PMID- 32189535
OWN - NLM
STAT- MEDLINE
DCOM- 20200703
LR  - 20200703
IS  - 1745-2422 (Electronic)
IS  - 1743-4440 (Linking)
VI  - 17
IP  - 4
DP  - 2020 Apr
TI  - A novel metric for treatment durability in clinical trials of minimally invasive 
      treatments for benign prostatic hyperplasia.
PG  - 365-369
LID - 10.1080/17434440.2020.1742699 [doi]
AB  - Introduction: Clinical trial manuscripts commonly report results of individual 
      endpoints. However, durability of a medical treatment may be difficult to 
      determine when evaluating endpoint outcomes individually. We reviewed pivotal 
      trial manuscripts of two minimally invasive benign prostatic hyperplasia (BPH) 
      treatments and estimated the rate of treatment durability using a composite, 
      symptom-centric metric.Methods: Data were derived from published pivotal trial 
      reports of two minimally invasive BPH treatments - water vapor thermal therapy 
      (WVTT) and prostatic urethral lift (PUL). We estimated the risk of medical or 
      surgical retreatment using life-table methods, and the number of patients 
      achieving the minimal clinically important difference (MCID) for the 
      International Prostate Symptom Score (IPSS) using z-score methods. Treatment 
      durability was defined as a MCID on the IPSS at the 4-year follow-up visit while 
      free from medical or surgical retreatment.Results: Comparing WVTT to PUL, the 
      rate of medical or surgical retreatment was 10.6% vs. 31.8%, the IPSS MCID was 
      achieved in 82.2% vs. 79.5%, and treatment durability rates were 71.8% vs. 
      51.7%.Conclusions: Utilization of a composite treatment durability metric derived 
      from endpoints commonly reported in the BPH literature may allow patients and 
      their providers to make better informed treatment decisions.
FAU - Miller, Larry E
AU  - Miller LE
AD  - Miller Scientific, Johnson City, TN, USA.
FAU - Te, Alexis E
AU  - Te AE
AD  - Brady Prostate Center & Urodynamic Laboratory, Urology Program, Iris Cantor Men's 
      Health Center, Weill Medical College of Cornell University, New York, NY, USA.
FAU - Bhattacharyya, Samir K
AU  - Bhattacharyya SK
AD  - Boston Scientific, Marlborough, MA, USA.
FAU - Lilienfeld, Sean
AU  - Lilienfeld S
AD  - Boston Scientific, Marlborough, MA, USA.
FAU - Dornbier, Ryan A
AU  - Dornbier RA
AD  - Center for Male Health, Department of Urology, Stritch School of Medicine, Loyola 
      University Medical Center, Maywood, IL, USA.
FAU - McVary, Kevin T
AU  - McVary KT
AD  - Center for Male Health, Department of Urology, Stritch School of Medicine, Loyola 
      University Medical Center, Maywood, IL, USA.
LA  - eng
PT  - Journal Article
DEP - 20200319
PL  - England
TA  - Expert Rev Med Devices
JT  - Expert review of medical devices
JID - 101230445
RN  - 0 (Steam)
SB  - IM
MH  - Aged
MH  - *Clinical Trials as Topic
MH  - Computer Simulation
MH  - Humans
MH  - Hyperthermia, Induced
MH  - Lower Urinary Tract Symptoms
MH  - Male
MH  - Middle Aged
MH  - *Minimally Invasive Surgical Procedures
MH  - Monte Carlo Method
MH  - Prostate/surgery
MH  - Prostatic Hyperplasia/*surgery
MH  - Quality of Life
MH  - Risk Factors
MH  - Steam
MH  - Treatment Outcome
MH  - Urethra/surgery
OTO - NOTNLM
OT  - BPH
OT  - lower urinary tract symptoms
OT  - prostatic urethral lift
OT  - water vapor thermal therapy
EDAT- 2020/03/20 06:00
MHDA- 2020/07/04 06:00
CRDT- 2020/03/20 06:00
PHST- 2020/03/20 06:00 [pubmed]
PHST- 2020/07/04 06:00 [medline]
PHST- 2020/03/20 06:00 [entrez]
AID - 10.1080/17434440.2020.1742699 [doi]
PST - ppublish
SO  - Expert Rev Med Devices. 2020 Apr;17(4):365-369. doi: 
      10.1080/17434440.2020.1742699. Epub 2020 Mar 19.