Overactive Bladder
Conditions
Keywords
TENS
Brief summary
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day voiding diaries to record instances of UI episodes and OAB quality of life.
Interventions
DEVICETENS
Transcutaneous electrical nerve stimulation
Sponsors
Stanford University
Theranova, L.L.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Females 2. 55-100 years old 3. Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding training diary) 4. Have self-reported bladder symptoms of more than 3 months 5. Are ambulatory and able to use the toilet independently 6. Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months 7. Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe) 8. Able to provide informed consent 9. Capable and willing to follow all study-related procedures
Exclusion criteria
1. Have primary complaint of stress urinary incontinence 2. Have a pacemaker or implantable defibrillator 3. Had botox injections in the bladder or pelvic floor muscles in the past 12 months 4. Have a current urinary tract or vaginal infection 5. Have an active implantable SNS device (InterStim & Bion) 6. Have been diagnosed with peripheral neuropathy or nerve damage 7. Currently pregnant 8. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Urge Incontinence Episodes | Baseline and 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Micturitions Per Day | Baseline and 8 weeks | Mean number of urinary voids per day (taken over a 3-day period) |
| Change in Health-related Quality of Life (HRQL) | Baseline and 8 weeks | Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TENS Treatment Arm This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.
TENS: Transcutaneous electrical nerve stimulation | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | TENS Treatment Arm |
|---|---|
| Age, Continuous | 70.7 Years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
| UUI | 5.6 Episodes STANDARD_DEVIATION 4.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Change in Urge Incontinence Episodes
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENS Treatment Arm | Change in Urge Incontinence Episodes | 3.9 UUI | Standard Deviation 4 |
Secondary
Change in Health-related Quality of Life (HRQL)
Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENS Treatment Arm | Change in Health-related Quality of Life (HRQL) | -19.5 units on a scale | Standard Deviation 14.5 |
Secondary
Change in Micturitions Per Day
Mean number of urinary voids per day (taken over a 3-day period)
Time frame: Baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TENS Treatment Arm | Change in Micturitions Per Day | 5.6 voids per day | Standard Deviation 13.9 |