ABSTRACT
Introduction and Objectives: The objectives of the study were the evaluation of the efficacy and tolerability of propiverine hydrochloride immediate (IR) and extended release (ER) forms comparing placebo in patients with overactive bladder (OAB) and urge urinary incontinence (UUI) in a double-blind, double-dummy, randomized active and placebo-controlled parallel-group phase III/IV trial.
Materials and Methods: Sixty-two patients aged 54.97 ± 12.07 with OAB (detrusor hyperactivity) and UUI were randomized by 2:2:1 into 3 clinical groups receiving trial medication for 28 days: group A (27 patients), prop-ER 30 mg, s.i.d.; group B (22 patients), prop-IR 15 mg b.i.d.; group C (13 patients) placebo. At the beginning (baseline) and the end of the treatment period, efficacy and safety data were collected.
Results: On the 28th day of treatment, the clinical symptoms of OAB and UUI gained the differences in clinical groups: OAB symptoms: Episodes/24 hours:
| OAB symptoms: Episodes/24 hours | A (ER) | B (IR) | C (placebo) |
| UUI | -4.00* | -1.53 | -1.16 |
| Frequency | -6.85* | -5.10* | -4.06 |
| Urgency | -2.54* | -1.71 | -1.20 |
| Nocturia | -2.10* | -1.67 | -1.50 |
The administration of prop ER and IR resulted in superior efficacy compared to placebo. Both forms, IR and ER, showed superiority over placebo (*P < 0.001), respectively. The subjective assessment of OAB symptom reduction showed: group A (ER) – 14.82% disappeared, 70.37% improved, 14.81% did not change; for group B (IR) – 9.1%, 63.63%, 27.27%, respectively; for group C (placebo) – 0%, 53.85%, 46.15%, respectively. The evaluation of efficacy by investigator distributed as: for A (ER) – 33.40% were excellent, 40.70% were good; B (IR) – 36.38%, 27.27%, respectively; and C (placebo) – 23.07%, 30.78%, respectively. Efficacy assessment by patients showed: for A (ER) – 25.90%, 59.30%, respectively; B (IR) – 27.31%, 45.45%, respectively; and C (placebo) – 23.08%, 30.76%, respectively. The tolerability data evaluated by investigator were: for A(ER) – 14.82% were excellent, 81.48% were good; for B (IR) – 9.11%, 59.10%, respectively; for C (placebo) – 38.46%, 53.84%, respectively.The tolerability data evaluated by patients showed: for A (ER) – 25.92%, 66.66%, respectively; for B (IR) – 13.64%, 50.00%, 59.10%, respectively; for C (placebo) – 23.07%, 69.23%, respectively. The major relevant side effects of treatment were: for A (ER) – 25.92% had blurred vision, 48.14% had dry mouth, 3.7% had dyspepsia; for B (IR) – 18.18%, 40.90%, 13.63%, respectively; and 0% for C (placebo).
Conclusion: The results showed superiority in efficacy of propiverine in both forms compared to placebo in the reduction of the most bothersome symptoms of OAB. The subjective assessment showed good efficacy reported by the investigator and patients. The tolerability in the vast majority patients was good in ER and IR groups. The major side effects were comparable to other M2/M3, non-selective antimuscarins.