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Minimally Invasive Surgical Therapy for BPH

NCT00064649 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2010-01-14

No results posted yet for this study

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

Interventions

DEVICE

Transurethral Microwave Thermotherapy (TUMT)

type of minimally invasive surgical therapy for BPH

DEVICE

Transurethral Needle Ablation (TUNA) Therapy

type of minimally invasive surgical therapy for BPH

DRUG

Finasteride and Alfuzosin

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

Sponsors & Collaborators

  • Diagnostic Ultrasound

    collaborator INDUSTRY

  • Urologix

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Sanofi-Synthelabo

    collaborator INDUSTRY

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Reginald Bruskewitz, M.D. · University of Wisconsin, Madison, WI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2006-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00064649 on ClinicalTrials.gov