BPH Treatment - In Office or Outpatient Enlarged Prostate Treatment
Cooled ThermoTherapy™ an In-Office BPH Treatment
Microwave Therapy For BPH That Allows You To Customize Treatment And Provide:
- Long-term durability1
- Customizable energy settings for Patient comfort2
- Treatment of the broadest patient population, including retention patients3
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.
² Effects of Temperature on Patient Outcomes for Benign Prostatic Hyperplasia with Cooled High Energy TUMT. Utz, W., Moderated Poster, AUA 2009.
³ Data on file at Urologix. CTC Advance IFU 250348 Rev B 12/08. www.urologix.com.
Clinical Results
Durability | Patient Comfort | Compared Against Pharmaceutical Therapy
Prospective Multi-Center 5 year trial data on Cooled ThermoTherapy™ Presented at 2009 American Urological Association Annual Meeting
Proven 5 Year Durability
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 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. The chart below displays the patient status at the conclusion of the study.
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.
For further information and detail regarding our 5 Year Results, view our AUA 2009 presented poster.
Customizable Treatment for Individualized Patient Comfort.
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.
¹Bishof, et. al., Heat Sensitivity of Human Prostate Tissue: Implications for Thermal Therapy. Poster AUA 2003.
How does Cooled ThermoTherapy™ stack up against pharmaceutical therapy?
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.
Threshold Improvement
*Differences between groups were statistically significant (p<0.0005).
Adverse Event Comparison
|
|
Terazosin |
CTT |
||
|
Adverse Event |
6 Months* |
18 Months* |
6 Months* |
18 Months* |
|
Dizziness |
7 |
2 |
0 |
0 |
|
Asthenia |
4 |
1 |
0 |
0 |
|
Headache |
3 |
1 |
0 |
0 |
|
Hypotension |
1 |
1 |
0 |
0 |
|
Nausea |
1 |
1 |
0 |
0 |
|
Postural dizziness |
1 |
0 |
0 |
0 |
|
UTI |
0 |
0 |
3 |
1 |
|
Epididymitis |
0 |
0 |
1 |
1 |
|
Hemospermia |
0 |
0 |
1 |
1 |
|
Loss of ejaculate |
0 |
0 |
1 |
2 |
|
Urinary retention >1 week in duration |
0 |
0 |
1 |
0 |
*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%).
Works Cited
Djavan, B. et al (2001). Targeted Transurethral Microwave Thermotherapy Versus Alpha-Blockade in Benign Prostatic Hyperplasia: Outcomes at 18 Months. Urology , 66-70.
For complete indications, contraindications, warnings, precautions and instructions for use, please visit our Products page on this web site.
Prescriptive Information
Indications:
The Targis® System is a non-surgical device intended to be used as an in-office BPH treatment to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH).
Targis System Description:
The Targis System is comprised of a Control Unit which produces the microwave energy and monitors all aspects of the Cooled ThermoTherapy™ procedure, a Microwave Catheter which delivers the microwave energy to the targeted prostatic tissue, an RTU which measures rectal temperatures during the Cooled ThermoTherapy procedure and a Coolant Bag which provides a reservoir of sterile coolant water to the Microwave Catheter. The Targis System treats BPH by applying microwave power to the prostate, and continuously heating the diseased tissue via transurethral catheter. It also minimizes patient discomfort and risk to the urethra by circulating cooling fluid through the Microwave Catheter.
Contraindications:
Patients with a prostatic urethra<2.5 cm in length, measured from the bladder neck to the verumontanum. Patients with urinary sphincter or any implant (metallic or non-metallic) which is within 1.5 inches (38 mm) of the prostatic urethra. Patients with urethral stricture (unable to pass 22 F urethroscope). Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e. claudication of the buttocks or perineum). Patients who have undergone pelvic radiation therapy. Patients with implanted active devices, including pacemakers or defibrillators, within 2.6 inches (6.5 cm) of the prostatic urethra. For patients with active implanted devices located greater than 2.6 inches (6.5 cm) from the prostatic urethra, it is recommended that non-cardiac devices be turned OFF during treatment with the Targis System, if possible(e.g. active implanted devices used in the treatment of pain or incontinence), to lessen the likelihood of adverse interaction caused by electromagnetic interference.
Warnings & Precautions
Only those physicians who have been thoroughly trained on the operation of the Targis System and the Cooled ThermoTherapy procedure should deliver the Cooled ThermoTherapy procedure. The Targis System and components should not be used in any way other than the intended and indicated use and according to the Instructions for Use. This outpatient enlarged prostate treatment procedure must not be initiated without assurance that the Microwave Catheter is properly positioned in the patient. The Cooled ThermoTherapy procedure must not be initiated until an enema has been given and the RTU is properly placed into the patient’s rectum and inflated. It is important that the patient not be over sedated. This may compromise his ability to communicate pain. All components of the Targis System must be used in a manner consistent with the instructions set forth in their respective Instructions for Use insert and the Targis System User Manual. Failure to do so may result in insufficient treatment or increased risk of injury or infection to the patient.
