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
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.
Arms & 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
Outcome measures
Primary
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
Secondary
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
Eligibility criteria
Study locations (1)
Cleveland Clinic Foundation
Cleveland, Ohio, 44195