An interventional study of Focused shockwave and Radial wave in Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction and Erectile Dysfunction Due to Arterial Disease, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Participants who meet eligibility requirements will be randomized in a double blind manner (participant and investigator) to each treatment arm depending on their primary complaint. Participants with erectile dysfunction will be randomized 2:2:1 to either fSWT, rWT or sham therapy. Patients with chronic pelvic pain syndrome will be randomized 1:1 to either fSWT with pelvic floor physical therapy (PFPT) or PFPT with sham treatment.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 186 is above the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)
Exclusion Criteria (ED):
Chronic Pelvic Pain Syndrome Group:
Inclusion Criteria (CPPS): (all of the following)
Exclusion criteria (CPPS):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Focused Shock wave treatments
Device: Focused shockwave
Radial wave treatments
Device: Radial wave
Sham treatments
Device: Sham treatment
Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
Handheld sham probe
Erectile Dysfunction
To evaluate change/minimum clinically important difference (MCID) of International Index of Erectile Function score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms.
Time frame: baseline, 3 and 6 months
Chronic Prostatitis/Chronic Pelvic Pain Syndrome:
To evaluate change/MCID in Chronic Prostatitis Symptom Index (CPSI) score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms.
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.
Time frame: baseline, 3 and 6 months
Plan to share: No
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