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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05868668
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Device: Focused shockwave; Device: Radial wave; Device: Sham treatment	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Pelvic Pain
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. ED [baseline, 3 and 6 months]

   To evaluate change/minimum clinically important difference (MCID) of International Index of Erectile Function score

2. CP/CPPS: [baseline, 3 and 6 months]

   To evaluate change/MCID in Chronic Prostatitis Symptom Index (CPSI) score

Secondary Outcome Measures

1. ED [baseline, 3 and 6 months]

   SEP- Sexual Encounter Profile Questionnaire

2. ED [baseline, 3 and 6 months]

   GAQ- Global Assessment Questionnaire

3. ED [baseline, 3 and 6 months]

   EHS- Erection Hardness Score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Erectile dysfunction cohort Inclusion Criteria:

1. Cis-gendered heterosexual adult males ≥40 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) for at least 3 months

4. 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.

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

Erectile dysfunction cohort Exclusion Criteria:

1. History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (Multiple sclerosis, Alzheimer's, Parkinsons disease)

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 (penile prosthesis, penectomy, plication, grafting etc but not circumcision)

6. History of penile injury or trauma (priapism, penile fracture)

7. Use of intracavernosal injection for ED within the last year

8. If diabetic, HbA1c 7.5 or higher within 3 months prior to trial

9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound

10. Active smoker

11. Poorly controlled hyperlipidemia

12. Poorly controlled hypertension >130/80 mmHg

13. Severe cardiac disease or history of myocardial infarction

14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression; patients using SSRI or psychotropic medication

15. Severe ED based on IIEF-EF (score 10 or below)

16. Acute prostatitis

CP/CPPS cohort inclusion criteria:

(all of the following)

1. Adult males ≥40 years old

2. Chronic pelvic pain with no obvious signs of infection in urine (<10 WBC per HPF in mid-stream urine)

3. Agreeable to undergo PFPT

CP/CPPS cohort exclusion criteria:

1. History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis), Multiple sclerosis, Alzheimer's, Parkinsons disease

2. Acute prostatitis or any acute infection of the pelvic region

3. History of pelvic trauma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Petar Bajic, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT05868668
• Other Study ID Numbers: 23-103
• First Posted: May 22, 2023
• Last Update Posted: May 22, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by The Cleveland Clinic: shockwave; radial wave; pelvic floor physical therapy
• Additional relevant MeSH terms: Erectile Dysfunction; Prostatitis; Pelvic Pain

Study Results

No Results Posted as of May 22, 2023