Overactive BladderNCT04758247
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
A study testing TheraNova Neuromodulation System in people with Overactive Bladder, run by Theranova, L.L.C. at 2 sites in United States.
Trial summary
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. 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?
- TheraNova Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2021to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women and men ≥18 years of age
- Individual has a diagnosis of OAB with urge urinary incontinence or mixed incontinence (urge and stress) with urge urinary incontinence being the most bothersome type of urinary incontinence for at least 6 months (self-reported)
- Individual has ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary
- Individual has a mean frequency of urinary voiding events per day ≥10 times in one 24-hour day as recorded in the baseline 3-day voiding diary
- Individual is ambulatory and able to use the toilet independently
- Individual has not taken antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment
- Individual is able to provide informed consent
- Individual is capable and willing to follow all study-related procedures
Who cannot join
- • Individual has stress urinary incontinence as the most bothersome type of urinary incontinence (self-report)
- Individual has an abnormal post-void residual urine volume (>150 cc at baseline)
- Male who has a clinically significant bladder outlet obstruction (assessed by uroflow, maximum flow rate <15 mL/s for a voided volume of at least 150 cc)
- Male who has been previously diagnosed with Benign Prostate Hyperplasia
- Male who has abnormal serum PSA (>2.5 ng/mL)
- Individual has abnormal serum creatinine levels (>1.2 mg/dL for women and >1.4 mg/dL for men)
Show all 30Show fewer
- Individual has history of chronic kidney disease
- Female of childbearing age (≤50 years old) who is pregnant as confirmed by urine pregnancy test, or who plans to become pregnant during the study period
- Female who is less than one-year post-partum and/or is breast-feeding
- Female with a clinically significant pelvic organ prolapse (≥ stage III on POP-Q evaluation)
- Individual has diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C ≥ 8.5)
- Individual has known polyuria
- Individual has an active urinary tract infection (UTI) at the time of enrollment
- Individual has recurrent UTI defined as ≥4 UTIs in the past 12 months
- Individual has peripheral arterial disease
- Individual has the presence of a urinary fistula, bladder stone, or interstitial cystitis
- Individual has a diagnosis of prostate, urethral, or bladder cancer
- Individual has morbid obesity (BMI ≥ 40)
- Individual has clinically significant urethral stricture disease or bladder neck contracture
- Individual has a metallic implant that is exposed above the bone surface (e.g. a bone fracture fixation plate, but not an embedded bone screw) and is located under the skin on the bottom of the foot for either or under the skin on the anterior aspect of the mid-thigh for either leg.
- Individual has an implanted electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
- Individual has had previous treatment with sacral neuromodulation
- Individual has been treated with percutaneous tibial nerve stimulation or pelvic floor muscle stimulation
- Individual is currently using, or has used in the past 3 months, transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, legs, or feet
- Individual has been treated with onabotulinumtoxinA in the past 9 months
- Individual has a clinically significant peripheral neuropathy
- Individual has a history of pelvic pain as primary diagnosis in the past 12 months (VAS score of >4 (scale of 0 to 10))
- Individual has neurogenic bladder (i.e. Multiple Sclerosis, Parkinson's, Spinal Cord Injury)
- Individual has used an investigational drug, biologic, or medical device in the past 4 weeks
- Individual is deemed unsuitable for enrollment in the study by the investigator based on the subject's history or physical examination
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UC Davis Health
Sacramento, California, 95817
Stanford Medicine
Stanford, California, 94305
About this study
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
- Conditions
- Overactive Bladder
- Being tested
- TheraNova Neuromodulation System
- 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.
TheraNova Neuromodulation SystemDevice
The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Device: TheraNova Neuromodulation System |
| Sham | Sham comparator | Not described Receives: Device: TheraNova Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start28 Oct 2021
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758247
- Sponsor's protocol ID
- CRD-10-1330
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
- ClinicalTrials.gov ID
- NCT04758247
- Acronym / sponsor ID
- CRD-10-1330
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: TheraNova Neuromodulation System |
| Sham | Sham comparator | Device: TheraNova Neuromodulation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women and men ≥18 years of age
- Individual has a diagnosis of OAB with urge urinary incontinence or mixed incontinence (urge and stress) with urge urinary incontinence being the most bothersome type of urinary incontinence for at least 6 months (self-reported)
- Individual has ≥4 incontinence events with associated moderate or severe urgency (UUI events), with at least one UUI event per day, as recorded in the baseline 3-day voiding diary
- Individual has a mean frequency of urinary voiding events per day ≥10 times in one 24-hour day as recorded in the baseline 3-day voiding diary
- Individual is ambulatory and able to use the toilet independently
Key exclusion criteria (30 listed)
- • Individual has stress urinary incontinence as the most bothersome type of urinary incontinence (self-report)
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 |
|---|---|---|
| TheraNova Neuromodulation SystemThe investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin. | Device | Active, Sham |
Primary outcome
The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraNova Neuromodulation System in people with Overactive Bladder, run by Theranova, L.L.C. at 2 sites 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 8 inclusion and 30 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary effectiveness endpoint is the percentage of subjects with at least a 50% reduction in frequency of UUI events from baseline to 12 weeks as measured in 3-day voiding diaries. (time frame: 12 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 28 Feb 2024.