Potential Adverse Effects
The following complications have been observed: post-treatment catheterization, mild hematuria, dysuria, clots in urine, temporary or partial ejaculate loss, pain or irritation in the groin or pelvis, bladder spasms, hemospermia, prostatic urethra damage, rectal irritation, temporary acute incontinence, interrupted flow, sensation of not emptying bladder, bladder trabeculation, severe pain during treatment, pain or discomfort during sexual activity, frequency, hesitancy, urgency, post-void dribbling, blood pressure changes during treatment, hospitalization in general related to treatment, transient erectile dysfunction, urinary tract infection, complete loss of ejaculate, bladder diverticali, weak stream, erectile dysfunction, epididymitis, prostatitis, nocturia, urethral stricture, and rectal fistula.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
View the complete Instructions for Use.
Publications
Web site Clinical References
Since 1991, Urologix’ strong reputation for scientific integrity has been supported by extensive basic science. Nearly 200 peer-reviewed clinical articles and presentations support the efficacy and safety of our products and our consistent clinical results.
Our clinical outcomes represent more than 2,200 patients treated with Cooled ThermoTherapy™ at many of the world’s leading medical institutions.
The following is a sampling of articles:
Peer Reviewed Journal Articles
Durability and General Efficacy
Long-Term Pooled Analysis of Multicenter Studies of Cooled Thermotherapy for Benign Prostatic Hyperplasia: Results at Three Months Through Four Years. Trock, M., et al., Urology, 63 (4) pp 716-721 April 2004 B.
Cooled Thermotherapy for The Treatment of Benign Prostatic Hyperplasia: Durability of Results Obtained with the Targis System. P. Miller, et al., Urology, 61 (5) pp. 1160-1165 June 2003.
Transurethral Microwave Therapy in 200 Patients with a Minimum Follow-Up of 2 Years: Urodynamic and Clinical Results. G. Thalmann, et al., Journal of Urology, Vol. 167, 2496-1502, June 2002.
A High Efficiency Microwave Thermoablation System in the Treatment of Benign Prostatic Hyperplasia: Results of a Randomized, Sham-Controlled, Prospective, Double-Blind, Multicenter Clinical Trial. T. Larson, et al., Urology, 51 (5), 731-742, June 1998.
A Novel Transurethral Microwave Thermoablation System to Treat Benign Prostatic Hyperplasia? Results of a Prospective Multicenter Clinical Trial. E. Ramsey, et al., The Journal of Urology, vol. 158, 112-119, July 1997.
Cooled ThermoTherapy vs. Medical Management
Targeted Transurethral Microwave Thermotherapy versus Alpha-Blockade in Benign Prostatic Hyperplasia: Outcomes at 18 Months. B. Djavan, et al, Urology, Vol. 57(1) pp. 66-70, January 2001.
Cost Consequences of Surveillance, Medical Management or Surgery for Benign Prostatic Hyperplasia. T. Chirikos, E. Sanford, Journal of Urology Vol. 155 (4) April 1996
Interstitial Temperature Mapping
Detailed Interstitial Temperature Mapping During Treatment with a New Transurethral Microwave Thermoblation System in Patients with Benign Prostatic Hyperplasia. T. Larson, J. Collins, A. C—rica, Journal of Urology, vol. 159, 258-264, January, 1998.
Urinary Retention
Efficacy of High-Energy Transurethral Microwave Thermotherapy in Alleviating Medically Refractory Urinary Retention Due to Benign Prostatic Hyperplasia. D. Kellner, et. al. Urology 64 (4) pp. 703-706, October 2004.
Transurethral Microwave Thermotherapy (TUMT) with the Targis System: A Single-Centre Study on 78 Patients with Acute Urinary Retention and Poor General Health. A. Berger, et al., European Urology 43 (2003) pp. 176-180
Microwave Thermotherapy in Patients with Chronic Urinary Retention. B. Djavan et. al., Techniques in Urology, 6(4), 278-281, December 2000.
High-Energy Transurethral Microwave Thermotherapy in Patients With Acute Urinary Retention Due to Benign Prostatic Hyperplasia. B. Djavan, C. Seitz, K. Ghawidel, A. Basharkhah, B. Bursa, S. Hruby, and M. Marberger, Urology, vol. 54 (1), 18-22, July 1999.
Abstracts
Results of a Multi-Center Trial of a New Generation Cooled TUMT for Benign Prostatic Hyperplasia, C. Roehrborn, L. Mynderse, et al. Presented at the 2009 AUA Annual Meeting.
Continuing Results of a Multi-Center Trial of a New Generation Cooled TUMT for Benign Prostatic Hyperplasia, L. Mynderse, C. Roehrborn, et al. Presented at the 2008 AUA Annual Meeting.
Continuing Results of a Multi-Center Trial of a New Generation Cooled TUMT for Benign Prostatic Hyperplasia, L. Mynderse, C. Roehrborn, et al. Presented at the 2007 AUA Annual Meeting.
