Clinical Trial: Foot Neuromodulation for Nocturnal Enuresis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Foot Neuromodulation for Nocturnal Enuresis in Children

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

Detailed Summary: 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.
Sponsor: Children's Hospital of Pittsburgh

Current Primary Outcome: Aim1 (determine decrease in nocturnal enuresis in children as measured by daily night-time voiding log.) [ Time Frame: 6 weeks ]

To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log.


Original Primary Outcome: Same as current

Current Secondary Outcome: Aim 2 (quality of life questionnaire scores ) [ Time Frame: 6 weeks ]

To determine if foot stimulation can improve quality of life questionnaire scores during a 6-week period, with foot stimulation applied during the third and fourth week, as measured by a validated quality of life survey.


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Pittsburgh

Dates:
Date Received: December 9, 2014
Date Started: September 2014
Date Completion: September 2018
Last Updated: February 14, 2017
Last Verified: February 2017