Efficacy and safety of novel low-intensity pulsed ultrasound (LIPUS) in treating mild to moderate erectile dysfunction: a multicenter, randomized, double-blind, sham-controlled clinical study

Cui, Wanshou; Li, Huixi; Guan, Ruili; Li, Meng; Yang, Bicheng; Xu, Zhanwei; Lin, Maofan; Tian, Long; Zhang, Xiaodong; Li, Bao; Li, Weiguang; Dong, Zhilong; Wang, Zhiping; Zheng, Tao; Zhang, Weixing; Lin, Guiting; Guo, Yinglu; Xin, Zhongcheng

doi:10.21037/tau.2019.07.03

Cited by 19 publications

(21 citation statements)

References 34 publications

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“…Furthermore, the applied energy density dosage of LIPUS ranges between 2 and 150 J/cm 2 [ 37 ]. A recent multicenter randomized clinical study administered a twice-weekly LIPUS treatment for 4 weeks with the treatment areas include left crus, right crus, left corpus cavernosum, and right corpus cavernosum (each session lasted for 20 minutes in total with 5 minutes per area) [ 38 ].…”

Section: Treatment Templates and Patient Selectionmentioning

confidence: 99%

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

Chung

Lee

Liu

et al. 2021

World J Mens Health

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Published literature shows low intensity extracorporeal shock wave therapy (LIESWT) and low intensity pulsed ultrasound (LI-PUS) therapy to improve erectile function and penile hemodynamic by inducing neovascularisation 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, controversial exists due to sampling heterogeneity, non-standardised treatment protocol and lack of large multiinstitutional studies. There is a need to better define which subgroup of ED population is best-suited, and specific treatment protocol to optimise shock wave energy delivery. More stringent and larger multi-institutional randomised placebo-controlled trials are warranted before clinical adoption of LIESWT and LIPUS as the new standard of care for men with ED.

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Section: Treatment Templates and Patient Selectionmentioning

confidence: 99%

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

Chung

Lee

Liu

et al. 2021

World J Mens Health

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“…2019 Cui et al [100] ED: erectile dysfunction, LI-SWT: low-intensity shock wave therapy, EHS: erection hardness score, IIEF: international index of erectile function, MCID: minimum clinically important differences, IIEF-EF: international index of erectile function-erectile function, LIPUS: low intensity pulsed ultrasound, SEP-3: sexual encounter profile questionnaires 3.…”

Section: Discussionmentioning

confidence: 99%

“…In the randomized clinical trial conducted in mild to moderate ED [ 100 ], during the 12-week follow-up period, IIEF-EF score significantly increased. The response rate in LIPUS group was 67.5%, which was 20% higher than the sham group at 3 months.…”

Section: Emerging Therapies For Erectile Dysfunctionmentioning

confidence: 99%

Novel Emerging Therapies for Erectile Dysfunction

Kim¹,

Cho

et al. 2021

World J Mens Health

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Erectile dysfunction (ED) is defined as the "consistent inability to attain or maintain a penile erection, or both, sufficient for adequate sexual relations" [1]. It is a common disease that can have an adverse effect on men's health and quality of life. The prevalence of ED reported in epidemiological data vary depending on patient age group and definition used. In the United States, it has been reported that ED affects 52% of men aged 40 to 70 years and more than 70% in men older than 70 years [2-4]. In the past, ED was considered a purely psychogenic disorder; however, current evidence suggests that the pathogenesis of ED is related to a multitude of factors. Up to 80% of patients have, at least partly, an organic etiology [5]. ED is associated

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“…In animal models LIPUS improved erectile function (measured by improvement of intracavernous pressure) of diabetic rats by influencing on penile tissue, causing increased endothelial and smooth muscle content, increased expression of eNOS and nNOS, and decreased collagen and fiber changes with down-regulation of TGF-β1/Smad/CTGF signaling pathway [11].…”

mentioning

confidence: 99%

“…What results in gene expression of inflammatory molecules such as IL-1 and IL-6, and neural growth-related factors such as BDNF. In ED treatment LIPUS showed effect of induction of extracellular matrix molecular changes and intracellular composition changes in local tissue cells what results in endogenous stem cell activation for local tissue regeneration [11].…”

mentioning

confidence: 99%

Combination of Platelet Rich Plasma, Lowintensity Pulsed Ultrasound and Sildenafil Oral Spray in Treatment of Erectile Dysfunction

Zasieda¹

2019

UJMH

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Relevance. Some non-pharmacological methods, such as low-intensity pulsed ultrasound (LIPUS) proved to be effective in ED treatment due to stimulation of penile tissue regeneration and penile hemodynamics increase. The biological methods that utilize cellular growth factors such as platelet-rich plasma (PRP) therapy proved to be effective in stimulation of neovascularization processes and correction of endothelial dysfunction while ED treatment.Local negative pressure (LNP) therapy shall be considered as an auxiliary method to PRP and LIPUS due to its ability to slow down PRP outflow from injection zones. Sildenafil («Strondex») is perspective pharmacological addition to ED treatment protocol. Aim. Evaluation of the efficacy and safety of therapeutic model of combined application of PRP intracavernous injections, LNP, LIPUS and Sildenafil («Strondex») for vasculogenic (arterial and corporal veno-occlusive) ED treatment.Materials and methods. Prospective study was conducted in a group of 64 outpatients with diagnosis of erectile dysfunction of vascular genesis (ICD-10: N48.4) in Men’s Health Clinic (Kyiv, Ukraine). “International Index of Erectile Function-5” (IIEF-5), “Erectile Hardness Score” (EHS) were used as the tools for clinical assessment. Ultrasonic cavernous bodies scanning and pharmacodopplersonography were used for the data validation.Study results. Main group patients underwent treatment consisting of 6 sessions of PRP intracavernous injections and 12 sessions of local penile LIPUS combined with LNP and Sildenafil («Strondex») pharmacotherapy. Control group underwent 12 sessions of local penile LIPUS combined with LNP and the same pharmacotherapy. According to the IIEF-5 data obtained 12 weeks after the study the erectile function improvement was found in 27 patients of the main group and 20 patients of the control group. EHS improved by 1 point or more in 29 and 20 patients correspondingly.Conclusions. Treatment protocol specifying combination of PRP, LIPUS, LNP and Sildenafil («Strondex») is promising due to PRP-therapy augmentation by intracavernous ultrasonic activation of platelet growth factors, but the data obtained require further physiological validation and clinical placebo-controlled studies with involvement of larger groups of population.

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Efficacy and safety of novel low-intensity pulsed ultrasound (LIPUS) in treating mild to moderate erectile dysfunction: a multicenter, randomized, double-blind, sham-controlled clinical study

Cited by 19 publications

References 34 publications

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

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

Novel Emerging Therapies for Erectile Dysfunction

Combination of Platelet Rich Plasma, Lowintensity Pulsed Ultrasound and Sildenafil Oral Spray in Treatment of Erectile Dysfunction

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