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Lack of continued funding
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMG group | Experimental | Foot stimulation will be applied during a cystometrogram (CMG). |
|
| 3 hours group | Active Comparator | Foot stimulation will be applied daily for 3 hours in the evening. |
|
| 1/2 hour group | Active Comparator | Foot stimulation will be applied daily for 1/2 hour in the evening. |
|
| 3 hour hand group | Active Comparator | Hand stimulation will be applied daily for 3 hours in the evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foot stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1, Week 2, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1, Week 2, Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | CMG #1 and CMG#2 |
| Number of Urinary Voids Per Day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Chermansky, MD | University of Pittsburgh | Principal Investigator |
| Dawn McBride, RN | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The funding was not available to complete the 3 hour hand group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Urinary Incontinence Episodes | Week 1, Week 2, Week 3 |
|
3 Weeks at the individual participant level.
Adverse events were tracked from the time of consent until study completion. The study team followed the data safety and monitoring plan outlined in the protocol. The Principal Investigator and study team reviewed the data at regular intervals to assess, record and report any Adverse Events or Serious Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The 3 hour hand group was not started or completed due to lack of funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Chermansky | University of Pittsburgh | 412-6418385 | chermanskycj2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2018 | Nov 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)
| Week 1, Week 2, Week 3 |
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
|
|
| 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. | Posted | Mean | Standard Deviation | Urinary urgency episodes per day | Week 1, Week 2, Week 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 | Posted | Number | ml | CMG #1 and CMG#2 |
|
|
|
| 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) | Posted | Mean | Standard Deviation | urinary voids per day | Week 1, Week 2, Week 3 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Week 3 |
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| Week 3 |
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