Overactive Bladder (OAB)Phase 2RELIEVENCT07553065
RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
A Phase 2 study testing NT 201 200U and Vibe System and NT 201 300U and Vibe System in people with Overactive Bladder (OAB), run by Vensica Therapeutics Ltd. at 3 sites in United States.
Trial summary
This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- NT 201 200U and Vibe System and NT 201 300U and Vibe System
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Aug 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Female aged 18-80
- Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment
- Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary
- Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day
- Participants on antimuscarinics and/or beta-3 adrenergic agonists drugs should be on a stable dose for at least 1 month prior to screening and agree to remain on stable medication consumption until the 12-week follow-up visit
- Participants on tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) drugs should be on stable dose for at least 3 months prior to enrollment and agree to remain on stable medication consumption until the 12-week follow-up visit
Who cannot join
- Participant with Body Mass Index > 40 kg/m2
- Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct
- Participant with known or suspected overactive bladder caused by any neurological conditions (neuromuscular disorders such as Myasthenia Gravis, Amyotrophic Lateral Sclerosis (ALS), Eaton-Lambert Syndrome, Alzheimer's, Parkinson, Multiple Sclerosis (MS), stroke, etc.)
- Participant with suspected retention or with Post Void Residue (PVR)> 150 ml, as measured during screening. Post void residual may be repeated one week after first assessment if the original value is greater than 150 ml
- Participant is pregnant or breastfeeding
- Participant with current or known recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone
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- Participant who has received botulinum toxin injections for any condition within the past 9 months
- Participant who has received neurostimulation for the treatment of Overactive Bladder in the last 6 months.
- Participant on any active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the past 4 weeks (Self-performed Kegels exercises are allowed)
- Participant with more than minimal level of suspected stress incontinence or mixed incontinence with stress component likely to confound study outcome, based on a 3-day voiding diary or medical history, or when stress incontinence score in the Medical, Epidemiologic, and Social Aspects (MESA) incontinence questionnaire is higher than the urgency incontinence score
- Participant with current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines as well as tubocurarine-type muscle relaxants)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
National Research Centers
Margate, Florida, 33063
Maria Pena, mpena@nrcinc.com
- Recruiting
Clinical Research Centers of Florida
Pompano Beach, Florida, 33060
Zachary Weiss, zachary@floridacrc.com
- Recruiting
Urology Nevada
Reno, Nevada, 89511
Angelique Vollmer, avollmer@urologynevada.com
About this study
Official title: RELIEVE (RandomizEd triaL of Intravesical xEomin for Incontinence Via the VibE System) - a Randomized, Prospective, Multicenter, Double Blind, Placebo and Sham Controlled Study to Assess the Safety and Efficacy of NT 201 Intravesical Administration Using Vibe System in the Treatment of Female Participants Suffering From Idiopathic Overactive Bladder
This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB).
- Conditions
- Overactive Bladder (OAB)
- Being tested
- NT 201 200U and Vibe System, NT 201 300U and Vibe System, Placebo and sham
- 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.
NT 201 200U and Vibe SystemCombination product
Combination of NT 201 200U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
NT 201 300U and Vibe SystemCombination product
Combination of NT 201 300U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure
Placebo and shamCombination product
Placebo identical in package and appearance to NT 201 together with all steps of Vibe System preparation and insertion to the bladder, but without the actual activation of the ultrasound energy
| Study group | Role | What they receive |
|---|---|---|
| Active arm: NT 201 200U and Vibe System | Active comparator | Not described Receives: Combination Product: NT 201 200U and Vibe System |
| Active arm: NT 201 300U and Vibe System | Active comparator | Not described Receives: Combination Product: NT 201 300U and Vibe System |
| Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act | Placebo comparator | Not described Receives: Combination Product: Placebo and sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean daily urinary incontinence
Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary
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 posted27 Apr 2026
- Study start14 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vensica Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553065
- Sponsor's protocol ID
- ViXe-CLP-003
- Acronym
- RELIEVE
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEVE (RandomizEd triaL of Intravesical xEomin for Incontinence Via the VibE System) - a Randomized, Prospective, Multicenter, Double Blind, Placebo and Sham Controlled Study to Assess the Safety and Efficacy of NT 201 Intravesical Administration Using Vibe System in the Treatment of Female Participants Suffering From Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT07553065
- Acronym / sponsor ID
- RELIEVE / ViXe-CLP-003
- Conditions
- Overactive Bladder (OAB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Vensica Therapeutics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Apr 2026 (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.
This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active arm: NT 201 200U and Vibe System | Active comparator | Combination Product: NT 201 200U and Vibe System |
| Active arm: NT 201 300U and Vibe System | Active comparator | Combination Product: NT 201 300U and Vibe System |
| Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act | Placebo comparator | Combination Product: Placebo and sham |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent
- Female aged 18-80
- Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment
- Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary
- Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day
Key exclusion criteria (11 listed)
- Participant with Body Mass Index > 40 kg/m2
- Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct
- Participant with known or suspected overactive bladder caused by any neurological conditions (neuromuscular disorders such as Myasthenia Gravis, Amyotrophic Lateral Sclerosis (ALS), Eaton-Lambert Syndrome, Alzheimer's, Parkinson, Multiple Sclerosis (MS), stroke, etc.)
- Participant with suspected retention or with Post Void Residue (PVR)> 150 ml, as measured during screening. Post void residual may be repeated one week after first assessment if the original value is greater than 150 ml
- Participant is pregnant or breastfeeding
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 |
|---|---|---|
| NT 201 200U and Vibe SystemCombination of NT 201 200U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure | Combination product | Active arm: NT 201 200U and Vibe System |
| NT 201 300U and Vibe SystemCombination of NT 201 300U and the ultrasound based system (Vibe System) for intravesical administration of the drug in a minimally invasive procedure | Combination product | Active arm: NT 201 300U and Vibe System |
| Placebo and shamPlacebo identical in package and appearance to NT 201 together with all steps of Vibe System preparation and insertion to the bladder, but without the actual activation of the ultrasound energy | Combination product | Control arm: Placebo (drug-free solution) and sham (i.e., insertion of the Vibe Catheter with no act |
Primary outcome
Mean daily urinary incontinence
Time frame: 12 weeks
Change from baseline in mean daily Urinary Incontinence (UI) episodes at 12-weeks post treatment according to a 3-day diary
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT 201 200U and Vibe System and NT 201 300U and Vibe System in people with Overactive Bladder (OAB), run by Vensica Therapeutics Ltd. at 3 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tami Abudi (972525989833, tami@vensica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean daily urinary incontinence (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 16 Oct 2026.