Hand & Foot Nocturnal Enuresis TENS Study

Not Applicable

Completed

Conditions: Bedwetting

Registration Number: NCT02747849

Lead Sponsor: Rajeev Chaudhry

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

Inclusion Criteria

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
Currently having no daytime overactive bladder symptoms, i.e. urinary frequency, urgency, or daytime incontinence
Having been assessed for and treated if applicable for behavioral etiologies of nocturnal enuresis - consuming excess fluids or specific bladder irritants
Having been assessed for and treated if applicable for constipation

Exclusion Criteria

Children with known neurological disorders which may be contributing to nocturnal enuresis episodes
Children found through history to have significant behavioral causes of nocturnal enuresis including consumption of excessive fluids or known bladder irritants
Children with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
Children who are not adequately potty trained
Children with significant daytime symptoms of overactive bladder including frequency, urgency, and daytime incontinence
Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Children's Hospital of Pittsburgh og UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States
Children's Hospital of Pittsburgh og UPMC
🇺🇸Pittsburgh, Pennsylvania, United States