NCT07331961

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 31, 2025

Last Update Submit

January 8, 2026

Conditions

Erectile Dysfunction (ED)

Keywords

erectile dysfunctionlow intensity shock wave treatmentextracorporeal shock wave therapy

Outcome Measures

Primary Outcomes (2)

  • detection of complications from the use of ESWL machine

    the patients will be evaluated after the procedure for 1 month to identify any side-effects as hematoma or difficult urination

    follow up will begin after the first session and then repeated weekly for 1 month

  • improvement in the international erectile function score

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

Study Arms (1)

patients diagnosed with erectile dysfunctiom

EXPERIMENTAL

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

Device: extracorporeal shock wave therpy

Interventions

extracorporeal shock wave therpyDEVICE

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

patients diagnosed with erectile dysfunctiom

Eligibility Criteria

Age30 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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: 21855209RESULT

  • 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: 40654049RESULT

  • 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: 20451317RESULT

  • 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: 35830338RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Central Study Contacts

Abdelrahman M Abdelkader, Master of Urology & Andrology

CONTACT

+201068336396abdelrahmanmohamed.aa@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
teaching assistant

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 12, 2026

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion

March 30, 2026

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
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