Wound Healing Following Penile Prosthesis Implant

Stopped early · Not applicable · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.

Key facts

Study ID

NCT05196191

Run by

VIVEX Biologics, Inc.

People needed

32

Starts

2022-01-03

Expected to finish

2023-12-30

Last updated by the study team

2024-03-01

Who can join

Age: 30 and older, up to 70. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• The patient must be willing and able to provide informed consent
• The patient is a male between >/= 30 and =/< 70 years of age
• The patient has ED based of International Index of Erectile Dysfunction (IIEF) scores
• The patient has been in a stable relationship for over 3 months prior to enrollment
• A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by IIEF
• The patient is suffering from erectile dysfunction and undergoing penile implant surgery for the first time
• IIEF-EF score between 16 and 25
• Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
• A1C level </= 7% within 1 month prior to enrollment

You may not qualify if…

• The patient is currently or has participated in another study within the past three months that may interfere with the results or conclusions of this study
• The patient is under judicial protection (prison or custody)
• The patient is an adult under guardianship
• The patient refuses to sign the consent
• History of radical prostatectomy or extensive pelvic surgery
• Evidence of venous leak
• Past radiation therapy of the pelvic region within 12 months prior to enrollment
• Recovering from any cancer within 12 months prior to enrollment
• Neurological disease such as Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator
• Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic that affects erectile function or any other medications at the discretion of the investigator
• Anatomical malformation of the penis, including Peyronie's disease
• Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
• A1C level > 7% within 1 month prior to enrollment or history of insulin dependent diabetes
• The patient is taking blood thinners and has an international normalized ratio >3
• Received shockwave treatment at least 6 months before enrollment

Where it is running

• Atlanta Cosmetic Urology — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.