Foot Neuromodulation for Nocturnal Enuresis

• Sponsor: Heidi Stephany (Other)
• Overall Status: Completed
• CT.gov ID: NCT02315560
• Collaborator: Society of Urodynamics and Female pelvic Medicine and Urogenital Reconstruction (SUFU) (Other)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 31.1
• Patients Per Site Per Month: 0.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bedwetting	Device: TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Foot Neuromodulation for Nocturnal Enuresis in Children
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Apr 6, 2017
• Actual Study Completion Date: Apr 6, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Decrease in Nocturnal Enuresis [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2014

More Information

Publications

None provided.

• Responsible Party: Heidi Stephany, Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02315560
• Other Study ID Numbers: PRO14080250
• First Posted: Dec 12, 2014
• Last Update Posted: Jun 12, 2018
• Last Verified: May 1, 2018

• Keywords provided by Heidi Stephany, Assistant Professor, University of Pittsburgh: bedwetting
• Additional relevant MeSH terms: Enuresis; Nocturnal Enuresis

Study Results

Participant Flow

Arm/Group Title	Tibial Nerve Stimulation
Arm/Group 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Period Title: Overall Study
STARTED	25
COMPLETED	22
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Tibial Nerve Stimulation
Arm/Group 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Overall Participants	22
Age (Count of Participants)
<=18 years	22 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	11.4
Sex: Female, Male (Count of Participants)
Female	10 45.5%
Male	12 54.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	22 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Foot Stimulation
Arm/Group 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Measure Participants	22
Count of Participants [Participants]	16 72.7%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Foot Stimulation
Arm/Group 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Measure Participants	22
Pre-stimulation	13.9
Stimulation	11.6
Post-stimulation	10.5

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Foot Stimulation
Arm/Group 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
All Cause Mortality
	Foot Stimulation
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Serious Adverse Events
	Foot Stimulation
	Affected / at Risk (%)	# Events
Total	0/22 (0%)
Other (Not Including Serious) Adverse Events
	Foot Stimulation
	Affected / at Risk (%)	# Events
Total	0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.