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.
Study objectives have included: collection of safety and efficacy data, support of new indications and marketing claims, generation of long-term durability data, and data collection for Medicare and other reimbursement approvals in various markets. The results of these trials showed a majority of patients received significant long-term relief from the symptoms and obstruction caused by their BPH. BPH symptoms were measured using validated symptoms score instruments, such as the American Urological Association Symptom Score (AUASS). Quality of life (QoL) was also measured using a validated scoring instrument where higher scores indicated a lower quality of life. Peak flow rates (Qmax) were measured in numerous studies where values were expressed in milliliters (mL) per second.
Patients participating 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.
The five year data presentation is only the most recent long term data. It supports multiple other peer reviewed Cooled ThermoTherapy™ Publications and Prostiva® RF Therapy Publications showing the effectiveness of this procedure in properly selected patients 4 and 5 years after treatment.
The effectiveness of the Cooled ThermoTherapy BPH treatment is demonstrated by the fact that 90% of the patients treated with the Urologix Cooled ThermCath® (CTC) Microwave Catheter had no need for any further minimally invasive or surgical procedure. In addition, 67% of the patients treated never had to take chronic medication for their BPH during the study period. The study had exhaustive follow up of the patients treated with only 4% of all treated patients lost to follow up.
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.
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:
- In 1999 Roehrborn et al summarized outcomes of symptom improvement, QoL, bladder wall pressure and Qmax at 6 months;
- In 2001 Hindley et al compared Prostiva RF to TURP in 50 patients over 2 years, reporting on symptom improvement, QoL, and urodynamics;
- In 2003 Cimentepe et al also provided symptom improvement, QoL and urodynamics results after 18 months of follow-up on 59 patients; and
- In 2004 Hill and colleagues provided 5-year follow-up on same patient cohort as Roehrborn et al, 1999. Results included symptom improvement, QoL, and urodynamics in the same group of 121 patients.
Roehrborn et al (1999) found that symptom scores of Prostiva RF subjects were decreased by nearly 50% at six months. At 60 months Hill et al (2004) reported symptom improvement for the same cohort of subjects was maintained. Hindley et al (2001) reported symptoms were decreased by nearly 65% for Prostiva. QoL results followed a similar trend for Roehrborn and Hindley, and results were maintained at 5 years as reported by Hill et al. Cimentepe et al (2003) found similar trends in symptom scores, QoL measures and urodynamics as reported by the other studies identified above. From these 4 studies, no significant short-term complications from Prostiva, including need for transfusion, were reported. In a confirmation of the results of the 4 randomized, prospective trials comparing Prostiva RF Therapy to TURP, the 2010 AUA BPH Practice Guidelines Committee concluded that: “… based on these reports, the symptom improvement is significant and sustained for both treatments, with somewhat greater improvement in the symptom score for TURP.”
In addition to the 4 randomized prospective trials detailed above, numerous single-group cohort studies of Prostiva RF Therapy have been published as well. Symptom improvement, QoL, and urinary flow rate improved in a fashion very similar to that reported in the randomized trials. Short-term complications, including the need for transfusion, were uncommon or nonexistent. Erectile dysfunction and retrograde ejaculation were more common with TURP than Prostiva RF Therapy, and generally Prostiva patients reported very few sexual side effects. In fact, in 2010 the AUA BPH Practice Guideline Committee concluded that Prostiva RF Therapy is an attractive BPH therapy due to its safety; low perioperative complications, and low to nonexistent rate of sexual dysfunction. The Committee also noted that improvements in symptoms, QoL and urinary flow rates were significant for Prostiva RF.
In summary, since being introduced to the U.S. market, multiple prospective trials have established Prostiva RF Therapy’s significant clinical benefit as well as the attractive safety profile when compared to surgical therapy.
The Urologix® Cooled ThermoTherapy™ System employs High Energy TUMT with an advanced cooling system.
Urologix presented a second poster at the 2009 AUA. Effects of Urethral Temperature on Patient Outcomes for Benign Prostatic Hyperplasia with Cooled High Energy TUMT, presented by William Utz, MD., showed that physicians modifyed the urethral temperature set point to positively impact patient comfort during treatment.
The study concluded:
- With High Energy TUMT from Urologix, clinically significant improvement is seen at one year with MDS temperature settings from 32°C to 41°C.
- The intra-prostatic temperatures remain above 50°C needed for tissue necrosis¹ in 28.5 minutes.
- High Energy TUMT provides significant patient outcomes with customizable settings, at one year.
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 the CTT procedure.
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
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.
*Differences between groups were statistically significant (p<0.0005).
Adverse Event Comparison
*Number of adverse events occurring between baseline and 6 months, and between 6 and 18 months.
Enlarged Prostate Treatment Failures
*The approximately sevenfold higher treatment failure rate for Terazosin was significantly greater than that for CTT (p< 0.0005).
Relative Effectiveness and Durability
After 18 months, Cooled ThermoTherapyTM showed significantly (p< 0.0005) greater improvements than terazosin in International Prostate Symptom Score (35%), Peak Flow Rate (22%), and QOL score (43%).
Djavan, B. et al (2001). Targeted Transurethral Microwave Thermotherapy Versus Alpha-Blockade in Benign Prostatic Hyperplasia: Outcomes at 18 Months. Urology , 66-70.