Improved urination and sexual function after UroLift for BPH procedure
Benign prostatic hyperplasia BPH is the most common cause of lower urinary tract symptoms in elderly men. Selective alfa 1 -adrenergic antagonists are now first-line drugs in the medical management of BPH. We conducted a single-blind, parallel group, randomized, controlled trial to compare the effectiveness and safety of the new alfa 1 -blocker silodosin versus the established drug tamsulosin in symptomatic BPH.
Subjects were randomized in ratio to receive either tamsulosin 0. Primary outcome measure was reduction in IPSS. Treatment BPH und Sex adverse events were recorded. Data of 53 subjects — 26 on silodosin and 27 on tamsulosin were analyzed.
Final IPSS at week was significantly less than baseline for both groups. However, groups remained comparable in terms of IPSS at all visits. There was a significant impact on sexual function assessed by IPSS sexual function score in silodosin arm compared BPH und Sex tamsulosin. Prostate size and uroflowmetry parameters did not change.
Both treatments were well-tolerated. Retrograde ejaculation was encountered only BPH und Sex silodosin and postural hypotension only with tamsulosin. Silodosin is comparable to tamsulosin in the treatment of BPH in Indian men. However, retrograde ejaculation may be troublesome for sexually active patients. Lower urinary tract symptoms LUTS are a common problem of aging males. Symptomatic BPH is characterized by a mix of obstructive and irritative symptoms, collectively known as prostatism.
The former include difficulty in initiation of micturition hesitancypoor or interrupted flow, post-void dribbling, and sensation of incomplete voiding that can manifest as the piss-en-deux urge to revisit the toilet immediately after voiding phenomenon.
The latter includes frequency of micturition, nocturia, dysuria and urgency or even urge incontinence. Acute retention of urine is an unfortunate obstructive complication.
Histologically, BPH affects both glandular epithelium and connective tissue stroma of the prostate to a variable degree. Pathophysiologically, BPH related LUTS results not only from fixed mechanical obstruction of the prostatic urethra but also from a dynamic component to the obstruction from prostatic muscle activity. The definitive management of symptomatic BPH is surgery to relieve the obstruction imposed by the enlarged portion of the prostate.
However, apart from invasiveness, there BPH und Sex potential complications of surgery, including the unfortunate development of permanent urinary incontinence. The former category is expected to provide relatively rapid symptom relief starting within weeks, while the latter acts more slowly restricting the hyperplasia, and taking 6 months or longer to produce symptom relief.
Alfa-blockers are BPH und Sex considered as first-line drugs in the medical management of BPH. The study was conducted as a single blind, parallel BPH und Sex, randomized, controlled trial at the urology outpatient department of a tertiary care hospital in Kolkata.
Subjects were randomized in ratio to one of the two study groups in fixed blocks of 8, using computer generated random number list. They took either tamsulosin 0. The capsules BPH und Sex removed from their commercial blister strip packaging and repackaged in air-tight, screw cap containers and suitably labeled and coded as trial medication.
Repackaging was done with the help of residents not otherwise involved in the study. Capsule identity was not revealed to the patients who received the total medication in three installments. Allocation BPH und Sex was achieved using the serially numbered, opaque, sealed envelope technique. The randomization list and the code breaking authority was retained by a senior pharmacologist not directly interacting with the subjects.
Patients were followed up at 4 and 8-week from the start of the treatment, with the final study visit being at week. Compliance was assessed by measuring the number of capsules returned at the next study visit. The primary effectiveness variable for this study was symptom relief as assessed by IPSS scoring.
The total score was taken as the sum of seven individual symptom scores. In addition, the quality of life QoL assessment was done on a 7-point scale and quality of sexual life assessed by a 6-item questionnaire that form part of the broader symptom scoring.
For safety assessment, subjects underwent standard laboratory investigations complete blood count, fasting plasma glucose, routine liver function tests and creatinine level at baseline and study end. Vital signs were recorded at each study visit and all treatment-emergent adverse events, BPH und Sex reported spontaneously by trial subjects or noted by the attending investigator, were recorded BPH und Sex the structured case report form.
History suggestive of postural hypotension and retrograde ejaculation in sexually active patients was specifically sought at each visit. The target BPH und Sex size was 25 evaluable patients in BPH und Sex group. Efficacy analysis was on modified intention-to-treat basis for subjects reporting for at least one post-baseline follow-up visit.
All subjects randomized were considered for adverse event analysis. Missing values were dealt with by the last observation carried forward strategy. The null hypothesis was that test drug silodosin is equivalent to an active comparator tamsulosin in the treatment of symptomatic BPH.
