A Trial of Transcutaneous Nerve Stimulation for OAB

Overactive Bladder Clinical Trial

Official title:

A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511717
• Other study ID #: 106903
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• Transcutaneous tibial nerve stimulation
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
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.

Locations

Country	Name	City	State
Canada	St Josephs Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overactive Bladder Questionnaire Short Form (OAB-q SF)	OAB quality of life questionnaire	12 weeks
Secondary	Voiding Diary		12 weeks
Secondary	24hr Pad Weights		12 weeks
Secondary	Physician Assessment of Treatment Benefit		12 weeks