Foot Neuromodulation for Nocturnal Enuresis

Foot Neuromodulation for Nocturnal Enuresis in Children

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

Study Overview

• Status: Completed
• Conditions: Bedwetting
• Intervention / Treatment: Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh og UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

5. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment

6. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tibial Nerve Stimulation; 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

Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS; electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Nocturnal Enuresis	To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire Scores	The NLUTD/DES questionnaire (Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome) has been validated and is reliable for assessing lower urinary tract and bowel dysfunction. The questionnaire is scored using a 5-point Likert scale. The questionnaire consists of a total of 14 questions, each question asking about a symptom. Question #7 specifically addresses nocturnal enuresis. A score of 4 indicates severe symptoms, while a score of 0 indicates none. The maximum score is 52, indicating the most severe symptoms, while the minimum score of zero indicates zero symptoms. Scores of 11 or greater indicate bladder or bowel dysfunction.	6 weeks

Collaborators and Investigators

• Sponsor: Heidi Stephany
• Collaborators: Society of Urodynamics and Female pelvic Medicine and Urogenital Reconstruction (SUFU)

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): April 6, 2017
• Study Completion (Actual): April 6, 2017

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: bedwetting
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urination Disorders; Elimination Disorders; Enuresis; Nocturnal Enuresis
• Other Study ID Numbers: PRO14080250