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• W2016984979 abstract "You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Medical and Non-Surgical Therapy I1 Apr 2015PD37-07 TESTOSTERONE GEL TREATMENT SIGNIFICANTLY AMELIORATES URINARY URGENCY AND SLEEP DISTURBANCE: DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL Shin-ichi Hisasue, Hisamitsu Ide, Akira Tsujimura, Naoya Nagaya, Masaki Kimura, Amr Abdelhamed, Masato Shirai, Satoru Muto, Raizo Yamaguchi, and Shigeo Horie Shin-ichi HisasueShin-ichi Hisasue More articles by this author , Hisamitsu IdeHisamitsu Ide More articles by this author , Akira TsujimuraAkira Tsujimura More articles by this author , Naoya NagayaNaoya Nagaya More articles by this author , Masaki KimuraMasaki Kimura More articles by this author , Amr AbdelhamedAmr Abdelhamed More articles by this author , Masato ShiraiMasato Shirai More articles by this author , Satoru MutoSatoru Muto More articles by this author , Raizo YamaguchiRaizo Yamaguchi More articles by this author , and Shigeo HorieShigeo Horie More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2269AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Recent reports suggested that Late-onset hypogonadism (LOH) is closely related to lower urinary tract symptoms (LUTS). It is also reported testosterone replacement therapy may worsen sleep apnea. We developed a new formulation of testosterone gel (2.5%) and carried out a randomized controlled clinical trial and assessed its efficacy for LUTS and sleeping status as well as LOH. METHODS We conducted a 12-week, double-blind, placebo-controlled clinical trial of testosterone gel (TG) versus placebo gel (PG) in men with LOH symptoms. A total of 62 men ≥ 40 years old with LOH (total testosterone < 450 ng/dl and total AMS scores ≥ 27) were randomized into TG or PG. For patients in TG group, 25 mg of 2.5% TG was administered, and for those in PG group, gel without testosterone was administered once every morning for 12 weeks. Self-administered questionnaires (IPSS, SHIM, EHS, Self-rating Depression Scale; SDS, State-Trait Anxiety Inventory; STAI, Athens Insomnia Scale; AIS), blood sample, and physical measurement were completed at weeks 0 and 12. RESULTS One patient from TG group and 4 patients from PG group dropped-out during the study period. Total of 57 patients were analyzed (TG group; n=30, PG group; n=27). There was no significant difference between 2 groups in blood test, BMI, W/H ratio, grip strength, and questionnaires results at baseline. IPSS (8.8 to 10.7, p=0.020), STAI (state anxiety) (38.7 to 40.3, p=0.021), AIS (8.07 to 6.48, p=0.013) were significantly improved only in TG group. In IPSS, Q7 (nocturnal frequency) was not significantly improved; however, Q4 (urgency) was significantly improved in TG group. CONCLUSIONS This double-blind placebo controlled trial showed that newly developed testosterone gel treatment significantly improved STAI, AIS and urgency symptom in IPSS compared with placebo. Testosterone relieved urgency and it might have led to the improvement of sleep disturbance. This is the first study suggesting that LOH patients with urinary urgency and sleep disturbance are good candidates for the testosterone replacement. Results before and after treatment Placebo Testosterone before after before after Total testosterone (ng/dl) 360.4 366.1 350.3 614.8∗ Free testosterone (pg/ml) 6.75 6.61 6.67 13.7∗ AMS total 48.4 42.4∗ 50.9 43.2∗ AMS sexual 16 14.7 16.9 15.1∗ AMS physical 19.9 17.7 20.9 17.5∗ AMS psychological 12.5 10.0∗ 13.1 10.6∗ EHS 2.4 2.5 2.3 2.4 SHIM 9.9 10.2 7.9 9.1 IPSS 10.6 9.8 10.7 8.8∗ STAI Q1 40.0 39.2 40.3 38.7∗ STAI Q2 45.2 44.0 44.7 43.1 AIS 7.73 7.08 8.1 6.5∗ SDS 41.9 40.8 40.4 39.3 ∗ p < 0.05, Student's t-test © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e772-e773 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shin-ichi Hisasue More articles by this author Hisamitsu Ide More articles by this author Akira Tsujimura More articles by this author Naoya Nagaya More articles by this author Masaki Kimura More articles by this author Amr Abdelhamed More articles by this author Masato Shirai More articles by this author Satoru Muto More articles by this author Raizo Yamaguchi More articles by this author Shigeo Horie More articles by this author Expand All Advertisement Advertisement PDF DownloadLoading ..." @default.
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• W2016984979 title "PD37-07 TESTOSTERONE GEL TREATMENT SIGNIFICANTLY AMELIORATES URINARY URGENCY AND SLEEP DISTURBANCE: DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL" @default.
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