Minimally Invasive Surgical Therapy for BPH (MIST)

This study has been terminated.
(Inability to recruit required sample size.)
Sponsor:
Collaborators:
Diagnostic Ultrasound
Urologix
Medtronic
Merck Sharp & Dohme Corp.
Sanofi-Synthelabo
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00064649
First received: July 10, 2003
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Device: Transurethral Microwave Thermotherapy (TUMT)
Device: Transurethral Needle Ablation (TUNA) Therapy
Drug: Finasteride and Alfuzosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimally Invasive Surgical Therapy Consortium for Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Enrollment: 49
Study Start Date: April 2004
Study Completion Date: June 2006
Arms Assigned Interventions
Active Comparator: 2
Transurethral Needle Ablation (TUNA)
Device: Transurethral Needle Ablation (TUNA) Therapy
type of minimally invasive surgical therapy for BPH
Active Comparator: 3
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
Drug: Finasteride and Alfuzosin
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
Active Comparator: 1
Transurethral Microwave Thermotherapy (TUMT)
Device: Transurethral Microwave Thermotherapy (TUMT)
type of minimally invasive surgical therapy for BPH

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064649

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Diagnostic Ultrasound
Urologix
Medtronic
Merck Sharp & Dohme Corp.
Sanofi-Synthelabo
Investigators
Study Chair: Reginald Bruskewitz, M.D. University of Wisconsin, Madison, WI
  More Information

No publications provided

Responsible Party: Kathryn Hirst/Coordinating Center Principal Investigator, George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT00064649     History of Changes
Other Study ID Numbers: MIST (terminated), 5 U01 DK060817
Study First Received: July 10, 2003
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
prostate
benign disease
TUNA
TUMT
medical therapy

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Alfuzosin
Finasteride
5-alpha Reductase Inhibitors
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 22, 2014