Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study
Abstract Background To preliminary investigate the effects of silodosin 8 mg once daily on obstruction urodynamic parameters and subjective symptoms in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement. Methods We performed a single-center, open-label, s...
Main Authors: | , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2018-03-01
|
Series: | BMC Urology |
Subjects: | |
Online Access: | http://link.springer.com/article/10.1186/s12894-018-0326-7 |
id |
doaj-2a95d98be6c141da93414028636575ba |
---|---|
record_format |
Article |
spelling |
doaj-2a95d98be6c141da93414028636575ba2020-11-25T01:02:20ZengBMCBMC Urology1471-24902018-03-011811710.1186/s12894-018-0326-7Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical studyFerdinando Fusco0Massimiliano Creta1Nicola Longo2Francesco Persico3Marco Franco4Vincenzo Mirone5Department of Neurosciences, Human Reproduction and Odontostomatology, University of NaplesDepartment of Neurosciences, Human Reproduction and Odontostomatology, University of NaplesDepartment of Neurosciences, Human Reproduction and Odontostomatology, University of NaplesDepartment of Neurosciences, Human Reproduction and Odontostomatology, University of NaplesDepartment of Neurosciences, Human Reproduction and Odontostomatology, University of NaplesDepartment of Neurosciences, Human Reproduction and Odontostomatology, University of NaplesAbstract Background To preliminary investigate the effects of silodosin 8 mg once daily on obstruction urodynamic parameters and subjective symptoms in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement. Methods We performed a single-center, open-label, single-arm, post-marketing interventional clinical trial. Inclusion criteria were: Caucasian subjects aged ≥50 years waiting to undergo surgery for lower urinary tract symptoms suggestive of benign prostatic enlargement, international prostate symptom total score ≥ 13, international prostate symptom-quality of life score ≥ 3, prostate volume ≥ 30 ml, maximum urine flow rate ≤ 15 mL/s, bladder outlet obstruction index > 40. Eligible subjects received one capsule of silodosin 8 mg once daily for 8 weeks. Invasive urodynamic evaluations were performed at baseline and at 8-weeks follow-up. International prostate symptom questionnaire was administered at baseline, after 4-weeks and 8-weeks of treatment. Results Overall, 34 subjects were included. Mean bladder outlet obstruction index significantly decreased from 70.6 to 39.2 and bladder outlet obstruction index class improved in 16 patients (53.3%). Statistically significant improvements of mean total international prostate symptom score, mean storage sub-score, mean voiding sub-score and mean quality of life sub-score were evident after 4-weeks of treatment with further improvements after 8-weeks. At the end of the treatment, all patients declared that their condition improved enough to spare or delay surgery. Conclusions Silodosin 8 mg once daily significantly improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement waiting for surgery. Trial registration EudraCT n. 2015-002277-38 Date of registration: 15th December 2017.http://link.springer.com/article/10.1186/s12894-018-0326-7Benign prostatic enlargementBenign prostatic obstructionLower urinary tract symptomsSilodosinUrodynamic |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Ferdinando Fusco Massimiliano Creta Nicola Longo Francesco Persico Marco Franco Vincenzo Mirone |
spellingShingle |
Ferdinando Fusco Massimiliano Creta Nicola Longo Francesco Persico Marco Franco Vincenzo Mirone Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study BMC Urology Benign prostatic enlargement Benign prostatic obstruction Lower urinary tract symptoms Silodosin Urodynamic |
author_facet |
Ferdinando Fusco Massimiliano Creta Nicola Longo Francesco Persico Marco Franco Vincenzo Mirone |
author_sort |
Ferdinando Fusco |
title |
Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study |
title_short |
Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study |
title_full |
Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study |
title_fullStr |
Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study |
title_full_unstemmed |
Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study |
title_sort |
silodosin 8 mg improves benign prostatic obstruction in caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study |
publisher |
BMC |
series |
BMC Urology |
issn |
1471-2490 |
publishDate |
2018-03-01 |
description |
Abstract Background To preliminary investigate the effects of silodosin 8 mg once daily on obstruction urodynamic parameters and subjective symptoms in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement. Methods We performed a single-center, open-label, single-arm, post-marketing interventional clinical trial. Inclusion criteria were: Caucasian subjects aged ≥50 years waiting to undergo surgery for lower urinary tract symptoms suggestive of benign prostatic enlargement, international prostate symptom total score ≥ 13, international prostate symptom-quality of life score ≥ 3, prostate volume ≥ 30 ml, maximum urine flow rate ≤ 15 mL/s, bladder outlet obstruction index > 40. Eligible subjects received one capsule of silodosin 8 mg once daily for 8 weeks. Invasive urodynamic evaluations were performed at baseline and at 8-weeks follow-up. International prostate symptom questionnaire was administered at baseline, after 4-weeks and 8-weeks of treatment. Results Overall, 34 subjects were included. Mean bladder outlet obstruction index significantly decreased from 70.6 to 39.2 and bladder outlet obstruction index class improved in 16 patients (53.3%). Statistically significant improvements of mean total international prostate symptom score, mean storage sub-score, mean voiding sub-score and mean quality of life sub-score were evident after 4-weeks of treatment with further improvements after 8-weeks. At the end of the treatment, all patients declared that their condition improved enough to spare or delay surgery. Conclusions Silodosin 8 mg once daily significantly improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement waiting for surgery. Trial registration EudraCT n. 2015-002277-38 Date of registration: 15th December 2017. |
topic |
Benign prostatic enlargement Benign prostatic obstruction Lower urinary tract symptoms Silodosin Urodynamic |
url |
http://link.springer.com/article/10.1186/s12894-018-0326-7 |
work_keys_str_mv |
AT ferdinandofusco silodosin8mgimprovesbenignprostaticobstructionincaucasianpatientswithlowerurinarytractsymptomssuggestiveofbenignprostaticenlargementresultsfromanexplorativeclinicalstudy AT massimilianocreta silodosin8mgimprovesbenignprostaticobstructionincaucasianpatientswithlowerurinarytractsymptomssuggestiveofbenignprostaticenlargementresultsfromanexplorativeclinicalstudy AT nicolalongo silodosin8mgimprovesbenignprostaticobstructionincaucasianpatientswithlowerurinarytractsymptomssuggestiveofbenignprostaticenlargementresultsfromanexplorativeclinicalstudy AT francescopersico silodosin8mgimprovesbenignprostaticobstructionincaucasianpatientswithlowerurinarytractsymptomssuggestiveofbenignprostaticenlargementresultsfromanexplorativeclinicalstudy AT marcofranco silodosin8mgimprovesbenignprostaticobstructionincaucasianpatientswithlowerurinarytractsymptomssuggestiveofbenignprostaticenlargementresultsfromanexplorativeclinicalstudy AT vincenzomirone silodosin8mgimprovesbenignprostaticobstructionincaucasianpatientswithlowerurinarytractsymptomssuggestiveofbenignprostaticenlargementresultsfromanexplorativeclinicalstudy |
_version_ |
1725205450187603968 |