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Procedure

Shockwave Therapy for Erectile Dysfunction

N/A

Waitlist Available

Led By Brian J. Miles, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented nerve sparing during radical prostatectomy procedure

Be older than 18 years old

Must not have

Unwilling to remove piercing from genital region

Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Summary

This trial is investigating whether Low-Intensity shock wave therapy (LiSWT) is a safe and effective treatment for patients who are experiencing erectile dysfunction (ED) after undergoing radical prostatectomy.

Who is the study for?

This trial is for men experiencing erectile dysfunction after having surgery to remove the prostate (radical prostatectomy). Specific eligibility details are not provided, but typically participants would need to meet certain health standards and have a history of ED following their surgery.

What is being tested?

The study is testing Low-Intensity Shockwave Therapy (LiSWT) to see if it's safe and can help improve symptoms of erectile dysfunction in patients who've had their prostates surgically removed.

What are the potential side effects?

While specific side effects are not listed, LiSWT is generally considered non-invasive with minimal risks. Possible side effects might include mild pain or discomfort during treatment, skin redness, or bruising.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery for prostate cancer preserved my nerves.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unwilling to remove any genital piercings.

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I have had or will have treatment involving hormone therapy or radiation to the pelvis.

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I have no complications from prostate surgery affecting safety or treatment effectiveness.

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I have physical irregularities in my genital or pelvic area.

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I have had surgery on my penis before.

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I have sores or infections on my genital area.

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I am not on blood thinners, except possibly low-dose aspirin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the Erectile Hardness Score questionnaire.

To assess the effectiveness of LiSWT in participants with mild to moderate erectile dysfunction post-prostatectomy with the International Index of Erectile Function questionnaire.

Secondary study objectives

To determine whether LiSWT improves the Peak systolic velocity in the Duplex Doppler Ultrasound.

To determine whether LiSWT improves the Resistive index in the Duplex Doppler Ultrasound.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

1. Patient lies down with legs extended. 2. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring. 3. Connect the headpiece to the ring. 4. Apply ultrasound gel for proper energy transmission on the shaft of the penis 5. 1500 shocks to the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis 6. Duration of the procedure: approximately 30 minutes

Group II: ControlPlacebo Group1 Intervention

0 / 8Eligibility criteria met