PMID- 29804815
OWN - NLM
STAT- MEDLINE
DCOM- 20201102
LR  - 20201102
IS  - 2405-4569 (Electronic)
IS  - 2405-4569 (Linking)
VI  - 5
IP  - 6
DP  - 2019 Nov
TI  - Clinical Trials in Benign Prostatic Hyperplasia: A Moving Target of Success.
PG  - 1101-1104
LID - S2405-4569(18)30124-X [pii]
LID - 10.1016/j.euf.2018.05.007 [doi]
AB  - Benign prostatic hyperplasia (BPH) affects over 50% of men above the age of 50 
      yr. With half of these men having bothersome lower urinary tract symptoms, this 
      area represents a hot bed of novel treatments. Many BPH therapies have favorable 
      short-term outcomes but lack durability or well-defined adverse events (AEs). 
      Clinical trials are a gold standard for comparing treatments. We characterized 
      all BPH clinical trials registered worldwide from inception to 2017. A total of 
      251 clinical trials were included. Of the studies, 30.1% used patient-reported 
      outcomes such as the American Urological Association Symptom Score. Approximately 
      70% of clinical trials studied medical interventions, while the remaining trials 
      investigated surgical approaches. Seventy-nine percent of trials were industry 
      sponsored, while a minority were funded without commercial interest. Only 42% of 
      trials had 12-mo follow-up, with the majority with <3 mo of follow-up. No trials 
      evaluated prevention, diet, behavior, or alternative methods Overall, only 23% of 
      trials reported results. Management options for BPH need unified benchmarks of 
      success, AEs, durability, and standard reporting for all clinical trials, 
      regardless of outcomes. PATIENT SUMMARY: We found that the majority of clinical 
      trials were medical intervention, with very few trials evaluating prevention, 
      diet, behavior, or alternative methods Furthermore, a few trials reported results 
      in peer-reviewed journals. All clinical trials need to report results regardless 
      of outcome, and in conclusion, standardized methods are needed in order to 
      document the successes, adverse events, and durability for all clinical trials.
CI  - Copyright (c) 2018 European Association of Urology. Published by Elsevier B.V. All 
      rights reserved.
FAU - Thomas, Dominique
AU  - Thomas D
AD  - Department of Urology, Weill Cornell Medical College, New York Presbyterian 
      Hospital, New York, NY, USA.
FAU - Chung, Caroline
AU  - Chung C
AD  - Department of Urology, Weill Cornell Medical College, New York Presbyterian 
      Hospital, New York, NY, USA.
FAU - Zhang, Yiye
AU  - Zhang Y
AD  - Department of Healthcare Policy and Research, Weill Cornell Medical College, New 
      York Presbyterian Hospital, New York, NY, USA.
FAU - Te, Alexis
AU  - Te A
AD  - Department of Urology, Weill Cornell Medical College, New York Presbyterian 
      Hospital, New York, NY, USA.
FAU - Gratzke, Christian
AU  - Gratzke C
AD  - Department of Urology, Ludwig-Maximilians-University (LMU), Munich, Germany.
FAU - Woo, Henry
AU  - Woo H
AD  - Department of Surgery (Urology), The University of Sydney, Wahroonga, NSW, 
      Australia.
FAU - Chughtai, Bilal
AU  - Chughtai B
AD  - Department of Urology, Weill Cornell Medical College, New York Presbyterian 
      Hospital, New York, NY, USA. Electronic address: bic9008@med.cornell.edu.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
DEP - 20180525
PL  - Netherlands
TA  - Eur Urol Focus
JT  - European urology focus
JID - 101665661
SB  - IM
MH  - Behavior Therapy/methods
MH  - Case-Control Studies
MH  - Diet Therapy/methods
MH  - Follow-Up Studies
MH  - Humans
MH  - Lower Urinary Tract Symptoms/*drug therapy/*etiology/psychology/*surgery
MH  - Male
MH  - Patient Reported Outcome Measures
MH  - Peer Review
MH  - Prevalence
MH  - Prostatic Hyperplasia/*complications/epidemiology
OTO - NOTNLM
OT  - Benign prostatic hyperplasia
OT  - Clinical trials
OT  - Male lower urinary tract symptoms
EDAT- 2018/05/29 06:00
MHDA- 2020/11/03 06:00
CRDT- 2018/05/29 06:00
PHST- 2018/04/09 00:00 [received]
PHST- 2018/05/01 00:00 [revised]
PHST- 2018/05/11 00:00 [accepted]
PHST- 2018/05/29 06:00 [pubmed]
PHST- 2020/11/03 06:00 [medline]
PHST- 2018/05/29 06:00 [entrez]
AID - S2405-4569(18)30124-X [pii]
AID - 10.1016/j.euf.2018.05.007 [doi]
PST - ppublish
SO  - Eur Urol Focus. 2019 Nov;5(6):1101-1104. doi: 10.1016/j.euf.2018.05.007. Epub 
      2018 May 25.