Evidence for Restorative Therapies For ED: Shockwave, Stem Cells and PRP
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This document discusses emerging restorative therapies for erectile dysfunction including shockwave therapy, stem cells, and platelet-rich plasma injections. It provides an overview of the proposed mechanisms of action and current evidence from studies on each therapy. While initial studies show promise, the document concludes that more rigorous randomized controlled trials are still needed to establish efficacy and safety before these therapies can be considered non-experimental options for treating erectile dysfunction.
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Evidence for Restorative Therapies For ED: Shockwave, Stem Cells and PRP
- 1. Evidence for Restorative Therapies For ED: Shockwave, Stem Cells and PRP Ranjith Ramasamy, MD Director, Reproductive Urology University of Miami
- 2. ⢠Acerus Pharmaceuticals â Consultant, Investigator ⢠Aytu Biosciences â Ad Board, Investigator ⢠Boston Scientific â Ad Board, Investigator ⢠Coloplast â Consultant ⢠Direx â Investigator ⢠Endo Pharmaceuticals â Ad Board, Investigator ⢠Nestle Health â Consultant Disclosures
- 3. None of these therapies however reverse the pathophysiology of erections Treating ED Shah J. Erectile dysfunction through the ages. BJU Int. 2002;90(4):443-41.
- 4. ED treatment algorithm (prior to 2018) Lifestyle modification Penile prosthesis Vacuum devices InjectionsPDE-5 inhibitors
- 5. 2018 AUA Erectile Dysfunction Guideline Lifestyle modification Penile prosthesis Vacuum devices Injections PDE-5 inhibitors Shared Decision Making
- 6. Shockwave Therapy To Treat ED
- 8. ESWL vs. LI-SWT ⢠Smaller focal volume ⢠Energy concentrated ⢠Larger focal volume ⢠Energy spread greater area
- 9. Shockwave Therapy to Treat Other Medical Conditions
- 10. Several LI-ESWT Devices Dornier (France)- Aries 2 Richard-Wolf GmbH (Germany) - PiezoWave2 Stortz (Switzerland) - DUOLITH SD1 - FDA approved Medispec (Israel) â ED1000 Direx (Israel) - MORENOVA
- 11. ⢠Shockwave: a disturbance that propagates through any medium (in this case liquid/tissue) at a speed faster than the speed of sound travels through that medium ⢠Characterized by rapid rise in pressure over a very short interval of time ⢠Energy density or energy flux density (EFD), is the amount of energy delivered to a specific area of tissue E = the energy of the shockwave p = pressure A = area of the wave surface is A Ď = the density of the medium is c = the propagation speed in the fluid t = time
- 12. Radial Shockwaves (Gainswave Technology) Focal vs Radial Shockwaves: ⢠maximum pressures are 100 times lower ⢠pulse durations are 1,000 times longer ⢠Corresponding lower EFD and depth of penetration McClure, S., & DorfmĂźller, C. (2003). Extracorporeal shock wave therapy: Theory and equipment. Clinical Techniques in Equine Practice, 2(4), 348â357. doi:10.1053/j.ctep.2004.04.008 ⢠Therefore, medical class 1 device (low-risk of harm to patient)
- 13. Radial Wave Devices â Class I FDA Shockwave -Class II FDA
- 14. Number of studies done using Gainswave to demonstrate improvement in ED 0
- 15. Cavernosal Tissue Response to Shockwaves Fode M, et al. Low-intensity shockwave therapy for erectile dysfunction: is the evidence strong enough? Nat Rev Urol. 2017;14(10):593-606.
- 16. LiSWT for ED - Meta â Analysis of RCTs ⢠Meta-analysis of 7 randomized controlled trials using LiSWT for ED reporting IIEF-EF scores o 602 subjects o Age â 60y o Follow-up â 5 months ⢠Improvement in IIEF-EF score was 6.4 (Treat) vs. 1.6 (Sham) Clavijo RI, Kohn TP, Ramasamy R J Sex Med. 2017 Studies in this meta-analysis: 1. Kitrey ND, Gruenwald I, Appel B, et al. J Urol 2016. 2. Feldman R, Denes B, Appel B, et al. J Urol 2015. 3. Fojecki GT, Osther P. Poster ESSM 2015; København. 4. Srini VS, Reddy RK, Shultz T, et al. Can J Urol 2015. 5. Hatzichristou DG, Kalyvianakis DE. EAU, 2015, abstract 124. 6. Yee CH, Chan ESY, Hou S-M, et al. Int J Urol 2014. 7. Vardi Y, Appel B, Kilchevsky A, et al J Urol 2012.