IPSS and allied scores had skewed distribution, and therefore were compared between groups by Mann—Whitney U-test and within group by Friedman's analysis of variance, followed by Dunn's test for BPH und Sex comparison between two individual time points. Prostate volume and uroflowmetry parameters were also non-parametric, and study-end versus baseline comparisons were done by Wilcoxon's matched pairs signed rank test.
Numerical variables that were normally distributed were compared between groups by Student's independent samples t -test. Chi-square test or Fisher's exact test was employed for intergroup BPH und Sex of categorical variables, as appropriate.
Sixty-one patients were enrolled in BPH und Sex study. Six subjects did not return even for the BPH und Sex follow-up visit. One patient withdrew consent to participate in the trial, and another subject withdrew due to itching all over the body just after starting BPH und Sex. Fifty-three patients Figure 1 depicts the flow of study BPH und Sex.
Silodosin in comparison to tamsulosin in benign prostatic hyperplasia: Flow of study participants. Baseline profiles of the subjects are summarized in Table 1. Evidently, the majority of patients were in their sixties or seventies and the median symptom duration at presentation was 8 months in both groups. Silodosin in comparison to tamsulosin in benign prostatic hyperplasia: Baseline clinical profile of the study subjects.
Table 2 depicts the serial change in IPSS in the two groups — the scores declined significantly from baseline in both groups change from median 18 to 7 in both but remained comparable between groups throughout the week study period.
Silodosin in comparison to tamsulosin in benign prostatic hyperplasia: IPSS changes in the study groups. This did not change with tamsulosin but increased significantly from baseline with silodosin, indicating a worsening of sexual performance. Silodosin in comparison to tamsulosin in benign prostatic hyperplasia IPSS: Sexual function score changes in the study groups. There was no change in prostate size or post-void residual urine after week of treatment in both groups as shown in Table 4.
Tamsulosin arm experienced 1 mL increase in prostate volume which, however, was not significant statistically. Comparison between the pre- and post-treatment peak urine flow rate also did not reveal anything remarkable in either group. The values are summarized in Table 5. Modest improvements in BPH und Sex uroflowmetry parameters were seen, but these were not significant statistically. Silodosin in comparison to tamsulosin BPH und Sex benign prostatic hyperplasia: Change in prostate size as assessed by USG.
Silodosin in comparison to tamsulosin in benign prostatic hyperplasia: Comparison of pre- and post-treatment uroflowmetry parameters. Adverse events were reported for 15 patients out of the 61 recruited However, there were no significant BPH und Sex in weight or vital signs heart rate and blood pressure and laboratory safety parameters.
Treatment emergent events encountered BPH und Sex 12 in the silodosin arm commonest dyspepsia in 5 instances and 10 in the tamsulosin arm commonest headache and postural hypotension in 3 instances each. There were 3 reports of retrograde ejaculation among 13 sexually active men There were no instances of postural hypotension in the silodosin arm.
All adverse events were mild in nature and did not require interruption of trial medication. There were no hospitalizations owing to adverse events. Benign prostatic hyperplasia is non-malignant enlargement BPH und Sex the prostate caused by cellular hyperplasia of both glandular and stromal elements. BPH und Sex, their role in patients with frank LUTS but small prostate gland is yet to be established.
Although safety and efficacy of drugs are expected to be established prior to marketing, there is scope for evaluating drugs further in the post-marketing phase. Therefore even the finding that silodosin, efficacy-wise, does not add further to tamsulosin in the drug therapy of BPH in Indian patients is useful information.
Published studies from other countries report that silodosin is comparable to tamsulosin in the management of BPH. In a multicentric RCT conducted by Chapple et al. Responder rates according to total BPH und Sex were significantly higher with silodosin The authors concluded that the overall efficacy of silodosin is not inferior to tamsulosin. Another non-inferiority trial conducted by Yu et al. The first double-blind, placebo-controlled, RCT comparing tamsulosin and silodosin was reported in The authors concluded that the silodosin was better than a placebo and not inferior to BPH und Sex.
Marks et al. A recent systematic review conducted by Ding et al. We have conducted our BPH und Sex with BPH und Sex. The final IPSS scores at week were significantly less than baseline for both tamsulosin and silodosin. However, scores remained comparable between the BPH und Sex study groups throughout the week duration of the study. These results suggest that silodosin effectiveness is similar to tamsulosin in the short-term treatment of BPH in Indian men.
The QoL component was also comparable between groups at week. The proportion of subjects who became completely or relatively symptom-free at the end of week of treatment also did not differ significantly between groups; reinforcing the conclusion from the primary efficacy variable. As expected, these did not change significantly in either group. Our findings are in conformity with those in earlier studies.