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MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia Clinical research trials and MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia. MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia clinical trial. Participants frequently obtain the most expert healthcare available for their MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia  MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia
MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia
For Condition: Benign Prostatic Hyperplasia
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Diagnostic Ultrasound,Urologix,Medtronic,Merck,Sanofi-Synthelabo
Synopsis: The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Male
Protocol Entry Criteria: Inclusion - Patient signed informed consent prior to the performance of any study procedures or discontinuation of any exclusionary medications. - Male at least 50 years of age. - AUA symptom severity score >= 10. - Voided volume >= 100 ml. - Post-void residual < 350 ml. - Prostatic length 30–50 mm by cystoscopy (from bladder neck to verumontanum) or 35–60 mm by TRUS (from bladder neck to apex). - Prostate volume 25–100 cc by TRUS. - Prostate transverse diameter 34–80 mm. - Patient able to complete the study protocol in the opinion of the investigator. Exclusion - Any prior surgical intervention for BPH. - Enrolled in another treatment trial for any disease within the past 30 days. - Previously failed to respond to combination therapy with an alpha blocker and a 5-alpha reductase inhibitor. - Previous hypersensitivity, idiosyncrasy, or clinically suspected drug reaction to alfuzosin or finasteride. - On alpha-blocker within the past month. - On a 5-alpha reductase inhibitor within the past 4 months. - On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks. - On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months. - Bleeding disorder or taking anticoagulation medication unless patient is able to be off anti-platelet medication for at least 10 days prior to MIST treatment. - Clinically significant renal or hepatic impairment as determined by abnormal creatinine or AST levels (i.e., creatinine > 2.0 mg/dL or AST > 1.5 times the upper limit of institutional norms). - Serum prostate specific antigen level > 10 ng/ml. - Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture, or two documented urinary tract infections of any type in the past year (UTI defined as > 100,000 colonies per ml urine from midstream clean catch or catheterized specimen). - Biopsy of the prostate within the past 6 weeks. - Daily use of a pad or device for incontinence required or International Continence Society male incontinence symptoms score >= 13. - Episode of unstable angina pectoris, myocardial infarction, transient ischemic attack, or cerebrovascular accident (stroke) within the past 6 months, or peripheral arterial disease with intermittent claudication or Leriches syndrome. - Orthostatic hypotension defined as drop of > 20 mm Hg in supine to standing SPB or a drop of > 10 mm Hg in supine to standing DBP, in either standing BP reading, or the development of symptoms of postural hypotension (e.g., dizzy or light-headed). - Penile prosthesis. - Artificial urinary sphincter or any implant, metallic or nonmetallic, within 1.5 inches of the prostatic urethra. - History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, or urethral stricture that requires dilation to pass a flexible cystoscope. - Non-symmetric median prostatic lobe enlargement or a prominent obstructing “ball valve” prostatic lobe as determined by cystoscopy. - Known primary neurologic conditions such as multiple sclerosis or Parkinson’s disease, any component of an implantable neurostimulation system, or other neurological diseases known to affect bladder function. - Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years). - Defibrillator or pacemaker that cannot be deactivated during MIST. - Neurogenic decompensated or atonic bladder in the opinion of the investigator. - Patient has an interest in future fertility. - Previous rectal surgery other than hemorrhoidectomy. - Any serious medical condition likely to impede successful completion of the study.
Total Enrollment: 714
Location and Contact Information:
Overall Study Official:
ReginaldBruskewitz, Study Chair, University of Wisconsin, Madison, WI
Mayo Clinic *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Jane Smith 507-284-3369
Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Linda Hardy 212-305-0146
University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Kevin Homan 303-724-1160
University of Texas Southwestern Medical Center *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Allison Ahrens 214-648-6781
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Sharon Harrison 713-798-8517
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Sherryl Wolfe 312-908-7026
Milwaukee College of Medicine *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Maria Pigsley 414-456-6978
Additional Information:
Study ID Numbers: MIST;
Study Start Date: April 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064649
Other Benign Prostatic Hyperplasia Studies:
1. Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
2. Dose Escalation Study with QLT0074 for Benign Prostatic Hyperplasia
3. Safety/tolerability study of Alcohol Injection for Treatment of BPH (enlarged prostate)
4. Saw Palmetto Extract in Benign Prostatic Hyperplasia
5. MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia
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MIST: A Comparison of Transuretheral Needle Ablation (TUNA), Transuretheral Microwave Therapy (TUMT), and Medical Therapy for Benign Prostatic Hyperplasia
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