OnabotulinumtoxinA Bladder Injection Study

• Status: Terminated
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Beaumont Hospitals
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Women and men, 18 years of age or older

• Discontinued antimuscarinics/beta-3 agonists for > 2 weeks prior to study enrollment

• 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, 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.

Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.