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A Trial of Transcutaneous Nerve Stimulation for OAB

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transcutaneous tibial nerve stimulation
Sham transcutaneous tibial nerve stimulation
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current or previous percutaneous or sacral neuromodulation therapy
  2. Stress predominant urinary incontinence
  3. 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)
  4. Intravesical botulinum toxin use within the last 1 year
  5. Implanted pacemaker or defibrillator
  6. History of epilepsy
  7. Unable or unwilling to commit to study treatment schedule
  8. Pregnant, or possible pregnancy planned for the duration of the study period
  9. Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
  10. Documented allergy to patch electrodes or their adhesive
  11. Abnormal sensory function of the lower limb
  12. Metallic implant within the lower limb

Sites / Locations

  • St Josephs Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham

Transcutaneous nerve stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overactive Bladder Questionnaire Short Form (OAB-q SF)
OAB quality of life questionnaire
Voiding Diary
24hr Pad Weights
Physician Assessment of Treatment Benefit

Full Information

First Posted
July 28, 2015
Last Updated
October 1, 2019
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02511717
Brief Title
A Trial of Transcutaneous Nerve Stimulation for OAB
Official Title
A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks
Arm Title
Transcutaneous nerve stimulation
Arm Type
Active Comparator
Arm Description
Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks
Intervention Type
Other
Intervention Name(s)
Transcutaneous tibial nerve stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham transcutaneous tibial nerve stimulation
Intervention Description
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 Outcome Measure Information:
Title
Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overactive Bladder Questionnaire Short Form (OAB-q SF)
Description
OAB quality of life questionnaire
Time Frame
12 weeks
Title
Voiding Diary
Time Frame
12 weeks
Title
24hr Pad Weights
Time Frame
12 weeks
Title
Physician Assessment of Treatment Benefit
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St Josephs Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

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A Trial of Transcutaneous Nerve Stimulation for OAB

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