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WithdrawnNCT02320201Updated Dec 27, 2022

Foot Neuromodulation for Overactive Bladder in Children

An interventional study of Transcutaneous Electrical Nerve Stimulator (TENS) in Overactive Bladder, sponsored by Rajeev Chaudhry. Withdrawn at 1 site in United States. Open to participants aged 5 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-27.

Sponsored by Rajeev Chaudhry · Not applicable, Interventional, and Other

Why this study was withdrawn
Not enough patients enrolled for analysis.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
5 Years to 16 Years
Sex
All
01

Study summary

To determine the effects of electrical stimulation of the nerves in the foot on overactive bladder conditions in children.

Read the detailed description

Bladder overactivity in the pediatric population presents a more challenging clinical situation than in adults after failure of medical therapy, as other treatments with proven efficacy such as botulinum injections and interstim sacral nerve stimulators are too invasive for the routine use in children. A non-invasive, effective way to improve overactive bladder in this population would have a great impact on a child's quality of life.

02

Conditions studied

  • Overactive Bladder
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Who can participate

Ages eligible
5 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Children ages 5 to 16 years old without any specific neurological disorder or urinary tract infection, clinically diagnosed as idiopathic over active bladder (OAB)
  2. Currently having OAB symptoms, i.e. urinary frequency, urgency, or incontinence
  3. Having been assessed for and treated if applicable for behavioral etiologies of OAB - holding urine too long, consuming excess caffeine or other bladder irritants.
  4. Having been assessed for and treated if applicable for constipation

Exclusion criteria

Exclusion Criteria:

  1. Patients with known neurological disorders which may be contributing to OAB symptoms
  2. Patients found through history to have significant behavioral causes of OAB including consumption of known bladder irritants and dysfunctional voiding.
  3. Patients with chronic constipation who are non-compliant with previous pharmacologic efforts to treat.
  4. Patients who are not adequately potty trained
  5. Patients who do not tolerate initial stimulation training session in the urology clinic upon enrollment
  6. Children with any implantable medical devices such as a pacemaker will be excluded from the study

Note: Any patient currently taking medication such as an anti-muscarinic or a tricyclic antidepressant for overactive bladder at time of enrollment will be eligible to participate and will be continued on their usual medication and dosage throughout the study.

04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Electrical stimulation

    Transcutaneous Electrical Nerve Stimulator (TENS) will be applied to the foot via skin surface electrodes for a minimum of 2 hours per day for 1 week to 20 subjects. Subjects will be required to keep a daily voiding diary for one week before treatment to establish a control, during the treatment week and for one week after treatment. Subjects will also be asked to complete a validated questionnaire prior to treatment, during treatment week and one week after treatment. The primary outcomes of this study are improvement in objective measures of frequency as indicated by voiding diary and subjective symptom improvement based on questionnaire comparison.

    Device: Transcutaneous Electrical Nerve Stimulator (TENS)

Interventions

  • DeviceTranscutaneous Electrical Nerve Stimulator (TENS)

    Electrical stimulation will be applied to the foot via skin surface electrodes for a minimum of 2 hours per day for 1 week to 20 subjects.

05

What researchers measure

Primary outcomes

  1. Number of participants with decreased urinary frequency

    Foot stimulation decreases urinary frequency measured by a daily voiding diary.

    Time frame: 3 weeks

Secondary outcomes

  1. Number of participants with improved over active bladder symptoms

    Foot stimulation improves OAB symptoms over the course of 3-week period, with foot stimulation applied during the second week measured by a validated symptom survey

    Time frame: 3 weeks

06

Study locations

1 site
  • Children's Hospital of Pittsburgh og UPMC
    Pittsburgh, Pennsylvania 15224, United States
07

References and documents

Publications

  • stimulation in cats. J Urol 2011;186(1):326-30. 2. Chen M, Chermansky C, et al. Electrical stimulation of somatic afferent nerves in the foot increase bladder capacity in healthy human subjects. J Urol. April 2014, 191:1009-1013. 3. Gaziev G, Topazio L, et al. Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urology. 2013, 13:61-72. 4. Sillen U, Arwidsson C, et al. Effects of transcutaneous neuromodulation (TENS) on overactive bladder symptoms in children: A randomized clinical trial. J Pediatr Urol. 2014, in press - accepted 30 March 2014 5. Barroso U, Viterbo W, et al. Posterior tibial nerve stimulation vs parasacral transcutaneous neuromodulation for overactive bladder in children. J Urol. Aug 2013, 190(2):673-677 6. DeGannaro M, Capitanucci ML, et al. Current state of stimulation technique for lower urinary tract dysfunction in children. J Urol. May 2011; 185(5):1571-7. 7. Lordelo P, Teles A, et al. Transcutaneous electrical stimulation in children with overactive bladder: a randomized clinical trial. J Urol. Aug 2010;184(2):683-9. 8. Malm-Buatsi E, NeppleKG, et al. Efficacy of transcutaneous electrical nerve stimulation in children with overactive bladder refractory to pharmacotherapy. Urology 2007. Nov; 70(5):980-3.
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Registry details

Key details

Study ID
NCT02320201
Lead sponsor
Rajeev Chaudhry
Responsible party
Rajeev Chaudhry (Assistant Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Dec 19, 2014
Start date
Sep 2014
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Dec 27, 2022

Study contacts

Rajeev Chaudhry, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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