Overactive BladderFootStimNCT01972061
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
A study testing Foot stimulation in people with Overactive Bladder, run by Christopher J Chermansky, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Foot stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 11 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 year old men and women and older
- Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence
- No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB
Who cannot join
- Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder.
- Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator.
- Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Foot stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CMG group | Experimental | Foot stimulation will be applied during a cystometrogram (CMG). Receives: Device: Foot stimulation |
| 3 hours group | Active comparator | Foot stimulation will be applied daily for 3 hours in the evening. Receives: Device: Foot stimulation |
| 1/2 hour group | Active comparator | Foot stimulation will be applied daily for 1/2 hour in the evening. Receives: Device: Foot stimulation |
| 3 hour hand group | Active comparator | Hand stimulation will be applied daily for 3 hours in the evening. Receives: Device: Foot stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, Week 2, Week 3
Secondary outcomes (1)
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.
Measured: Week 1, Week 2, Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startMar 2014
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Why it stopped: Lack of continued funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher J Chermansky, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher J Chermansky, MD, University of Pittsburgh
- Investigators
- Christopher Chermansky, MD, Principal investigator, University of PittsburghDawn McBride, RN, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972061
- Sponsor's protocol ID
- PRO13020474
- Acronym
- FootStim
- Status last verified
- Feb 2020
- First submitted
- 18 Oct 2013
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot/Hand Neuromodulation for Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT01972061
- Acronym / sponsor ID
- FootStim / PRO13020474
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of continued funding
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Christopher J Chermansky, MDUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CMG group | Experimental | Device: Foot stimulationFoot stimulation will be applied during a cystometrogram (CMG). |
| 3 hours group | Active comparator | Device: Foot stimulationFoot stimulation will be applied daily for 3 hours in the evening. |
| 1/2 hour group | Active comparator | Device: Foot stimulationFoot stimulation will be applied daily for 1/2 hour in the evening. |
| 3 hour hand group | Active comparator | Device: Foot stimulationHand stimulation will be applied daily for 3 hours in the evening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 year old men and women and older
- Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence
- No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB
Key exclusion criteria (3 listed)
- Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder.
- Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator.
- Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot stimulationFoot 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. | Device | 1/2 hour group, 3 hour hand group, 3 hours group, CMG group |
Primary outcome
Number of Urinary Incontinence Episodes Per Day
Time frame: 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.
1 secondary outcome
Number of Urinary Urgency Episodes Per Day
Time frame: Week 1, Week 2, Week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Chermansky, MD principal investigator
University of Pittsburgh
Dawn McBride, RN study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot stimulation in people with Overactive Bladder, run by Christopher J Chermansky, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Urinary Incontinence Episodes Per Day (time frame: Week 1, Week 2, Week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.