Prostate Health - Presented at WakeMed's Men's Health Event on 9/21/11

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  • The artificial urinary sphincter is similar to a penile prosthesis in concept but on a much smaller scale. This cuff wraps around the urethra and is closed at rest. When one feels the sensation to urinary, he simply pumps the control located in the scrotum and the cuff deflates, allowing the urine to drain. The cuff then spontaneously inflates after about a minute.
  • Prostate Health - Presented at WakeMed's Men's Health Event on 9/21/11

    1. 1. Men’s Health Solutions for Incontinence and Erectile Dysfunction Dr. Kevin Perry, September 21, 2011
    2. 2. Satisfying Solutions Understanding Male Continence
    3. 3. What is Incontinence? <ul><li>Male urinary incontinence is usually caused by a damaged sphincter, the circular muscle that controls the flow of urine out of the bladder. </li></ul><ul><li>When damaged, often the unavoidable result of prostate cancer surgery, the muscle cannot squeeze and close off the urethra. This causes urine to leak. </li></ul>“ My plumbing has a faulty washer”
    4. 4. <ul><li>Stress Urinary Incontinence (SUI) </li></ul><ul><li>Leakage during a physical activity like lifting, exercising, sneezing, and coughing, most common following prostate cancer surgery. </li></ul><ul><li>Urge Incontinence </li></ul><ul><ul><li>Leakage associated with an overwhelming need to urinate… Gotta go, gotta go! </li></ul></ul><ul><li>Overflow Incontinence </li></ul><ul><ul><li>Leakage when your bladder never completely empties </li></ul></ul><ul><li>Total Incontinence </li></ul><ul><ul><li>Leakage when the urinary sphincter muscle is completely deficient. </li></ul></ul>Types of Incontinence
    5. 5. How Does the Process Work? <ul><li>In men, the urinary sphincter muscle is located below the prostate. </li></ul><ul><li>The sphincter muscle surrounds the urethra. </li></ul><ul><li>When the sphincter muscle tightens, it holds urine in the bladder. </li></ul><ul><li>When it relaxes, the bladder contracts and the urethra opens, allowing urine to flow outside the body. </li></ul><ul><li>When the sphincter muscle is damaged, it cannot close off the urethra. </li></ul>
    6. 6. What Causes Incontinence? <ul><li>Prostate Cancer Surgery </li></ul><ul><ul><li>(Radical Prostatectomy or TURP) </li></ul></ul><ul><li>Conditions such as diabetes, multiple sclerosis, Parkinson’s disease or stroke </li></ul><ul><li>Pelvic Trauma </li></ul><ul><li>Birth Defects </li></ul>
    7. 7. <ul><li>150 men reported the practical inconveniences associated with incontinence 28 : </li></ul><ul><li>52% Extra laundry </li></ul><ul><li>37% Smell </li></ul><ul><li>17% Extra expense </li></ul><ul><li>12% Skin irritation </li></ul><ul><li>11% Disturbed sleep </li></ul>28 Hunskaar s, Sandvik H. one hundred and fifty men with urinary incontinence. Scand J Prim Health Care 1993 v. 11 p.193-196 Why Treat Incontinence?
    8. 8. Am I the only one suffering from Incontinence? <ul><li>Worldwide, 55 million men suffer from incontinence 29 . </li></ul><ul><li>5 million men in the United States suffer from incontinence 29 . </li></ul><ul><li>Rate of incontinence ranges between 2.5% up to 69% after prostate surgery 30 . </li></ul>NO! 29. AMS Market Research on file 30. Tewari A. et al. Anatomic Restoration Technique of Continence Mechanism and Preservation of Puboprostatic Collar: A Novel Modification to Achieve Early Urinary Continence in Men Undergoing Robotic Prostatectomy. Urology. 2007; 69(4): 726-731.
    9. 9. Can you Live Life Dry? Do you have to live with Incontinence? NO! YES!
