Hypothesis / aims of study
Female patients usually don’t have bladder outlet obstruction unlike to male patients, so, improving overactive bladder with alpha blocker is not secondary effect by relieving obstruction which is seen in male patients. Besides of relieving obstruction of bladder outlet, alpha blocker is known to have a role of improving bladder storage function by directly acting on the spinal cord and bladder wall. The most common drugs to control overactive bladder are anticholinergics or beta-3 agonist. But, in some patients, alpha blocker is prescribed as combination. That is more common in male patients but, female patients are prescribed also maybe due to the hope of good action on the bladder wall and spinal cord. But, there were no studies on the efficacy of alpha blocker only in female overactive bladder. So, we examined if alpha blocker only has any efficacy and compliance in female overactive bladder patients.
Study design, materials and methods
Thirty-one female patients who visited our urology department due to the overactive bladder symptoms with more than 8 times voiding per day, more than three point scores of overactive bladder symptoms score(OABSS), more than two point scores of question number 3 of OABSS were enrolled in this study. Patients were randomly allocated into 3 groups. The combination of tamsulosin 0.2mg and solifenacin 5mg per day was used in 18 patients (group I). Tamsulosin 0.2mg per day monotherapy was used in 6 patients (group II). Solifenacin 5mg only per day was used in 7 patients (group III). Baseline, 4 weeks and 12 weeks later, OABSS, international prostate symptoms score (IPSS), bladder diary, urgency perception scale (UPS) was compared in three groups. Statistical methods were ANOVA, Mann-Whitney test and p-value less than 0.05 was regarded as significant.
Results
All baseline clinical parameters were comparable among the three groups. The age of group I was 55.6±14.0 years and group II was 57.8±11.6 years and group III was 54.4±11.5 years old. The baseline OABSS scores of group I was 6.3±2.0 and group II was 5.8±2.2 and group III was 7.6±1.8 points, respectively. The baseline UPS scores of group I was 1.8±0.9 and group II was 1.7±0.5 and group III was 1.6±0.5 points, respectively. There was no difference among the three groups. Until four weeks after treatment, two patients of group II(tamsulosin monotherapy) have dropped out but none dropped out in other groups (group I and gropu III). Follow up OABSS scores of group I(tamsulosin and solifenacin) was 4.6±1.9 and group II(tamsulosin monotherapy) was 6.5±1.5 and group III(solifenacin monotherapy) was 5.2±3.1 points, respectively. Changes of OABSS after 4 weeks later in group II (0.3±1.3) was different from those of group I (-2.1±0.7) and group III (-2.8±1.0). Follow up UPS scores of group I was 1.9 and group II, III was 1.5 and 1.6 respectively. Changes of UPS after 4 weeks later in group II (0.3±0.3) was not different from group I (0.3±0.2) and group III (0.4±0.5). IPSS of 4 weeks later was 11.4±8.2 (group I), 14.8±4.9 (group II) and 11.4±5.5 (group III) respectively. Until 12 weeks, total 5 patients of group II dropped out (83.3%, 5/6). Analysis of 12 weeks after treatment was not made because of high drop-out rate in group II patients.
Interpretation of results
Tamsulosin monotherapy didn't make any significant efficacy in female overactive bladder patients and many subjects in this group have dropped out, therefore, the treatment made poor compliance during the treatment period compared with anticholinergics group and combination of anticholinergics plus tamsulosin group. There was no difference between anticholinergics group and combination of anticholinergics plus tamsulosin group.