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RecruitingNCT05868668ShockwaveUpdated Aug 19, 2026

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

An interventional study of Focused shockwave and Radial wave in Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction and Erectile Dysfunction Due to Arterial Disease, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
40 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • 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

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Keywords

  • shockwave
  • radial wave
  • pelvic floor physical therapy
03

In context

Erectile Dysfunction

701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.

This study's planned enrollment of 186 is above the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)

  1. Cis-gendered heterosexual adult males18 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) in the last 3 months
  4. If ED responsive or partially responsive to current use of PDE5I, participant must be willing to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for the duration of the 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

Exclusion Criteria (ED):

  1. Nerve-injury related ED (/spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (e.g, multiple sclerosis, alzheimer's disease, parkinsons disease, amyotrophic lateral sclerosis)
  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 (e.g, penile prosthesis, penectomy, plication, grafting)
  6. History of penile injury or trauma (e.g, priapism, penile fracture)
  7. Use of intracavernosal injection for ED within the last year
  8. If diabetic, 8% or higher within the past 12 months
  9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound
  10. Current tobacco smoker, or has smoked in the past year
  11. Poorly controlled hyperlipidemia
  12. Poorly controlled hypertension
  13. Severe cardiac disease or history of myocardial infarction
  14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression
  15. Patients currently using SSRI or psychotropic medication
  16. Severe ED based on IIEF-EF (score 10 or below)
  17. Current acute prostatitis

Chronic Pelvic Pain Syndrome Group:

Inclusion Criteria (CPPS): (all of the following)

  1. Adult males ≥18 years old
  2. Chronic pelvic pain not explained by concurrent urinary tract infections. urine)
  3. Willing to do PFPT

Exclusion criteria (CPPS):

  1. Nerve-injury related pelvic pain (history of /spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting pain in the pelvic region(Multiple sclerosis, Alzheimer's, Parkinsons disease)
  2. Acute prostatitis or any acute infection of the pelvic region
  3. History of pelvic trauma
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
186 participants (estimated)

Study arms

  • Experimental
    fSWT

    Focused Shock wave treatments

    Device: Focused shockwave

  • Active comparator
    rWT

    Radial wave treatments

    Device: Radial wave

  • Sham comparator
    Sham

    Sham treatments

    Device: Sham treatment

Interventions

  • DeviceFocused shockwave

    Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)

  • DeviceRadial wave

    Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)

  • DeviceSham treatment

    Handheld sham probe

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 3 and 6 months

  2. 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.

    Time frame: baseline, 3 and 6 months

Secondary outcomes

  1. Erectile Dysfunction

    SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)

    Time frame: baseline, 3 and 6 months

  2. Erectile Dysfunction

    GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.

    Time frame: baseline, 3 and 6 months

  3. Erectile Dysfunction

    EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.

    Time frame: baseline, 3 and 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05868668
Responsible party
Sponsor
First posted
May 22, 2023
Start date
Sep 19, 2023
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Petar Bajic
Contact
bajicp@ccf.org
216-444-1231
Petar Bajic, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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