    10. 10. Treatment Options for Stress Incontinence
    11. 11. Behavioral Modification and Medication <ul><li>Decrease fluid intake </li></ul><ul><li>Urinate frequently </li></ul><ul><li>Avoid caffeine, alcohol </li></ul><ul><li>Avoid activity that increases intra-abdominal pressure </li></ul><ul><li>No FDA approved medication for stress incontinence in men </li></ul>
    12. 12. Absorbent Products: Pads, Diapers <ul><li>Is this a satisfactory solution for you? </li></ul><ul><li>Are these the best solution? </li></ul><ul><li>How often is your patient changing them? </li></ul><ul><li>Skin irritation and rashes </li></ul><ul><li>Inconvenience </li></ul>
    13. 13. <ul><li>Cost is a factor… </li></ul>Absorbent Products: Pads, Diapers 31. Brown J.A., Elliott D.S., Barrett D.M. Post prostatectomy Urinary Incontinence: A Comparison of the Cost of Conservative Versus Surgical Management. Adult Urology. 1998; 51(5): 715-720 Cost Comparison of Wearing 5 Pads a Day for 10 Years Entrust Undergarments $0.99 each Active Style Pads $0.52 each Coveen Drip Collectors $1.05 each Depends Undergarments $0.52 each Cost/10 years 31
    14. 14. Devices: Clamps 32 <ul><ul><li>Cunningham Clamp, C3-clamp </li></ul></ul><ul><ul><li>Some Advantages </li></ul></ul><ul><ul><ul><li>Non-medical, non-surgical </li></ul></ul></ul><ul><ul><ul><li>Easy to use </li></ul></ul></ul><ul><ul><ul><li>Functional </li></ul></ul></ul><ul><ul><ul><li>Inexpensive </li></ul></ul></ul><ul><ul><li>Some Disadvantages </li></ul></ul><ul><ul><ul><li>Bulky </li></ul></ul></ul><ul><ul><ul><li>Scarring </li></ul></ul></ul><ul><ul><ul><li>Pain </li></ul></ul></ul><ul><ul><ul><li>Skin and tissue problems </li></ul></ul></ul>32. http://www.prostate-cancer.com/coping-with-prostate-cancer/incontinence-penile-clamps.html; downloaded 1/7/10
    15. 15. Devices: Catheters 33 <ul><ul><li>External vs. Internal </li></ul></ul><ul><ul><li>Some Advantages </li></ul></ul><ul><ul><ul><li>Functional </li></ul></ul></ul><ul><ul><li>Some Disadvantages </li></ul></ul><ul><ul><ul><li>Attached to a bag </li></ul></ul></ul><ul><ul><ul><li>Increased risk of infection </li></ul></ul></ul>33. http://www.prostate-cancer.com/coping-with-prostate-cancer/incontinence-condom-catheter.html, downloaded 11/17/10
    16. 16. Collagen Injections <ul><li>Collagen, carbon beads, autologous fat </li></ul><ul><li>Success rates for collagen ~ 17% after prostatectomy 34 </li></ul>34 Klingler HC et al. Incontinence after radical prostatectomy: surgical treatment options. Curr Opin Urol 2006; 16:60-64.
