Back to results

Wound Healing Following Penile Prosthesis Implant

Primary Purpose

Erectile Dysfunction

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VIAGENEX Max

Hibiclens wash

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Viagenex Max, penile implant, erectile dysfunction

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Atlanta Cosmetic Urology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Viagenex Max

Standard of care

Arm Description

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

Hibiclens wash will be performed.

Outcomes

Primary Outcome Measures

Penile implant activation

Time to use implant for sexual activity

Secondary Outcome Measures

Pain after undergoing penile prosthesis surgery

Numerical pain scale (0=no pain to 10=worst pain) used to

Full Information

NCT ID

NCT05196191

First Posted

December 14, 2021

Last Updated

October 17, 2023

Sponsor

VIVEX Biologics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05196191

Brief Title

Wound Healing Following Penile Prosthesis Implant

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 3, 2022 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VIVEX Biologics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Viagenex Max, penile implant, erectile dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

Subjects will not be told which treatment group they receive until the end of study participation.

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Viagenex Max

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of care

Arm Type

Active Comparator

Arm Description

Hibiclens wash will be performed.

Intervention Type

Biological

Intervention Name(s)

VIAGENEX Max

Intervention Description

Collagenous membrane derived from umbilical cord

Intervention Type

Procedure

Intervention Name(s)

Hibiclens wash

Intervention Description

Antiseptic skin cleanser

Primary Outcome Measure Information:

Title

Penile implant activation

Description

Time to use implant for sexual activity

Time Frame

up to 3 months

Secondary Outcome Measure Information:

Title

Pain after undergoing penile prosthesis surgery

Description

Numerical pain scale (0=no pain to 10=worst pain) used to

Time Frame

surgery to 12 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tariq Hakky, MD

Organizational Affiliation

Atlanta Cosmetic Urology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Atlanta Cosmetic Urology

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared.

Learn more about this trial

Wound Healing Following Penile Prosthesis Implant

We'll reach out to this number within 24 hrs