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ED, EjD, and Hypogonadism in Diabetic Males. Steven N. Gange, MD, FACS. 4252 S. Highland Drive. Lane Childs, MD Peter Fisher, MD Steven Gange, MD Scott Hopkins, MD Regan Brooks, PA-C Elizabeth Darling, PA-C. This is a talk about sex, and contains potentially offensive images….

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ED, EjD, and Hypogonadism in Diabetic Males

Steven N. Gange, MD, FACS


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4252 S. Highland Drive

Lane Childs, MD

Peter Fisher, MD

Steven Gange, MD

Scott Hopkins, MD

Regan Brooks, PA-C

Elizabeth Darling, PA-C


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This is a talk about sex, and containspotentially offensive images…


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Men’s Health Statistics

Reality bites…


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With Respect to American Women, Men…

  • Die 7 years younger (1 year younger in 1920)

  • Die more often from all 15 leading causes of death (except Alzheimer’s)

  • Greater risk of serious chronic diseases, and suffer from them at an earlier age

  • Are twice as likely to die from heart disease (3 of 4 heart attack deaths under 65 are men)


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With Respect to American Women, Men…

  • More likely to be drug abusers, pathological gamblers, alcoholics, and smokers…


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With Respect to American Women, Men…

  • Are responsible for 8 of 10 car accidents!


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Men Avoid Doctors

  • Twice as many men than women have no regular source of medical care

  • Men comprise 70% of those who haven’t seen a doctor in the past 5 years

  • 25% of men would wait “as long as possible” to see a doctor


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And, yet…

  • What universally gets a man’s attention:


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Older Men Are Still Sexually Active

92%

Sexual activity = Intercourse, masturbation and any activity that the participant considered “sexual”

83%

83%

100%

65%

80%

60%

% of men with sexual activity in the last 4 weeks

40%

20%

0%

Total

50-59

60-69

70-79

Age

Rosen R. Multinational Survey of the Aging Male (MSAM-7). Presented at the

Annual Meeting of the AUA ; May 26, 2002; Orlando, Fla.


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Massachusetts Male Aging Study:Prevalence of Erectile Dysfunction (ED)

  • In 2005, 30 million men are affected worldwide

  • By 2025, over 300 million men will have ED

Feldman HA et al. J Urol. 1994;151:54-61.


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Major Risk Factors for ED: Aging

Age-Adjusted Progression of ED

67

57

48

Prevalence (%)

40

Severe ED

Moderate ED

Mild ED

Feldman HA, Goldstein I, Hatzichristou DG et al. Impotence and its medical and psychosocial correlates: results from the Massachusetts Male Aging Study. J Urol. 1994;151(1):54-61.


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Major Risk Factors for ED

  • Aging

  • Chronic diseases

    • Hypertension

    • Diabetes

    • Depression

    • Cardiovascular disease

  • Medications

    • Antihypertensives

      • Thiazide diuretics

      • Beta-blockers

  • Lifestyle

    • Stress

    • Alcohol abuse

    • Smoking

Feldman HA et al. J Urol. 1994;151:54-61.


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ED and Endothelial Injury

Precursors

Diabetes

Dyslipidemia

OxidativeStress

Hypertension

Tobacco

EndothelialCell Injury

Vasoconstriction

Atherosclerosis

Erectile Dysfunction

Thrombosis

Outcomes

Dzau et al. Am J Cardiol. 1997;80:33I-39I

Cooke, Dzau. Annu Rev of Med. 1997;48:489-509

Solomon et al. Heart. 2003;89:251-254.






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Biochemistry of an Erection:The Nitric Oxide (NO) Story

  • Prior to 1990: an air pollutant

  • Named “Molecule of the Year” by Science magazine in 1992

  • Nobel Prize in Medicine 1998 to 3 PhDs responsible for discovery


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Phosphodiesterases

  • Main role: termination of cyclic nucleotide second messenger signal, often cGMP

  • 11 PDE groups (PDE 1-11)

  • PDE-5 breaks down cGMP (the second messenger of Nitric Oxide—NO), reversing the muscle-relaxant effect of NO

  • PDE-5 is found in corpus cavernosum, vascular and visceral muscles, and in platelets


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N.O. Release Increases Penile Bloodflow

Lue,T. NEJM 2000. 342:1802


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PDE-5 Terminates the Process and Slows Blood Flow

