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
Conditions
Keywords
shockwave, radial wave, pelvic floor physical therapy
Brief 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.
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
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 for desired sexual activity, or poorly maintained erection despite initially good response. 5. Agreeable to attempt sexual intercourse at least 4 times per month for duration of study without being under the influence of alcohol or recreational drugs 6. Morning total testosterone level over 300ng/dL
Exclusion criteria
(ED): 1. Nerve-injury related ED (/spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (e.g, multiple sclerosis, alzheimer's disease, parkinsons disease, amyotrophic lateral sclerosis) 2. Untreated hypogonadism (morning total testosterone \<300 ng/dL) or on androgen deprivation therapy in the last 12 months 3. Predominately psychogenic ED based upon expert clinician opinion 4. Peyronie's disease, palpable plaque or curvature/penile anatomic abnormality that affects penetrative intercourse to any degree 5. History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting) 6. History of penile injury or trauma (e.g, priapism, penile fracture) 7. Use of intracavernosal injection for ED within the last year 8. If diabetic, HbA1c 8% or higher within the past 12 months 9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound 10. Current tobacco smoker, or has smoked in the past year 11. Poorly controlled hyperlipidemia 12. Poorly controlled hypertension 13. Severe cardiac disease or history of myocardial infarction 14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression 15. Patients currently using SSRI or psychotropic medication 16. Severe ED based on IIEF-EF (score 10 or below) 17. Current acute prostatitis Chronic Pelvic Pain Syndrome Group: Inclusion Criteria (CPPS): (all of the following) 1. Adult males ≥18 years old 2. Chronic pelvic pain not explained by concurrent urinary tract infections. urine) 3. Willing to do PFPT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Dysfunction | baseline, 3 and 6 months | 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. |
| Chronic Prostatitis/Chronic Pelvic Pain Syndrome: | baseline, 3 and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Dysfunction | baseline, 3 and 6 months | SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt) |
Countries
United States
Contacts
CONTACTPetar Bajic
PRINCIPAL_INVESTIGATORPetar Bajic, MD
The Cleveland Clinic
Outcome results
None listed