Foot Neuromodulation for Nocturnal Enuresis

NCT02315560 | Completed Results

• 1 other identifier: PRO14080250
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bedwetting

Keywords

bedwetting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life Questionnaire Scores

  6 weeks

Study Arms (1)

Tibial Nerve Stimulation

EXPERIMENTAL

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

Interventions

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS DEVICE

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

Tibial Nerve Stimulation

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidi Stephany: lead
• Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh og UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Nocturnal Enuresis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Heidi Stephany
• Organization: University of Pittsburgh

heidi.stephany@chp.edu

412-692-7932

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: September 1, 2014
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: June 12, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-05

Locations

US (1)