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Foot Neuromodulation for Nocturnal Enuresis

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ClinicalTrials.gov Identifier: NCT02315560
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Society of Urodynamics and Female pelvic Medicine and Urogenital Reconstruction (SUFU)
Information provided by (Responsible Party):
Heidi Stephany, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Bedwetting Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foot Neuromodulation for Nocturnal Enuresis in Children
Study Start Date : September 2014
Actual Primary Completion Date : April 6, 2017
Actual Study Completion Date : April 6, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Decrease in Nocturnal Enuresis [ Time Frame: 6 weeks ]
    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 :
  1. Quality of Life Questionnaire Scores [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315560


Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh og UPMC
Pittsburgh, Pennsylvania, United States, 15224
Sponsors and Collaborators
Heidi Stephany
Society of Urodynamics and Female pelvic Medicine and Urogenital Reconstruction (SUFU)
  Study Documents (Full-Text)

Documents provided by Heidi Stephany, University of Pittsburgh:

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Responsible Party: Heidi Stephany, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02315560     History of Changes
Other Study ID Numbers: PRO14080250
First Posted: December 12, 2014    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: June 12, 2018
Last Verified: May 2018

Keywords provided by Heidi Stephany, University of Pittsburgh:
bedwetting

Additional relevant MeSH terms:
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Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders