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
The Cleveland Clinic
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.
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 treatmen…
Eligibility
- Age range
- 40+ years
- Sex
- Male
- Healthy volunteers
- No
Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following) 1. Cis-gendered heterosexual adult males18 years old 2. Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration. 3. Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months 4. If ED responsive or partially responsive to current use of PDE5I, participant must be willing to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for the duration of the study. Partially responsive ED is defined as inadequate response…
Interventions
- DeviceFocused shockwave
Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
- DeviceRadial wave
Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
- DeviceSham treatment
Handheld sham probe
Location
- Cleveland Clinic FoundationCleveland, Ohio