Foot Neuromodulation for Nocturnal Enuresis

Heidi Stephany

Status: Completed

Conditions: Bedwetting

Treatments: Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT02315560

PRO14080250

Details and patient eligibility

About

To determine the effects of electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children

Full description

Nocturnal Enuresis is a very common and difficult to treat problem in the pediatric population which can have significant negative impact on a child's quality of life. Apart from medications which can have significant side effects limiting their use, there is a lack of effective and safe treatment options for children with frequent nocturnal enuresis. If foot stimulation prior to bed does indeed improve the frequency of nocturnal enuresis, it may provide a safe and non-invasive therapeutic option.

Enrollment: 25 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children ages 5 to 16 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
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Tibial Nerve Stimulation

Experimental group

Description:

The subject/parents will be instructed to record a night-time voiding log specifying the number of incontinent episodes per night. This log is included in the Institutional Review Board 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 the two week foot stimulation period to measure any acute effect on nocturnal enuresis episodes and finally during the two weeks after stimulation to evaluate any post-stimulation residual benefit

Treatment:

Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS