Medical Therapy Of Prostatic Symptoms Research Articles

Protecting Bladder Function and Reducing Disease Progression

Infravesical obstruction impairs bladder function, and α 1-adrenoceptor (AR) antagonists can relieve such dysfunction in part due to their moderate deobstructing effects. Moreover, α 1-AR antagonists may also have beneficial effects on bladder function via mechanisms independent from those regulating bladder outlet resistance. Such beneficial effects have repeatedly been reported from various animal models of bladder outlet obstruction, and preliminary data indicate that this may perhaps also occur in lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) patients. The contribution of such effects on the bladder in the long-term treatment of LUTS/BPH remains to be assessed. The recently completed Medical Therapy Of Prostatic Symptoms (MTOPS) study has demonstrated that α 1-AR antagonists have beneficial effects on the progression of LUTS/BPH which are quantitatively similar to but qualitatively different from those of 5α-reductase inhibition. Due to this differential mode of action, long-term combination treatment was significantly more effective than either treatment alone. Since combination therapy is at least associated with the side effects of both the α 1-AR antagonist and 5α-reductase inhibitor, great care should be taken to identify patients at high risk in whom the benefits of combination treatment outweigh its risk. Use of an α 1-AR antagonist with very high tolerability may facilitate the use of combination treatment.

Study design of the Medical Therapy of Prostatic Symptoms (MTOPS) trial

Alpha-blockers and 5-alpha-reductase inhibitors are medical therapies that are being used as alternatives to surgical interventions to relieve symptoms of benign prostatic hyperplasia (BPH). Taken as monotherapy, alpha-blockers and 5-alpha-reductase inhibitors have each been shown to provide relief from BPH symptoms. Treatment with finasteride over 4 years has been shown to reduce both BPH symptoms and the likelihood of acute urinary retention and the need for surgery. Direct comparison of the alpha-blocker terazosin with finasteride has been done, but only for a period of 1 year. The Medical Therapy of Prostatic Symptoms (MTOPS) trial is a multicenter, randomized, placebo-controlled, double-masked clinical trial designed to evaluate the long-term efficacy of the alpha-blocker doxazosin and the 5-alpha-reductase inhibitor finasteride, whether taken as a monotherapy or in combination, in preventing or delaying the progression of BPH. We describe in this paper the design of the MTOPS trial, the concept of BPH progression, the definition and methods of determining the primary outcome events and the proposed statistical analysis methods. A unique feature of MTOPS is the inclusion of prostate biopsies on a subgroup of randomized participants. Volunteers among randomized participants are to undergo a biopsy of the prostate at predetermined time points during the trial. Studies that will be conducted using the tissue specimens collected in MTOPS can potentially provide information at the molecular level on the natural history of BPH among medically treated and untreated men with moderate to severe symptoms of BPH.

Recruitment strategies used in the medical therapy of prostatic symptoms (MTOPS) trial

s 97S P38 RECRUITMENT STRATEGIES USED IN THE MEDICAL THERAPY OF PROSTATIC SYMPTOMS (MTOPS) TRIAL Pamela K. Burrows, John W. Kusek, Kevin McVary, Harry Clarke, Harris Foster, Aaron Kirkemo, Valory Pavlik, and Zana Parman for the MTOPS Research Group. George Washington University Rockville, Maryland MTOPS is a 17-center randomized, placebo controlled clinical trial of drug therapy in men (sample size = 2,800, randomized in 2 years) with benign prostatic hyperplasia (BPH). Although several large multi-center clinical trials have evaluated the effects of drug therapy on BPH, specific recruitment strategies have not been previously described in men with this condition. The target population for MTOPS is men > 50 years of age with reduced urinary flow rates and an American Urological Association Symptom Severity Score > 8 and < 30. As of August 4, 1997, 2106 men have been randomized (75 % of goal for the first 20 months of recruitment) into the trial. The first screen efficiency and proportion of randomized participants for each recruitment strategy is shown below. Recruitment Strategy First Screen Efficiency* Percent of Randomized Newspaper 79.5 28.9 Mail 77.0 23.2 Physician Referral 85.8 11.2 Newsletter 74.8 9.7 Television 87.7 8.5 Radio 82.0 6.5 Word of Mouth 83.0 4.2 Poster/Display 73.5 4.1 Event/Presentation 86.4 0.9 Total 79.9 100.0 *First screen efficiency: number randomized/number completing first screening visit We conclude that all of the recruitment strategies used in MTOPS yield a high proportion of randomized participants from the first screening visit and that targeted mass mailing and newspaper advertising/feature articles account for approximately one-half of the randomized participants.

Use of mass mail to recruit older men into a clinical trial for medical treatment of benign prostatic hyperplasia (BPH): The medical therapy of prostatic symptoms (MTOPS) trial

Use of mass mail to recruit older men into a clinical trial for medical treatment of benign prostatic hyperplasia (BPH): The medical therapy of prostatic symptoms (MTOPS) trial