Clinical trial NCT02747849: Hand & Foot Nocturnal Enuresis TENS Study
Official title: Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bedwetting
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Coulter Foundation
First posted: 2016-04-22
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Number of Nights Wet Per 2 Weeks
timeFrame: 6 weeks
measure: Response to Treatment
timeFrame: An average of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh og UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rajeev Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
References: