OnabotulinumtoxinA Bladder Injection Study

Stopped early · Phase 4

Conditions studied: Overactive Bladder, Overactive Bladder Syndrome, Urinary Urgency, Urinary Incontinence, Urinary Frequency/Urgency, Urinary Bladder, Overactive

In brief

Patients with overactive bladder (OAB) will be randomly assigned (like a flip of a coin) to receive 100 units of onabotulinumtoxinA injected into the bladder at either 3 sites or 10 sites. Patient satisfaction and the effectiveness of the medication will be evaluated.

Key facts

Study ID

NCT03523091

Run by

Corewell Health East

People needed

6

Starts

2018-08-08

Expected to finish

2020-09-01

Last updated by the study team

2022-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Women and men, 18 years of age or older
• Self-reported failed conservative care of behavioral modifications and/or oral medications for the treatment of OAB
• Average urinary frequency of > 8 voids per day as recorded on initial 3-day voiding diary
• Self-reported bladder symptoms > 3 months
• Discontinued antimuscarinics/beta-3 agonists for > 2 weeks prior to study enrollment. May restart antimuscarinics/beta-3 agonists if indicated > 6 weeks after Botox injections.
• Capable of giving informed consent
• Capable and willing to follow all study-related procedures
• Previous OnabotulinumtoxinA injection at least three months prior to study enrollment.

You may not qualify if…

• Pregnant or planning to become pregnant during study duration
• Diagnosis of neurogenic bladder with the exception of highly functioning stroke patients
• If a patient has had a previous neuromodulation device placed, it will have to be turned off for 2 weeks for a washout period and remain off throughout the study
• Previous non-responders to onabotulinumtoxinA (BTX) therapy
• Patient cannot be receiving percutaneous nerve stimulation (PTNS) therapy. If patient is receiving PTNS, they need to stop for 1 month prior to entering the study.
• Refusal to self-catheterize or have indwelling catheter in the event of urinary retention
• Use of investigational drug/device therapy within past 4 weeks
• Participation in any clinical investigation involving or impacting gynecologic, urinary or renal function within past 4 weeks
• Current or past history of any physical condition that, in the investigator's opinion, might put the subject at risk or interfere with study results interpretation
• Pelvic radiation treatment
• Known hypersensitivity to OnabotulinumtoxinA.
• Previous infection at OnabotulinumtoxinA injection site.

Where it is running

• Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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