Overactive Bladder (OAB)NCT07892417
Parasacral TENS Project
A study testing Parasacral transcutaneous electric nerve stimulation (TENS) and Oxybutynin in people with Overactive Bladder (OAB) and Lower Urinary Tract Dysfunction, run by University of Virginia.
Trial summary
The purpose of the project is to compare the efficacy of parasacral transcutaneous electric nerve stimulation (TENS) versus standard second-line therapy (oral anticholinergics) for pediatric patients with overactive bladder (OAB) and lower urinary tract dysfunction who have previously failed standard urotherapy. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
- What is being tested?
- Parasacral transcutaneous electric nerve stimulation (TENS) and Oxybutynin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 28 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient in UVA Pediatric Urology seen for LUTD
- Ages: 4-18
- Male or female
- Toilet trained for > 6 months
- LUTS have not resolved with first-line urotherapy
Who cannot join
- Recurrent UTIs
- Conditions that may affect the ability to respond to treatment for LUTD with standard therapies: Neurogenic bladder, PUV, spinal dysraphism, anatomic abnormalities (VACTERYL, Cloacal Anomalies), dilating VUR, and high-grade hydronephrosis
- Previous use of anticholinergic medications for LUTD
- Current use of anticholinergic medications, alpha blockers, or phenazopyridine hydrochloride
- Non-English speaking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Parasacral Transcutaneous Electrical Nerve Stimulation vs. Standard Second-Line Therapy for Overactive Bladder in Pediatric Patients
The purpose of the project is to compare the efficacy of parasacral transcutaneous electric nerve stimulation (TENS) versus standard second-line therapy (oral anticholinergics) for pediatric patients with overactive bladder (OAB) and lower urinary tract dysfunction who have previously failed standard urotherapy. The investigators aim to evaluate the changes in lower urinary tract symptoms, quality of life scores, adherence to treatment, and parental/patient satisfaction with both treatment models. Pediatric patients aged 6 years and older who are seen in the clinic for overactive bladder and have failed to improve their lower urinary tract symptoms with standard urotherapy alone will be randomized to receive either parasacral TENS or oxybutynin, an oral anticholinergic medication routinely used in pediatric patients for this condition.
Patients randomized to parasacral TENS will receive a treatment plan that includes initial instructions on how to apply and use the TENS unit. The patients will perform 30-minute sessions, twice a week, for 12 weeks. A TENS unit will be loaned to the family for the duration of the treatment. This therapy will be administered at home by their guardians. Bladder diaries, the Vancouver Scoring System for Dysfunctional Elimination, and Likert scales for parental and patient preference and adherence to treatment will be administered prior to starting the study, at week 4, week 8, and upon completion of treatment to analyze the efficacy of TENS in treating pediatric overactive bladder compared to oxybutynin.
- Being tested
- Parasacral transcutaneous electric nerve stimulation (TENS), Oxybutynin
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasacral transcutaneous electric nerve stimulation (TENS)Other
Also called TENS
Electrical stimulation can be delivered in multiple ways: transcutaneously (using EMG patches or needle electrodes) or via the implantation of a stimulator. Stimulation is applied at the parasacral plexus or via the posterior tibial nerve to the sacral plexus. In children, transcutaneous EMG patches that deliver a current to the parasacral space have been used to treat bladder overactivity and are preferable due to the associated ability to provide care at home and with less discomfort than needle electrode insertion.
OxybutyninDrug
Also called Oral anticholinergics
Standard second-line therapy (oral anticholinergics)
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Parasacral transcutaneous electric nerve stimulation (TENS) Receives: Other: Parasacral transcutaneous electric nerve stimulation (TENS) |
| Standard second-line therapy (oral anticholinergics) | Active comparator | Oxybutynin Receives: Drug: Oxybutynin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of TENS
The primary endpoint is the change from baseline to 12 weeks in the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome (NLUTD/DES) Symptom Score (VSS), a validated composite score ranging from 0-54.
