Wound Healing Following Penile Prosthesis Implant

NCT05196191 | Terminated

• 1 other identifier: CYG-2021-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 randomized in a 2:1 ratio of active to sham treatment groups.

Conditions

Erectile Dysfunction

Keywords

Viagenex Max; penile implant; erectile dysfunction

Outcome Measures

Primary Outcomes (1)

• Penile implant activation

  Time to use implant for sexual activity

  up to 3 months

Secondary Outcomes (1)

• Pain after undergoing penile prosthesis surgery

  surgery to 12 months

Study Arms (2)

Viagenex Max

EXPERIMENTAL

VIAGENEX Max graft will be placed in the incision at the end of surgery prior to closing.

Biological: VIAGENEX Max

Standard of care

ACTIVE COMPARATOR

Hibiclens wash will be performed.

Procedure: Hibiclens wash

Interventions

VIAGENEX Max BIOLOGICAL

Collagenous membrane derived from umbilical cord

Viagenex Max

Hibiclens wash PROCEDURE

Antiseptic skin cleanser

Standard of care

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead

Study Sites (1)

Atlanta Cosmetic Urology

Atlanta, Georgia, 30305, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Tariq Hakky, MD

  Atlanta Cosmetic Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will not be told which treatment group they receive until the end of study participation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects meeting criteria will be randomized 4:1 treatment (Viagenex Max) or sham (standard of care).

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 19, 2022
• Study Start: January 3, 2022
• Primary Completion: December 13, 2023
• Study Completion: December 30, 2023
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)