A, multi-centre Open Study to Evaluate the Efficacy and Safety of Mirabegron in NDO patients affected by multiple sclerosis (MS) .
An open study was conducted. The patients (n = 68 ) were enrolled into 2-week run-in period followed by 10 weeks a treatment period. when received mirabegron 50 mg daily.
We evaluated 68 Patients (18 Man and 50 woman ≥18 years of age) that were enrolled in the study. All patients had diagnosis of SM > of 3 years and a previous treatment with antimuscarinics with low efficacy.
All patients had symptoms of OAB (urinary frequency and urgency with or without urgency incontinence); a frequency of micturition on average ≥8 times/24 hr; and ≥3 episodes of urgency (grade 3 or 4), with or without incontinence, during the 3-day micturition diary period.
Major exclusion criteria included clinically significant outflow obstruction; significant post-void residual (PVR) volume (>200 ml); incontinence where stress was the predominant factor; intermittent self-catheterization; ; diabetic neuropathy; symptomatic previous or current malignant disease of the pelvic organs; contraindications for anticholinergics such as uncontrolled narrow angle glaucoma, other recognized pathologies affecting the urinary or colorectal systems; non-drug treatment including electro-stimulation therapy.
Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24 hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24 hr; severity of urgency; . Safety parameters included adverse events, and post-void residual volume.
The patients performed 3 visits : visit 1 screening and run in, visit 2 baseline and start of treatment and visit 3 at the end of treatment after 8 weeks.
At visit 1, patients received a micturition diary which was to be completed during the 3-day period preceding visit 2 and 3. For each micturition or incontinence episode, patients were asked to rate the degree of associated urgency on a 5-point categorical scale (0, no urgency; 1, mild urgency; 2, moderate urgency; 3, severe urgency; and 4, urgency incontinence).
Patients' perception of intensity of urgency scale (PPIUS) was evaluated once per visit, starting at visit 2, by completing the statement “my bladder condition …” with one of the following: “does not cause me any problems,” “causes me some very minor problems,” “causes me some minor problems,” “causes me some moderate problems,” causes me severe problems,” or “causes me many severe problems.
Patients' assessment of treatment benefit was also evaluated once per visit, starting at visit 2, with the question “has the treatment been of any benefit to you?” and three possible responses of “no,” “yes, a little,” or “yes, very much.
Adverse events were assessed and blood pressure and pulse rate were measured at each study visit.
PVR was assessed by ultrasonography or bladder scan at visits 1, 2, and 3.
EDSS (expanded disability status scale) medium 3