    17. 17. <ul><li>AdVance Male Sling </li></ul><ul><li>Artificial Urinary Sphincter </li></ul>Surgical Options
    18. 18. AdVance Male Sling: Benefits <ul><li>Outpatient surgery </li></ul><ul><li>May be performed under spinal or general anesthesia </li></ul><ul><li>Often no catheter necessary upon discharge </li></ul><ul><li>No device activation required </li></ul><ul><li>Immediate improvement 35 </li></ul><ul><li>Restored dignity and quality of life </li></ul>35. Rehder P., Gozzi C. Transobturator Sling Suspension for Male Urinary Incontinence Including Post-Radical Prostatectomy. Eur Urol 2007
    19. 19. AdVance Male Sling System <ul><li>AdVance is not for people with: </li></ul><ul><li>Urinary tract infections </li></ul><ul><li>Blood coagulation disorders </li></ul><ul><li>Compromised immune systems or any other condition that would compromise healing </li></ul><ul><li>Renal insufficiency and urinary tract obstruction </li></ul><ul><li>For a complete list of risks associated with AdVance, refer to: </li></ul><ul><li>device labeling at www.amselabeling.com . </li></ul><ul><li>Rx Only </li></ul>
    20. 20. <ul><li>The Gold Standard for treatment of moderate to severe incontinence </li></ul><ul><li>The cuff wraps around the urethra and is inflated/closed at rest </li></ul><ul><li>Pump in the scrotum deflates/opens sphincter and allows urination </li></ul><ul><li>The next slide will illustrate how this system works </li></ul>Artificial Urinary Sphincter
    21. 21. 1 2 3 Full Bladder Empty Balloon Cuff filled w/ saline
    22. 22. 36. Litwiller SE, et al. Post-prostatectomy incontinence and the artificial urinary sphincter; a long-term study of patient satisfaction and criteria for success. J of Urol 1996; 156:1975-1980. Artificial Urinary Sphincter <ul><li>Outpatient procedure </li></ul><ul><li>Effectively gives most men the ability to achieve continence </li></ul><ul><li>92% of patients would have the device placed again 36 </li></ul><ul><li>96% of patients would recommend it to a friend 36 </li></ul><ul><li>Device is placed completely inside the body, providing simple, discreet urinary control </li></ul><ul><li>Published clinical data shows long-term effective results </li></ul>
    23. 23. AMS 800 Artificial Urinary Sphincter <ul><li>The AMS 800 is not for those men: </li></ul><ul><li>Who are not good candidates for surgical procedures or anesthesia </li></ul><ul><li>With an irreversibly blocked lower urinary tract </li></ul><ul><li>With irresolvable detrusor hyperreflexia or bladder instability </li></ul><ul><li>With a known allergy or sensitivity to rifampin, mimocycline or other tetracyclines </li></ul><ul><li>For a complete list of risks associated with the AMS 800, refer to device labeling at www.amselabeling.com . </li></ul>
    24. 24. Summary <ul><li>Incontinence is a common problem </li></ul><ul><li>Some treatments are more effective than others </li></ul><ul><li>Surgical treatment options offer proven, long-term solutions </li></ul><ul><li>Talk to your Urologist – talk to your partner </li></ul><ul><li>You can Live Life Dry! </li></ul>
    25. 25. <ul><li>Rx Only </li></ul><ul><li>The AMS Sphincter 800™ Urinary Prosthesis device is intended to treat urinary incontinence due to reduced outlet resistance (Intrinsic Sphincter Deficiency). The device is contraindicated in patients who are determined to be poor surgical candidates, have an irreversibly blocked lower urinary tract, have irresolvable detrusor hyperreflexia or bladder instability, or (for the AMS 800 with InhibiZone ® ) have a known sensitivity or allergy to rifampin, minocycline or other tetracyclines. Patients with urinary tract infections, diabetes, spinal cord injuries, open sores or regional skin infections may have increased infection risk. Device-skin erosion may occur. Proper patient evaluation, selection and counseling of realistic expectations should occur. Possible adverse events include, but are not limited to, compromised device function, pain/discomfort, delayed wound healing, migration and recurrent incontinence. </li></ul><ul><li>Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contradictions, warnings, precautions and potential adverse events. </li></ul>Brief Summary – AMS AUS 800
    26. 26. Satisfying Solutions Erectile Restoration
    27. 27. Erectile Dysfunction (ED) <ul><li>What is it? </li></ul><ul><li>The inability to maintain an erection firm enough to have sexual intercourse </li></ul><ul><li>How prevalent is it? </li></ul><ul><li>1 in 5 American men 1 </li></ul><ul><li>Over 30 million American men 2 </li></ul><ul><li>Over 150 million men worldwide 2 </li></ul><ul><li>Causes: 90% physical, 10% psychogenic 3 </li></ul>1. Selvin E, Burnett A, Platz E. Prevalence and risk factors for erectile dysfunction in the US. Am Jour of Med 2007(120) 151-157 2. Sun P, Seftel A, Swindle R, Ye W, Pohl G. The costs of caring for erectile dysfunction in a managed care setting: evidence from a large national claims database. J Urol. 2005 Nov;174(5):1948-52 3. Mulligan T, Teitelman, J. Geriatric sexual dysfunction. Va Med Q. 1991 Spring;118(2):97-9.
