Minimally Invasive Surgical Therapy for BPH

NCT00064649 | Terminated Phase 3 DMC

• 2 other identifiers: MIST (terminated)5U01DK060817
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

prostate; benign disease; TUNA; TUMT; medical therapy

Study Arms (3)

2

ACTIVE COMPARATOR

Transurethral Needle Ablation (TUNA)

Device: Transurethral Needle Ablation (TUNA) Therapy

3

ACTIVE COMPARATOR

finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg

Drug: Finasteride and Alfuzosin

1

ACTIVE COMPARATOR

Transurethral Microwave Thermotherapy (TUMT)

Device: Transurethral Microwave Thermotherapy (TUMT)

Interventions

Transurethral Microwave Thermotherapy (TUMT) DEVICE

type of minimally invasive surgical therapy for BPH

1

Transurethral Needle Ablation (TUNA) Therapy DEVICE

type of minimally invasive surgical therapy for BPH

2

Finasteride and Alfuzosin DRUG

finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg

3

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Diagnostic Ultrasound: collaborator
• Urologix: collaborator
• Medtronic: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Sanofi-Synthelabo: collaborator

Study Sites (7)

University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate; Therapeutics; Finasteride; alfuzosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Reginald Bruskewitz, M.D.

  University of Wisconsin, Madison, WI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 10, 2003
• First Posted: July 11, 2003
• Study Start: April 1, 2004
• Study Completion: June 1, 2006
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

US (7)