Trials / Recruiting
RecruitingNCT05868668
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Focused Shockwave and Sham Therapy for Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- The Cleveland Clinic · Academic / Other
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Erectile Dysfunction Due to Arterial Insufficiency
- Erectile Dysfunction
- Erectile Dysfunction Due to Arterial Disease
- Chronic Pelvic Pain Syndrome
- Chronic Prostatitis
- Erectile Dysfunction Following Radical Prostatectomy
- Erectile Dysfunction Following Radiation Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Focused shockwave | Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland) |
| DEVICE | Radial wave | Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany) |
| DEVICE | Sham treatment | Handheld sham probe |
Timeline
- Start date
- 2023-09-19
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2023-05-22
- Last updated
- 2026-01-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05868668. Inclusion in this directory is not an endorsement.