madman
Super Moderator
Clinical Practice Guideline Recommendation on the Use of Low-Intensity Extracorporeal Shock Wave Therapy and Low-Intensity Pulsed Ultrasound Shock Wave Therapy to Treat Erectile Dysfunction: The Asia-Pacific Society for Sexual Medicine Position Statement
Published literature shows low-intensity extracorporeal shock wave therapy (LIESWT) and low-intensity pulsed ultrasound (LIPUS) therapy to improve erectile function and penile hemodynamic by inducing neovascularization and promoting tissue regeneration. Key opinion leaders across the Asia Pacific region attended the recent biennial meeting of the Asia Pacific Society for Sexual Medicine in Australia and presented the current evidence on LIESWT and LIPUS for erectile dysfunction (ED). The clinical findings were internally discussed, and the quality of evidence was graded based on the Oxford Centre for evidence-based medicine recommendations. Existing literature supports the use of LIESWT and LIPUS in men with ED, with many clinical studies reported encouraging results with improved erectile function, good safety profile, and short-term durability. However, controversy exists due to sampling heterogeneity, non-standardized treatment protocol, and lack of large multi-institutional studies. There is a need to better define which subgroup of ED population is best-suited, and specific treatment protocol to optimize shock wave energy delivery. More stringent and larger multi-institutional randomized placebo-controlled trials are warranted before the clinical adoption of LIESWT and LIPUS as the new standard of care for men with ED.
PROPOSED MECHANISMS OF ACTION ON ERECTILE FUNCTION
Summary recommendation
There is convincing basic science evidence to support the use of LIESWT in improving penile erectile hemodynamic (Level 2; Grade B). The clinical evidence on LIPUS in ED is accruing and should have similar biologic effects as LIESWT. Given the fact that ED is often multifactorial in pathogenesis, further confirmatory shock wave studies on the effects of LIESWT and LIPUS across various animal models of ED should be conducted.
TREATMENT TEMPLATES AND PATIENT SELECTION
Summary recommendation
Published literature shows LIESWT and LIPUS should be administered in at least 3 separate locations along the penis to be effective. Current treatment templates and protocols are largely derived from earlier published studies and based on manufacturer guidelines (clinical principle). To date, there is no head-to-head comparison between focussed and linear shock wave generators, and the various LIESWT machines. Furthermore, these outcomes should be interpreted with some caution due to underlying study heterogeneities and methodological flaws with inclusion and exclusion criteria, varying treatment templates, shock wave energy flow density, the number of shockwaves per session, and duration of treatment among published [5].
There is a need to define which subgroup of ED population is best suited and the LIESWT protocols including modality of shock wave energy, emission frequency, and total energy delivery. The patient selection appears paramount to treatment success and patients with mild-moderate ED, younger age group, those with minimal cardiovascular comorbidities, and absence of diabetes or cavernous nerve are likely going to report high EF recovery and spontaneous erection (Level 2; Grade B). The use of adjunctive measures such as combination PDE5i may enhance LIESWT effects and EF recovery (Level 2; Grade C).
There is a need to define which subgroup of ED population is best suited and the LIESWT protocols including modality of shock wave energy, emission frequency, and total energy delivery. The patient selection appears paramount to treatment success and patients with mild-moderate ED, younger age group, those with minimal cardiovascular comorbidities, and absence of diabetes or cavernous nerve are likely going to report high EF recovery and spontaneous erection (Level 2; Grade B). The use of adjunctive measures such as combination PDE5i may enhance LIESWT effects and EF recovery (Level 2; Grade C).
CLINICAL OUTCOMES
Summary recommendation
LISWT improves EF scores and penile hemodynamic parameters in men with vasculogenic ED (Level 1; Grade B). However, the clinical long-term significance of this improvement is uncertain. Published literature suggests these positive effects of LIESWT to last up to 12 months after treatment (Level 2; Grade B). While current evidence for the use of LIESWT and to extent LIPUS is promising, more large-scale, well-designed, and long-term follow-up time studies are needed owing to the limited number and quality of the studies. At present, there is no published data on the cost-effective analysis between LIESWT and other contemporary treatments for ED. The positive benefits of concurrent adjunctive therapy such as oral PDE5i and cellular-based therapy in humans remain largely unknown. Given the limitations study methodology and modest reported changes in EF scores by most of the trials, patients should be aware that the scientific evidence is controversial and that the expected improvement may not be clinically relevant. The clinical adoption of LIESWT and LIPUS as an effective treatment option should be restricted to men with mild-moderate vasculogenic ED, either responder or non-responders to PDE5is, and ideally performed in the highly specialized centers with documented experience with this type of therapy (Level 2; Grade B).
