Saltzman RG et al., 2022: Rationale and Design for the COCKTAIL Trial: A Single-center, Randomized, Double-blind, Sham-controlled Study Combining Shockwave Therapy and Platelet-rich Plasma for Erectile Dysfunction

Thursday, 23 February 2023

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Saltzman RG, Molina ML, Ledesma BR, Ibrahim E, Masterson TA, Ramasamy R.
Desai Sethi Urology Institute, Miller School of Medicine, University of Miami, Miami, FL, USA.
Desai Sethi Urology Institute, Miller School of Medicine, University of Miami, Miami, FL, USA.

Abstract

Restorative therapies are a promising option for the treatment of erectile dysfunction. Several studies have assessed platelet-rich plasma and shockwave therapy alone. However, COCKTAIL is the first study to evaluate the synergistic effects of these two therapies in combination.
Eur Urol Focus. 2022 Oct 21;S2405-4569(22)00224-3. doi: 10.1016/j.euf.2022.09.015. Online ahead of print. PMID: 36280578

Comments 1

Jens Rassweiler on Thursday, 23 February 2023 09:30

This is an article describing the design of an upcoming study combining Li-ESWT and platelet-rich plasma for erectile dysfunction. The schedule is as follows:

The device used will be the MoreNova (Direx Group, Canton, MA, USA) designed to deliver linear shockwaves to the left and right corpora cavernosa in the stretched flaccid state. The energy intensity is 0.09 mJ/ mm2 and the pulse frequency is 1 Hz. Per session 720 impluses are applied.
Autologous PRP is prepared from 120 ml of peripheral blood collected from each subject. Blood samples are pro- cessed using an autologous platelet separator with an optical sensor (Arthrex Angel; Arthrex, Naples, FL, USA). Approximately 2.5 ml of PRP is injected into the right and left corpora cavernosa.

The sham-control group receives saline intracorporeal injection and ESWT with a shielded probe.

The primary outcome is the incidence of serious adverse events within 30 d of therapy (safety). All adverse events are recorded and classified according to the Common Ter- minology Criteria for Adverse Events.
Secondary outcomes include: (1) the change in IIEF-EF score from baseline to 3 and 6 mo after therapy; (2) the per- centage of participants experiencing a minimum clinically important difference (MCID) in IIEF-EF from baseline to 3 and 6 months after therapy (defined as an increase of 2 points for mild and 5 points for moderate ED on IIEF-EF); and (3) the percentage of participants who decrease or discontinue their PDE5i use at 3 months after therapy.
The authors can be congratulated to their effort for this trial. Unfortunately, the authors did not choose a well-established protocol like for focused Li-ESWT devices (i.e. 0.2 mJ/mm2 at 3-4 Hz; 3000 impulses – 500 at the base, 500 distal penis and 500 at the cura on both sides). Moreover, they will not be able to distinguish between the success of ESWT and the platelet-rich plasma. This would have required a four-arm study.

Jens Rassweiler

This is an article describing the design of an upcoming study combining Li-ESWT and platelet-rich plasma for erectile dysfunction. The schedule is as follows:

[img]https://www.storzmedical.com/images/blog/Saltzman.png[/img]

The device used will be the MoreNova (Direx Group, Canton, MA, USA) designed to deliver linear shockwaves to the left and right corpora cavernosa in the stretched flaccid state. The energy intensity is 0.09 mJ/ mm2 and the pulse frequency is 1 Hz.  Per session 720 impluses are applied. 
Autologous PRP is prepared from 120 ml of peripheral blood collected from each subject. Blood samples are pro- cessed using an autologous platelet separator with an optical sensor (Arthrex Angel; Arthrex, Naples, FL, USA). Approximately 2.5 ml of PRP is injected into the right and left corpora cavernosa.

The sham-control group receives saline intracorporeal injection and ESWT with a shielded probe.

The primary outcome is the incidence of serious adverse events within 30 d of therapy (safety). All adverse events are recorded and classified according to the Common Ter- minology Criteria for Adverse Events. 
Secondary outcomes include: (1) the change in IIEF-EF score from baseline to 3 and 6 mo after therapy; (2) the per- centage of participants experiencing a minimum clinically important difference (MCID) in IIEF-EF from baseline to 3 and 6 months after therapy (defined as an increase of 2 points for mild and 5 points for moderate ED on IIEF-EF); and (3) the percentage of participants who decrease or discontinue their PDE5i use at 3 months after therapy. 
The authors can be congratulated to their effort for this trial. Unfortunately, the authors did not choose a well-established protocol like for focused Li-ESWT devices (i.e. 0.2 mJ/mm2 at 3-4 Hz; 3000 impulses – 500 at the base, 500 distal penis and 500 at the cura on both sides). Moreover, they will not be able to distinguish between the success of ESWT and the platelet-rich plasma. This would have required a four-arm study.

Jens Rassweiler

This is an article describing the design of an upcoming study combining Li-ESWT and platelet-rich plasma for erectile dysfunction. The schedule is as follows: [img]https://www.storzmedical.com/images/blog/Saltzman.png[/img] The device used will be the MoreNova (Direx Group, Canton, MA, USA) designed to deliver linear shockwaves to the left and right corpora cavernosa in the stretched flaccid state. The energy intensity is 0.09 mJ/ mm2 and the pulse frequency is 1 Hz. Per session 720 impluses are applied. Autologous PRP is prepared from 120 ml of peripheral blood collected from each subject. Blood samples are pro- cessed using an autologous platelet separator with an optical sensor (Arthrex Angel; Arthrex, Naples, FL, USA). Approximately 2.5 ml of PRP is injected into the right and left corpora cavernosa. The sham-control group receives saline intracorporeal injection and ESWT with a shielded probe. The primary outcome is the incidence of serious adverse events within 30 d of therapy (safety). All adverse events are recorded and classified according to the Common Ter- minology Criteria for Adverse Events. Secondary outcomes include: (1) the change in IIEF-EF score from baseline to 3 and 6 mo after therapy; (2) the per- centage of participants experiencing a minimum clinically important difference (MCID) in IIEF-EF from baseline to 3 and 6 months after therapy (defined as an increase of 2 points for mild and 5 points for moderate ED on IIEF-EF); and (3) the percentage of participants who decrease or discontinue their PDE5i use at 3 months after therapy. The authors can be congratulated to their effort for this trial. Unfortunately, the authors did not choose a well-established protocol like for focused Li-ESWT devices (i.e. 0.2 mJ/mm2 at 3-4 Hz; 3000 impulses – 500 at the base, 500 distal penis and 500 at the cura on both sides). Moreover, they will not be able to distinguish between the success of ESWT and the platelet-rich plasma. This would have required a four-arm study. Jens Rassweiler

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