Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

Allergan

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive; Urinary Incontinence

Treatments: Drug: Placebo (saline); Biological: onabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT03052764

CMO-US-URO-0470

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

BOTOX® 100 U/BOTOX® 100 U

Active Comparator group

Description:

BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.

Treatment:

Biological: onabotulinumtoxinA

Placebo/BOTOX® 100 U

Placebo Comparator group

Description:

Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.

Treatment:

Drug: Placebo (saline)

Biological: onabotulinumtoxinA