Norepinephrine

released

Lue,T. NEJM 2000. 342:1802




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Components of Ejaculation

  • Seminal emission: semen is delivered into the posterior urethra

  • Propulsion of semen from the posterior urethra outside, involving muscular contractions of the epididymus, vas deferens, seminal vesicles, and prostate

  • Simultaneous bladder neck closure

  • Orgasm is the sensation that accompanies ejaculation in the male (it is rare for one to occur without the other)


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Erection and Ejaculation Necessities

  • Libido

  • Intact neural pathway

  • Adequate blood inflow

  • Expandable penis

  • Compressible veins

  • Continued stimulation

  • Prostate and seminal vesicles

  • Competent bladder neck


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Erection and Ejaculation Necessities

  • Libido

  • Intact neural pathway

  • Adequate blood inflow

  • Expandable penis

  • Compressible veins

  • Continued stimulation

  • Prostate and seminal vesicles

  • Competent bladder neck


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It doesn’t take much for a man with testosterone to become aroused


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Male Hypogonadism(symptomatic low testosterone level)


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Hypothalamus

Production and Regulationof Testosterone

GnRH

Pituitary

Free T

2%

FSH

Testosterone

LH

Albumin-

bound T

38%

SHBG-bound T

60%

Testis

40% of serum testosterone is “bioavailable”

Testosterone

Adapted from Braunstein G.D.. In: Basic & Clinical Endocrinology. 5th ed. Stamford, Conn: Appleton & Lange; 1997:403-433.

Sperm

Adapted from Bagatell C.J., Bremner W.J.. N Engl J Med. 1996;334:707-715.


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Testosterone At Work

Dihydrotestosterone (DHT) is the primary end-organ androgen


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Hypogonadism in the Aging Man

  • All components of testosterone decline with normal aging

  • Decline in Leydig cell count and function

  • Increase SHBG, lowers bioavailable T

  • Not all men with low testosterone have symptoms or need treatment

Tenover J.L. Endocrinol Metab Clin North Am. 1998;27:969-987.

Swerdoff, R.S. Summary of the Consensus Session from the 1st Annual

Andropause Consensus Meeting. The Endocrine Society, April 2000.


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Age-Related Changes in Testosterone

20

(177)

18

(144)

(151)

16

Testosterone (nmol/L)

(109)

14

(43)

(158)

12

10

30

40

50

60

70

80

90

Age (Years)

Adapted from Harman S.M., et al. J Clin Endocrinol Metab. 2001;86:724-731.


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Rates of Low T in Selected Conditions

Other Areas of Concern

HIV/AIDS

30% of HIV-infected men and 50% of men with AIDS have low testosterone.2

Chronic Pain

74% of men consuming sustained-action oral opioids have low testosterone.3

Type 2 Diabetes

Hyperlipidemia

Hypertension

Obesity

1. Mulligan, et al. Int J Clin Pract 2006 Jul;60(7):762–769

2. Dobs A.S. Clin Endocrinol Metab 1998;12:379-370

3. Daniell HW. J Pain 2002 Oct;3(5):377-84


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Potential Effects of Hypogonadism

Long-term complications

  • Decline in libido and erectile function

  • Increased body fat mass

  • Decreased muscle mass, bone mass, and strength

  • Possibly: fatigue, mood / cognitive changes

  • Increased incidence of osteoporosis

Tenover J.L.. Endocrinol Metab Clin North Am. 1998;27:969-987.

Petak S.M., et al. AACE Clinical Practice Guidelines. Available at: http://www.aace.com/clin/guidelines/hypogonadism.html.


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Hormones and Osteoporosis

Annual Fracture Incidence

Donaldson L..F, et al. J Epidemiol Community Health. 1990;44:241-245.


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Testosterone and Sex

  • ED exclusively related to hypogonadism is rare (5%)

  • In hypogonadal men with ED, return to low level of normal testosterone range is adequate

  • Libido is most likely to improve with treatment

  • Spermatogenesis is greatly reduced with testosterone replacement, and may not be reversible with cessation

Bhasis, S., Mayo Clin Proc 2000; 75: S70.

Leungwattanakij, S., et al, Mediguide to Urology, 2000; 13:1.