Measured: baseline to completion of treatment (week 12)
Secondary outcomes (3)
Voiding Diary
frequency of voids and incontinence episodes per 24 hours
Measured: baseline to completion of treatment (week 12)
Comparison of Uroflowmetry changes from baseline to completion of treatment (week 12)
A uroflow test will be performed at baseline and completion of the treatment to evaluate changes in uroflow patterns. Uroflowmetry measure the volume, time, and strength of urine flow and converts it into a graph so it can be compared against a normal for age and sex. It can also be used to evaluate changes in voiding patterns in the same person over time.
The outcome measures will be:
- Pre-void bladder volume
- Post-void bladder volume
- Flow Curve Pattern
- Time to Max Flow
- Max Flow Rate
- Average Flow Rate
- Voided Volume
- Franco Flow Index
- EMG Used: yes/no
If yes:
EMG lag time present: yes/no EMG activation during voiding: yes/no
Measured: baseline to completion of treatment (week 12)
Patient Questionnaires
Questionnaires will assess treatment adherence, perceived importance of medication use, ease of treatment administration, symptom relief, quality of life, treatment preferences, and treatment tolerability.
Individual questionnaire items are scored using ordinal scales ranging from 1 to 4 or 1 to 5, depending on the assessment domain. For treatment adherence and ease of use, higher scores indicate less favorable outcomes, including poorer treatment adherence and greater difficulty administering treatment. For quality of life, higher scores indicate more favorable outcomes. Higher medication-use importance scores reflect a greater preference for avoiding or reducing medication use and do not directly represent clinical improvement.
The symptom relief only uses yes/no answers, so this cannot be scaled.
Measured: baseline to completion of treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion29 Sep 2028 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- 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
- Sixty patients will be randomized to receive either parasacral TENS or oral oxybutynin. Lower urinary tract symptoms will be assessed at the initiation of treatment, at week 4, week 8, and after 12 weeks of therapy using the Vancouver Score, voiding diaries, and uroflow assessment. Parental satisfaction scores and treatment adherence will be assessed after 12 weeks of therapy. Outcomes will be compared between the two groups, with a difference of more than 10% in scores considered clinically significant.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susie Leroy, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892417
- Sponsor's protocol ID
- 303276
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study protocol is not a multi-site study.
Publications
Ebert KM, Terry H, Ching CB, Dajusta DG, Fuchs ME, Jayanthi VR, McLeod DJ, Alpert SA. Effectiveness of a Practical, At-Home Regimen of Parasacral Transcutaneous Electrical Nerve Stimulation in Pediatric Overactive Bladder. Urology. 2022 Jul;165:294-298. doi: 10.1016/j.urology.2022.01.017. Epub 2022 Jan 21.
PubMed 35065988Gomaa MD, AbdAllah HA, Ismail IY, Wasfy IS, Sherief MH. Outcomes of para-sacral transcutaneous electric nerve stimulation in treatment of primary and refractory overactive bladder among children. Int Urol Nephrol. 2024 Aug;56(8):2475-2482. doi: 10.1007/s11255-024-04006-8. Epub 2024 May 13.
PubMed 38739240Maternik M, Lakomy-Gawryszewska A, Jozefowicz K, Chudzik I, Golebiewski A, Zurowska A. Immediate and continued results of parasacral transcutaneous electrical nerve stimulation in paediatric patients with overactive bladders. J Pediatr Urol. 2024 Oct;20(5):868-876. doi: 10.1016/j.jpurol.2024.07.006. Epub 2024 Jul 14.
PubMed 39069460Fernandez N, Chua ME, Ming JM, Silangcruz JM, Zu'bi F, Dos Santos J, Lorenzo AJ, Braga LH, Lopes RI. Neurostimulation Therapy for Non-neurogenic Overactive Bladder in Children: A Meta-analysis. Urology. 2017 Dec;110:201-207. doi: 10.1016/j.urology.2017.08.003. Epub 2017 Aug 17.
PubMed 28823638Lordelo P, Teles A, Veiga ML, Correia LC, Barroso U Jr. Transcutaneous electrical nerve stimulation in children with overactive bladder: a randomized clinical trial. J Urol. 2010 Aug;184(2):683-9. doi: 10.1016/j.juro.2010.03.053. Epub 2010 Jun 18.
