NT 201 therapy delivered via the Vibe System for idiopathic overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized study evaluating the safety and efficacy of NT 201 delivered intravesically using the Vibe System in adults with idiopathic overactive bladder. Participants are randomized to receive NT 201 at two dose levels or placebo, with a sham control to maintain blinding. The study includes dose–response assessment and follows participants through a 12-week period on a stable medication regimen when applicable. Primary outcomes focus on urinary frequency, urgency, and incontinence episodes, with safety monitoring throughout. Eligible participants are women aged 18-80 with documented OAB symptoms for at least six months and specific diary-based criteria.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Signed written informed consent
2. Female aged 18-80
3. Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment
4. Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary
5. Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day
6. 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
7. 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

Key Exclusion Criteria:

1. Participant with Body Mass Index \> 40 kg/m2
2. Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct
3. 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.)
4. 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
5. Participant is pregnant or breastfeeding
6. 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
7. Participant who has received botulinum toxin injections for any condition within the past 9 months
8. Participant who has received neurostimulation for the treatment of Overactive Bladder in the last 6 months.
9. Participant on any active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the past 4 weeks (Self-performed Kegels exercises are allowed)
10. 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
11. 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)

Where it's running

• National Research Centers
  Margate, Florida, United States Recruiting
• Clinical Research Centers of Florida
  Pompano Beach, Florida, United States Recruiting
• Urology Nevada
  Reno, Nevada, United States Recruiting

Study contacts

• Study coordinator: Tami Abudi
• Email: tami@vensica.com
• Phone: 972525989833

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predictive value of inflammatory biomarkers for mirabegron response in women with overactive bladder

  This study tests whether baseline blood inflammation markers can predict how well women with OAB respond to mirabegron after 3 months.

  Recruiting Bagcilar Training and Research Hospital · Istanbul, Bagcilar · NCT07773532

• Ambulatory tibial nerve stimulation for overactive bladder in adults

  A portable nerve-stimulation device used at home is being tested to see if it can reduce urgency and improve bladder symptoms in adults with overactive bladder.

  Recruiting Başakşehir Çam & Sakura City Hospital · Istanbul, Istanbul · NCT07540273

• Low-intensity shockwave versus daily solifenacin for women's overactive bladder

  This test compares once-weekly low-intensity shockwave therapy with daily solifenacin to see which better reduces overactive bladder symptoms in adult women.

  Recruiting Phase 4 Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07473310

• Low-dose tadalafil versus solifenacin for treating overactive bladder in women

  This trial will test whether taking daily low-dose tadalafil or daily solifenacin reduces overactive bladder symptoms in women aged 18–75.

  Recruiting at 14 sites Phase 4 Mansoura University · Shibīn al Kawm, Al-Minūfiyyah and 13 other locations · NCT07416968

• Zinc plus phytase given before botulinum toxin injections for overactive bladder

  This trial will test whether a short course of oral zinc plus phytase before botulinum toxin bladder injections helps adult women with overactive bladder go longer without needing another injection over six months.

  Recruiting Phase 2 Endeavor Health · Skokie, Illinois · NCT07405554

• Aquarius Pilot of the New Axonics External System for Bladder and Bowel Control

  This pilot will try the Axonics External Trial System in adults with overactive bladder or fecal incontinence to see if they respond to sacral neuromodulation before getting a permanent implant.

  Recruiting at 5 sites Axonics, Inc. · Birmingham, Alabama and 4 other locations · NCT07335484

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.