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

No phase Interventional Erectile Dysfunction (ED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: extracorporeal shock wave therpy.
Who it may be relevant to
Registry conditions: Erectile Dysfunction (ED). Basic parameters: from 30 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

  • Device extracorporeal shock wave therpy
    we will use a Dornier lithotripsy delta 2 for treatment of patient with erectile dysfunction

Primary outcome measures

  • 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]
  • improvement in the international erectile function score [Time frame: follow up will begin after day one and then repeated weekly for 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30. PMID 21855209
  • Ergun O, Kim K, Kim MH, Hwang EC, Blair Y, Gudeloglu A, Parekattil S, Dahm P. Low-intensity shockwave therapy for erectile dysfunction. Cochrane Database Syst Rev. 2025 Jul 14;7(7):CD013166. doi: 10.1002/14651858.CD013166.pub3. PMID 40654049
  • Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6. PMID 20451317
  • Kalyvianakis D, Mykoniatis I, Pyrgidis N, Kapoteli P, Zilotis F, Fournaraki A, Hatzichristou D. The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial. J Urol. 2022 Aug;208(2):388-395. doi: 10.1097/JU.0000000000002684. Epub 2022 May 6. PMID 35830338

Identifiers

NCT: NCT07331961 · ESWT in erectile dysfunction

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