SAFETY AND TOLERABILITY
Summary recommendation
LISWT is a safe and well-tolerated procedure without clinically significant adverse events (Level 1; Grade A).
CONCLUSION
Published literature supports the clinical use of LIESWT in men with ED with improved EF, good safety records, and short-term durability. Although the exact mechanisms remain to be elucidated, it is agreed upon that LIESWT stimulates the release of various angiogenic and neurotrophic factors and promotes the regeneration of cavernosal smooth muscle and endothelium. Furthermore, LIESWT has the potential to recruit endogenous mesenchymal stem cells, which has beneficial effects for the repair of damaged tissue. Patient selection appears paramount to treatment success and patients with mild-moderate ED, younger age group, those with minimal cardiovascular comorbidities, and the absence of diabetes or cavernous nerve injury are likely going to report higher EF recovery and spontaneous erection.
Currently, there is no widely adopted treatment template with existing treatment protocol often based on manufacturer’s guidelines and is derived from existing literature. While current clinical studies show that the vasculogenic effects and therapeutic mechanisms among the LIESWT machines are similar, regardless of the physical differences and treatment protocols, it remains unknown if one machine is superior to another. Furthermore, other relevant factors such as the actual physiological changes in penile tissues and the longterm risk of shock waves remain largely unknown.
At this stage, more multi-institutional randomized placebo-controlled studies with dose-finding study, the comparison between various treatment protocols and shock wave machines, and the concurrent use of adjunctive measures are needed before LIESWT and LIPUS can be adopted as the standard of care in ED. Future research direction should incorporate a cost-effective analysis model, mechanisms to miniaturize shock wave technology with better energy delivery for use at home, and the role of concurrent administration of similar regenerative technology to treat men with ED.
Published literature shows low-intensity extracorporeal shock wave therapy (LIESWT) and low-intensity pulsed ultrasound (LIPUS) therapy to improve erectile function and penile hemodynamic by inducing neovascularization and promoting tissue regeneration. Key opinion leaders across the Asia Pacific region attended the recent biennial meeting of the Asia Pacific Society for Sexual Medicine in Australia and presented the current evidence on LIESWT and LIPUS for erectile dysfunction (ED). The clinical findings were internally discussed, and the quality of evidence was graded based on the Oxford Centre for evidence-based medicine recommendations. Existing literature supports the use of LIESWT and LIPUS in men with ED, with many clinical studies reported encouraging results with improved erectile function, good safety profile, and short-term durability. However, controversy exists due to sampling heterogeneity, non-standardized treatment protocol, and lack of large multi-institutional studies. There is a need to better define which subgroup of ED population is best-suited, and specific treatment protocol to optimize shock wave energy delivery. More stringent and larger multi-institutional randomized placebo-controlled trials are warranted before the clinical adoption of LIESWT and LIPUS as the new standard of care for men with ED.
PROPOSED MECHANISMS OF ACTION ON ERECTILE FUNCTION
Summary recommendation
There is convincing basic science evidence to support the use of LIESWT in improving penile erectile hemodynamic (Level 2; Grade B). The clinical evidence on LIPUS in ED is accruing and should have similar biologic effects as LIESWT. Given the fact that ED is often multifactorial in pathogenesis, further confirmatory shock wave studies on the effects of LIESWT and LIPUS across various animal models of ED should be conducted.
TREATMENT TEMPLATES AND PATIENT SELECTION
Summary recommendation
Published literature shows LIESWT and LIPUS should be administered in at least 3 separate locations along the penis to be effective. Current treatment templates and protocols are largely derived from earlier published studies and based on manufacturer guidelines (clinical principle). To date, there is no head-to-head comparison between focussed and linear shock wave generators, and the various LIESWT machines. Furthermore, these outcomes should be interpreted with some caution due to underlying study heterogeneities and methodological flaws with inclusion and exclusion criteria, varying treatment templates, shock wave energy flow density, the number of shockwaves per session, and duration of treatment among published [5].
