The Feasibility of Using Dornier Machine in Patients With Erectile Dysfunction, a Pilot Study. (DED-Pilot)

Assiut University

Status: Not yet enrolling

Conditions: Erectile Dysfunction (ED)

Treatments: Device: extracorporeal shock wave therpy

Study type: Interventional

Funder types: Other

Identifiers

NCT07331961

ESWT in erectile dysfunction

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with erectile dysfunction (ED) confirmed by clinical assessment and penile duplex Doppler ultrasound

Exclusion criteria

• 1-Coagulapathy. 2-Penile prosthesis. 3-Post Radical Cystectomy 4-Intellectual disability 5-Skeletal abnormalty

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

patients diagnosed with erectile dysfunctiom

Experimental group

Description:

they will receive shock wave therapy on their penis by using a machine that is not designed for this purpose.

Treatment:

Device: extracorporeal shock wave therpy