Parasacral TENS Project

NCT07892417 | Not Yet Recruiting

• 1 other identifier: 303276
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Overactive Bladder (OAB); Lower Urinary Tract Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline to completion of treatment (week 12)

Secondary Outcomes (3)

• Voiding Diary

  baseline to completion of treatment (week 12)

• Comparison of Uroflowmetry changes from baseline to completion of treatment (week 12)

  baseline to completion of treatment (week 12)

• Patient Questionnaires

  baseline to completion of treatment (week 12)

Study Arms (2)

TENS

EXPERIMENTAL

Parasacral transcutaneous electric nerve stimulation (TENS)

Other: Parasacral transcutaneous electric nerve stimulation (TENS)

Standard second-line therapy (oral anticholinergics)

ACTIVE COMPARATOR

Oxybutynin

Drug: Oxybutynin

Interventions

Parasacral transcutaneous electric nerve stimulation (TENS) OTHER

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.

Also known as: TENS

TENS

Oxybutynin DRUG

Standard second-line therapy (oral anticholinergics)

Also known as: Oral anticholinergics

Standard second-line therapy (oral anticholinergics)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (15)

• 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.

  PMID: 35065988 BACKGROUND

• Gomaa 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.

  PMID: 38739240 BACKGROUND

• Maternik 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.

  PMID: 39069460 BACKGROUND

• Fernandez 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.

  PMID: 28823638 BACKGROUND

• Lordelo 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.

  PMID: 20561643 BACKGROUND

• Barroso 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.

  PMID: 16831163 BACKGROUND

• O'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.

  PMID: 33410536 BACKGROUND

• Wijekoon 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.

  PMID: 38584856 BACKGROUND

• de 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.

  PMID: 33525925 BACKGROUND

• Barroso 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.

  PMID: 21717502 BACKGROUND

• Chang 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.

  PMID: 26473630 BACKGROUND

• 4. OxyBUTYnin. Lexi-Drugs. UpToDate Lexidrug.UpToDate Inc. https://online.lexi.com. Accessed September 25, 2025.

  BACKGROUND

• 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.

  PMID: 38296001 BACKGROUND

• Schafer 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.

  PMID: 28948380 BACKGROUND

• Nieuwhof-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.

  PMID: 33478902 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation; oxybutynin; Cholinergic Antagonists

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Central Study Contacts

Susie Leroy, CPNP

CONTACT

4349245786; svg5m@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: October 23, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): September 29, 2028
• Study Completion (Estimated): September 28, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share