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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fSWT | Experimental | Focused Shock wave treatments |
|
| rWT | Active Comparator | Radial wave treatments |
|
| Sham | Sham Comparator | Sham treatments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused shockwave | Device | Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | baseline, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Dysfunction | SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt) | baseline, 3 and 6 months |
| Erectile Dysfunction | GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function. |
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Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)
Exclusion Criteria (ED):
Chronic Pelvic Pain Syndrome Group:
Inclusion Criteria (CPPS): (all of the following)
Exclusion criteria (CPPS):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petar Bajic | Contact | 216-444-1231 | bajicp@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Petar Bajic, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| Radial wave |
| Device |
Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany) |
|
| Sham treatment | Device | Handheld sham probe |
|
| baseline, 3 and 6 months |
| Erectile Dysfunction | EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity. | baseline, 3 and 6 months |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| C537308 | Spinocerebellar ataxia, autosomal recessive 1 |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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