- 17. LiSWT for ED - Meta â Analysis Lu Z, Lue TF et al. Eur Urol 2017;71(2): 223-233. Studies in this meta-analysis: 1. Chitale S, Morsey M, Swift L, et al. BJU Int 2010. 2. Poulakis V, Skriapas K, de Vries R, et al. Asian J Androl 2006. 3. Zimmermann R, Cumpanas A, Miclea F, et al. Eur Urol 2009. 4. Srini VS, Reddy RK, Shultz T, et al. Can J Urol 2015. 5. Vardi Y, Appel B, Kilchevsky A, et al. J Urol 2012. 6. Yee CH,Chan ES,Hou SS, et al. Int J Urol 2014. 7. Olsen AB, Persiani M, Boie S, et al. Scand J Urol 2015. ⢠Meta-analysis of 7 randomized controlled trials using LiSWT for ED reporting IIEF-EF scores o 833 subjects o Follow-up â 3-6 months ⢠Improvement in IIEF (mean difference: 2.00; 95% confidence interval [CI], 0.99â 3.00; p < 0.0001) ⢠Therapeutic efficacy at least 3 months ⢠Patients with mild- moderate ED had better therapeutic efficacy
- 18. ⢠80 men with ED (30-80 y/o) ⢠Baseline IIEF-EF: 11-25 ⢠Randomized 1:1 ⢠Group A: 5 consecutive daily treatments of 720 shockwaves (N=45) ⢠Group B: 6 treatments of 600 shockwaves qOD over 2 weeks (N=43) ⢠IIEF and EHS baseline and 1, 3 and 6 months
- 21. Treatment Group MCID for IIEF at 6mo 1 week 66% 2 week 75%
- 22. ED treatment algorithm â SWT? ⢠Non-surgical ED treatment consists of PRN medications/ interventions. ⢠The goal of LI-ESWT is to restore spontaneous erection. Lifestyle modification Penile prosthesisVacuum devices InjectionsPDE-5 inhibitors LI-ESWT LI-ESWT
- 23. AUA ED Guidelines: Low Intensity Shock Wave Therapy ⢠For men with ED, low-intensity extracorporeal shock wave therapy (ESWT) should be considered investigational. (Conditional Recommendation; Evidence Level: Grade C) ⢠Given the availability of other treatments that are less burdensome and known to be effective and the fact that ESWT is not FDA-approved, the Panel concludes that ESWT should only be used in investigational settings in the context of an institutional review board (IRB)-approved clinical trial.
- 24. Emerging Tools for ED: A Role for Regenerative Medicine Hakim L, et al. Emerging tools for erectile dysfunction: a role for regenerative medicine. Nat Rev Urol. 2012;9(9):520-36.
- 25. What are stem cells and where can they be obtained from? Stem cells have 3 distinctive properties ⢠Self-renewal ⢠Potential to proliferate extensively ⢠Ability to develop into multiple lineages Sources of Adult Mesenchymal Stem cells ⢠Bone Marrow (most commonly used) ⢠Adipose tissue ⢠Umbilical Cord https://stemcells.nih.gov/
- 26. Stem cells: How might they be used in men with ED and PyD? ⢠Direct replacement of corpus cavernosum (building block theory) ⢠Mesenchymal cells provide support by releasing cytokines (paracrine theory) Spees JL et al. Stem Cell Res Ther. 2016
- 27. 6 clinics - Cost? $8 â 10k - Success? >80% - Tissue? adipose, umbilical cord, bone marrow 5 clinics - Cost? ~4kâ 16k - Success? âHighly successfulâ - Tissue? adipose, umbilical cord, bone marrow 4 clinics - Cost? 5k â 10k - Success? âhighly successfulâ - Tissue? Adipose, bone marrow 3 clinics - Cost? 8k â 10k - Success? âVery successfulâ - Tissue? Adipose 3 clinics - Cost? 8k â 10k - Success? âVery successfulâ - Tissue? Adipose Stem cell clinics reported outcomes for treatment of ED and PyD Jordan Best, Premal Patel, Ramasamy R et al. SMSNA 2019
- 28. Current Status of Human Trials in ED/PD Peyronieâs Disease ED after Radical Prostatectomy Haahr MK et al. EBioMedicine 2016 ⢠Stem cells harvested from adipose tissue under GA and injected 2 hours ⢠6-18 months are RP ⢠53% erections sufficient for intercourse. (not in incontinent or pre- op ED men). Levy et al. J Am Osteopath Assoc. 2015 ⢠Placental derived stem cells injected into plaque X 1 injection ⢠7 of 10 plaques disappeared completely. ⢠Curvature improved by 14-100% ED (Phase IIa trial) Goldstein I (San Diego) and Khera M (Baylor) NCT01601353 ⢠Prospective two-arm open label phase IIa randomized trial, 30 men ⢠12 month follow-up ⢠Study completed; Results pending ED (Phase IIb trial) Mohit Khera, Irwin Goldstein, Joseph Alukal, Trinity Bivalacqua NCT01601353 ⢠Evaluate the Use of Liposuction and Cell Separation Devices for Autologous Fat (Adipose) Derived Cells to Treat the Symptoms of ED; 60 men; Not Yet Recruiting
