extracorporeal shock wave therpy
Devicewe will use a Dornier lithotripsy delta 2 for treatment of patient with erectile dysfunction
NCT Number: NCT07331961
Extracorporeal Shockwave Therapy (ESWT) is a well-established modality for treating various urological and musculoskeletal conditions. Recently, its application has expanded to include vasculogenic erectile dysfunction (ED), primarily due to its ability to trigger neo-angiogenesis and significantly improve penile blood flow.
Trial opening soon.
Get Notified30 year and older
Male
Interventional
Not applicable
Extracorporeal Shockwave Therapy (ESWT) is a well-established modality for treating various urological and musculoskeletal conditions. Recently, its application has expanded to include vasculogenic erectile dysfunction (ED), primarily due to its ability to trigger neo-angiogenesis and significantly improve penile blood flow. While the clinical efficacy of Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT) is increasingly recognized globally, it currently remains non-FDA approved for this specific indication. Furthermore, the accessibility of this treatment is often limited, as dedicated Li-ESWT machines are expensive and frequently unavailable in public healthcare settings.
This pilot study investigates the feasibility of adapting the Dornier Delta Lithotripter utilized for high-energy renal stone fragmentation for penile therapy. The central research question focuses on whether this high-energy platform can be safely and precisely calibrated to low-intensity levels to provide therapeutic benefits without inducing tissue damage and complications.
Our clinical rationale is inspired by shifting paradigms in other medical fields, such as prostate cancer radiotherapy, which emphasize delivering a concentrated therapeutic dose in fewer sessions. Since early pilot studies most notably by Vardi et al experimented with standardized five-point techniques over multiple weeks, we seek to optimize this by evaluating the impact of focused energy delivery and modified patient positioning.This research aims to provide a cost-effective, accessible alternative for ED treatment using existing hospital infrastructure.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
we will use a Dornier lithotripsy delta 2 for treatment of patient with erectile dysfunction
Time frame: follow up will begin after the first session and then repeated weekly for 1 month
the patients will be evaluated after the procedure for 1 month to identify any side-effects as hematoma or difficult urination
Time frame: follow up will begin after day one and then repeated weekly for 1 month
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Assessment of the Feasibility and Clinical Efficacy of Low-Intensity Extracorporeal Shockwave Therapy (Li-ESWT) Using the Dornier System in Patients With Vasculogenic Erectile Dysfunction: A Pilot Study
Acronym: DED-Pilot
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