    28. 28. Main Physical Causes of ED 4 Vascular Diabetes Medication Pelvic Surgery, Radiation or Trauma Neurological Causes Endocrine Problems Other 4. Goldstein I. Male sexual circuitry. Working Group for the study of central mechanisms in erectile dysfunction. Sci Am ., Aug 2000;283(2):70-75. Vascular Diabetes Medication Vascular
    29. 29. Degree of ED by Age 5 5. Dymedex Market Research Data on file at AMS Prevalence of ED by Age and Severity (%) Severe Moderate Mild or Mild/Moderate 100% 80% 60% 40% 20% 0%
    30. 30. Heart Disease and ED… <ul><li>Coronary artery risk factors are associated with ED </li></ul><ul><li>If you have cardiovascular disease, chances are you may be suffering from ED… and vice versa </li></ul><ul><li>In fact, ED could also stand for endothelial disease </li></ul><ul><li>Looking at Artery Sizes… </li></ul>
    31. 31. Nearly every man can be successfully treated. Do you have to live with ED? NO!
    32. 32. Treatment Options For Erectile Dysfunction
    33. 33. Oral Medications <ul><ul><ul><li>Not effective in approximately 30% of cases 6 </li></ul></ul></ul><ul><ul><ul><li>Work only in response to sexual stimulation 7 </li></ul></ul></ul><ul><ul><ul><li>Must take at least ½ hour to one hour before anticipated sexual activity 8 </li></ul></ul></ul><ul><ul><ul><li>Viagra ® can remain effective for up to 4 hours 7 , Cialis ® can be effective up to 36 hours 8 </li></ul></ul></ul><ul><ul><ul><li>High fat meals can affect absorption of Viagra 9 </li></ul></ul></ul><ul><ul><ul><li>Estimated cost per pill: $15-$30 10 </li></ul></ul></ul>6 Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PF, for the Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med. 1998 May 14;338(20):1397-404 7 http://www.viagra.com/taking-viagra/viagra-erectile-dysfunction/how-viagra-works.aspx; downloaded 3/3/11 8 http://www.cialis.com/Pages/what-to-know-about-cialis.aspx; downloaded 2/15/11 9 http://www.viagra.com/taking-viagra/how-to-take-viagra.aspx; downloaded 2/15/11 10 http://www.buyviagrapillsonline.com/; downloaded 3/3/11 Viagra is a trademark of Pfizer, Inc., Cialis is a trademark of Lily ICOS and Muse is a trademark of VIVUS, Inc.
