OnabotulinumtoxinA Bladder Injection Study

Overactive bladder (OAB) is a common condition which often has a negative impact on health
related quality of life. Primary and secondary treatments include behavior modification,
pelvic floor physical therapy, and OAB medications. OnabotulinumtoxinA (BTX) is a
well-established third line therapy for refractory OAB.

BTX has transitioned over the years from a procedure conducted in the operating room to one
that is commonly done in the clinic or physician office. While ten injection sites is
commonly practiced, there has been continuing interest in reducing the number of injection
sites to make the technique more tolerable and more efficient.

In this study, refractory OAB patients will be randomized to receive 100 units of BTX over 3
or 10 injection sites. The investigators hypothesize that decreasing the number of injection
sites may improve patient tolerability and satisfaction with this office-based procedure and
potentially reduce the rates of adverse events including hematuria and urinary tract
infection.

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

- 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

- No history of recurrent urinary tract infections (UTIs), defined as more than 1 UTI in
6 months or more than 2 UTIs in a year

- 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 (i.e.
pelvic cancer or 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.