 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04313192 about?
NCT04313192 is a clinical study titled "TENS Treatment for Bedwetting". 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 NCT04313192?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2020-01-20. Estimated completion is 2024-12-01.
What interventions are being tested in trial NCT04313192?
The interventions under investigation include: pulse rate of 2 Hz (DEVICE), pulse rate of 10 Hz (DEVICE), pulse rate of 150 Hz (DEVICE).
Who is sponsoring clinical trial NCT04313192?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
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