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

NCT ID: NCT07331961

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-03-30

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.

Conditions

Erectile Dysfunction (ED)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients diagnosed with erectile dysfunctiom

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

Group Type: EXPERIMENTAL

extracorporeal shock wave therpy

Intervention Type: DEVICE

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

Interventions

extracorporeal shock wave therpy

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Mohamed Abdelkader

teaching assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Abdelrahman M Abdelkader, Master of Urology & Andrology

Role: CONTACT

abdelrahmanmohamed.aa@gmail.com

+201068336396

References

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.

Reference Type: RESULT

PMID: 21855209 (View on PubMed)

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.

Reference Type: RESULT

PMID: 40654049 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20451317 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35830338 (View on PubMed)

Other Identifiers

ESWT in erectile dysfunction

Identifier Type: -

Identifier Source: org_study_id