A Study Evaluating the Efficacy and Safety of Botulinum Toxin Type A and Solifenacin in Patients with Overactive Bladder and Urinary Incontinence

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 12-010237
    NCT ID: NCT01767519
    Sponsor Protocol Number: 191622-125

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Paul Pettit, M.D.

Closed for enrollment

.
CLS-20118297

Mayo Clinic Footer