Overactive Bladder (OAB)NCT05211193
Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
An observational study of Overactive Bladder (OAB) and Failed Any OAB Pharmacotherapy, run by Stimvia s.r.o. at 1 site in Czechia.
Trial summary
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Failed Any OAB Pharmacotherapy
- What is being tested?
- eTNM delivered by URIS I nerve stimulation device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCzechia
- Study dates
- 8 Jan 2020to 2 Nov 2020
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: females age 18 years or older. The women had a diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms. The women were dissatisfied with current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months.
Who may be able to join
- Women 18 years or older, inclusive
- Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
- Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
- Treatment Satisfaction VAS <50
- Ability to understand and sign ICF
- Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests
- Subject agreed not to participate in another research study from the time of screening until the final study visit
- Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit
Who cannot join
- Prior treatment with botulotoxin for OAB
- Previous pharmacotherapy for OAB if >12 months ago
- Urinary retention with post void residual > 150ml
- Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
- History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.
Read the detailed description
Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).
- Being tested
- eTNM delivered by URIS I nerve stimulation device
- 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.
eTNM delivered by URIS I nerve stimulation deviceDevice
eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42.
| Study group | Role | What they receive |
|---|---|---|
| eTNM arm | eTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1- 42. Receives: Device: eTNM delivered by URIS I nerve stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of severe urgency episodes
The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation.
Measured: baseline and end of study (6weeks treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start8 Jan 2020
- Primary completion28 Apr 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Stimvia s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211193
- Sponsor's protocol ID
- TS003
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).
- ClinicalTrials.gov ID
- NCT05211193
- Acronym / sponsor ID
- TS003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stimvia s.r.o.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 27 Jan 2022 (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.
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.
Detailed description
Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eTNM arm | – | Device: eTNM delivered by URIS I nerve stimulation deviceeTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1- 42. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- females age 18 years or older. The women had a diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms. The women were dissatisfied with current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months.
Key inclusion criteria (8 listed)
- Women 18 years or older, inclusive
- Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
- Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
- Treatment Satisfaction VAS <50
- Ability to understand and sign ICF
Key exclusion criteria (5 listed)
- Prior treatment with botulotoxin for OAB
- Previous pharmacotherapy for OAB if >12 months ago
- Urinary retention with post void residual > 150ml
- Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
- History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant
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 |
|---|---|---|
| eTNM delivered by URIS I nerve stimulation deviceeTNM delivered by URIS I nerve stimulation device, self administered in the subject's home for 30 minutes per day, for a minimum of 34 therapy session between day 1-42. | Device | eTNM arm |
Primary outcome
Change of severe urgency episodes
Time frame: baseline and end of study (6weeks treatment)
The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation.
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 17 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Overactive Bladder (OAB)
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
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?
An observational study of Overactive Bladder (OAB) and Failed Any OAB Pharmacotherapy, run by Stimvia s.r.o. at 1 site in Czechia.
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 5 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 17 Feb 2022. 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 Czechia. 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?
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?
Change of severe urgency episodes (time frame: baseline and end of study (6weeks treatment)). 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 17 Feb 2022.