To determine if men with self-reported lower urinary tract symptoms (LUTS) can make a correct decision to use an over-the-counter (OTC) alpha-1 blocker. Further, to assess the frequency of medically significant conditions (MSCs) presenting with urinary symptoms in these consumers.
Subjects reviewed a mock-up of the OTC product for male LUTS (Part 1). Subjects who selected the product underwent urine dipstick testing and male subjects completed the AUA Symptom Index (AUA-SI) (Part 2). Urologic assessment was conducted in women; men
Of 1967 subjects enrolled, 1953 completed Part 1 (men/women: 1697/256), 1311 (1294/17) entered Part 2, and 1289 (1274/15) were evaluated. Frequently reported baseline medical conditions were hypertension (45. 8%/46. 7%) and dyslipidemia (36. 4%/60. 0%). LUTS were present for >3 years in 47. 6% men and 40% women. The mean AUA-SI score was 18. 9. Urine dipstick results were positive in 20. 9% men. Overall, 729 men and 12 women underwent urologic assessment: 517 (70. 9%) men had urologist-confirmed LUTS, 200 (27. 4%) men did not. Newly diagnosed MSCs causing/contributing to LUTS were identified in 21 (2. 9%) men and 2 (16. 7%) women.
Most men correctly selected the OTC product for management of LUTS/BPH, while most women correctly de-selected to use the product. Since very few men had undiagnosed MSCs causing/contributing to urinary symptoms, the risk of harm due to incorrect selection was low.
The Journal of urology. 2015 Sep 10 [Epub ahead of print]
Claus G Roehrborn, Franklin C Lowe, Marc Gittelman, Jan M Wruck, Anna E Verbeek
University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd. , Dallas, TX 75390, United States. , Weiler Hospital, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY 10461, United States. , South Florida Medical Research, 21150 Biscayne Blvd, Aventura, FL 33180, United States. , Boehringer Ingelheim Pharmaceuticals, Inc. , 900 Ridgebury Road, Ridgefield, CT 06877, United States. , Boehringer Ingelheim Pharmaceuticals, Inc. , 900 Ridgebury Road, Ridgefield, CT 06877, United States.