Overactive Bladder
Conditions
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.
Interventions
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.
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.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Questionnaire Short Form (OAB-q SF) | 12 weeks | OAB quality of life questionnaire |
| Voiding Diary | 12 weeks | — |
| 24hr Pad Weights | 12 weeks | — |
| Physician Assessment of Treatment Benefit | 12 weeks | — |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 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. | 10 |
| Transcutaneous Nerve Stimulation Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks
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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Transcutaneous Nerve Stimulation | Total | Sham |
|---|---|---|---|
| Age, Continuous | 64 years | 64 years | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 20 Participants | 10 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sham | Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question) | 4 units on a scale |
| Transcutaneous Nerve Stimulation | Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question) | 3 units on a scale |
Secondary
24hr Pad Weights
Time frame: 12 weeks
Secondary
Overactive Bladder Questionnaire Short Form (OAB-q SF)
OAB quality of life questionnaire
Time frame: 12 weeks
Secondary
Physician Assessment of Treatment Benefit
Time frame: 12 weeks
Secondary
Voiding Diary
Time frame: 12 weeks