MTS Medical – First comparative report for MTS/TRT UroGold, (broad-focused shockwaves “SoftWaves” ) and Radial/Ballistic waves, (broad-focused Storz D-Actor, aka “acoustic pressure pulse” (APP) for the treatment of Erectile Health. Introduction: In the USA, since 2007, approximately 400 shockwave therapy (SWT) or acoustic pressure pulse (APP) devices have been sold for the treatment of erectile dysfunction (ED) with over 250,000 patient treatments performed. The average fee for these treatments is $4000 (6 – 12 treatments per patient) and is most often performed by a non-urologist. Non-medical entrepreneurs are the typical purchaser/provider for this therapy in the USA. At least 90% of the devices sold in the USA are low cost radial shockwave devices (APP). As reported by physicians from the Mayo clinic at the 2018 ISSM conference in Lisbon, the average success rate is about 50% worldwide (Gainswave, the largest marketer of SWT for ED in the USA reports a much higher success rate).

December 2019

Comparative SWT Data to Evaluate Competing Technologies in the Treatment of Penile Connective Tissue for Improved Erectile Function.  First comparative report for MTS/TRT UroGold, (broad-focused shockwaves “SoftWaves” ) and Radial/Ballistic waves, (broad-focused Storz D-Actor, aka “acoustic pressure pulse” (APP)) for the treatment of Erectile Health. Introduction: In the USA, since 2007, approximately 400 shockwave therapy (SWT) or acoustic pressure pulse (APP) devices have been sold for the treatment of erectile dysfunction (ED) with over 250,000 patient treatments performed. The average fee for these treatments is $4000 (6 – 12 treatments per patient) and is most often performed by a non-urologist. Non-medical entrepreneurs are the typical purchaser/provider for this therapy in the USA. At least 90% of the devices sold in the USA are low cost radial shockwave devices (APP). As reported by physicians from the Mayo clinic at the 2018 ISSM conference in Lisbon, the average success rate is about 50% worldwide (Gainswave, the largest marketer of SWT for ED in the USA reports a much higher success rate).

This study was initiated to show a clear distinction in outcomes between radial/APP devices and
broad-focused electro-hydraulic SoftWaves.  The clinic where this study was performed originally acquired a Storz device early in 2018 and performed over 1000 treatments. The same clinic acquired the TRT UroGold in September of 2018 and operates both at this time. The study was designed to evaluate if SoftWave technology can improve the outcomes for patients who had completed their radial SWT protocols and to compare the treatment parameters and outcomes. Methods: Thirty three (33) patients were enrolled in the study after having previously completed an average of 12 treatments with the Storz device. The Storz protocol averaged 6000 pulses per treatment at energy level 2.6-3.6 Bar and treatment times exceeded 25 minutes. Outcomes ranged from minor to moderate improvement after 12 sessions of 6000 shocks each. The average length of treatments was 10 -12 weeks with patients interviewed after the treatment regimen.

These same patients were later treated with the UroGold SoftWave device. The study was designed to provide 6 additional treatments and measure the improvements after these 6 treatments. The additional treatment protocol
included 2000 pulses per treatment at an average energy level of .1mj/mm sq. A similar treatment protocol was utilized with both devices where the shaft, crura, and perineum were targeted equally. Average treatment time for the UroGold averaged 15 minutes (compared to 25 minutes). The frequency averaged 4 pulses per second.

Results: The improvement of the Patients treated with the UroGold after the completion of treatments with the Storz D-Actor was statistically significant. The 33 patients were evaluated after an average of only 4 additional UroGold treatments instead of the recommended 6 treatment protocol. Thirty six percent (36.4%) of all of the patients treated with the secondary protocol showed significant clinical improvement in their outcomes. More importantly, for those patients who completed all six treatments with the UroGold, 62.5% showed significant clinical improvement.
Important differences in treatment parameters were also observed. The Storz radial SWT required 12 treatments and 6000 pulses per treatment contrasted the SoftWave therapy which required an average of less than 5 treatments and 2000 pulses per session. The SoftWave protocol was also quicker and less painful and the testicles could be targeted for improved outcomes.
The therapy was performed with the FDA cleared UroGold SoftWave therapy device (FDA Registered or Cleared only for connective tissue activation, pain and improved blood supply). The device was manufactured by MTS, Konstanz, Germany, www.mts-medical.com; and distributed by TRT, Woodstock, GA, www.trtllc.com.

Discussion: There appears to be substantial, statistical advantages with the broad-focused SoftWave therapy when compared to radial SWT. This will be further studied as we compare the next several months of our patient’s SoftWave outcomes with our previous radial SWT data. Additionally, all of the patients (33) in this study will be evaluated after 6 treatments and we will report the final observations/comparisons.