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Completed

NCT Number: NCT02315560

Foot Neuromodulation for Nocturnal Enuresis

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

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh og UPMC

Pittsburgh, Pennsylvania, 15224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Heidi Stephany

Other

Collaborators

  • Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction

Registry information

Official study title

Foot Neuromodulation for Nocturnal Enuresis in Children

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2014
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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