- 29. Erectile Function Does Not Appear to Improve with Stem cells given systemically
- 30. ⢠How many cells to administer? ⢠How often to administer cells? ⢠Source of cells? ⢠Whether cells can be frozen / thawed or fresh? Safety Considerations ⢠Embolic phenomena (clogged stem cells) ⢠Allergic / infectious reactions ⢠Formation of abnormal tissue or cancer
- 31. Effects of Mesenchymal Stem Cell on Cavernous Smooth Muscle Salgado AJ, et al. Adipose tissue derived stem cells secretome: soluble factors and their roles in regenerative medicine. Curr Stem Cell Res Ther. 2010;5(2):103-10.
- 33. AUA ED Guidelines: Stem cells For men with ED, intracavernosal stem cell therapy should be considered investigational. (Conditional Recommendation; Evidence Level: Grade C) Findings from studies that have evaluated ICI stem cell therapy do not indicate that benefits reliably outweigh risks/burdens for men with ED. In particular, the treatmentâs ability to restore normal erectile function in various populations of men with ED has not been convincingly demonstrated. Further, neither the most effective source and dose of stem cells nor the duration of treatment effects has been established, and the burdens associated with obtaining the treatment (i.e., cost, need for tissue harvest) can be substantial. Given the paucity of data obtained in human participants, the risks of treatment also are not well- established.
- 34. Platelet Rich Plasma Injections ⢠Injection rich in autologous growth factors that help repair nerve damage contributing to ED and activate NO pathway ⢠Commonly used in orthopedics to promote healing of soft tissue damage ⢠Can be leukocyte poor and leukocyte rich. Recommendation depends on indication
- 35. Problems with PRP Injections ⢠Major problem: Lack of standardization in injection concentrations due to variation in patients has led study results to be highly variable. As a result insurance companies typically do not back PRP injections ⢠Solution: Arthrex Angel System â allows physician to modulate and monitor injection concentrations.
- 36. PRP Statistics ⢠One study in Phase 2 listed on www.clinicaltrials.gov for PRP and ED ⢠Google âPlatelet rich plasma, erectile dysfunctionâ: 147,000 results (10/2017) ⢠Website marketing (2015) âbigger erections, improved sex life, improvement in climax/orgasm, increased sensation, increased libidoâ and âimproved sensation even years after prostatectomyâ ⢠Cost: $1500 to $3000 cash per injection ⢠2018 first PRP/ED study published (case series)
- 37. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions Ethan L. Matz, Amy M Pearlman, Ryan P. Terlecki ⢠4 with ED only and 1 with ED and Peyronies disease ⢠Between 4 and 9 mL of PRP was injected in corpora cavernosa per treatment session ⢠A mean of 2.1 injection procedures per patient were performed ⢠IIEF-5 improvement of 4.14 ⢠AEs (in all patients): mild pain (23.5%) and bruising (5.9%) Matz EL, et al. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol. 2018;59(1):61-65.
- 39. PRP for ED â University of Miami Trial ⢠Randomized double blind study including 72 men with ED â 30-75 years old â IIEF-EF bw 11-25 â HbA1c <9% â May be on 1 PDE5 inhibitor ⢠Primary outcomes: â Changes in IIEF, SEP3 Thomas Masterson MD tmasterson@miami.edu Navin Balaji
- 40. AUA ED Guidelines: Platelet Rich Plasma ⢠For men with ED, platelet-rich plasma (PRP) therapy should be considered experimental. (Expert Opinion) ⢠PRP should not be offered to men with ED unless it is administered in the context of an IRB-approved experimental clinical research protocol. At this time, no full-text peer-reviewed publications are available to constitute an evidence base.
