RECRUITING

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

Conditions

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 shockwave radial wave pelvic floor physical therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-19

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05868668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Petar Bajic

CONTACT

216-444-1231

bajicp@ccf.org

Principal Investigator

Petar Bajic, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Petar Bajic, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19

Study Completion Date2025-06

Study Record Updates

Study Start Date2023-09-19

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

shockwave
radial wave
pelvic floor physical therapy

Additional Relevant MeSH Terms

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