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67th Annual Meeting Abstracts
Silodosin Promotes Urodynamic and Symptomatic Improvement in Men With Symptoms Secondary to Benign Prostatic Hyperplasia: Relationship Between Efficacy and Retrograde Ejaculation
Claus G. Roehrborn1, *Herbert Lepor2, Steven A. Kaplan3, *Weining Volinn4, *Lawrence Hill4
1UT Southwestern Medical Center, Dallas, TX;2NYU School of Medicine, New York, NY;3Weill Cornell Medical College, New York, NY;4Watson Laboratories, Salt Lake City, UT
Introduction: Alpha-blockers are thought to improve urine flow and symptoms related to benign prostatic hyperplasia (BPH) through smooth muscle relaxation in the bladder neck and prostate. We wondered whether the occurrence of retrograde ejaculation (RE), an indirect indicator of smooth muscle relaxation, is related to improvement in symptoms or flow rate.
Materials & Methods: In two 12-week, randomized, placebo-controlled studies, silodosin (8 mg/day), a selective α1A-adrenergic antagonist, was given to patients (age >50y) with moderate to severe BPH-related symptoms (IPSS ≥13; peak flow rate [Qmax] between 4 and 15 ml/sec; voided volume >125 ml; postvoid residual <250 ml). For this analysis, patients were stratified by whether they experienced RE during the study.
Results: Of 466 silodosin-treated patients, 131 (28.1%) experienced RE (SIL+RE) and 335 experienced no RE (SIL-RE). Both groups had similar baseline values for IPSS and Qmax and, compared with placebo, experienced significant improvement (P< .02) in IPSS and Qmax after 12 weeks of treatment; mean improvement in IPSS and Qmax was greater in the SIL+RE compared with the SIL-RE group (Table).
Conclusions: On average, retrograde ejaculation was associated with greater improvement in symptoms and Qmax, with a clinically meaningful difference between SIL+RE and SIL-RE for Qmax. Superior relaxation of smooth muscle in genital and lower urinary tracts may result in both RE and greater efficacy in “unobstructing” urinary flow.
Efficacy in patients with and without silodosin-related retrograde ejaculation | | | | | P value SIL+RE | P value SIL+RE | | Mean (SD) | PLA | SIL-RE | P value SIL-RE vs PLA | SIL+RE | vs PLA | vs SIL-RE | | IPSS | | | | | | | | Baseline | 21.3 (4.9) | 21.0 (5.1) | | 22.2 (5.0) | | | | CFB to wk 12 (LOCF) | -3.5 (5.8) | -6.1 (6.4) | <.0001 | -7.2 (7.2) | <.0001 | .3856 | | Qmax, ml /sec | | | | | | | | Baseline | 8.9 (2.8) | 8.6 (2.6) | | 8.9 (2.4) | | | | CFB to wk 12 (LOCF) | 1.5 (4.4) | 2.4 (4.3) | .0184 | 3.1 (4.8) | .0003 | .0699 | | | | | | | | | | | | | | |
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