    34. 34. Oral Medications <ul><li>Common side effects 7,12 </li></ul><ul><ul><ul><li>Headache, Facial Flushing, Runny Nose, Upset Stomach, Body Aches </li></ul></ul></ul><ul><li>What to watch out for 7,12 </li></ul><ul><ul><ul><li>Cannot take with NITRATES </li></ul></ul></ul><ul><ul><ul><li>Precautions with medications for prostate problems </li></ul></ul></ul><ul><ul><ul><li>If you have serious liver or kidney problems </li></ul></ul></ul>7 http://www.viagra.com/taking-viagra/viagra-erectile-dysfunction/how-viagra-works.aspx; downloaded 3/3/11 12 www.cialis.com/Pages/index.aspx; downloaded 11/12/2010
    35. 35. Vacuum Erection Device <ul><li>Some Advantages 14 </li></ul><ul><li>On-demand use </li></ul><ul><li>Non-invasive </li></ul><ul><li>Safe and effective </li></ul><ul><li>Drug free </li></ul><ul><li>Cost effective </li></ul>13. Levine L, Dimitrious R. Vacuum constriction and external erection devices in erectile dysfunction. Urologic Clinics of North America 2001 May (28) No. 2, 335-341 14. Yuan J., et al. Vacuum therapy in erectile dysfunction – science and clinical evidence. International Journal of Impotence Research. 2010; 12: 211-219 15. The Process of Care Consensus Panel. The process of care model for evaluation and treatment of erectile dysfunction. Int J Impot Res. 1999;11:59 - 70. Position Paper. 16. Miner M.M., Kuritzky L. Erectile Dysfunction: A sentinel marker for cardiovascular disease in primary care. Cleveland Clinic Journal of Medicine. 2007 May; 74 (3); 30-37 <ul><li>Some Disadvantages </li></ul><ul><li>Cumbersome 16 </li></ul><ul><li>Unnatural erection 16 </li></ul><ul><li>Erection is not warm to the touch 16 </li></ul><ul><li>Bruising/burst blood vessels 13, 15 </li></ul><ul><li>Penile pain/discomfort 15 </li></ul><ul><li>Numbness 15 </li></ul><ul><li>Delayed ejaculation 15 </li></ul>
    36. 36. Urethral Suppository: MUSE ® <ul><li>Small medicated pellet placed in the tip of the penis </li></ul><ul><li>opens blood vessels to increase blood flow to the penis. </li></ul>MUSE is a trademark of VIVUS, Inc. 17. http://www.muserx.net/res/pack_inserts_PFI_1.3.pdf downloaded 11/12/10 18. http://www.infertility-male.com/erectdys/muse.htm, downloaded 2/15/11 <ul><li>Some Disadvantages </li></ul><ul><li>Penile Pain & Burning 17 </li></ul><ul><li>Inadequate penile ridigity 18 </li></ul><ul><li>Must be refrigerated 17 </li></ul><ul><li>Cost is approximately $25 per application 18 </li></ul><ul><li>Patients with poor manual dexterity/vision or severe obesity may find administration difficult </li></ul><ul><li>Some Advantages </li></ul><ul><li>No needles or injections </li></ul><ul><li>Erection within 10 to 15 minutes 17 </li></ul>
    37. 37. Penile Injection Therapy <ul><li>Some Advantages </li></ul><ul><li>Effective 19 </li></ul><ul><li>On-set of erection within 5-20 minutes 19 </li></ul><ul><li>Some Disadvantages </li></ul><ul><li>Risk of erection lasting 4 hours or more (priapism) 20 </li></ul><ul><li>Possible bleeding at injection site 20 </li></ul><ul><li>Possible pain at injection site 20 </li></ul><ul><li>Requires training 20 </li></ul><ul><li>Bruising, prolonged erection, cavernosal fibrosis 21 </li></ul><ul><li>Can cause Peyronie’s disease 21 </li></ul><ul><li>Poor long-term tolerability 22 </li></ul><ul><li>Fear of sticking needle in penis 22 </li></ul>19. http://www.caverject.com/AboutCI.aspx, downloaded 2/15/11 20. Pharmacia and Upjohn Company http://media.pfizer.com/files/products/ppi_caverject_powder.pdf; October 2002 21. http://www.caverject.com/ISI.aspx; downloaded 3/8/11 22. Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile dysfunction in urology practice. J Urol Jul 2003 v.170(1)p.159-63.
