Trial Outcomes & Findings for Foot Neuromodulation for Nocturnal Enuresis (NCT NCT02315560)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS: electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
Overall Study noncompliance by subjects	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tibial Nerve Stimulation n=22 Participants 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
Age, Categorical <=18 years	22 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=22 Participants
Age, Categorical >=65 years	0 Participants n=22 Participants
Age, Continuous	11.4 years n=22 Participants
Sex: Female, Male Female	10 Participants n=22 Participants
Sex: Female, Male Male	12 Participants n=22 Participants
Region of Enrollment United States	22 Participants n=22 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Foot Stimulation n=22 Participants 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
Decrease in Nocturnal Enuresis	16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Foot Stimulation n=22 Participants 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
Quality of Life Questionnaire Scores Pre-stimulation	13.9 units on a scale Interval 5.0 to 35.0
Quality of Life Questionnaire Scores Stimulation	11.6 units on a scale Interval 5.0 to 33.0
Quality of Life Questionnaire Scores Post-stimulation	10.5 units on a scale Interval 2.0 to 28.0

Adverse Events

Foot Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heidi Stephany

University of Pittsburgh

Phone: 412-692-7932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place