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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT05868668
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Pelvic Pain Syndrome
  • Chronic Prostatitis
  • Erectile Dysfunction
  • Erectile Dysfunction Due to Arterial Disease
  • Erectile Dysfunction Due to Arterial Insufficiency
  • Erectile Dysfunction Following Radiation Therapy
  • Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

Sex
MALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focused shockwave — DEVICE
    Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
  • Radial wave — DEVICE
    Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
  • Sham treatment — DEVICE
    Handheld sham probe

Study Details

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.

Key Dates

Start date
Sep 19, 2023
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: fSWT
    Focused Shock wave treatments
  • Active Comparator: rWT
    Radial wave treatments
  • Sham Comparator: Sham
    Sham treatments

Primary Outcome Measure

Erectile Dysfunction [ Time Frame: baseline, 3 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Raevti Bole
[email protected]
216-445-8640
Petar Bajic, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic Foundation· Cleveland, OH

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