    38. 38. Penile Implants <ul><li>Ideal for men who have tried other treatments without success </li></ul><ul><li>On the market for over 30 years </li></ul><ul><li>Over 300,000 implants to date 23 </li></ul><ul><li>High patient and partner satisfaction 24 </li></ul>23 &quot;Penile Prosthesis.&quot; The Sexual Medicine Web Site. 2008. European Society for Sexual Medicine. 23 Jan 2009 http://www.essm.org/patient-area/penileprosthesis.asp; downloaded 1/8/09 24 Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis: results of a 2 center study. J Urol. 2001 Sep;166(3):932-7
    39. 39. Penile Implant Versus Other Treatment Options 25. Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile dysfunction in urology practice. J Urol Jul 2003 v.170(1)p.159-63. Overall Patient Satisfaction with ED Treatments 25 Percentage Satisfied n=22 n=31 n=32
    40. 40. Three-Piece Inflatable Penile Implant <ul><li>Some Advantages </li></ul><ul><li>Totally concealed in body </li></ul><ul><li>Like a natural erection </li></ul><ul><li>Device is inflated to provide rigidity and deflated for concealment </li></ul><ul><li>Erection longevity is controllable </li></ul><ul><li>When deflated, the cylinders are soft and flaccid </li></ul><ul><li>Expands in girth (all AMS 700 ® cylinders) and length (AMS 700 LGX™ and Ultrex™ cylinders) </li></ul><ul><li>AMS 700 with InhibiZone ® is the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision due to infection </li></ul>
    41. 41. Implants are Highly Recommended 26 26. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis; results of a 2 center study. J Urol. 2001 Sep; 166 (3) :932-7 These recommendations pertain to the AMS Two-piece inflatable prosthesis
    42. 42. <ul><li>Offers a long-term solution to ED </li></ul><ul><li>Provides the ability to have an erection </li></ul><ul><li>anytime you choose </li></ul><ul><li>Allows for greater spontaneity – have sex when the mood strikes </li></ul><ul><li>Enables you to maintain an erection as long as you desire </li></ul><ul><li>Eliminates the need for costly pills or shots </li></ul><ul><li>Feels natural during intercourse 27 </li></ul><ul><li>Does not interfere with ejaculation or orgasm </li></ul>Benefits 27 Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis; results of a 2 center study. J Urol. 2001 Sep; 166 (3) :932-7
    43. 43. Possible Risks <ul><li>Will make latent natural or spontaneous erections as well as other interventional treatment options impossible </li></ul><ul><li>If an infection occurs, the prosthesis may have to be removed </li></ul><ul><li>May cause the penis to become shorter, curved or scarred </li></ul><ul><li>There may be mechanical failures of the prosthesis </li></ul><ul><li>Pain </li></ul>
    44. 44. <ul><li>As with any medical procedure, there are risks involved and not all patients are candidates for a penile implant. Discuss the risks and benefits of this procedure in more detail with your doctor. </li></ul><ul><li>For a complete list of indications, contraindications and precautions, contact your Urologist or refer to specific device labeling at www.amselabeling.com </li></ul>
    45. 45. Insurance Coverage <ul><li>Is a penile implant covered by insurance or Medicare? </li></ul>
    46. 46. Summary <ul><li>ED is a common problem </li></ul><ul><li>Nearly every man can be successfully treated for ED </li></ul><ul><li>Penile implants offer a dependable, long-term solution </li></ul><ul><li>Talk to your partner, talk to your Prosthetic Urologist </li></ul>
    47. 47. Questions?
    48. 48. <ul><li>As with most surgical procedures, inherent risks are present and potential adverse reactions may occur. Although rare, some of the most severe risks include infection, erosion, and perforation. Some potential adverse reactions to surgical procedures to correct incontinence include: </li></ul><ul><li>• Pain/Discomfort/Irritation </li></ul><ul><li>• Inflammation </li></ul><ul><li>• Incomplete correction of urinary incontinence </li></ul><ul><li>• Urinary Tract Infections/Obstruction/Retention </li></ul><ul><li>• Urge symptoms </li></ul><ul><li>• Difficulty with urination </li></ul><ul><li>You should talk to your doctor about the benefits and risks before moving forward with any treatment option. For additional product and risk information visit: </li></ul><ul><li>www.AmericanMedicalSystems.com </li></ul>

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