PubMed 20561643Barroso U Jr, Lordelo P, Lopes AA, Andrade J, Macedo A Jr, Ortiz V. Nonpharmacological treatment of lower urinary tract dysfunction using biofeedback and transcutaneous electrical stimulation: a pilot study. BJU Int. 2006 Jul;98(1):166-71. doi: 10.1111/j.1464-410X.2006.06264.x.
PubMed 16831163O'Sullivan H, Kelly G, Toale J, Cascio S. Comparing the outcomes of parasacral transcutaneous electrical nerve stimulation for the treatment of lower urinary tract dysfunction in children: A systematic review and meta-analysis of randomized controlled trials. Neurourol Urodyn. 2021 Feb;40(2):570-581. doi: 10.1002/nau.24601. Epub 2021 Jan 7.
PubMed 33410536Wijekoon N, Deshpande A. Treatment modalities for paediatric functional daytime lower urinary tract disorders: an updated review. Ther Adv Urol. 2024 Apr 4;16:17562872241241848. doi: 10.1177/17562872241241848. eCollection 2024 Jan-Dec.
PubMed 38584856de Abreu GE, de Souza LA, da Fonseca MLV, Barbosa TBC, de Mello ERD, Nunes ANB, Barroso UO Jr. Parasacral Transcutaneous Electrical Nerve Stimulation for the Treatment of Children and Adolescents with Bladder and Bowel Dysfunction: A Randomized Clinical Trial. J Urol. 2021 Jun;205(6):1785-1791. doi: 10.1097/JU.0000000000001579. Epub 2021 Feb 2.
PubMed 33525925Barroso U Jr, Tourinho R, Lordelo P, Hoebeke P, Chase J. Electrical stimulation for lower urinary tract dysfunction in children: a systematic review of the literature. Neurourol Urodyn. 2011 Nov;30(8):1429-36. doi: 10.1002/nau.21140. Epub 2011 Jun 29.
PubMed 21717502Chang SJ, Van Laecke E, Bauer SB, von Gontard A, Bagli D, Bower WF, Renson C, Kawauchi A, Yang SS. Treatment of daytime urinary incontinence: A standardization document from the International Children's Continence Society. Neurourol Urodyn. 2017 Jan;36(1):43-50. doi: 10.1002/nau.22911. Epub 2015 Oct 16.
PubMed 264736304. OxyBUTYnin. Lexi-Drugs. UpToDate Lexidrug.UpToDate Inc. https://online.lexi.com. Accessed September 25, 2025.
Chancellor MB, Lucioni A, Staskin D. Oxybutynin-associated Cognitive Impairment: Evidence and Implications for Overactive Bladder Treatment. Urology. 2024 Apr;186:123-129. doi: 10.1016/j.urology.2023.11.033. Epub 2024 Jan 29.
PubMed 38296001Schafer SK, Niemczyk J, von Gontard A, Pospeschill M, Becker N, Equit M. Standard urotherapy as first-line intervention for daytime incontinence: a meta-analysis. Eur Child Adolesc Psychiatry. 2018 Aug;27(8):949-964. doi: 10.1007/s00787-017-1051-6. Epub 2017 Sep 25.
PubMed 28948380Nieuwhof-Leppink AJ, Hussong J, Chase J, Larsson J, Renson C, Hoebeke P, Yang S, von Gontard A. Definitions, indications and practice of urotherapy in children and adolescents: - A standardization document of the International Children's Continence Society (ICCS). J Pediatr Urol. 2021 Apr;17(2):172-181. doi: 10.1016/j.jpurol.2020.11.006. Epub 2020 Nov 5.
PubMed 33478902
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasacral Transcutaneous Electrical Nerve Stimulation vs. Standard Second-Line Therapy for Overactive Bladder in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07892417
- Acronym / sponsor ID
- 303276
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the project is to compare the efficacy of parasacral transcutaneous electric nerve stimulation (TENS) versus standard second-line therapy (oral anticholinergics) for pediatric patients with overactive bladder (OAB) and lower urinary tract dysfunction who have previously failed standard urotherapy. The investigators aim to evaluate the changes in lower urinary tract symptoms, quality of life scores, adherence to treatment, and parental/patient satisfaction with both treatment models. Pediatric patients aged 6 years and older who are seen in the clinic for overactive bladder and have failed to improve their lower urinary tract symptoms with standard urotherapy alone will be randomized to receive either parasacral TENS or oxybutynin, an oral anticholinergic medication routinely used in pediatric patients for this condition.
