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Procedure

Active for Erectile Dysfunction

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My surgery for prostate cancer preserved my nerves.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Patient lies down with legs extended. In order to get a proper transmission, a drop of silicone oil is applied on the anatomical stand-off before putting the ring. Connect the headpiece to the ring. Apply ultrasound gel for proper energy transmission on the shaft of the penis 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 Duration of the procedure: approximately 30 minutes

Group II: ControlPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,435 Total Patients Enrolled

Brian J. Miles, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this medical study?

"To be eligible for this research study, individuals must have a diagnosis of erectile dysfunction and fall within the age range of 45 to 70 years old. The trial aims to recruit a total of 100 participants."

Answered by AI

Are there any current opportunities for potential participants to enroll in this trial?

"Indeed, as per the details available on clinicaltrials.gov, this trial is currently seeking eligible participants. The initial posting of the study was made on January 10th, 2024, and it underwent its most recent update on January 19th, 2024."

Answered by AI

What is the current number of participants being admitted into this clinical study?

"Indeed, clinicaltrials.gov confirms that this ongoing clinical trial is actively seeking individuals to participate. The initial posting of the trial took place on January 10th, 2024, and it was most recently updated on January 19th, 2024. The study aims to recruit a total of 100 participants from one designated location."

Answered by AI

Does this medical study include the participation of individuals who have surpassed their 85th year?

"For this particular clinical trial, potential participants must be within the age range of 45 to 70. It is important to note that there are separate clinical trials available for individuals under the age of 18 (consisting of three trials) and those over the age of 65 (comprising a total of sixty trials)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction

2024. "Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06219785.

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