Introduction and Objectives
The present non-interventional study was performed to elucidate efficacy and tolerability of add-on therapy with Spasmex®30 in patients with an overactive bladder (OAB) and benign prostate syndrome (BPS) without obstruction who are insufficiently treated with an α-receptor blocker.
Over a period of 7 months this observational study was performed by urologists in private practices. Only patients suffering from symptoms of OAB and BPS, who were insufficiently treated with an underlying therapy with an α-receptor blocker, were eligible for this prospective study. Spasmex®30 contains 30 mg trospium chloride as the active ingredient, which is an anticholinergic quarternary ammonium compound. It is registered for the treatment of diseases in which an inhibition of increased activity of the detrusor muscle is indicated, including functional disorders of the bladder, urge incontinence, and neurogenic bladder incontinence. Daily dose of Spasmex®30 and duration of treatment were not predetermined in this study, but a minimal treatment period of 4 weeks was suggested, and urologists were informed of the recommended daily dosage in the product's package leaflet, i.e. 3 times daily ∏ film coated tablet (FCT), or 1 FCT in the morning and ∏ FCT in the evening.In order to evaluate the treatment effect of Spasmex®30, the following parameters were recorded for each patient at the initial and final examination: daily micturition frequency and micturition frequency at night, average intensity of desire to urinate, number of incontinence incidents per week, number of used incontinence pads per week, International Prostatic Symptom Score (IPSS), and Quality of Life (QoL). In addition, the efficacy and tolerability of treatment were assessed by the physician and the patient at the final visit. At this visit adverse events and treatment withdrawals were also recorded. According to the study protocol, patients with missing IPSS or IPSS ≤ 7 at the initial visit, missing IPSS at the final visit, missing data regarding duration of treatment, or duration of treatment < 10 days had to be excluded from evaluation of efficacy. All data were to be evaluated by descriptive methods only.
Of the 4,382 patients participating in this trial, 57 with data before the predefined treatment period had to be excluded from further analysis. A further 224 patients had to be excluded from evaluation of efficacy, leaving 4,104 patients for the evaluation of the treatment effect of Spasmex®30. All 4,382 patients were included in the analysis of tolerability. After an average treatment period of 40 days, a considerable decrease of all symptoms was evident. The mean initial value of 11.8 daily micturitions decreased by 28% to 8.5, and the mean micturitions at night were nearly halved from 3.2 to 1.7. The fraction of patients with a strong urge to urinate decreased from 44.2% to 4.0%, while the fraction of patients with only mild symptoms increased from 6.4% to 51.5%. The percentage of patients using incontinence pads was nearly halved from 19.9% to 11.7%. The mean number of required pads decreased from 9 to 7 per week. Under therapy with Spasmex®30, the median of IPSS dropped from 18 to 12, the median of QoL improved from 4 to 2. Treatment efficacy was assessed as "very good" or "good" by 82.6% of the physicians and 78.3% of the patients (n = 4.104). 94.2% of the physicians assessed the treatment tolerability as "very good" or "good" and 89.2% of the patients shared this opinion (n = 4.382). In only 121 cases (2.8%) was therapy prematurely discontinued, and in only 35 patients (0.8%) were adverse events documented.
The study results show that patients with OAB and BPS, who are insufficiently treated with an α-receptor blocker, can benefit considerably from additional therapy with Spasmex®30. Furthermore, therapy with Spasmex®30 is well tolerated by the vast majority of patients.
α-receptor blocker - benign prostate syndrome - overactive bladder - trospium chloride