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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868668
• Other study ID #: 23-103
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: The Cleveland Clinic
• Contact: Petar Bajic
• Phone: 216-444-1231
• Email: bajicp[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Erectile Dysfunction
• Erectile Dysfunction Due to Arterial Insufficiency
• Erectile Dysfunction Following Radiation Therapy
• Erectile Dysfunction Following Radical Prostatectomy
• Pelvic Pain
• Prostatitis

Intervention

Device:
• Focused shockwave
Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
• Radial wave
Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
• Sham treatment
Handheld sham probe

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline, 3 and 6 months
Primary	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	Erectile Dysfunction	SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)	baseline, 3 and 6 months
Secondary	Erectile Dysfunction	GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.	baseline, 3 and 6 months
Secondary	Erectile Dysfunction	EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.	baseline, 3 and 6 months