Trial Outcomes & Findings for Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder (NCT NCT02582151)
NCT ID: NCT02582151
Last Updated: 2020-01-09
Results Overview
Patient perception 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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2020-01-09
Participant Flow
Participant milestones
| Measure |
Sham Tibial Nerve Stimulation
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder
Baseline characteristics by cohort
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
60 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPatient perception 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.
Outcome measures
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
Patient Perception of Bladder Condition Questionnaire
|
3 units on a scale
Interval 3.0 to 3.0
|
3 units on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: 3 monthsThe NBSS is a patient reported symptom score covering three domains: incontinence, storage/voiding, and consequences. It is scored from 0 to 72, and a higher score is worse outcome.
Outcome measures
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
Neurogenic Bladder Symptom Score (NBSS) Questionnaire
|
33 Units on a scale
Interval 29.0 to 38.0
|
29 Units on a scale
Interval 25.0 to 33.0
|
SECONDARY outcome
Timeframe: 3 monthsPatient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.
Outcome measures
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
Qualiveen-Short Form Questionnaire
|
27 units on a scale
Interval 23.0 to 31.0
|
27 units on a scale
Interval 24.0 to 31.0
|
SECONDARY outcome
Timeframe: 3 monthsDaily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.
Outcome measures
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
3-day Voiding Diary
|
9 voids per 24 hrs
Interval 8.0 to 11.0
|
9 voids per 24 hrs
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
24hr Incontinence Pad Weights
|
364 grams
Interval 333.0 to 395.0
|
362 grams
Interval 334.0 to 391.0
|
SECONDARY outcome
Timeframe: 3 monthsCompleted by physicians based on their assessment after discussion with the patient as to the amount of benefit they received. Reported on a scale of 0 (no benefit) to 7 (substantial benefit)
Outcome measures
| Measure |
Sham Tibial Nerve Stimulation
n=14 Participants
Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
Tibial Nerve Stimulation
n=16 Participants
Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.
EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine: Percutaneous patch electrodes are used to deliver low level electrical currents.
|
|---|---|---|
|
Physician Assessment of Patient Benefit (Global Response Scale)
|
3 units on a scale
Interval 3.0 to 3.0
|
3 units on a scale
Interval 2.0 to 3.0
|
Adverse Events
Sham Tibial Nerve Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tibial Nerve Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place