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Completed

NCT Number: NCT01767519

A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
  • Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion criteria

  • Overactive Bladder caused by neurological condition
  • Patient has predominance of stress incontinence
  • Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening
  • Previous use of solifenacin
  • History or evidence of pelvic or urological abnormality
  • Previous use of any botulinum toxin of any serotype for any urological condition
  • Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization
  • Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Treatment and study plan

BOTOX®

Biological

BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.

Other names: onabotulinumtoxinA, botulinum toxin Type A

solifenacin

Drug

Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.

Other names: Vesicare

Botox placebo (normal saline)

Drug

Botox placebo (normal saline) intradetrusor injection at Day 1.

solifenacin placebo

Drug

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Primary outcomes

  1. Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1

    Time frame: Study Baseline, Week 12

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

  2. Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1

    Time frame: Study Baseline, Week 12

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

Secondary outcomes

  1. Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1

    Time frame: Week 12

    A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'

  2. Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1

    Time frame: Study Baseline, Week 12

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

  3. Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1

    Time frame: Study Baseline, Week 12

    Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. 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.

  4. Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

    Time frame: Study Baseline, Week 12

    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

  5. Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1

    Time frame: Study Baseline, Week 12

    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 14, 2013
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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