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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05868668
Other study ID # 23-103
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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