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.
PM-02124
02.2021
References
- Diabetes, Sexual & Bladder Problems. NIH: National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-problems/sexual-bladder-problems. Accessed March 2023.
- Definition & Facts for Erectile Dysfunction. NIH: National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/definition-facts. Accessed March 2023.
- Sooriyamoorthy T, Leslie SW. Erectile Dysfunction. [Updated 2022 May 27]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK562253/
- Renaissance School of Medicine, Stony Brook University Department of Urology. Male Incontinence. https://renaissance.stonybrookmedicine.edu/urology/male_incontinence.
- Surgery for Prostate Cancer. American Cancer Society. https://www.cancer.org/cancer/types/prostate-cancer/treating/surgery.html. Accessed August 2023.
- Penile curvature (Peyronie’s Disease). NIH: National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/urologic-diseases/penile-curvature-peyronies-disease. Accessed March 2023.
- Segundo A, Glina S. Prevalence, Risk Factors, and Erectile Dysfunction Associated With Peyronie’s Disease Among Men Seeking Urological Care. Sex Med. 2020 Jun;8(2):230-236.
- Skoogh J, Steineck G, Cavallin-Ståhl E, Wilderäng U, Håkansson UK, Johansson B, Stierner U; SWENOTECA. Feelings of loss and uneasiness or shame after removal of a testicle by orchidectomy: a population-based long-term follow-up of testicular cancer survivors. Int J Androl. 2011 Apr;34(2):183-92.
- Dieckmann KP, Anheuser P, Schmidt S, Soyka-Hundt B, Pichlmeier U, Schriefer P, Matthies C, Hartmann M, Ruf CG. Testicular prostheses in patients with testicular cancer – acceptance rate and patient satisfaction. BMC Urol. 2015 Mar 13;15:16.
- Li H, Gao T, Wang R. The role of the sexual partner in managing erectile dysfunction. Nat Rev Urol. 2016 Mar;13(3):168-77. doi: 10.1038/nrurol.2015.315. Epub 2016 Feb 2. PMID: 26832165.
- Data on file at Coloplast
- Bernal RM, Henry GD. Contemporary patient satisfaction rates for three-piece inflatable penile prostheses. Adv Urol. 2012;2012:707321.
- Symptoms and Causes of Erectile Dysfunction. NIH: National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/urologic-diseases/erectile-dysfunction/symptoms-causes. Accessed March 2023.
- Moses RA, Anderson RE, Kim J, Keihani S, Craig JR, Myers JB, Lenherr SM, Brant WO, Hotaling JM. Erectile dysfunction management after failed phosphodiesterase-5-inhibitor trial: a cost-effectiveness analysis. Transl Androl Urol. 2019 Aug;8(4):387-394.
- Walsh TJ, Hotaling JM, Smith A, Saigal C, Wessells H. Men with diabetes may require more aggressive treatment for ED. Int J of Impotence Research 2013; 26:112-115
- McCabe MP, Althof SE. A systematic review of the psychosocial outcomes associated with erectile dysfunction: does the impact of erectile dysfunction extend beyond a man’s inability to have sex? J Sex Med. 2014 Feb;11(2):347-63. doi: 10.1111/jsm.12374. Epub 2013 Nov 20. PMID: 24251371.
- Miller LE, Khera M, Bhattacharyya S, Patel M, Nitschelm K, Burnett AL. Long-Term Survival Rates of Inflatable Penile Prostheses: Systematic Review and Meta-Analysis. Urology. 2022 Aug;166:6-10.
- Tsikis ST, Nottingham CU, Faris SF. The Relationship Between Incontinence and Erectile Dysfunction After Robotic Prostatectomy: Are They Mutually Exclusive? J Sex Med. 2017 Oct;14(10):1241-1247. doi: 10.1016/j.jsxm.2017.08.002. Epub 2017 Sep 2. PMID: 28874332.