An interventional study of Foot stimulation in Overactive Bladder, sponsored by Christopher J Chermansky, MD. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Christopher J Chermansky, MD · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.
Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 44 is below the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Christopher J Chermansky, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Foot stimulation will be applied during a cystometrogram (CMG).
Device: Foot stimulation
Foot stimulation will be applied daily for 3 hours in the evening.
Device: Foot stimulation
Foot stimulation will be applied daily for 1/2 hour in the evening.
Device: Foot stimulation
Hand stimulation will be applied daily for 3 hours in the evening.
Device: 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
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.
Time frame: Week 1, Week 2, Week 3
Number of Urinary Urgency Episodes Per Day
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 urgency episodes was calculated for week 1 and week 2 for each subject.
Time frame: Week 1, Week 2, Week 3
Bladder Volume as Recorded on CMG for Strong Desire to Void
Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation
Time frame: CMG #1 and CMG#2
Number of Urinary Voids Per Day
Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)
Time frame: Week 1, Week 2, Week 3
| Milestone | CMG Group | 3 Hours Group | 1/2 Hour Group |
|---|---|---|---|
| Started | 1 | 23 | 20 |
| Completed | 1 | 23 | 20 |
| Not completed | 0 | 0 | 0 |
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.
| Urinary Incontinence Episodes | 3 Hours Group | 1/2 Hour Group |
|---|---|---|
| Week 1 | 3.7 ± 0.4 | 5.3 ± 0.4 |
| Week 2 | 2.8 ± 0.4 | 4.3 ± 0.3 |
| Week 3 | 2.8 ± 0.3 | 4.0 ± 0.3 |
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 urgency episodes was calculated for week 1 and week 2 for each subject.
| Urinary urgency episodes per day | 3 Hours Group | 1/2 Hour Group |
|---|---|---|
| Week 1 | 7.6 ± 0.4 | 8.1 ± 0.3 |
| Week 2 | 6.6 ± 0.3 | 8.0 ± 0.3 |
| Week 3 | 6.6 ± 0.3 | 8.0 ± 0.3 |
Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation
| ml | CMG Group |
|---|---|
| CMG#1 Baseline | 265 |
| CMG #2 Foot Stimulation | 255 |
Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)
| urinary voids per day | 3 Hours Group | 1/2 Hour Group |
|---|---|---|
| Week 1 | 9.1 ± 0.3 | 8.7 ± 0.3 |
| Week 2 | 7.3 ± 0.3 | 8.5 ± 0.2 |
| Week 3 | 7.3 ± 0.3 | 8.5 ± 0.2 |
Collected over 3 Weeks at the individual participant level.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CMG Group | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| 3 Hours Group | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| 1/2 Hour Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
The funding was not available to complete the 3 hour hand group.
| Age, Categorical(Participants) | CMG Group | 3 Hours Group | 1/2 Hour Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 11 | 11 | 22 |
| >=65 years | 1 | 12 | 9 | 22 |
| Sex: Female, Male(Participants) | CMG Group | 3 Hours Group | 1/2 Hour Group | Total |
|---|---|---|---|---|
| Female | 1 | 23 | 20 | 44 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | CMG Group | 3 Hours Group | 1/2 Hour Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 23 | 20 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CMG Group | 3 Hours Group | 1/2 Hour Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 0 | 4 |
| White | 0 | 20 | 19 | 39 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | CMG Group | 3 Hours Group | 1/2 Hour Group | Total |
|---|---|---|---|---|
| United States | 1 | 23 | 20 | 44 |
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Christopher J Chermansky, MD