UMIN-CTR Clinical Trial

A total of 17 patients withdrew because of adverse events and so on. 60 patients completed the study. Bladder capacity at first desire to void, maximum cystometric capacity and bladder compliance increased significantly. Neurogenic detrusor overactivity disappeared in 23.5%, and a significant increase was observed in bladder capacity at first involuntary contraction, and a significant decrease was observed in maximum detrusor contraction.

Patients with NDO or LCB in a stable condition for >6 months were included.

Various assessments were performed before and after treatment, including urodynamic testing.

Adverse events were observed in 40 patients (51.9%): dry mouth (n = 20), constipation (n = 7), blurred vision (n = 3) and others in 10 patients (voiding difficulty, urinary retention, headache, sleepiness, urethral discomfort, urgency, nausea, shivering and reflux esophagitis.

The primary end-point was change from baseline to the end of treatment in the MCC in V-UDS. The secondary end-points were the number of patients whose NDO disappeared, and changes in the following parameters from baseline to the post-treatment: bladder capacity at FDV, bladder capacity at FIC, maximum detrusor pressure and bladder compliance. If patients could void, Qmax, maximum detrusor pressure and PdetQmax were evaluated. Changes in OABSS, IPSS, ICIQ-SF and KHQ,18-20 and the changes in the number and the amount of voids, and the number of daily incontinence episodes in a 3-day FVC were evaluated from baseline to 4 and 12 weeks of treatment. In the SF-36, domains of physical functioning, physical role, body pain, general health, vitality, social functioning, role emotional and mental health were evaluated, with a minimum score of 0 (worst health), and the maximum score of 100 (best health).