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NCT Number: NCT07331961

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extracorporeal shock wave therpy

Device

we will use a Dornier lithotripsy delta 2 for treatment of patient with erectile dysfunction

Primary outcomes

  1. detection of complications from the use of ESWL machine

    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

  2. improvement in the international erectile function score

    Time frame: follow up will begin after day one and then repeated weekly for 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman M Abdelkader, Master of Urology & Andrology

CONTACT

[email protected]

+201068336396

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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