Foot Neuromodulation for Nocturnal Enuresis

NCT ID: NCT02315560

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-04-06

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 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.

Conditions

Bedwetting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS

Intervention Type: DEVICE

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

Interventions

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

OTHER

Sponsor Role: collaborator

Heidi Stephany

OTHER

Sponsor Role: lead

Responsible Party

Heidi Stephany

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Children's Hospital of Pittsburgh og UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO14080250

Identifier Type: -

Identifier Source: org_study_id