- 41. âThus, given the current lack of regulatory agency approval for any restorative (regenerative) therapies for the treatment of ED and until such time as approval is granted, SMSNA believes that the use of shock waves or stem cells or platelet rich plasma is experimental and should be conducted under research protocols in compliance with Institutional Review Board approval. Patients considering such therapies should be fully informed and consented regarding the potential benefits and risks. Finally, the SMSNA advocates that patients involved in these clinical trials should not incur more than basic research costs for their participation.â
- 43. Conclusions ⢠Current ED therapies do not provide a âcureâ for ED ⢠The mechanisms for how PRP, stem cells and LISW improve erectile dysfunction appear to be promising and some initial studies have demonstrated benefit ⢠At this time, the use of LISW, stem cells or PRP should be consider experimental until appropriate RCTs have demonstrated proven efficacy and safety
- 44. Thank You
Editor's Notes
- GM- Clinical and Pre-Clinical Evidence of Efficacy of Restorative Therapies: The US Perspective: How Common is their use, Clinical Evidence, FDA Standing, Economics  Speaker: Ranjith Ramasamy, MDÂ
- On this slide we look at what I would consider the modern era of ED therapy In 1973, we saw the precursor of the inflatable prostheses we utilize today [Shah/p438/c2/Âś4] In 1980, Ronald Virag, a French vascular surgeon, discovered intracavernosal therapy, specifically the effects of papaverine, almost by accident [Shah/p439/c1/Âś2] The first vacuum erection device to receive FDA approval was developed by Geddings Osbon, a pentacostal preacher who worked in the tire re-treading business [Shah/p438/c2/lastÂś-p439/c1/Âś1] The first anti-impotence drug, alprostadil, was first marketed in 1995 [Shah/p439/c1/Âś3] In 1998, sildenafil became the first oral drug to approved to treat ED [Shah/p439/c1/Âś4] Since then, several other oral agents, including STENDRA, which we will spend much of the day discussing, have been approved by the FDA for the treatment of ED Shah J. Erectile dysfunction through the ages. BJU Int. 2002;90(4):433-441.
- Gainswave is nothing but a brand. It is a marketing & price-fixing scheme for US doctors who offer shockwave therapy on the penis. You could do a provider search on the Gainswave website and find clinics who use different machines and different protocols. 6000 and 18 000 therapeutic shock- waves over a period of 6â10 wk. 10-14 HZ an energy intensity of 0.09 mJ/mm ------ 0.1mJ/mm ESWL- 50-100 MPa LIST 5-10 MPa  Supposedly there are 2 different machines popular amongst Gainswave affiliates: the EVIVE and the Storz machine.  1.     The EVIVE is distributed in the USA by Eclipse Aesthetics, but it's actually the German-produced Zimmer MedizynSysteme. A quick picture that I snapped is attached. The shocking bullet is driven electromagnetically. It's touted as less painful to the patient, and he does not numb the patient for it. Rorick is 65 and claims to have cured his own ED with the therapy he offers.  2.    The other machine used by Gainswave affiliates is made by Storz Medical. By contrast with the above machine, the Storz bullet is supposedly driven pneumatically (I have not confirmed that). Therapy is more painful and the patient's often numbed.  For frequency, Rorick quotes 10-14 HZ as his effective operating range using the EVIVE. There's no frequency quoted in the Greek paper (Kalyvianakis et al., 2017).
- integral is the area under the curve p squared (Fig 1), the area of the wave surface is A, the density of the medium is , the propagation speed in the fluid is c, and t is time
- Shockwaves form microbubbles (A) in the vasculature and tissue that collapse (B) and cause disruption of the endothelium (C). Endothelial disruption might activate resident stem cells (D) and result in chemokine production with attraction of (endothelial) progenitor cells (E) and release of VEGF (F); these factors combine to initiate neoangiogenesis (G). In addition, microbubble collapse induces shear stress and might simulate endothelial NO production (H). Furthermore, shockwave therapy might also enhance Schwann-cell-mediated nitrergic-nerve repair after injury (I).
