Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
Condition: Urinary Bladder, Overactive; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: onabotulinumtoxinA; Placebo (saline)
Intervention description: OnabotulinumtoxinA (BOTOX®) injection into the bladder.; Placebo (saline) injection into the bladder.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®),
      compared to placebo, when injected into the bladder using an alternative injection paradigm
      in reducing the number of daily urinary incontinence episodes in patients with overactive
      bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with
      an anticholinergic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant weighs ≥ 40 kg (88 lb)

          -  Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with
             urinary incontinence for a period of at least 6 months immediately prior to screening.

        Exclusion Criteria:

          -  Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord
             injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's
             disease, etc.)

          -  Participant has received pharmacologic therapy to treat symptoms of OAB, including
             nocturia, within 7 days of the start of the screening period procedures

          -  Participant uses clean intermittent catheterization (CIC) or indwelling catheter to
             manage urinary incontinence

          -  Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin,
             resiniferatoxin) within 12 months of Day 1

          -  Participant has had previous or current botulinum toxin therapy of any serotype for
             any urological condition

          -  Participant has had previous or current botulinum toxin therapy of any serotype for
             any non-urological condition within 12 weeks of Day 1

          -  Participant has been immunized for any botulinum toxin serotype

          -  Participant has history or evidence of any pelvic or urological abnormalities, bladder
             surgery or disease, other than OAB, that may affect bladder function

          -  Participant has an active genital infection, other than genital warts, either
             concurrently or within 4 weeks prior to screening

          -  Participant has a history or current diagnosis of bladder cancer or other urothelial
             malignancy

          -  Participant is male with previous or current diagnosis of prostate cancer

          -  Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months
             of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs

          -  Participant has current or previous uninvestigated hematuria

          -  Participant has hemophilia, or other clotting factor deficiencies, or disorders that
             cause bleeding diathesis

          -  Participant cannot withhold any antiplatelet, anticoagulant therapy or medications
             with anticoagulant effects for 3 days prior to Day 1

          -  Participant has a known allergy or sensitivity to any botulinum toxin preparation

          -  Participant has any medical condition that may put him/her at increased risk with
             exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or
             amyotrophic lateral sclerosis

          -  Participant has current swallowing or breathing difficulties.