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Diagnostic Testosterone Testing: Initial Tests

  • Serum Total Testosterone (free plus protein-bound)

    Morning sample recommended in young men

    Reasonable screening tool

  • Serum Free Testosterone (nonprotein-bound) Better in older/obese men

  • Serum Bioavailable T (free plus albumin-bound)

    Measures albumin-bound and free testosterone

    Best test, most expensive

    .

Tenover J.L.. Endocrinol Metab Clin North Am. 1998;27:969-987.

Braunstein G.D.. In: Basic & Clinical Endocrinology. 5th ed. Stamford, Conn: Appleton & Lange; 1997:403.


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Diagnostic Testosterone Testing: Additional Tests

  • LH and FSH

  • Serum Prolactin

  • Baseline PSA, Hematocrit

Tenover J.L.. Endocrinol Metab Clin North Am. 1998;27:969-987.


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Risks of Testosterone Replacement Therapy (TRT)

  • Hepatic adverse effects with oral therapy

  • Polycythemia

  • Edema

  • Gynecomastia

  • Precipitation or worsening of sleep apnea

  • Infertility

  • Acceleration of BPH or Prostate Cancer

Petak S.M., et al. AACE Clinical Practice Guidelines. Available at: http://www.aace.com/clin/guidelines/hypogonadism.html.

S.Leungwattanakij, et al. Mediguide to Urology 2000; 13:1.


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Absolute Contraindications of TRT

  • Male breast cancer

  • Known or suspected prostate cancer

  • Hematocrit > 55%

  • Known or suspected sensitivity to ingredients used in testosterone therapy systems

Petak S.M., et al. AACE Clinical Practice Guidelines. Available at: http://www.aace.com/clin/guidelines/hypogonadism.html.

Cunningham, G.R. Summary of the Consensus Session from the 2nd Annual Andropause Consensus Meeting. The Endocrine Society, April 2001.


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Testosterone Delivery Systems

  • Oral and transmucosal tablets

  • Injectables

  • Transdermal patches

  • Transdermal gel

Petak S.M., et al. AACE Clinical Practice Guidelines. Available at: http://www.aace.com/clin/guidelines/hypogonadism.html.

Bals-Pratsch M./, et al. Acta Endocrinol (Copenh). 1988;118:7-13.

Arver S., et al. J Urol. 1996;155:1604-1608.


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Oral Testosterone

  • Oral free- and methyl-testosterone: 98% first pass effect in liver; hepatotoxic

  • Transmucosal delivery (Striant): - twice a day

    - doesn’t fully dissolve

Leungwattanakij, S. et al, Mediguide to Urology, 2000; 13:1.


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Injectable Delivery Systems

  • Testosterone enanthate and cipionate (t1/2 = 4.5 d)

    200 mg injection dosed every 14 to 21 days

    100 mg every week minimizes troughs

  • Testosterone proprionate (t1/2 = 0.8 d) must inject every 2-3 days

Leungwattanakij, S. et al, Mediguide to Urology, 200; 13:1.


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Testosterone Enanthate 250 mg Administered IM Every 3 Weeks

Behre HM, et al. In: Testosterone: Action, Deficiency, Substitution. Berlin, Germany: Springer-Verlag; 1998:329-348.


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Transdermal Patches

  • Androderm 5 mg/d, applied to back, abdomen, etc

    High rate of skin irritation

Leungwattanakij, S. et al, Mediguide to Urology, 200; 13:1.


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AndroGel® and Testim™

  • Most physiologic application method

  • Testosterone gel 1%

    Recommended starting dose: 5 g / day to deliver 5 mg testosterone

    Can be titrated up to 10 g per day

    Wait 5-6 hrs after dosing to swim/shower

    Avoid partner contact with area

Wang C, et al. J Clin Endocrinol Metab. 2000;85:2839-2853.


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AndroGel vs. AndrodermMean Steady-state Concentrations

24-Hour Concentrations on Day 90 of Therapy

Upper limit of

Normal Range

T Gel 1% 5 g

T Gel 1% 10 g

T Patch 5 mg

Lower limit of

Normal Range

Wang C, et al. J Clin Endocrinol Metab. 2000;85:2839-2853.


