PMID- 30607798
OWN - NLM
STAT- MEDLINE
DCOM- 20190418
LR  - 20200309
IS  - 1179-1969 (Electronic)
IS  - 1170-229X (Linking)
VI  - 36
IP  - 2
DP  - 2019 Feb
TI  - Management of Male Lower Urinary Tract Symptoms in a Simulated, Over-the-Counter 
      Setting: An Exploratory Study of Tamsulosin.
PG  - 179-188
LID - 10.1007/s40266-018-0621-8 [doi]
AB  - BACKGROUND: Lower urinary tract symptoms (LUTS) attributed to benign prostatic 
      hyperplasia (BPH) are common in men, considerably affecting quality of life. 
      AIMS: The self-directed use of over-the-counter (OTC) tamsulosin (0.4 mg) and 
      potential safety risks were evaluated in an open-label, uncontrolled, 
      exploratory, 8-week OTC-simulated study. METHODS: Men (>/= 18 years) were recruited 
      via mass advertising about bothersome LUTS. In a working retail environment, 
      respondents reviewed the product and decided whether it was appropriate for them 
      to use (self-selection phase). After purchasing the product, participants' 
      ability to use it as directed by the proposed drug facts label (DFL) was assessed 
      (home-use phase). RESULTS: Of 1446 eligible men, 679 completed the self-selection 
      phase, and 73.9% (502/679) self-selected to use tamsulosin correctly according to 
      the DFL. Of 369 participants who purchased tamsulosin and entered the home-use 
      phase, 321 took one or more doses of tamsulosin and participated in at least one 
      telephone interview. In total, 85.4% (274/321) of participants adhered to the 
      'Stop Use' and 'Directions' instructions in the DFL. Overall, 139 (39.6%) 
      participants experienced one or more adverse events (AEs); 65 (18.5%) were deemed 
      drug-related, including dizziness (11 [3.1%]), ejaculation disorder (6 [1.7%]), 
      and semen volume decrease (6 [1.7%]). No unexpected AEs were reported. 
      CONCLUSIONS: Of the men interested in self-managing their LUTS, a majority had 
      moderate-to-severe LUTS of long duration. Most men were able to appropriately 
      self-select and use tamsulosin in concordance with DFL instructions and 
      directions. No unexpected AEs were reported during self-directed use. With 
      further label refinement, an over-the-counter tamsulosin option might be 
      feasible. TRIAL REGISTRATION: ClinicalTrials.gov NCT01726270.
FAU - Roehrborn, Claus G
AU  - Roehrborn CG
AD  - University of Texas Southwestern Medical Center, Dallas, TX, USA.
FAU - Lowe, Franklin C
AU  - Lowe FC
AD  - Weiler Hospital, Albert Einstein College of Medicine, Bronx, NY, USA.
FAU - Gittelman, Marc
AU  - Gittelman M
AD  - South Florida Medical Research, Uromedix/Division of 21st Century Oncology, 
      Aventura, FL, USA.
FAU - Wruck, Jan M
AU  - Wruck JM
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
FAU - Verbeek, Anna E
AU  - Verbeek AE
AD  - Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA. 
      Annelies.Verbeek@Sanofi.com.
AD  - Sanofi, 55 Corporate Drive, Bridgewater, NJ, 08807, USA. 
      Annelies.Verbeek@Sanofi.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01726270
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drugs Aging
JT  - Drugs & aging
JID - 9102074
RN  - 0 (Nonprescription Drugs)
RN  - 0 (Urological Agents)
RN  - G3P28OML5I (Tamsulosin)
SB  - IM
CIN - J Urol. 2019 Oct;202(4):636. PMID: 31766085
MH  - Adult
MH  - Health Behavior
MH  - Humans
MH  - Lower Urinary Tract Symptoms/*drug therapy/etiology
MH  - Male
MH  - Middle Aged
MH  - Nonprescription Drugs/administration & dosage/adverse effects
MH  - Prostatic Hyperplasia/complications
MH  - Quality of Life
MH  - Tamsulosin/*administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Urological Agents/administration & dosage/adverse effects
EDAT- 2019/01/05 06:00
MHDA- 2019/04/19 06:00
CRDT- 2019/01/05 06:00
PHST- 2019/01/05 06:00 [pubmed]
PHST- 2019/04/19 06:00 [medline]
PHST- 2019/01/05 06:00 [entrez]
AID - 10.1007/s40266-018-0621-8 [pii]
AID - 10.1007/s40266-018-0621-8 [doi]
PST - ppublish
SO  - Drugs Aging. 2019 Feb;36(2):179-188. doi: 10.1007/s40266-018-0621-8.