Status:
TERMINATED
Wound Healing Following Penile Prosthesis Implant
Lead Sponsor:
VIVEX Biologics, Inc.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
30-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various m...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05196191
Start Date
January 3 2022
End Date
December 30 2023
Last Update
March 1 2024
Active Locations (1)
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1
Atlanta Cosmetic Urology
Atlanta, Georgia, United States, 30305