The reviewers assessed types of studies, concealment of allocation, completeness of follow-up and blinding of investigators, participants and outcome assessors. They screened identified titles and abstracts independently. Potentially relevant trials were retained and full text examined. Review Manager software version 5. When the heterogeneity appears in a meta-analysis, there are several ways to deal with it. First, do not pool the study estimates at all.
Second, ignore the heterogeneity and analyze the data by fixed effect model. Third, when there is heterogeneity that cannot readily be explained, one analytical approach is to incorporate it into a random-effects model. Fourth, exclude studies and perform analyses both with and without outlying studies as part of a sensitivity analysis See Cochrane Handbook Version 5. Here in this meta-analysis, pooled estimates of efficacy and safety were calculated using a fixed-effects model Mantel-Haenszel and a randomized-effects model DerSimonian and Laird was used according to heterogeneity.
The I 2 statistic was also examined. We explored possible sources of heterogeneity participants, treatment, study qulity. In addition, sensitivity analysis was applied by removing individual studies from the data set and analyzing the effect on the overall results. Of 22 potentially relevant studies, 16 studies were excluded after reviewing abstracts 11 studies were reviews, 5 studies were not RCTs.
All the comparisons between silodosin and placebo were superiority design, and all the comparisons between silodosin and tamsulosin were based on a non-inferiority design. The five RCTs including participants were published in — The demographic and baseline characteristics of patients in the included trials were summarized in Table 1. From this table we can see that there were almost no noticeable differences in the study populations in aspects of age, prostate volume, IPSS, Q max , and QoL.
And the results for various outcome measures at 12 weeks after treatment were shown in Tables 2 and 3. Figure 1 summarized the risks of bias of each included trials. The main limitations pertained to an inadequate description of randomization or blinding. Only two studies 11 , 13 described how the random sequence was generated and allocation concealment.
No studies reported the blinding of outcome assessment. On the other hand, the pooled analysis revealed that no statistically significant differences were found between silodosin and tamsulosin in total symptom score WMD 0. Sensitivity analysis showed that the significant heterogeneity of outcome among reported trials could be attributed mainly to the trial reported by Yokoyama and colleagues. Meta-analysis of International Prostate Symptom Score total score a , storage subscore b and voiding subscore c between silodosin and placebo all available data.
Meta-analysis of International Prostate Symptom Score total score a , storage subscore b and voiding subscore c between silodosin and tamsulosin all available data.
For the secondary endpoint variables, silodosin achieved significant improvement at the end of treatment in Q max compared with placebo; and no significant differences were found between silodosin and tamsulosin for the mean change at 12 weeks from baseline in Q max and QoL Table 4. All the three trials reported the same results that QoL improved to a greater extent in patients receiving silodosin than in those receiving placebo.
Sensitivity analysis identified the study reported by Yokoyama and colleagues 12 as the main source of heterogeneity for Q max and QoL in silodosin versus tamsulosin. The most common treatment emergent AE was retrograde ejaculation, which was reported by 9.
The combined analysis indicated that retrograde ejaculation was significantly more frequent in silodosin than in tamsulosin and placebo group. As for cardiovascular AEs, the incidences of dizziness and headache in silodosin, tamsulosin and placebo group were 2. According to the pooled estimates, no statistically significant differences were found in the comparisons of silodosin versus tamsulosin and silodosin versus placebo Tables 3 and 4.
Sensitivity analysis identified the study reported by Marks and colleagues 11 as the main source of heterogeneity for dizziness and headache in silodosin versus placebo. Meanwhile, the treatment effect of silodosin was not inferior to tamsulosin when considering the change from baseline in IPSS total score, in IPSS subsores, in Q max and in QoL due to urinary symptoms.
And in the study of Chapple et al. The mechanism of this action remains to be unknown. Another noteworthy aspect is that treatment with silodosin also showed an early and rapid onset of improvement.
