OnabotulinumtoxinA Bladder Injection Study (NCT03523091) | Clinical Trial Compass
TerminatedPhase 4
OnabotulinumtoxinA Bladder Injection Study
Stopped: Lack of enrollment
United States6 participantsStarted 2018-08-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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, urina…