- Findings from randomized sham-controlled trials that have evaluated low-intensity ESWT do not clearly indicate that benefits reliably outweigh risks/burdens for men with ED. In particular, the treatmentâs ability to restore normal erectile function remains in question, the duration of treatment effects beyond possible short-term efficacy is not well-established, and the burdens associated with obtaining the treatment (i.e., time and cost) are substantial. Given the availability of other treatments that are less burdensome and known to be effective and the fact that ESWT is not FDA-approved, the Panel concludes that ESWT should only be used in investigational settings in the context of an institutional review board (IRB)-approved clinical trial. Seven RCTs compared responses to ESWT versus a sham treatment (quality range from low risk of bias to unclear risk of bias). The RCTs varied in methodology in terms the number of pulses per treatment (from 600 to 3,000), the number of treatments per week (one or two), the number of treatment sites (from 3 to 6), and the total number of treatments (from 5 to 12). Four trials focused on men who were PDE5i responders988-990 or partial responders.991 For these four trials, men were not permitted PDE5is during the study and outcomes reflect unassisted erectile function. All four trials reported statistically significant improvements in unassisted erectile function in response to ESWT but not the sham treatment; however, no trial reported that men experienced a return to normal erectile function (i.e., an IIEF-EF score âĽ26), suggesting the continued need for adjunctive ED therapy. Two trials followed men for one year. Srini et al. (2015) reported that mean IIEF-EF scores were 22.0 in the ESWT group compared to 10.5 in the sham group (baseline values of 9.5 and 9.2, respectively), and 90% of men in the ESWT group reported an EHS of 3 or 4 (the proportion in the sham group was not reported) at one-month post-treatment.989 At one-year post-treatment, IIEF-EF scores in the ESWT group had declined to 18.2 with 83% reporting EHS âĽ3; the sham group was not followed. The decay in function over time to mild to moderate ED, however, illustrates the Panelâs concerns with this therapy; even after completing the protocol a substantial portion of men eventually would require another ED therapy. In addition, although 95 men began the ESWT protocol, only 60 men completed the treatment (only 17 of 40 completed the sham protocol), raising questions about the generalizability of findings. Kalyvianakis and Hatzichristou (2017) reported at 12 months after treatment that the mean IIEF-EF score in the ESWT group was 19.1 and in the There were essentially no AEs reported in this group of studies; the most frequently reported reason for participant drop out was the inconvenience and/or cost of obtaining the treatment. Four published systematic reviews with meta-analyses evaluated the use of ESWT.995-998 These papers are compromised by conceptual weaknesses: the failure to address substantial heterogeneity that suggests flawed conclusions, the pooling of trials across non-comparable patient groups (i.e., ED, chronic pelvic pain; the pooling of trials that measured unassisted erectile function with trials that measured erectile function in response to PDE5is; and the use of non-standard data analytic procedures (i.e., separate analyses for active and sham-treated groups)). Therefore, collectively they offer little insight into this topic area.
- Well times are changingâŚ. THERE are many new potential treatment options in the future to treat ED. Not only medications, but gene therapy, stem cell therapy, transfected cells, and tissue engenererring Howver, I would argue that one of the most promising areas to treat ED today is stem cell therapy
- Peyronies: Levy et al: He used placental derived stem cells and injected them into the plaque and base of the penis in 5 men in a single injection. 6 months follow up. Curvature varied from 0 to 120 degrees, and the range of decrease was from 14 to 100%. Radical Prostate: 6-18 months after RP and had failed medical management. One injection. Stem cells harvested from adipose tissue under GA and injected 2 hours later. No incontinent men noticed improvement, but of the continent men, 53% regained function enough for intercourse. No man with pre=operative erectile dysfunction regained function. Peyronies: Levy et al: He used placental derived stem cells and injected them into the plaque and base of the penis in 5 men in a single injection. Not stated if they were in acute or chronic phase. 6 months follow up. Curvature varied from 0 to 120 degrees, and the range of decrease was from 14 to 100%. Radical Prostate: 6-18 months after RP and had failed medical management. One injection. Stem cells harvested from adipose tissue under GA and injected 2 hours later. No incontinent men noticed improvement, but of the continent men, 53% regained function enough for intercourse. No man with pre=operative erectile dysfunction regained function. Limitation here is it was given between 6 and 18 months after surgery, when many men can still regain erectile function.
- After 1 yearâs follow up, we looked at the placebo patients versus all stem cell patients, and then broke this up further into the type of stem cell. At this point, regardless of the subanalysis we did, there is no difference between placebo and stem cell groups with regards to total IIEF score or any of the IIEF domain scores. While the cells arenât as systemic as a simple IV infusion, this does support the need for local delivery of cells.
