Minimally Invasive Surgical Therapies (MIST) Treatment Consortium for Benign Prostatic
Hyperplasia (BPH)
Background
The Division of Kidney and Urologic and Hematologic Diseases of the National Institute
of Diabetes and Digestive and Kidney Diseases (NIDDK) has had a substantial and
longstanding interest in evaluating the effectiveness of treatment strategies for
the symptoms of benign prostatic hyperplasia (BPH). For many years, transurethral
resection of the prostate (TURP) has been the standard surgical therapy for this
condition. However, during the past decade, a number of technical innovations have
allowed the development of new surgical treatments that aim to achieve the same
long-term outcomes of TURP but with less morbidity, lower costs, office-based treatment
or shorter length of hospital stay, and more rapid recovery. These new, "minimally-invasive"
surgical approaches include laser therapy, hyperthermia and thermotherapy, transurethral
electrovaporization, microwave therapy, and transurethral needle ablation. Newer
techniques are appearing regularly. Published reports on the outcomes of these minimally-invasive
therapies are highly variable in their quality, and rigorously conducted randomized
clinical trials have only rarely been conducted.
To assess the long-term safety and effectiveness of these new therapies, the NIDDK
has formed a consortium of seven Prostate Evaluation Treatment Centers and a Biostatistical
Coordinating Center to develop and conduct randomized, controlled, clinical trials
that will give a clearer picture of the benefits and risks of these methods. The
seven clinical centers are Baylor College of Medicine, Columbia University, Mayo
Clinic, Milwaukee College of Medicine, Northwestern University, University of Colorado
Health Science Center, and Texas Southwestern Medical Center. The Data Coordinating
Center is at George Washington University.
Clinical Trial
The first trial to be conducted by the MIST consortium will evaluate the safety
and effectiveness of transurethral needle ablation (TUNA), transurethral microwave
therapy (TUMT), and combined medical therapy with afuzosin, an alpha blocker, and
finasteride, an alpha-reductase inhibitor. The primary outcome is treatment failure,
determined by an objective set of criteria, within 36 months. The recruitment goal
is 714 patients (238 per treatment group), and recruitment is scheduled to begin
in spring 2004 (www.clinicaltrials.gov ). The trial will end in July 2008 with the
last yearly follow-up exam. The results of the first trial will provide both physicians
and patients with the knowledge needed to make the most appropriate choices for
long-term management of BPH.
Project Officers: Dr. Leroy Nyberg and Dr. John Kusek, 301-594-7717
Last Update: 3/15/2004
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