Patients randomized to parasacral TENS will receive a treatment plan that includes initial instructions on how to apply and use the TENS unit. The patients will perform 30-minute sessions, twice a week, for 12 weeks. A TENS unit will be loaned to the family for the duration of the treatment. This therapy will be administered at home by their guardians. Bladder diaries, the Vancouver Scoring System for Dysfunctional Elimination, and Likert scales for parental and patient preference and adherence to treatment will be administered prior to starting the study, at week 4, week 8, and upon completion of treatment to analyze the efficacy of TENS in treating pediatric overactive bladder compared to oxybutynin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty patients will be randomized to receive either parasacral TENS or oral oxybutynin. Lower urinary tract symptoms will be assessed at the initiation of treatment, at week 4, week 8, and after 12 weeks of therapy using the Vancouver Score, voiding diaries, and uroflow assessment. Parental satisfaction scores and treatment adherence will be assessed after 12 weeks of therapy. Outcomes will be compared between the two groups, with a difference of more than 10% in scores considered clinically significant.
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Other: Parasacral transcutaneous electric nerve stimulation (TENS)Parasacral transcutaneous electric nerve stimulation (TENS) |
| Standard second-line therapy (oral anticholinergics) | Active comparator | Drug: OxybutyninOxybutynin |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patient in UVA Pediatric Urology seen for LUTD
- Ages: 4-18
- Male or female
- Toilet trained for > 6 months
- LUTS have not resolved with first-line urotherapy
Key exclusion criteria (5 listed)
- Recurrent UTIs
- Conditions that may affect the ability to respond to treatment for LUTD with standard therapies: Neurogenic bladder, PUV, spinal dysraphism, anatomic abnormalities (VACTERYL, Cloacal Anomalies), dilating VUR, and high-grade hydronephrosis
- Previous use of anticholinergic medications for LUTD
- Current use of anticholinergic medications, alpha blockers, or phenazopyridine hydrochloride
- Non-English speaking
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 electric nerve stimulation (TENS)Also: TENSElectrical stimulation can be delivered in multiple ways: transcutaneously (using EMG patches or needle electrodes) or via the implantation of a stimulator. Stimulation is applied at the parasacral plexus or via the posterior tibial nerve to the sacral plexus. In children, transcutaneous EMG patches that deliver a current to the parasacral space have been used to treat bladder overactivity and are preferable due to the associated ability to provide care at home and with less discomfort than needle electrode insertion. | Other | TENS |
| OxybutyninAlso: Oral anticholinergicsStandard second-line therapy (oral anticholinergics) | Drug | Standard second-line therapy (oral anticholinergics) |
Primary outcome
Efficacy of TENS
Time frame: baseline to completion of treatment (week 12)
The primary endpoint is the change from baseline to 12 weeks in the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome (NLUTD/DES) Symptom Score (VSS), a validated composite score ranging from 0-54.
3 secondary outcomes
Voiding Diary
Time frame: baseline to completion of treatment (week 12)
Comparison of Uroflowmetry changes from baseline to completion of treatment (week 12)
Time frame: baseline to completion of treatment (week 12)
Patient Questionnaires
Time frame: baseline to completion of treatment (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 35065988Ebert KM, Terry H, Ching CB, Dajusta DG, Fuchs ME, Jayanthi VR, McLeod DJ, Alpert SA. Effectiveness of a Practical, At-Home Regimen of Parasacral Transcutaneous Electrical Nerve Stimulation in Pediatric Overactive Bladder. Urology. 2022 Jul;165:294-298. doi: 10.1016/j.urology.2022.01.017. Epub 2022 Jan 21.
- Background: PubMed 38739240Gomaa MD, AbdAllah HA, Ismail IY, Wasfy IS, Sherief MH. Outcomes of para-sacral transcutaneous electric nerve stimulation in treatment of primary and refractory overactive bladder among children. Int Urol Nephrol. 2024 Aug;56(8):2475-2482. doi: 10.1007/s11255-024-04006-8. Epub 2024 May 13.
