Back to resultsFoot Neuromodulation for Nocturnal Enuresis
Primary Purpose
Bedwetting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS
Sponsored by
About this trial
This is an interventional treatment trial for Bedwetting focused on measuring bedwetting
Eligibility Criteria
Inclusion Criteria:
- 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
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
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.
Sites / Locations
- Children's Hospital of Pittsburgh og UPMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tibial Nerve Stimulation
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02315560
First Posted
December 9, 2014
Last Updated
May 14, 2018
Sponsor
Heidi Stephany
Collaborators
Society of Urodynamics and Female pelvic Medicine and Urogenital Reconstruction (SUFU)
1. Study Identification
Unique Protocol Identification Number
NCT02315560
Brief Title
Foot Neuromodulation for Nocturnal Enuresis
Official Title
Foot Neuromodulation for Nocturnal Enuresis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 6, 2017 (Actual)
Study Completion Date
April 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heidi Stephany
Collaborators
Society of Urodynamics and Female pelvic Medicine and Urogenital Reconstruction (SUFU)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bedwetting
Keywords
bedwetting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tibial Nerve Stimulation
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS
Intervention Description
electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Primary Outcome Measure Information:
Title
Decrease in Nocturnal Enuresis
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire Scores
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
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.
Facility Information:
Facility Name
Children's Hospital of Pittsburgh og UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
12. IPD Sharing Statement
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Foot Neuromodulation for Nocturnal Enuresis
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