DESCRIPTION (provided by applicant): The Institute for Bladder and Prostate Health at Weill Cornell Medical College - New York-Presbyterian Hospital evaluates and treats an ethnically diverse group of more than 3,200 men per year with lower urinary tract symptoms (LUTS) secondary to benign prostatic hypertrophy (BPH). It has been well positioned to meet the recruitment and patient retention goals as a Clinical Evaluation and Treatment Center (CETC) in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial. CAMUS is a randomized, double-blind, multi-center trial to determine if Serenoa repens reduces LUTS compared to placebo. Participants were randomized equally to one of two treatment arms: extract of Serenoa repens 320 mg once daily for 24 weeks (one gelcap), followed by 640 mg daily for 24 weeks (two gelcaps), followed by 960 mg daily for 24 weeks (three gelcaps) or placebo. Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. This trial will provide enormous insight into the progression of BPH and related symptoms in both an untreated population, i.e. placebo vs. one treated with Serenoa repens. This is of particular importance because efficacy can be truly determined only with an understanding of the untreated natural history of BPH. The primary objective is to ascertain if Serenoa repens extract reduces the AUA symptom score compared to placebo over 72 weeks of treatment and is well tolerated. Secondary objectives are as follows: to determine if Serenoa repens has a beneficial effect on subjective global assessment;to assess the impact of Serenoa repens on the following measures over time: BPH Impact Index, Quality of Life item score from the IPSS, Nocturia item score from the IPSS, Peak uroflow. Post-void residual volume, PSA level. Erectile and ejaculatory function, ICSmale Incontinence scale, Jenkins Sleep Dysfunction scale and NIH Chronic Prostatitis Symptom Index;and to assess the impact of the assigned treatments on conhplete blood counts and basic blood chemistries. PUBLIC HEALTH RELEVANCE: LUTS related to BPH are common among older men, and represent a significant source of morbidity. Extracts of Serenoa repens may have a modest favorable effect on some LUTS with few side effects. However, the trials documenting both the safety and efficacy of this agent have many methodological problems, and the mechanism of their clinical effect, if any, remain undefined.
|Effective start/end date||30/09/02 → 31/03/03|
- National Institute of Diabetes and Digestive and Kidney Diseases: $124,144.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $388,791.00
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