Clinical results have shown in-office BPH therapy to be a safe, effective, and durable solution for patients. We have provided a summary of key clinical studies for your review. To scroll to a specific clinical study, please select the link below. Both Cooled ThermoTherapy and Prostiva have built substantial clinical evidence over the years, unlike most of the competitive in-office BPH therapies. There are over 100 published peer reviewed clinical articles that are supportive of these technologies. Numerous multi-center, prospective, clinical trials of Cooled ThermoTherapy and Prostiva RF Therapy have been conducted both in the United States and internationally.
Patients participated in the FDA study of the Urologix CTC Microwave Catheter have been followed for 5 years. The results showed significant improvement in symptoms, peak flow rate and quality of life, out to that five year time point. The data was presented at the 2009 American Urological Association Annual Meeting and a copy of this presentation is below. Clinical sites for this study included leading academic centers such as The Mayo Clinic, University of Texas Southwestern, Johns Hopkins and Duke University. Based on Dr. Mynderse study in 2011, we see of those followed for 5 years, only 9% required an additional procedure for their BPH with 67% free of any need for medication after receiving Cooled ThermoTherapy.
1Mynderse LA, Roehrborn CG, et al. Results of a 5-Year Multicenter Trial of a New Generation Cooled High Energy Transurethral Microwave Thermal Therapy Catheter for Benign Prostatic Hyperplasia. Journal of Urology. Vol. 185, 1804-1811, May 2011
For further information and detail regarding our 5 Year Results, view our AUA 2009 presented poster.
¹ 5 Year Results of a Multi-Center Trial of a New Generation Cooled TUMT for BPH, Roehrborn, C. et. al., Moderated Poster, AUA 2009.
The following clinical results have been adapted from (Djavan, 2001).
In a randomized, controlled clinical trial, 103 patients were randomized to either Terazosin or Cooled ThermoTherapy with the Targis System. 78% of men given a CTT treatment had at least 50% improvement on their IPSS after 6 months, compared to only 33% of men given Terazosin. This study also showed that while some men stated their symptoms were better, the results of a Qmax test proved that Cooled ThermoTherapy helped me void significantly better then men given Terazosin.
After 18 months only 5.9% of patients given CTT had treatment failure compared to 41% of patients given Terazosin.
Through many studies, Urologix has been able to show that Cooled ThermoTherapy is a durable and effective treatment for men with BPH.
Djavan, B. et al (2001). Targeted Transurethral Microwave Thermotherapy Versus Alpha-Blockade in Benign Prostatic Hyperplasia: Outcomes at 18 Months. Urology , 66-70.
Prostiva is the newest generation of transurethral RF needle ablation of the prostate. This technology was first used in the early 1990s, with the first preliminary clinical trials published in 1993. The first human clinical studies in the United States began in 1994, and subsequent U.S. Food and Drug Administration (FDA) approval of the procedure was granted in 1996.
Since FDA approval of Prostiva RF Therapy, 4 randomized, prospective trials comparing it to transurethral resection of the prostate (TURP) have been published. The below is a summary of a 5 year durability comparison between men given a TURP and a Prostiva RF treatment.
When comparing Prostiva RF Therapy to TURP, the RF Therapy showed significant improvement of men’s IPSS, Qmax, and QOL. While TURP is and has been considered the gold standard of treatment for BPH. Prostiva RF, offers a much less invasive treatment option that provides quality and lasting results.
Hill B, Belville W, Bruskewitx R, Issa M, Perez-Marrero R, Roehrborn C, Terris M, Maslund M, J Urol (2004): Transuretheral Needle ablation versus transurethral resection of the prostate for the treatment of symptomatic benign prostatic hyperplasia: Five -Year results of a prospective randomized, multicenter clinical trial. 174:2336-2340