Wound Healing Following Penile Prosthesis Implant

Randomized Control Trial of Vivex Tissue for Accelerated Wound Healing Following Penile Prosthesis Placement With Follow-up

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.

Study Overview

• Status: Terminated
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Biological: VIAGENEX Max; Procedure: Hibiclens wash

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 modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia. Even though it is not a part of normal aging, it is seen in 52% of men in the age group 40 to 70 years, with a higher rate in the men more than 70 years.

VIAGENEX Max is a semi-transparent, collagenous membrane intended for soft tissue barrier or wound covering, derived from umbilical cord membrane. A total of 50 subjects with ED meeting the eligibility criteria will be randomized. The treatment graft will be placed into the wound at time of surgery. The treatment group will receive the VIAGENEX graft and the sham group will receive the standard of care for this surgery.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • Atlanta Cosmetic Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viagenex Max; VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing.	Biological: VIAGENEX Max; Collagenous membrane derived from umbilical cord
Active Comparator: Standard of care; Hibiclens wash will be performed.	Procedure: Hibiclens wash; Antiseptic skin cleanser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile implant activation	Time to use implant for sexual activity	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after undergoing penile prosthesis surgery	Numerical pain scale (0=no pain to 10=worst pain) used to	surgery to 12 months

Collaborators and Investigators

• Sponsor: VIVEX Biologics, Inc.
• Investigators: Principal Investigator: Tariq Hakky, MD, Atlanta Cosmetic Urology

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: erectile dysfunction; Viagenex Max; penile implant
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Chlorhexidine gluconate
• Other Study ID Numbers: CYG-2021-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No