- Background: PubMed 39069460Maternik M, Lakomy-Gawryszewska A, Jozefowicz K, Chudzik I, Golebiewski A, Zurowska A. Immediate and continued results of parasacral transcutaneous electrical nerve stimulation in paediatric patients with overactive bladders. J Pediatr Urol. 2024 Oct;20(5):868-876. doi: 10.1016/j.jpurol.2024.07.006. Epub 2024 Jul 14.
- Background: PubMed 28823638Fernandez N, Chua ME, Ming JM, Silangcruz JM, Zu'bi F, Dos Santos J, Lorenzo AJ, Braga LH, Lopes RI. Neurostimulation Therapy for Non-neurogenic Overactive Bladder in Children: A Meta-analysis. Urology. 2017 Dec;110:201-207. doi: 10.1016/j.urology.2017.08.003. Epub 2017 Aug 17.
- Background: PubMed 20561643Lordelo P, Teles A, Veiga ML, Correia LC, Barroso U Jr. Transcutaneous electrical nerve stimulation in children with overactive bladder: a randomized clinical trial. J Urol. 2010 Aug;184(2):683-9. doi: 10.1016/j.juro.2010.03.053. Epub 2010 Jun 18.
- Background: PubMed 16831163Barroso U Jr, Lordelo P, Lopes AA, Andrade J, Macedo A Jr, Ortiz V. Nonpharmacological treatment of lower urinary tract dysfunction using biofeedback and transcutaneous electrical stimulation: a pilot study. BJU Int. 2006 Jul;98(1):166-71. doi: 10.1111/j.1464-410X.2006.06264.x.
- Background: PubMed 33410536O'Sullivan H, Kelly G, Toale J, Cascio S. Comparing the outcomes of parasacral transcutaneous electrical nerve stimulation for the treatment of lower urinary tract dysfunction in children: A systematic review and meta-analysis of randomized controlled trials. Neurourol Urodyn. 2021 Feb;40(2):570-581. doi: 10.1002/nau.24601. Epub 2021 Jan 7.
- Background: PubMed 38584856Wijekoon N, Deshpande A. Treatment modalities for paediatric functional daytime lower urinary tract disorders: an updated review. Ther Adv Urol. 2024 Apr 4;16:17562872241241848. doi: 10.1177/17562872241241848. eCollection 2024 Jan-Dec.
- Background: PubMed 33525925de Abreu GE, de Souza LA, da Fonseca MLV, Barbosa TBC, de Mello ERD, Nunes ANB, Barroso UO Jr. Parasacral Transcutaneous Electrical Nerve Stimulation for the Treatment of Children and Adolescents with Bladder and Bowel Dysfunction: A Randomized Clinical Trial. J Urol. 2021 Jun;205(6):1785-1791. doi: 10.1097/JU.0000000000001579. Epub 2021 Feb 2.
- Background: PubMed 21717502Barroso U Jr, Tourinho R, Lordelo P, Hoebeke P, Chase J. Electrical stimulation for lower urinary tract dysfunction in children: a systematic review of the literature. Neurourol Urodyn. 2011 Nov;30(8):1429-36. doi: 10.1002/nau.21140. Epub 2011 Jun 29.
- Background: PubMed 26473630Chang SJ, Van Laecke E, Bauer SB, von Gontard A, Bagli D, Bower WF, Renson C, Kawauchi A, Yang SS. Treatment of daytime urinary incontinence: A standardization document from the International Children's Continence Society. Neurourol Urodyn. 2017 Jan;36(1):43-50. doi: 10.1002/nau.22911. Epub 2015 Oct 16.
- Background4. OxyBUTYnin. Lexi-Drugs. UpToDate Lexidrug.UpToDate Inc. https://online.lexi.com. Accessed September 25, 2025.
- Individual participant dataSharing planned: No. This study protocol is not a multi-site study.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Parasacral transcutaneous electric nerve stimulation (TENS) and Oxybutynin in people with Overactive Bladder (OAB) and Lower Urinary Tract Dysfunction, run by University of Virginia.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susie Leroy, CPNP (4349245786, svg5m@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of TENS (time frame: baseline to completion of treatment (week 12)). 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 NCT07892417, which also lists 15 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 23 Oct 2026.