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

Primary Purpose

Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction, Erectile Dysfunction Due to Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focused shockwave
Radial wave
Sham treatment
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction Due to Arterial Insufficiency focused on measuring shockwave, radial wave, pelvic floor physical therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

fSWT

rWT

Sham

Arm Description

Focused Shock wave treatments

Radial wave treatments

Sham treatments

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Erectile Dysfunction
SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)
Erectile Dysfunction
GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.
Erectile Dysfunction
EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.

Full Information

First Posted
May 11, 2023
Last Updated
September 26, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05868668
Brief Title
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Official Title
Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
shockwave, radial wave, pelvic floor physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fSWT
Arm Type
Experimental
Arm Description
Focused Shock wave treatments
Arm Title
rWT
Arm Type
Active Comparator
Arm Description
Radial wave treatments
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham treatments
Intervention Type
Device
Intervention Name(s)
Focused shockwave
Intervention Description
Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
Intervention Type
Device
Intervention Name(s)
Radial wave
Intervention Description
Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
Handheld sham probe
Primary Outcome Measure Information:
Title
Erectile Dysfunction
Description
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.
Time Frame
baseline, 3 and 6 months
Title
Chronic Prostatitis/Chronic Pelvic Pain Syndrome:
Description
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.
Time Frame
baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Erectile Dysfunction
Description
SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)
Time Frame
baseline, 3 and 6 months
Title
Erectile Dysfunction
Description
GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.
Time Frame
baseline, 3 and 6 months
Title
Erectile Dysfunction
Description
EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.
Time Frame
baseline, 3 and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baltas
Phone
(216) 444- 9338
Email
baltasn@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petar Bajic, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Baltas
Phone
216-444-9338
Email
baltasn@ccf.org
First Name & Middle Initial & Last Name & Degree
Petar Bajic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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