Overactive Bladder
Conditions
Brief summary
The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.
Detailed description
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.
Interventions
DEVICEFoot 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.
Sponsors
Christopher J Chermansky, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 year old men and women and older 2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence 3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB
Exclusion criteria
1. Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder. 2. Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator. 3. Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Urinary Incontinence Episodes Per Day | Week 1, Week 2, Week 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 incontinence episodes was calculated for week 1 and week 2 for each subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Urinary Urgency Episodes Per Day | Week 1, Week 2, Week 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bladder Volume as Recorded on CMG for Strong Desire to Void | CMG #1 and CMG#2 | Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation |
| Number of Urinary Voids Per Day | Week 1, Week 2, Week 3 | Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 23 |
| 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. | 20 |
| Total | 44 |
Baseline characteristics
| Characteristic | CMG Group | 3 Hours Group | 1/2 Hour Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 12 Participants | 9 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 11 Participants | 11 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 23 Participants | 20 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 20 Participants | 19 Participants | 39 Participants |
| Region of Enrollment United States | 1 participants | 23 participants | 20 participants | 44 participants |
| Sex: Female, Male Female | 1 Participants | 23 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 23 | 0 / 20 |
| other Total, other adverse events | 0 / 1 | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 1 | 0 / 23 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 Hours Group | Number of Urinary Incontinence Episodes Per Day | Week 1 | 3.7 Urinary Incontinence Episodes | Standard Deviation 0.4 |
| 3 Hours Group | Number of Urinary Incontinence Episodes Per Day | Week 2 | 2.8 Urinary Incontinence Episodes | Standard Deviation 0.4 |
| 3 Hours Group | Number of Urinary Incontinence Episodes Per Day | Week 3 | 2.8 Urinary Incontinence Episodes | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Incontinence Episodes Per Day | Week 1 | 5.3 Urinary Incontinence Episodes | Standard Deviation 0.4 |
| 1/2 Hour Group | Number of Urinary Incontinence Episodes Per Day | Week 2 | 4.3 Urinary Incontinence Episodes | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Incontinence Episodes Per Day | Week 3 | 4.0 Urinary Incontinence Episodes | Standard Deviation 0.3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 Hours Group | Number of Urinary Urgency Episodes Per Day | Week 1 | 7.6 Urinary urgency episodes per day | Standard Deviation 0.4 |
| 3 Hours Group | Number of Urinary Urgency Episodes Per Day | Week 2 | 6.6 Urinary urgency episodes per day | Standard Deviation 0.3 |
| 3 Hours Group | Number of Urinary Urgency Episodes Per Day | Week 3 | 6.6 Urinary urgency episodes per day | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Urgency Episodes Per Day | Week 1 | 8.1 Urinary urgency episodes per day | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Urgency Episodes Per Day | Week 2 | 8.0 Urinary urgency episodes per day | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Urgency Episodes Per Day | Week 3 | 8.0 Urinary urgency episodes per day | Standard Deviation 0.3 |
Other Pre-specified
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3 Hours Group | Bladder Volume as Recorded on CMG for Strong Desire to Void | CMG#1 Baseline | 265 ml |
| 3 Hours Group | Bladder Volume as Recorded on CMG for Strong Desire to Void | CMG #2 Foot Stimulation | 255 ml |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3 Hours Group | Number of Urinary Voids Per Day | Week 3 | 7.3 urinary voids per day | Standard Deviation 0.3 |
| 3 Hours Group | Number of Urinary Voids Per Day | Week 1 | 9.1 urinary voids per day | Standard Deviation 0.3 |
| 3 Hours Group | Number of Urinary Voids Per Day | Week 2 | 7.3 urinary voids per day | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Voids Per Day | Week 3 | 8.5 urinary voids per day | Standard Deviation 0.2 |
| 1/2 Hour Group | Number of Urinary Voids Per Day | Week 1 | 8.7 urinary voids per day | Standard Deviation 0.3 |
| 1/2 Hour Group | Number of Urinary Voids Per Day | Week 2 | 8.5 urinary voids per day | Standard Deviation 0.2 |