Incontinence, Urinary, Overactive Bladder, Voiding Disorders
Conditions
Brief summary
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.
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.
Interventions
DEVICEparasacral 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.
OTHERStandard 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.
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
patients will be randomized to standard urotherapy or urotherapy + PTENS
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Urotherapy 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. | 15 |
| 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.
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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Standard Urotherapy | Standard Urotherapy + PTENS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10 years | 9.1 years | 9.55 years |
| Initail Dysfunctional Voiding Scoring System Score | 10 units on a scale | 11 units on a scale | 10.5 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 13 Participants | 12 Participants | 25 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 13 |
| other Total, other adverse events | 0 / 11 | 2 / 13 |
| serious Total, serious adverse events | 0 / 11 | 0 / 13 |
Outcome results
Primary
Dysfunctional Voiding Symptom Score
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Urotherapy | Dysfunctional Voiding Symptom Score | 8 score on a scale |
| Standard Urotherapy + PTENS | Dysfunctional Voiding Symptom Score | 11 score on a scale |
Primary
Voiding Diary and the Number of Episodes of Incontinence Per Day
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
Population: number of patients who completed 48 hour voiding diary at 6 weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard Urotherapy | Voiding Diary and the Number of Episodes of Incontinence Per Day | 12 week Voiding Diary | 1 Incontinence Episodes |
| Standard Urotherapy | Voiding Diary and the Number of Episodes of Incontinence Per Day | 6 week Voiding Diary | 2 Incontinence Episodes |
| Standard Urotherapy + PTENS | Voiding Diary and the Number of Episodes of Incontinence Per Day | 6 week Voiding Diary | 1 Incontinence Episodes |
| Standard Urotherapy + PTENS | Voiding Diary and the Number of Episodes of Incontinence Per Day | 12 week Voiding Diary | 0.5 Incontinence Episodes |
Secondary
Secondary Outcome. Review of Adverse Events.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Urotherapy | Secondary Outcome. Review of Adverse Events. | 0 events |
| Standard Urotherapy + PTENS | Secondary Outcome. Review of Adverse Events. | 2 events |