OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER
Status:
Unknown status
Trial end date:
2018-07-01
Target enrollment:
Participant gender:
Summary
Overactive bladder is a condition associated with symptoms of feeling the urge to urinate,
urinating often, and may or may not be accompanied by leakage of urine. A patient who has a
spinal cord injury (SCI) often suffers from an overactive bladder which often leads to
urinary incontinence (UI - an unwanted leakage of urine).
OnaBoNT-A bladder injections have been studied in clinical research trials. The results have
shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by
increasing the amount of urine the bladder can hold.
This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when
injected into the bladder for the treatment of UI and if it works better than a drug that is
taken by mouth. A second purpose of the study is to perform research tests on the urine
samples provided by the volunteers. Urine presents a rich source of information for bladder
diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to
learn if there are yet undiscovered reasons for urinary diseases. These tests would be very
beneficial because the results would lead to better treatment of the urinary diseases.
Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo
oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg
capsule twice a day.
The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or
placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo
contains no active medicine. Participation in this study will be about 6-7 months and involve
5 visits to the clinic. The risks of bladder onaBoNT-A
Phase:
Phase 3
Details
Lead Sponsor:
Christopher Patrick Smith
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA Mandelic Acids onabotulinumtoxinA Oxybutynin