Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT04570605
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Voiding Disorders; Incontinence, Urinary	Device: parasacral transcutaneous electrical nerve stimulation (PTENS); Other: Standard Urotherapy	N/A

Detailed Description

Overactive bladder (OAB) is the most common voiding dysfunction in children1. While many children may outgrow these issues, for some these symptoms persists and can lead to emotional, social, behavioral and physical problems. Multiple treatments exist for OAB but rarely is there guaranteed success. Many behavioral and lifestyle treatments involve a significant time investment and office visits on the part of the patient and family. Furthermore, medication therapy is often associated with bothersome side effects and is discontinued, even despite efficacy2. As such, treatments with potentially less adverse effects, often used in adult urology, are making their way into the pediatric urology practice. These include intravesical botulinum toxin injections, sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS).

PTNS, first cleared by the United States Food and Drug Administration (FDA) in 2011 for adult use, has evolved into transcutaneous nerve stimulation in the pediatric population; obviating the need for needles during treatment. Studies suggest mixed efficacy in electric nerve stimulation for overactive bladder in the pediatric population, owing largely to the marked heterogeneity in treatment protocols. While some researchers follow the traditional tibial nerve pathway, others take a cue from SNS and target the parasacral area, while still others rely on signaling from even further peripheral nerves to modulate bladder overactivity 3-5. Perhaps further contributing to the disparate data is the varying treatment schedules used. Some centers perform treatments daily, others weekly, others twice or thrice a week. Similarly, some physicians recommend twenty-minute treatments, while others thirty or even sixty minutes. The majority of studies rely on an office-based treatment model, while a few have explored in home treatments 3-5. In the United States, there has been no study examining the feasibility or efficacy of home parasacral transcutaneous electric nerve stimulation (PTENS) on pediatric voiding dysfunction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trialrandomized controlled trial
• Masking: Single (Participant)
• Masking Description: patients will be randomized to standard urotherapy or urotherapy + PTENS
• Primary Purpose: Treatment
• Official Title: Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Urotherapy Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management.	Other: Standard Urotherapy; standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Experimental: Standard Urotherapy + PTENS Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment.	Device: parasacral transcutaneous electrical nerve stimulation (PTENS); electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.; Other: Standard Urotherapy; standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.

Outcome Measures

Primary Outcome Measures

1. Dysfunctional Voiding Symptom Score [week 6]

   At week 6 a Dysfunctional Voiding Scoring System Score. Descriptive statistics will be used to analyze these data in comparison to pre-study scores. As stated above, Dysfunctional Voiding Symptom Score is a validated clinical questionnaire designed to quantify the severity of pediatric voiding dysfunction on a scale of 0 (non-existent) to 30 (most severe).

2. Voiding Diary and the Number of Episodes of Incontinence Per Day [week 6, week 12]

   48-hour Voiding Diary and Nighttime Wetting log will be repeated and evaluated. This was added as a separate primary outcome as it is separate from the Dysfunctional Voiding Symptom Score. The voiding diary will be used to evaluate the number of episodes of incontinence per day and descriptive statistics will be used to compare this to pre-study numbers.

Secondary Outcome Measures

1. Secondary Outcome. Review of Adverse Events. [Week 6 through Week 12]

   Confirmation of safety and identification of potential adverse events. We will review all data for potential adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Toilet trained (age 6) to age 17

• Diagnosis of urinary dysfunction, voiding dysfunction, overactive bladder, urgency incontinence, nocturnal enuresis. (These patients may also have an element of bowel dysfunction; however, we will not include a patient who had ONLY bowel dysfunction and NOT a voiding dysfunction).

Exclusion Criteria:

• Known neurologic diagnosis - such as myelomeningocele, caudal regression

• Known seizure disorder

• Age < 6 or > 17

• Lack of follow-up within 6 months of treatment

• Pacemaker, vagal nerve stimulator, or other implanted electrical device

• Intolerance of electrical nerve stimulation

• Pregnancy

• Implanted metal hardware

• Open sores or wounds over the sacral area

• Currently catheterizing for bladder drainage

• Known anatomic lower urinary tract abnormality (may be congenital or iatrogenic)

• Bowel only voiding dysfunction (Constipation ICD-10 K59.00)

• Non-English speaking families

• Families with health literacy precluding completion of questionnaires and voiding diaries

• Concurrent use of anticholinergics, alpha blockers or beta agonists for urologic treatments

• Untreated urinary tract infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah/Primary Children's Pediatric Urology	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Glen A Lau, MD, University of Utah

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 23, 2019

More Information

Publications

• de Paula LIDS, de Oliveira LF, Cruz BP, de Oliveira DM, Miranda LM, de Moraes Ribeiro M, Duque RO, de Figueiredo AA, de Bessa J Jr, Netto JMB. Parasacral transcutaneous electrical neural stimulation (PTENS) once a week for the treatment of overactive bladder in children: A randomized controlled trial. J Pediatr Urol. 2017 Jun;13(3):263.e1-263.e6. doi: 10.1016/j.jpurol.2016.11.019. Epub 2016 Dec 21. Erratum in: J Pediatr Urol. 2021 Jun;17(3):e1.
• Farhat W, Bägli DJ, Capolicchio G, O'Reilly S, Merguerian PA, Khoury A, McLorie GA. The dysfunctional voiding scoring system: quantitative standardization of dysfunctional voiding symptoms in children. J Urol. 2000 Sep;164(3 Pt 2):1011-5.