The study of Chapple et al. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details. Last Update Posted : August 4, See Contacts and Locations. Study Description. This study will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with Silodosin. Detailed Description:. This is a randomised-intervention, parallel, multicentre study which will evaluate the efficacy of pelvic floor muscle training in men with benign prostatic hyperplasia and overactive bladder treated with silodosin.
Drug Information available for: Silodosin. Patients and methods: This randomized, double-blind, placebo-controlled study was conducted at 88 centres in Japan.
Patients were randomized to receive silodosin 4 mg twice daily, tamsulosin 0. The primary endpoint was the change in IPSS from baseline. At baseline, the following evaluations were performed: vital signs, urodynamic study. At the end of the 8-weeks treatment period, patients underwent the following evaluations: physical examination, IPSS questionnaire, vital signs, laboratory tests, PVR, urodynamic study.
Moreover, TEAEs were evaluated again. All urodynamic studies were performed by the same operator based on standard International Continence Society ICS procedure [ 20 ]. A 6-F double lumen catheter was inserted transurethrally, and a balloon catheter was inserted from the anus to measure abdominal pressure.
The test was done with the patient standing. Physiological saline solution was injected into the bladder at 50 ml per minute after evacuating the bladder. Intravesical pressure, abdominal pressure and detrusor pressure in the storage phase were simultaneously measured and recorded. Detrusor pressure was measured by electrically subtracting the abdominal pressure from the intravesical pressure.
Detrusor Overactivity DO was defined as involuntary detrusor contractions during the filling phase which may be spontaneous or provoked. The primary objective of the study was to evaluate BOOI variations with respect to baseline. Overall, 34 subjects were screened. Of them, 4 were excluded after PFS indicated that they were unobstructed. Demographic and clinical characteristics of the 30 subjects enrolled into the study are summarized in Table 1.
All patients completed the study protocol and were available for follow-up evaluations. Table 2 and Fig. Mean BOOI significantly decreased from No statistically significant variations in terms of incidence of DO and amplitude of the largest DO contraction were observed. Mean total IPSS score improved by 6.
Mean IPSS storage sub-score improved by 2. Mean IPSS voiding sub-score improved by 4. All TEAEs were drug related. There were no serious adverse events and all adverse evets were of mild intensity. There were no TEAEs leading to drug discontinuation. No clinical changes were found in terms of vital signs and laboratory parameters. ABs aim to inhibit the effect of endogenously released noradrenaline on smooth muscle cells in the prostate and thereby reduce prostate tone and BPO [ 21 , 22 ].
Although all ABs improve BPO, the magnitude of improvement varies according to the type of AB and is greater after silodosin with values comparable to that obtained after transurethral microwave thermotherapy [ 12 , 13 ].
We demonstrated that silodosin significantly improves BOOI in this selected subset of patients characterized by significant subjective and objective impairments.
The magnitude of BOOI improvement To date, the rationale behind the urodynamic profile of silodosin is not completely understood. Moreover, the magnitude of BOOI improvement with ABs has been reported to increase also with the percentage of patients with obstruction at baseline [ 13 ]. Nevertheless, direct comparisons among ABs in terms of BPO improvement are lacking thus limiting the value of current evidences.
We found that obstruction class improved in This finding is in line with published data. In the study by Yamanishi et al. Results from the present study show statistically significant improvements of both PdetQ max and Q max. However, although mean PdetQ max variation was clinically robust, mean Q max improvement was clinically marginal only 1.
From a pathophysiological point of view, we can hypothesize that the reduction of detrusor pressure represents a priority with respect to urinary flow improvement and, when the relief of outflow resistances is small as after therapy with ABs, the lower urinary tract mainly adapts by reducing detrusor pressures thus potentially preserving the integrity of the bladder itself and of the upper urinary tract [ 12 ]. Therefore, in everyday clinical practice, Q max improvement alone may underestimate the urodynamic benefits deriving from ABs therapy.
Unlike some published data, our study did not demonstrate statistically significant variations of urodynamic parameters relative to DO [ 15 , 16 , 17 ]. However, the number of patients with DO at baseline in the present study was very low and further studies are needed to specifically address this issue.
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