Health TrialsbyHealthPanel

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

ConditionsErectile Dysfunction Due to Arterial InsufficiencyErectile DysfunctionErectile Dysfunction Due to Arterial DiseaseChronic Pelvic Pain SyndromeChronic ProstatitisErectile Dysfunction Following Radical ProstatectomyErectile Dysfunction Following Radiation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cis-gendered heterosexual adult males18 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) in the last 3 months

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.

Disqualifiers

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)

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Focused shockwave

    Device

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

  • Radial wave

    Device

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

  • Sham treatment

    Device

    Handheld sham probe

Treatment groups

186 Participants
are divided into 3 treatment groups
Group A: fSWTExperimental treatment 1 intervention
Group B: rWTActive comparator 1 intervention
Group C: ShamSham comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov
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