Botox bladder treatment: could a simple procedure ease urgency?
NCT ID NCT07553065
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tests a new method to deliver botulinum toxin (NT 201) directly into the bladder using the Vibe System for women with overactive bladder. The goal is to reduce daily urine leakage episodes. About 210 women aged 18-80 will participate, and the treatment is compared to a placebo to see if it is safe and effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Urology Nevada
RECRUITINGReno, Nevada, 89511, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a nerve stimulation device outdo pelvic floor exercises for overactive bladder?
- Nerve zaps for bladder troubles: a hidden effect on heart rhythms?
- Shocking the saphenous nerve: a new way to calm an overactive bladder?
- Antibiotic-Free UTI shield after BOTOX-A? a new trial tests methenamine
- Blood test may predict bladder drug success