OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

Browse trials for

• Urinary Incontinence 1,363
• Urinary Bladder, Overactive 855

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 254 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Study arms

• Experimental
  OnabotulinumtoxinA

  OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).

  Biological: onabotulinumtoxinA

• Other
  Placebo/OnabotulinumtoxinA

  Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).

  Biological: onabotulinumtoxinA · Drug: Normal saline

Interventions

• BiologicalonabotulinumtoxinA

  OnabotulinumtoxinA (BOTOX®) injected into the detrusor.

  Also known as: BOTOX®, botulinum toxin Type A

• DrugNormal saline

  Normal saline (placebo) injected into the detrusor.

Primary outcomes

1. Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes

   Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

   Time frame: Baseline, Week 12

2. Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence

   Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

   Time frame: Baseline, Week 12

Secondary outcomes

1. Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores

   The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.

   Time frame: Baseline, Week 12

2. Change From Baseline in the Daily Average Number of Micturition Episodes

   The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

   Time frame: Baseline, Week 12

3. Change From Baseline in the Daily Average Number of Urgency Episodes

   The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

   Time frame: Baseline, Week 12

4. Change From Baseline in the Daily Average Number of Nocturia Episodes

   Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.

   Time frame: Baseline, Week 12

Baseline characteristics

Publications

• McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914. PubMed 32665528 ↗