• Responsible Party: Glen Lau, Assistant Professor of Surgery, University of Utah
• ClinicalTrials.gov Identifier: NCT04570605
• Other Study ID Numbers: 117756
• First Posted: Sep 30, 2020
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence; Enuresis

Study Results

Participant Flow

Arm/Group Title	Standard Urotherapy	Standard Urotherapy + PTENS
Arm/Group Description	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Period Title: Overall Study
STARTED	15	15
COMPLETED	11	13
NOT COMPLETED	4	2

Baseline Characteristics

Arm/Group Title	Standard Urotherapy	Standard Urotherapy + PTENS	Total
Arm/Group Description	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	15 100%	15 100%	30 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	10	9.1	9.55
Sex: Female, Male (Count of Participants)
Female	5 33.3%	7 46.7%	12 40%
Male	10 66.7%	8 53.3%	18 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 6.7%	0 0%	1 3.3%
White	13 86.7%	12 80%	25 83.3%
More than one race	0 0%	1 6.7%	1 3.3%
Unknown or Not Reported	1 6.7%	2 13.3%	3 10%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%
Initail Dysfunctional Voiding Scoring System Score (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	10	11	10.5

Outcome Measures

1. Primary Outcome

Title	Dysfunctional Voiding Symptom Score
Description	At week 6 a Dysfunctional Voiding Scoring System Score. Descriptive statistics will be used to analyze these data in comparison to pre-study scores. As stated above, Dysfunctional Voiding Symptom Score is a validated clinical questionnaire designed to quantify the severity of pediatric voiding dysfunction on a scale of 0 (non-existent) to 30 (most severe).
Time Frame	week 6

Outcome Measure Data

Analysis Population Description

Patients who met elegibility criteria and enrolled in the study and then completed the DVSS questionnaire at 6 weeks into the study. These numbers differ from the total number of patients enrolled as there were some who did not complete the 6 week questionnaire.

Arm/Group Title	Standard Urotherapy	Standard Urotherapy + PTENS
Arm/Group Description	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Measure Participants	8	7
Median (Inter-Quartile Range) [score on a scale]	8	11

2. Primary Outcome

Title	Voiding Diary and the Number of Episodes of Incontinence Per Day
Description	48-hour Voiding Diary and Nighttime Wetting log will be repeated and evaluated. This was added as a separate primary outcome as it is separate from the Dysfunctional Voiding Symptom Score. The voiding diary will be used to evaluate the number of episodes of incontinence per day and descriptive statistics will be used to compare this to pre-study numbers.
Time Frame	week 6, week 12

Outcome Measure Data

Analysis Population Description

number of patients who completed 48 hour voiding diary at 6 weeks.

Arm/Group Title	Standard Urotherapy	Standard Urotherapy + PTENS
Arm/Group Description	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Measure Participants	7	11
6 week Voiding Diary	2	1
12 week Voiding Diary	1	0.5

3. Secondary Outcome

Title	Secondary Outcome. Review of Adverse Events.
Description	Confirmation of safety and identification of potential adverse events. We will review all data for potential adverse events.
Time Frame	Week 6 through Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Urotherapy	Standard Urotherapy + PTENS
Arm/Group Description	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
Measure Participants	11	13
Number [events]	0	2

Adverse Events

Time Frame	12 weeks (time that data was collected between enrollment and subjects completing their participation in the study)
Arm/Group Title	Standard Urotherapy		Standard Urotherapy + PTENS
Arm/Group Description	Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.		Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. parasacral transcutaneous electrical nerve stimulation (PTENS): electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks. Standard Urotherapy: standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
All Cause Mortality
	Standard Urotherapy		Standard Urotherapy + PTENS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/13 (0%)
Serious Adverse Events
	Standard Urotherapy		Standard Urotherapy + PTENS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Standard Urotherapy		Standard Urotherapy + PTENS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		2/13 (15.4%)
Skin and subcutaneous tissue disorders
Pruritis at Pad Site	0/11 (0%)	0	1/13 (7.7%)	1
Discomfort when removing pad	0/11 (0%)	0	1/13 (7.7%)	1

Limitations/Caveats

Limitations included patients being lost to follow-up or not completing their voiding diaries or DVSS questionnaires so that the number of patients with complete information was only slightly higher than half of the total who were initially enrolled.

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.