Overactive BladderOAB Aim 2NCT03595215
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
A study testing TENS in people with Overactive Bladder, run by Theranova, L.L.C. at 1 site in United States.
Trial summary
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life. Read more about this study
- Who is it for?
- Ages 55 to 100 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 17 Sep 2019
- 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 55 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females
- 55-100 years old
- Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
- Have self-reported bladder symptoms of more than 3 months
- Are ambulatory and able to use the toilet independently
- Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
Show all 9Show fewer
- Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
- Able to provide informed consent
- Capable and willing to follow all study-related procedures
Who cannot join
- Have primary complaint of stress urinary incontinence
- Have a pacemaker or implantable defibrillator
- Had botox injections in the bladder or pelvic floor muscles in the past 12 months
- Have a current urinary tract or vaginal infection
- Have an active implantable SNS device (InterStim \& Bion)
- Have been diagnosed with peripheral neuropathy or nerve damage
- Currently pregnant
- Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Palo Alto, California, 94304
About this study
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
- Conditions
- Overactive Bladder
- Being tested
- TENS
- Keywords
- TENS
- 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.
TENSDevice
Transcutaneous electrical nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| TENS Treatment Arm | Experimental | This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. Receives: Device: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urge Incontinence Episodes
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Change in Micturitions Per Day
Mean number of urinary voids per day (taken over a 3-day period)
Measured: Baseline and 8 weeks
Change in Health-related Quality of Life (HRQL)
Change in incontinence health-related quality of life (HRQL) scores compared to pre-treatment. The survey consists of 13 questions that can be scored from 1 to 6. Lower scores correspond with better quality of life. The lowest score possible is 13 and the highest is 78.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start10 Sep 2018
- Primary completion10 Jul 2019
- Study completion17 Sep 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595215
- Sponsor's protocol ID
- CRD-12-1076
- Acronym
- OAB Aim 2
- Status last verified
- Apr 2021
- First submitted
- 22 Jun 2018
- Last updated
- 21 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
- ClinicalTrials.gov ID
- NCT03595215
- Acronym / sponsor ID
- OAB Aim 2 / CRD-12-1076
- Conditions
- Overactive Bladder
- Keywords
- TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Posted 3 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TENS Treatment Arm | Experimental | Device: TENSThis study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females
- 55-100 years old
- Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
- Have self-reported bladder symptoms of more than 3 months
- Are ambulatory and able to use the toilet independently
Key exclusion criteria (8 listed)
- Have primary complaint of stress urinary incontinence
- Have a pacemaker or implantable defibrillator
- Had botox injections in the bladder or pelvic floor muscles in the past 12 months
- Have a current urinary tract or vaginal infection
- Have an active implantable SNS device (InterStim \& Bion)
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 |
|---|---|---|
| TENSTranscutaneous electrical nerve stimulation | Device | TENS Treatment Arm |
Primary outcome
Change in Urge Incontinence Episodes
Time frame: Baseline and 8 weeks
2 secondary outcomes
Change in Micturitions Per Day
Time frame: Baseline and 8 weeks
Change in Health-related Quality of Life (HRQL)
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Overactive Bladder, run by Theranova, L.L.C. 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 21 May 2021. 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 3 Jan 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?
Change in Urge Incontinence Episodes (time frame: Baseline and 8 weeks). 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 21 May 2021.