Hand & Foot Nocturnal Enuresis TENS Study

Bedwetting Clinical Trial

Official title:

Pilot Study: Hand & Foot Neuromodulation for Nocturnal Enuresis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747849
• Other study ID #: Pro15120157
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators believe in order to strengthen the evidence in support of transcutaneous foot stimulation in this population the investigators need to move forward with a randomized comparison study using the TENS device on the hand and foot as a control.

Description:

Nocturnal enuresis is a common problem in children which can have a dramatic psychological and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of peripheral tibial nerve branches has been shown to produce a prolonged inhibition of micturition reflex contractions and significantly increase bladder capacity. The investigators primary goal was to evaluate the effect of foot stimulation on the frequency of nocturnal enuresis episodes in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Children ages 5 to 18 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, nocturnal enuresis is a DSM V diagnosable medical condition

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

6. Children who do not tolerate initial stimulation training session in the urology clinic upon enrollment

7. 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.

Related Conditions & MeSH terms

• Bedwetting
• Enuresis
• Nocturnal Enuresis

Intervention

Device:
• TENS
Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh og UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rajeev Chaudhry	Society of Urodynamics and Female Urology The Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Nights Wet Per 2 Weeks	The subject/parents will be instructed to record a night-time voiding log specifying the change in number of nights wet per 2 weeks. This log is included in the IRB 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 week 3 and 4 of the study the subjects will stimulate either their foot or hand to measure any acute effect on nocturnal enuresis episodes and finally during week 5 and 6 of the study, after stimulation subjects will keep a log to evaluate any post-stimulation residual benefit	6 weeks
Primary	Response to Treatment	Total number of participants that responded to treatment after stimulation with Hand or Foor unit.	An average of 6 weeks