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Completed

NCT Number: NCT02511717

A Trial of Transcutaneous Nerve Stimulation for OAB

Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St Josephs Health Care

London, Ontario, N6A 4V2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, >18 years of age, with the clinical diagnosis of overactive bladder.
  • Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
  • Baseline patient perception of bladder condition score of 2 or higher.

Exclusion criteria

  • Current or previous percutaneous or sacral neuromodulation therapy
  • Stress predominant urinary incontinence
  • Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron)
  • Intravesical botulinum toxin use within the last 1 year
  • Implanted pacemaker or defibrillator
  • History of epilepsy
  • Unable or unwilling to commit to study treatment schedule
  • Pregnant, or possible pregnancy planned for the duration of the study period
  • Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
  • Documented allergy to patch electrodes or their adhesive
  • Abnormal sensory function of the lower limb
  • Metallic implant within the lower limb

Treatment and study plan

Transcutaneous tibial nerve stimulation

Other

Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.

Sham transcutaneous tibial nerve stimulation

Other

Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.

Primary outcomes

  1. Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)

    Time frame: 12 weeks

    Patient percention of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes.

Secondary outcomes

  1. Overactive Bladder Questionnaire Short Form (OAB-q SF)

    Time frame: 12 weeks

    OAB quality of life questionnaire

  2. Voiding Diary

    Time frame: 12 weeks

  3. 24hr Pad Weights

    Time frame: 12 weeks

  4. Physician Assessment of Treatment Benefit

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2015
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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