Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Pelvic Pain

Conditions
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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

Intervention / Treatment
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* Device: Focused shockwave
* Device: Radial wave
* Device: Sham treatment


Participation Criteria
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Eligibility Criteria
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Erectile dysfunction cohort Inclusion Criteria: Cis-gendered heterosexual adult males ≥40 years old Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration. Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) for at least 3 months PDE5I responsive or partially responsive ED (patients using PDE5I will be asked to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for duration of study). Partially responsive ED is defined as inadequate response for desired sexual activity, or poorly maintained erection despite initially good response. 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 Morning total testosterone level over 300ng/dL Erectile dysfunction cohort Exclusion Criteria: History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (Multiple sclerosis, Alzheimer's, Parkinsons disease) Untreated hypogonadism (morning total testosterone <300 ng/dL) or on androgen deprivation therapy in the last 12 months Predominately psychogenic ED based upon expert clinician opinion Peyronie's disease, palpable plaque or curvature/penile anatomic abnormality that affects penetrative intercourse to any degree History of non-superficial penile surgery (penile prosthesis, penectomy, plication, grafting etc but not circumcision) History of penile injury or trauma (priapism, penile fracture) Use of intracavernosal injection for ED within the last year If diabetic, HbA1c 7.5 or higher within 3 months prior to trial Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound Active smoker Poorly controlled hyperlipidemia Poorly controlled hypertension >130/80 mmHg Severe cardiac disease or history of myocardial infarction History of psychiatric disorder including bipolar disorder, current moderate or severe depression; patients using SSRI or psychotropic medication Severe ED based on IIEF-EF (score 10 or below) Acute prostatitis CP/CPPS cohort inclusion criteria: (all of the following) Adult males ≥40 years old Chronic pelvic pain with no obvious signs of infection in urine (<10 WBC per HPF in mid-stream urine) Agreeable to undergo PFPT CP/CPPS cohort exclusion criteria: History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis), Multiple sclerosis, Alzheimer's, Parkinsons disease Acute prostatitis or any acute infection of the pelvic region History of pelvic trauma

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fSWT<br>Focused Shock wave treatments | Device: Focused shockwave<br>* Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)<br>|
| Active Comparator: rWT<br>Radial wave treatments | Device: Radial wave<br>* Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)<br>|
| Sham Comparator: Sham<br>Sham treatments | Device: Sham treatment<br>* Handheld sham probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shockwave, radial wave, pelvic floor physical therapy