OnabotulinumtoxinA Bladder Injection Study
Condition: Overactive Bladder; Overactive Bladder Syndrome; Urinary Urgency; Urinary Incontinence; Urinary Frequency/Urgency; Urinary Bladder, Overactive
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive
Intervention: OnabotulinumtoxinA 100Unit Injection
Intervention description: Initial treatment with the option of repeat injections every 3 months
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arm parallel study with 1 to 1 randomization
Masking: Single (Participant)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OnabotulinumtoxinA; Bladder Injections

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.
    

Eligibility criteria:

        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,
             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.