Prostatic Hyperplasia, Prostatic Hypertrophy, Benign
Conditions
Keywords
BPH progression, Medical Therapy, Finasteride, Doxazosin, Randomized, Multi-center, Clinical Trial, Proscar, Cardura
Brief summary
The Medical Therapy of Prostatic Symptoms (MTOPS) is a clinical research study sponsored by the National Institutes of Health (NIH). The study will test whether the oral drugs finasteride (Proscar) and doxazosin (Cardura), alone or together, can delay or prevent further worsening of symptoms in men with Benign Prostatic Hyperplasia (BPH). MTOPS is the largest and longest study to simultaneously test whether these drugs can delay or prevent the clinical progression (symptom worsening) of BPH. Seventeen U.S. medical centers recruited 2,931 men diagnosed with symptomatic BPH between December 1995 and March 1998. Study doctors will continue to follow these men through November 2001 on a quarterly basis. In addition to the clinical progression of BPH, MTOPS will include evaluations of prostate volume by ultrasound, prostate biopsies among a subgroup of volunteers, and quality of life.
Interventions
Sponsors
George Washington University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Peak urinary flow rate at least 4 ml/sec but not greater than 15 ml/sec; and voided volume is at least 125 ml. * American Urological Association Symptom Score is greater than or equal to 8 and less than or equal to 30. * Voluntarily signed the informed consent agreement prior to the performance of any study procedures.
Exclusion criteria
* Serum prostate specific antigen level greater than 10 ng/ml. * Supine blood pressure less than 90/70 mmHG. Orthostatic hypotension. * Any prior medical or surgical intervention for BPH. * Received any prior experimental intervention (either medical or surgical) for prostate disease or enrolled in any other study protocol.
Countries
United States
Outcome results
None listed