Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

Not Applicable

Recruiting

• Conditions: Chronic Prostatitis; Erectile Dysfunction Following Radical Prostatectomy; Chronic Pelvic Pain Syndrome; Erectile Dysfunction; Erectile Dysfunction Due to Arterial Insufficiency; Erectile Dysfunction Due to Arterial Disease; Erectile Dysfunction Following Radiation Therapy
• Interventions: Device: Focused shockwave; Device: Radial wave; Device: Sham treatment

• Registration Number: NCT05868668
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2023-09-19
• Status Verified: 2024-07
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 186

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fSWT	Focused shockwave	Focused Shock wave treatments
rWT	Radial wave	Radial wave treatments
Sham	Sham treatment	Sham treatments

Primary Outcome Measures

Name	Time	Method
Chronic Prostatitis/Chronic Pelvic Pain Syndrome:	baseline, 3 and 6 months	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.
Erectile Dysfunction	baseline, 3 and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Erectile Dysfunction	baseline, 3 and 6 months	EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States