Bedwetting
Conditions
Brief summary
The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.
Detailed description
Nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. The investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.
Interventions
DEVICETENS
Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
Sponsors
The Coulter Foundation
Rajeev Chaudhry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children ages 5 to 18 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as having nocturnal enuresis AT LEAST 4 episodes per month by history, nocturnal enuresis is a DSM V diagnosable medical condition 2. Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence 3. Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants 4. Having been assessed for and treated if applicable for constipation
Exclusion criteria
1. Children with known neurological disorders which may be contributing to nocturnal enuresis episodes 2. Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants 3. Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat. 4. Children who are not adequately potty trained 5. Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence 6. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment 7. Children with any implantable medical devices such as a pacemaker will be excluded from the study Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Nights Wet Per 2 Weeks | 6 weeks | The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit |
| Response to Treatment | An average of 6 weeks | Total number of participants that responded to treatment after stimulation with Hand or Foor unit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hand Neuromodulation The stimulation characteristics for this arm include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for finger twitching - or the intensity that the subject feels comfortable with. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms. | 12 |
| Foot Neuromodulation The stimulation characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for inducing toe twitching - or the intensity that the subject feels comfortable with. The subjects will be asked to wear socks on their foot to prevent the electrodes from detachment and to stop the stimulation during walking or in any non-resting situation. Subjects will be asked to use the stimulator for a minimum of 60 minutes prior to bedtime for two weeks, or longer if they can tolerate it, have the time, and accurately record the total duration. Stimulation will be performed during the first, second, and third weeks of the study.
TENS: Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | Hand Neuromodulation | Foot Neuromodulation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 14 Participants | 26 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12 years | 12.1 years | 12 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 12 participants | 14 participants | 26 participants |
| Sex/Gender, Customized Gender Did not identify | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Gender Female | 3 Participants | 4 Participants | 7 Participants |
| Sex/Gender, Customized Gender Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
Primary
Change in Number of Nights Wet Per 2 Weeks
The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB application. Subjects/parents will fill out the log for a two week period prior to foot stimulation to determine a baseline average of nocturnal enuresis episodes, during week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit
Time frame: 6 weeks
Population: Patients with primary nocturnal enuresis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hand Neuromodulation | Change in Number of Nights Wet Per 2 Weeks | # nights wet before stimulation over 2 weeks | 11 # nights wet over 2 weeks | Standard Deviation 3.46 |
| Hand Neuromodulation | Change in Number of Nights Wet Per 2 Weeks | # nights wet during stimulation over 2 weeks | 8.75 # nights wet over 2 weeks | Standard Deviation 3.99 |
| Hand Neuromodulation | Change in Number of Nights Wet Per 2 Weeks | # nights wet after stimulation over 2 weeks | 9.5 # nights wet over 2 weeks | Standard Deviation 3.82 |
| Foot Neuromodulation | Change in Number of Nights Wet Per 2 Weeks | # nights wet before stimulation over 2 weeks | 8.78 # nights wet over 2 weeks | Standard Deviation 4.12 |
| Foot Neuromodulation | Change in Number of Nights Wet Per 2 Weeks | # nights wet during stimulation over 2 weeks | 6.22 # nights wet over 2 weeks | Standard Deviation 4.21 |
| Foot Neuromodulation | Change in Number of Nights Wet Per 2 Weeks | # nights wet after stimulation over 2 weeks | 6.78 # nights wet over 2 weeks | Standard Deviation 5.19 |
Primary
Response to Treatment
Total number of participants that responded to treatment after stimulation with Hand or Foor unit.
Time frame: An average of 6 weeks
Population: Patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hand Neuromodulation | Response to Treatment | 8 Participants |
| Foot Neuromodulation | Response to Treatment | 9 Participants |