Peyronie’s Disease

Coloplast Therapy Options That Can be Used in the Presence of Peyronie’s Disease



Titan® Inflatable Penile Prosthesis

FDA Approved for Use in the Presence of Peyronie’s Disease.

 

Coloplast Interventional Urology Men’s Health is pleased to announce the recent FDA approval to update the Titan IPP instructions for use to include steps for manual modeling in the presence of Peyronie’s Disease. This advancement demonstrates Coloplast’s rich history of providing innovative solutions for patients with intimate healthcare needs.

We are on the move for patients!

Coloplast Therapy Options

1)  Titan® Inflatable Penile Prosthesis – Utilizing a manual modeling technique when a Titan Coloplast Penile Prosthesis is implanted in the presence of Peyronie’s Disease.

2)  Genesis® Malleable Penile Prosthesis – This semi-rigid implant is designed for the management of erectile dysfunction stemming from a variety of issues, including Peyronie’s Disease.

3) Grafting Procedure – Grafting materials, such as Tutoplast® Pericardium Allograft can be used for the repair, replacement, reconstruction, or augmentation of soft tissue.

What are the Benefits of the New FDA Approval for Manual Modeling using Titan IPP?

  • Manual Modeling continues to be considered the gold standard for surgical treatment of concomitant Peyronie’s Disease and Erectile Dysfunction.

  • This exclusive labeling allows for expanded training and educational opportunities for surgeons and enhanced patient education.

  • The Manual Modeling technique, as outlined in the Titan instruction for use document, is now covered by the device replacement policy should a mechanical malfunction occur due to the technique.

Model for Success: Using Titan in the Presence of Peyronie’s Disease

Presented by: Laurence Levine, MD

 

In this on-demand webinar, Dr. Laurence Levine – a world-renowned expert on Peyronie’s Disease, provides a brief overview of urological society guidelines and relevant clinical literature regarding the use of a penile prosthesis in the presence of Peyronie’s Disease. He also discusses the key points of his manual modeling and modeling and grafting techniques.

 

Titan® and Titan® Touch Inflatable Penile Prosthesis Brief Statement

Indications
The Titan and Titan Touch Inflatable Penile Prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

Contraindications
The Titan, and Titan Touch Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with a documented sensitivity to silicone. Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. Patients unwilling to undergo any further surgery for device revision.

Warnings
Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition, leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical.

Precautions
Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery. Removal of an implanted prosthesis without timely reimplantation of a new prosthesis may complicate subsequent reimplantation or may make it impossible. A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits. The prosthesis should not be implanted in patients who lack the manual dexterity or strength necessary to operate the device. The device may be used in the presence of Peyronie’s Disease. If the manual modeling technique is to be utilized, see the Surgical Protocol for more information.

Potential Complications
Scrotal swelling, auto-inflation, discomfort, angulation/curvature, edema, device malfunction, chronic pain, difficulty with ejaculation, transient urinary retention, fever, migration, patient dissatisfaction, site infection, deflation, hematoma/seroma, wound leakage, bleeding, delayed wound healing, phimosis, sensory loss, cylinder aneurysm, fibrous capsule formation, over/under inflation, erosion, scrotal erythema, genital change, wound infection, and inguinal hernia.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Indications
The Genesis Prosthesis is designed for the management of impotence stemming from a variety of causes, including: epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; cystectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie’s disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

Contraindications
Implantation procedures are not advisable if infection is present anywhere in the body, especially urinary tract or genital infection.  The Prosthesis should not be used in patients who have unresolved problems such as elevated residual urine from bladder outlet obstruction, or neurogenic bladder.  The Prosthesis should be used with caution in diabetic patients who are more susceptible to infection and the complications of infection than nondiabetic patients.  Other contraindications include unresolved urinary problems, any condition which may hamper sexual activity (such as severe angina), a history of sensitivity to foreign materials, compromised wound healing, compromised immune system, any anatomic or physiologic abnormality that could lead to significant postoperative complications, an unwillingness to undergo any further surgery for revision and psychological instability of the patient.

Warnings
Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition, leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. This device contains solid silicone elastomer. The risks and benefits of implanting this device in patients with lupus, scleroderma, myasthenia gravis, or documented sensitivity to silicone should be carefully considered. The issue of the possible relationship between silicone (and other implantable materials) and various diseases has been the subject of debate.

Precautions
A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.  Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery.

Potential Complications
Scrotal swelling, discomfort, angulation/curvature, edema, device malfunction, pain, difficulty with ejaculation, transient urinary retention, fever, migration, infection, hematoma  wound leakage, bleeding, delayed wound healing.

See the device instructions for use for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp and/or consult the company website at www.coloplast.com.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

Coloplast IFU Tutoplast® Pericardium Allograft

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