Overactive BladderNCT04570605
Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population
A study testing parasacral transcutaneous electrical nerve stimulation (PTENS) and Standard Urotherapy in people with Overactive Bladder and Voiding Disorders, run by University of Utah at 1 site in United States.
Trial summary
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder, Voiding Disorders, Incontinence, Urinary
- What is being tested?
- parasacral transcutaneous electrical nerve stimulation (PTENS) and Standard Urotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah/Primary Children's Pediatric Urology
Salt Lake City, Utah, 84112
About this study
Official title: Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.
Read the 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.
- Conditions
- Overactive Bladder, Voiding Disorders, Incontinence, Urinary
- Being tested
- parasacral transcutaneous electrical nerve stimulation (PTENS), Standard Urotherapy
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parasacral transcutaneous electrical nerve stimulation (PTENS)Device
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 UrotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Urotherapy | Active comparator | Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. Receives: Other: Standard Urotherapy |
| Standard Urotherapy + PTENS | Experimental | Patients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. Receives: Device: parasacral transcutaneous electrical nerve stimulation (PTENS); Other: Standard Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 6
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.
Measured: week 6, week 12
Secondary outcomes (1)
Secondary Outcome. Review of Adverse Events.
Confirmation of safety and identification of potential adverse events. We will review all data for potential adverse events.
Measured: Week 6 through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Apr 2019
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glen Lau, University of Utah
- Investigators
- Glen A Lau, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570605
- Sponsor's protocol ID
- 117756
- Status last verified
- Mar 2022
- First submitted
- 19 Apr 2019
- Last updated
- 17 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will be stored on password protected computers in the facility and collected data will be entered in a REDCap database. Individual participant data will not be shared with any individuals other than the study personnel as only these individuals will have access to the data.
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.
PubMed 28089606Farhat W, Bagli 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. doi: 10.1097/00005392-200009020-00023.
PubMed 10958730
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home Parasacral Transcutaneous Electrical Nerve Stimulation (PTENS) for the Voiding Dysfunction in the Pediatric Population: A Pilot Study
- ClinicalTrials.gov ID
- NCT04570605
- Acronym / sponsor ID
- 117756
- Conditions
- Overactive Bladder, Voiding Disorders, Incontinence, Urinary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 8 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Urotherapy | Active comparator | Other: Standard UrotherapyPatients who meet eligibility criteria who will be counselled on standard recommendations for bladder management. |
| Standard Urotherapy + PTENS | Experimental | Device: parasacral transcutaneous electrical nerve stimulation (PTENS), Other: Standard UrotherapyPatients who meet eligibility criteria who will be counselled on standard recommendations for bladder management AND use parasacral percutaneous TENS as additional treatment. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Standard Urotherapy + PTENS |
| Standard Urotherapystandard 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. | Other | Standard Urotherapy, Standard Urotherapy + PTENS |
Primary outcome
Dysfunctional Voiding Symptom Score
Time frame: 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
Time frame: 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.
1 secondary outcome
Secondary Outcome. Review of Adverse Events.
Time frame: Week 6 through Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28089606de 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.
- Background: PubMed 10958730Farhat W, Bagli 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. doi: 10.1097/00005392-200009020-00023.
- Individual participant dataSharing planned: No. Individual participant data will be stored on password protected computers in the facility and collected data will be entered in a REDCap database. Individual participant data will not be shared with any individuals other than the study personnel as only these individuals will have access to the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen A Lau, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parasacral transcutaneous electrical nerve stimulation (PTENS) and Standard Urotherapy in people with Overactive Bladder and Voiding Disorders, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysfunctional Voiding Symptom Score (time frame: week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.