There is a need to define which subgroup of ED population is best suited and the LIESWT protocols including modality of shock wave energy, emission frequency, and total energy delivery. The patient selection appears paramount to treatment success and patients with mild-moderate ED, younger age group, those with minimal cardiovascular comorbidities, and absence of diabetes or cavernous nerve are likely going to report high EF recovery and spontaneous erection (Level 2; Grade B). The use of adjunctive measures such as combination PDE5i may enhance LIESWT effects and EF recovery (Level 2; Grade C).
There is a need to define which subgroup of ED population is best suited and the LIESWT protocols including modality of shock wave energy, emission frequency, and total energy delivery. The patient selection appears paramount to treatment success and patients with mild-moderate ED, younger age group, those with minimal cardiovascular comorbidities, and absence of diabetes or cavernous nerve are likely going to report high EF recovery and spontaneous erection (Level 2; Grade B). The use of adjunctive measures such as combination PDE5i may enhance LIESWT effects and EF recovery (Level 2; Grade C).
CLINICAL OUTCOMES
Summary recommendation
LISWT improves EF scores and penile hemodynamic parameters in men with vasculogenic ED (Level 1; Grade B). However, the clinical long-term significance of this improvement is uncertain. Published literature suggests these positive effects of LIESWT to last up to 12 months after treatment (Level 2; Grade B). While current evidence for the use of LIESWT and to extent LIPUS is promising, more large-scale, well-designed, and long-term follow-up time studies are needed owing to the limited number and quality of the studies. At present, there is no published data on the cost-effective analysis between LIESWT and other contemporary treatments for ED. The positive benefits of concurrent adjunctive therapy such as oral PDE5i and cellular-based therapy in humans remain largely unknown. Given the limitations study methodology and modest reported changes in EF scores by most of the trials, patients should be aware that the scientific evidence is controversial and that the expected improvement may not be clinically relevant. The clinical adoption of LIESWT and LIPUS as an effective treatment option should be restricted to men with mild-moderate vasculogenic ED, either responder or non-responders to PDE5is, and ideally performed in the highly specialized centers with documented experience with this type of therapy (Level 2; Grade B).
SAFETY AND TOLERABILITY
Summary recommendation
LISWT is a safe and well-tolerated procedure without clinically significant adverse events (Level 1; Grade A).
CONCLUSION
Published literature supports the clinical use of LIESWT in men with ED with improved EF, good safety records, and short-term durability. Although the exact mechanisms remain to be elucidated, it is agreed upon that LIESWT stimulates the release of various angiogenic and neurotrophic factors and promotes the regeneration of cavernosal smooth muscle and endothelium. Furthermore, LIESWT has the potential to recruit endogenous mesenchymal stem cells, which has beneficial effects for the repair of damaged tissue. Patient selection appears paramount to treatment success and patients with mild-moderate ED, younger age group, those with minimal cardiovascular comorbidities, and the absence of diabetes or cavernous nerve injury are likely going to report higher EF recovery and spontaneous erection.
Currently, there is no widely adopted treatment template with existing treatment protocol often based on manufacturer’s guidelines and is derived from existing literature. While current clinical studies show that the vasculogenic effects and therapeutic mechanisms among the LIESWT machines are similar, regardless of the physical differences and treatment protocols, it remains unknown if one machine is superior to another. Furthermore, other relevant factors such as the actual physiological changes in penile tissues and the longterm risk of shock waves remain largely unknown.
At this stage, more multi-institutional randomized placebo-controlled studies with dose-finding study, the comparison between various treatment protocols and shock wave machines, and the concurrent use of adjunctive measures are needed before LIESWT and LIPUS can be adopted as the standard of care in ED. Future research direction should incorporate a cost-effective analysis model, mechanisms to miniaturize shock wave technology with better energy delivery for use at home, and the role of concurrent administration of similar regenerative technology to treat men with ED.
