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Shockwave Therapy + Platelet Rich Plasma for Erectile Dysfunction (COCKTAIL Trial)
COCKTAIL Trial Summary
This trial will study whether Shock Wave Therapy combined with Platelet Rich Plasma can improve erectile function by improving vasodilation and endothelial function in men with microvascular Erectile Dysfunction.
COCKTAIL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOCKTAIL Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COCKTAIL Trial Design
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Who is running the clinical trial?
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- You must agree to comply with all study related tests/procedures.My testosterone levels are either below 300 ng/dL or above 1197 ng/dL.I am between 30 and 80 years old.I use injections for erectile dysfunction treatment.I have tried ED medications without success.I am male.You are willing to have sex at least 4 times a month during the study, without using alcohol or recreational drugs.I have been in a stable, heterosexual relationship for over three months.I have not used hormones except for testosterone, clomiphene, or thyroid meds.I have been in a stable, heterosexual relationship for over three months.I have had erectile dysfunction due to physical causes for at least 6 months.I have had penile surgery, excluding circumcision and condyloma removal.I have a physical or nerve condition in my genital area that affects my sex life.I have had erectile dysfunction due to physical causes for at least 6 months.I have a condition like severe diabetes, multiple sclerosis, or Parkinson's affecting my nerves.I have a history of significant psychiatric disease or am currently on SSRI or psychotropic medications.I am between 30 and 80 years old.
- Group 1: SWT plus PRP Group
- Group 2: Sham SWT plus Placebo Saline Group
- 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
Are any additional participants needed for this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov attests that this medical experiment, which was initialised on June 27th 2022, is actively recruiting subjects. Approximately 60 participants are needed from 1 research centre."
What is the total participant quota for this medical experiment?
"Affirmative. According to clinicaltrials.gov, this trial is currently enrolling participants and was first made available on June 27th 2022 with the most up-to-date changes occurring on September 12th of the same year. The said research aims to recruit 60 volunteers from a single site."
Has the FDA sanctioned Shock Wave therapy (SWT) for public use?
"With limited evidence to support it, the safety rating of Shock Wave therapy (SWT) was appraised by our team at Power with a score of 1."
What characteristics make someone a suitable candidate for this research initiative?
"This clinical trial seeks 60 participants aged 30 to 80 with erectile dysfunction. To be considered for inclusion, applicants must agree to: Attempt sexual intercourse at least 4 times per month without being impaired by alcohol/recreational drugs., Abide by all study related tests/procedures., Present an International Index of Erectile Function-Erectile Function score between 12 and 25 at screening, Have a diagnosis of ED due to organic origin for 6 months prior to voluntary consent.."
Are individuals aged 35 and over eligible to become participants in this research?
"The guidelines for this trial dictate that the age range of eligible participants is between 30 and 80."
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