Trial Outcomes & Findings for Foot/Hand Neuromodulation for Overactive Bladder (OAB) (NCT NCT01972061)
NCT ID: NCT01972061
Last Updated: 2020-02-26
Results Overview
Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Week 1, Week 2, Week 3
Results posted on
2020-02-26
Participant Flow
Participant milestones
| Measure |
CMG Group
Foot stimulation will be applied during a cystometrogram (CMG).
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
3 Hours Group
Foot stimulation will be applied daily for 3 hours in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
1/2 Hour Group
Foot stimulation will be applied daily for 1/2 hour in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
23
|
20
|
|
Overall Study
COMPLETED
|
1
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Baseline characteristics by cohort
| Measure |
CMG Group
n=1 Participants
Foot stimulation will be applied during a cystometrogram (CMG).
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
3 Hours Group
n=23 Participants
Foot stimulation will be applied daily for 3 hours in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
1/2 Hour Group
n=20 Participants
Foot stimulation will be applied daily for 1/2 hour in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
23 participants
n=7 Participants
|
20 participants
n=5 Participants
|
44 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 2, Week 3Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject.
Outcome measures
| Measure |
3 Hours Group
n=23 Participants
Foot stimulation will be applied daily for 3 hours in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
1/2 Hour Group
n=20 Participants
Foot stimulation will be applied daily for 1/2 hour in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
|---|---|---|
|
Number of Urinary Incontinence Episodes Per Day
Week 1
|
3.7 Urinary Incontinence Episodes
Standard Deviation 0.4
|
5.3 Urinary Incontinence Episodes
Standard Deviation 0.4
|
|
Number of Urinary Incontinence Episodes Per Day
Week 2
|
2.8 Urinary Incontinence Episodes
Standard Deviation 0.4
|
4.3 Urinary Incontinence Episodes
Standard Deviation 0.3
|
|
Number of Urinary Incontinence Episodes Per Day
Week 3
|
2.8 Urinary Incontinence Episodes
Standard Deviation 0.3
|
4.0 Urinary Incontinence Episodes
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Week 1, Week 2, Week 3Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary urgency episodes was calculated for week 1 and week 2 for each subject.
Outcome measures
| Measure |
3 Hours Group
n=23 Participants
Foot stimulation will be applied daily for 3 hours in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
1/2 Hour Group
n=20 Participants
Foot stimulation will be applied daily for 1/2 hour in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
|---|---|---|
|
Number of Urinary Urgency Episodes Per Day
Week 1
|
7.6 Urinary urgency episodes per day
Standard Deviation 0.4
|
8.1 Urinary urgency episodes per day
Standard Deviation 0.3
|
|
Number of Urinary Urgency Episodes Per Day
Week 2
|
6.6 Urinary urgency episodes per day
Standard Deviation 0.3
|
8.0 Urinary urgency episodes per day
Standard Deviation 0.3
|
|
Number of Urinary Urgency Episodes Per Day
Week 3
|
6.6 Urinary urgency episodes per day
Standard Deviation 0.3
|
8.0 Urinary urgency episodes per day
Standard Deviation 0.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: CMG #1 and CMG#2Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation
Outcome measures
| Measure |
3 Hours Group
n=1 Participants
Foot stimulation will be applied daily for 3 hours in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
1/2 Hour Group
Foot stimulation will be applied daily for 1/2 hour in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
|---|---|---|
|
Bladder Volume as Recorded on CMG for Strong Desire to Void
CMG#1 Baseline
|
265 ml
|
—
|
|
Bladder Volume as Recorded on CMG for Strong Desire to Void
CMG #2 Foot Stimulation
|
255 ml
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1, Week 2, Week 3Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)
Outcome measures
| Measure |
3 Hours Group
n=23 Participants
Foot stimulation will be applied daily for 3 hours in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
1/2 Hour Group
n=20 Participants
Foot stimulation will be applied daily for 1/2 hour in the evening.
Foot stimulation: Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
|
|---|---|---|
|
Number of Urinary Voids Per Day
Week 1
|
9.1 urinary voids per day
Standard Deviation 0.3
|
8.7 urinary voids per day
Standard Deviation 0.3
|
|
Number of Urinary Voids Per Day
Week 2
|
7.3 urinary voids per day
Standard Deviation 0.3
|
8.5 urinary voids per day
Standard Deviation 0.2
|
|
Number of Urinary Voids Per Day
Week 3
|
7.3 urinary voids per day
Standard Deviation 0.3
|
8.5 urinary voids per day
Standard Deviation 0.2
|
Adverse Events
CMG Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Hours Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1/2 Hour Group
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