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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07331961
Acronym
DED-Pilot
Enrollment
30
Registered
2026-01-12
Start date
2026-01-01
Completion date
2026-03-30
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction (ED)

Keywords

erectile dysfunction, low intensity shock wave treatment, extracorporeal shock wave therapy

Brief summary

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.

Detailed 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.

Interventions

DEVICEextracorporeal shock wave therpy

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
30 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
detection of complications from the use of ESWL machinefollow up will begin after the first session and then repeated weekly for 1 monththe patients will be evaluated after the procedure for 1 month to identify any side-effects as hematoma or difficult urination
improvement in the international erectile function scorefollow up will begin after day one and then repeated weekly for 1 month

Contacts

Primary ContactAbdelrahman M Abdelkader, Master of Urology & Andrology
abdelrahmanmohamed.aa@gmail.com+201068336396

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026