Mirabegron and Oxybutynin Safety and Efficacy Trial in Spinal Cord Injury (MOSET-SCI)
Spinal Cord Injuries, Urinary Bladder, Neurogenic
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Randomized Controlled Trial, Neurogenic Bladder, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- The subject has a neurological impairment secondary to a traumatic spinal cord injury that occurred at least twelve (12) months prior to the screening visit.
- The injury is classified as complete or incomplete (AIS grade A-D) and the neurological level of the injury is above T12.
- The subject's method of bladder management is intermittent catheterization (IC) or indwelling catheter (transurethral or suprapubic).
- There is urodynamic documentation of neurogenic detrusor overactivity (NDO).
- The subject is on a stable dose of oxybutynin IR three times daily.
- The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits and locomotor training sessions.
- The subject is able to and has voluntarily given informed consent prior to the performance of any study-specific procedures.
Exclusion Criteria:
- The subject has taken mirabegron within one month of the Screening Visit.
- The subject has received a botulinum toxin injection to the bladder within one year of the Screening Visit.
- The subject is allergic to mirabegron.
- The subject has a history of uncontrolled autonomic dysreflexia or significant autonomic dysreflexia on urodynamics (systolic BP≥150 mm/Hg).
- The subject has a known history of significant anatomical problems of the upper tracts, including hydronephrosis, kidney stones, or ureteropelvic junction obstruction.
- The subject has a known history or treatment for a non-neurogenic bladder or prostate problem (prostate cancer, bladder cancer).
- The subject has recurrent UTIs, defined as a UTI more than every three months.
- The subject has untreated Grade 3 or above vesicoureteral reflux.
- If female, the subject is pregnant (documented by a urine pregnancy test) or breastfeeding.
- The subject has taken another investigational drug within 30 days before screening.
- The subject has a medical condition that might pose a safety issue or would interfere with interpretation of study results or study conduct.
Sites / Locations
- Kessler Institute for RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Oxybutynin chloride IR then Mirabegron
Mirabegron then Oxybutynin chloride IR
Subjects randomized to this group will receive oxybutynin IR (5 mg three times daily) for 6 weeks. After the initial 6 weeks, subjects in this group will then be switched to an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily).
Subjects randomized to this group will receive an escalating dose of mirabegron for 6 weeks (25 mg once daily for 2 weeks, followed by 50 mg once daily for 4 weeks; Note: two placebo daily will be included with mirabegron once daily to match the frequency of dosing to oxybutynin IR three times daily). After the initial 6 weeks, subjects in this group will then be switched to receive oxybutynin IR (5 mg three times daily) for 6 weeks