A Trial of Transcutaneous Nerve Stimulation for OAB

NCT02511717 | Completed Results

• 1 other identifier: 106903
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)

  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.

  12 weeks

Secondary Outcomes (4)

• Overactive Bladder Questionnaire Short Form (OAB-q SF)

  12 weeks

• Voiding Diary

  12 weeks

• 24hr Pad Weights

  12 weeks

• Physician Assessment of Treatment Benefit

  12 weeks

Study Arms (2)

Sham

SHAM COMPARATOR

Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks

Other: Sham transcutaneous tibial nerve stimulation

Transcutaneous nerve stimulation

ACTIVE COMPARATOR

Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks

Other: Transcutaneous tibial nerve stimulation

Interventions

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.

Transcutaneous nerve stimulation

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.

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

St Josephs Health Care

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Results Point of Contact

• Title: Dr Blayne Welk
• Organization: Lawson Health Institute

lawson@lawsonsresearch.com

5196466000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 30, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Locations

CA (1)