- Even less guidance regarding Peyronieâs Disease and stem cells.
- BUT WHAT IS MOSE EXCITING IS THE⌠MECHANISM FOR HOW STEM CELLS ARE IMPROVING ED. What is the mechanism for how these ADSC or lysate improve erectile function? In animal studies have demonstrated that ADSC injected into cavernous smooth muscle Preserve smooth muscle content Prevent fibrosis And preserve penile dorsal nerve innervation Similar results have also been demonstrated with lysate only This to me is a potential CURE for ED. If you recall from my earlier slides, two major reasons for developing ED were a decline in corporal smooth muscle and increase in corporal fibrosis et al. [46]. Albersen et al. [21] tested the application of ADSCs in the CNI rat model. Besides ADSCs, they injected the CC of another group of rats with ADSC-derived lysate. Lysate treatment exposes injured tissues to soluble factors contained in ADSCs, without allowing live cells to directly act on the host tissue [47]. In that study, both ADSCs and ADSC-lysate improved the erectile responses to cavernous nerve stimulation at 4 weeks after injection, and both therapies partly restored the smooth muscle content of the penis, decreased CC fibrosis, and importantly, restored nNOS expression in the dorsal penile nerves. In agreement with previous studies, few engrafted ADSCs (which were marked with the fluorescent thymidine analogue EdU) were detected in the CC after 4 weeks.
- Findings from studies that have evaluated ICI stem cell therapy do not indicate that benefits reliably outweigh risks/burdens for men with ED. In particular, the treatmentâs ability to restore normal erectile function in various populations of men with ED has not been convincingly demonstrated. Further, neither the most effective source and dose of stem cells nor the duration of treatment effects has been established, and the burdens associated with obtaining the treatment (i.e., cost, need for tissue harvest) can be substantial. Given the paucity of data obtained in human participants, the risks of treatment also are not well-established Panel concludes that ICI stem cell therapy should only be used in investigational settings in the context of an IRB-approved clinical trial. Levy et al. (2016) used placental matrix-derived stem cells in eight men with ED who were able to have intercourse pre-treatment with the use of ICI medications.1003 Post-procedure, three men were able to achieve erections without medications and four were able to have intercourse using low-dose PDE5i. However, two men were lost to follow-up during the study, leaving it unclear whether effects were sustained. Body of evidence strength. This literature consists primarily of observational designs with extremely small sample sizes; the available literature reports findings from <50 men in total. The stem cell source and dose varied across studies, making it unclear which protocols might be effective. Patient populations also differed substantially across studies, including men with diabetes, men post-RP, and men from the general ED population. The safety profile of this therapy is unclear given the limited number of human participants. Overall, confidence in reliable outcomes without significant risks is compromised by an inadequate body of evidence comprised of robustly designed studies with sufficient sample sizes for a particular stem cell methodology in a particular patient group.
- collection tubes were filled with 9 mL of whole blood. The samples were centrifuged at 6,000 RPMS for six minutes, and the supernatant was separated from the remaining blood sample using a proprietary system. Ten percent calcium chloride solution was then added to the PRP in a 1:10 ratio, converting fibrinogen to fibrin. This process would generally yield approximately 5.5 mL of injectable PRFM per tube with patients receiving either 1 or 2 tubes. PRFM, referred to some as âactivated PRPâ was chosen so as to allow better local retention of product and thus avoid early washout. Administration was performed within ten minutes of final preparation. Injections were performed based on the targeted genitourinary pathology. Between 4 and 9 mL of PRFM was injected per treatment session. Intracavernosal injection was performed for ED. For patients with PD, an artificial erection was induced with 20 Îźg of alprostadil to assess curvature, and injections were placed directly into tunical plaques under ultrasound guidance. After a thorough discussion of potential risks and benefits, three patients elected needle fracture of plaque(s) with concomitant 10 mL saline injection prior to PRFM injections. For SUI, a pediatric cystoscope and transurethral injection needle were used to inject PRFM into the urethral submucosa, distal to the bladder neck.
- PRP should not be offered to men with ED unless it is administered in the context of an IRB-approved experimental clinical research protocol. At this time, no full-text peer-reviewed publications are available to constitute an evidence base. Therefore, reliable information about potential benefits and risks/burdens of PRP therapy is not available. Because of the absence of evidence and given the availability of multiple other proven treatment options, it is the Panelâs expert opinion that PRP therapy is not appropriate for men with ED except as part of an IRB-approved research trial.