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Medical Device
Shockwave Therapy for Erectile Dysfunction After Prostate Cancer Surgery
N/A
Recruiting
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 month following liswt initiation
Awards & highlights
Study Summary
This trial tests LiSWT to see if it can improve erectile dysfunction after nerve-sparing prostatectomy for prostate cancer.
Who is the study for?
Men aged 18-80 with localized prostate cancer who've had nerve-sparing surgery to remove the prostate and experience erectile dysfunction. They must be willing to take ED medication, attempt sexual activity, and have been in a sexual relationship for at least 3 months. Excluded are those with prior penile surgery, pacemakers, substance abuse issues, recent investigational drug use or certain treatments like PRP.Check my eligibility
What is being tested?
The trial is testing if low-intensity shockwave therapy can improve erectile function after prostate removal surgery. Men will receive this painless treatment that aims to increase blood flow and tissue healing. The study includes surveys and compares active treatment against sham (fake) interventions.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of LiSWT may include mild pain during treatment, skin redness or bruising where treated, temporary swelling of the penis or surrounding area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 month following liswt initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 month following liswt initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient reported sexual function
Secondary outcome measures
Change in duplex doppler ultrasound measurement
Erectile function
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARM I (LiSWT)Experimental Treatment4 Interventions
Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.
Group II: ARM II (sham LiSWT)Placebo Group4 Interventions
Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duplex Ultrasound
2019
N/A
~90
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,409 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak or understand English.I am willing and able to follow all study rules and attend all appointments.I am unwilling to remove my genital piercings.I have had surgery on my penis before.I have undergone acoustic wave therapy before.I have difficulty making decisions due to cognitive impairment.I have received PRP treatment within the last 3 months.I have sores or infections on my genitals or nearby area.I need radiation or hormone therapy for my metastatic disease before starting shockwave treatments.I am willing to stop using any erectile aids not provided by this study.I am a man aged 18-80 with localized prostate cancer.I am scheduled for or have had a nerve-sparing prostate surgery.I am taking PDE5 inhibitor medication and will continue for the study duration.I have received a stem cell transplant within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: ARM I (LiSWT)
- Group 2: ARM II (sham LiSWT)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limitation for this clinical experiment capped at sixty or below?
"As indicated by the conditions of participation, the minimum and maximum age for this research project is 18 and 80, respectively."
Answered by AI
Am I eligible to become a participant in this research project?
"Those wishing to partake in this research project must suffer from erectile dysfunction and be aged between 18-80. Up to 30 participants will be accepted for participation."
Answered by AI
Are participants being recruited for this scientific trial at present?
"This particular study, which was first posted on June 1st 2023 and last modified on May 23rd, is no longer recruiting patients. Nevertheless, there are 1321 other opportunities available to prospective participants at this time."
Answered by AI
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