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Procedure

Shockwave Therapy for Erectile Dysfunction

N/A

Waitlist Available

Led By Ranjith Ramasamy, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Undergo radical prostatectomy for prostate cancer (nerve sparing or non-nerve sparing without neoadjuvant chemotherapy or radiation therapy.)

Be ≥ 40 and ≤ 75 years of age (inclusive).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months and baseline to 12 months.

Awards & highlights

Study Summary

This trial tested if shockwaves can help men with ED after prostate surgery, comparing it to no treatment.

Who is the study for?

Men aged 40-75 who've had prostate cancer surgery, are in a stable relationship, and have moderate to severe erectile dysfunction can join. They must not be on certain medications or treatments that affect sexual function, have normal testosterone levels, no recent cancer other than prostate cancer, and no detectable PSA.Check my eligibility

What is being tested?

The study is testing if Shockwave Therapy (SWT) is better than a placebo (fake treatment) for improving erectile function in men who've had surgery for prostate cancer. Participants will randomly receive either real SWT or sham therapy to compare outcomes.See study design

What are the potential side effects?

While the trial information provided does not specify side effects of Shockwave Therapy for ED post-prostatectomy, typical concerns may include pain during treatment, skin redness or bruising at the site of shockwaves.

Eligibility Criteria

Inclusion Criteria

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

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I am having or had a major surgery for prostate cancer without prior strong cancer treatments.

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I am between 40 and 75 years old.

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I am male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months and baseline to 12 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months and baseline to 12 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months and baseline to 12 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

Change in number of participants reporting on Penetrative Intercourse

Secondary outcome measures

Change in EHS- Erection Hardness Score

Change in GAQ- Global Assessment Questions

Change in IIEF-EF Scores

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SWT groupActive Control1 Intervention

Participants randomized to the treatment group will receive nine (9) shockwave sessions in total: one (1) shockwave session once per week for four (4) weeks, followed by one (1) shockwave session once per month (30±7 days) for the next five (5) months. 1,440 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) for a total of 12,960 shocks. Participants will be in this group for up to 6 months.

Group II: SHAM groupPlacebo Group1 Intervention

Participants randomized to the sham (control) group will have nine (9) sham therapy sessions in total: one (1) sham session once per week for four (4) weeks, followed by one (1) sham session once per month (30±7 days) for the next five (5) months. The shockwave machine will be set to deliver 1,440 shock treatments, but a barrier will be placed around the shockwave probe to ensure that no shockwaves are delivered. Participants will be in this group for up to 6 months.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

University of MiamiLead Sponsor

898 Previous Clinical Trials

409,552 Total Patients Enrolled

6 Trials studying Erectile Dysfunction

502 Patients Enrolled for Erectile Dysfunction

Ranjith Ramasamy, MDPrincipal InvestigatorUniversity of Miami

12 Previous Clinical Trials

828 Total Patients Enrolled

4 Trials studying Erectile Dysfunction

247 Patients Enrolled for Erectile Dysfunction

Frequently Asked Questions

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

Could I potentially qualify to participate in this experiment?

"To qualify for this study, individuals must be experiencing erectile dysfunction and within the age range of 40 to 75 years old. The research team plans on recruiting 99 participants in total."

Answered by AI

Does this trial permit minors to participate?

"Participants must be 40 years or older, and not exceed the age of 75 to qualify for this trial."

Answered by AI

Is there still space available for participants in this experiment?

"The clinical trial associated with this study has currently concluded their patient recruitment. This experiment was initially posted on August 1st 2024 and subsequently last updated on November 29th 2023. Luckily, there are 64 other studies that are presently recruiting participants for similar treatments and medications."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy

Ranjith Ramasamy, MD 2024. "Clinical Trial of Low Intensity Shockwaves Therapy for Erectile Dysfunction Post-Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06152146.

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