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TRT Efficacy and Cost

  • Efficacy: Gel = Patch > Shots

  • Side Effects: Shots > Patch > Gel

  • Cost: Gel > Patch > Shots

  • Testosterone enanthate $21/mo Androderm 5gm $178/mo AndroGel 5gm $197/mo Testim 50mg $181/mo

Harmon’s Pharmacy 8/07


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Evaluation of ED: Tests

  • AMTestosterone, if low libido

  • Glucose (fasting or at least dipstick)

  • Thyroid tests

  • Fasting lipid profile

  • Total PSA if age-appropriate

  • Others, selectively: - Nocturnal tumescence testing - Penile doppler studies



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Sexual Activity Requires the Same Effort as Gardening

Description

Physical Activities

Estimated METs

2

Sitting

Reading, watching TV

3

Very light exertion

Moderate sexual activity with long-term partner, office work, strolling in park

4-5

Moderate exertion

Vigorous sexual activity, normal walking, golfing on foot, gardening

5-6

Vigorous to

heavy exertion

Running, racquetball, fast biking, heavy snow-shoveling

METs = metabolic equivalents of oxygen consumption

Adapted from DeBusk et al. Am J Cardiol. 2000;86:175-181.


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Patient Preferences for ED Treatment Options

Oral therapies are the preferred treatment option by patients with ED

Percent

Injectiontherapy

Oral

Intraurethraltherapy

Surgery

Prosthesis

Vacuum

Braun et al. Int J Imp Res. 2000;12:305.


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Mechanism of Action of PDE5 Inhibitors

Lue, T NEJM 2000. 342:1802


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PDE5 Inhibitors: Pharmacokinetics

1Klotz et al. ACCP. 2002;2 As reported in Kim et al. Formulary. 2002;37.

*Median (range).


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MyTake on PDE-5 Inhibitors

  • All three are excellent drugs for ED

  • All work best with practice

  • All work least well in post-prostatectomy patients

  • Can’t use ANY with nitrates

  • Some patients prefer “spontaneity” of tadalafil


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Patient Preferences for ED Treatment Options

Oral therapies are the preferred treatment option by patients with ED

…but 100,000 men fail oral ED therapy PER MONTH!

Percent

Injectiontherapy

Oral

Intraurethraltherapy

Surgery

Prosthesis

Vacuum

Braun et al. Int J Imp Res. 2000;12:305.



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MUSE (Medicated Urethral System for Erection)



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Penile Prosthesis Surgery

  • 1936: human rib cartilage inserted into corpora

  • Silicone prostheses implanted successfully since 1973: - 29,000 in 1991 - 8,000 in 1998 - 17,000 in 2001 - 23,000 in 2009 - 90,000 breasts; 600,000 hips/knees - penile prostheses have lower infection and revision rates than breast and orthopedic implants - well-controlled diabetics do well, no higher infection rate

  • An EXCELLENT option




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AMS 700 Penile Prosthesis with InhibiZone™

  • InhibiZone™ is the first FDA approved permanent implant with an antibiotic surface treatment

  • InhibiZone™ is a combination of rifampin and minocycline HCl impregnated into the outer silicone surface of the device


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Coloplast Titan

  • Girth enhancement vs AMS

  • Hydrophilic coating which

    absorbs antibiotic fluid

    (R10/G1)


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Step-Care Approach toED Management

Therapeutic Options

Second-Line Therapy

Vacuum constriction device

Intracavernosal injection or

Transurethral therapy

ED Unresolved

ED Unresolved

First-Line Therapy

Third-Line Therapy

Lifestyle / drug therapy modification

Psychosocial counseling

Androgen replacement therapy

Oral therapy

Penile Prosthesis

Recommendations of the 1st International Consultation on Erectile Dysfunction.

In: Erectile Dysfunction; Jardin A, et al, eds. Plymouth, UK: Health Publication Ltd; 2000:725


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Its never so “broke” that a

Urologist can’t fix it


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Ejaculatory Dysfunction

  • Anejaculation

  • Retrograde Ejaculation

  • Premature (Rapid) Ejaculation


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Anejaculation

  • Different than “anorgasmia” (usually psychogenic)

  • Medical Causes:

    • Anatomical/Surgical: Obstruction of the ejaculatory duct; Radical Prostatectomy (for cancer)

    • Neurogenic (“sympathectomy”): severe lumbar disk disease or surgery; retroperitoneal lymph node dissection for testis cancer; spinal cord injury

    • Medications: certain alpha-blockers for benign prostatic hyperplasia (BPH)—e.g., tamsulosin (Flomax®); SSRIs

    • Inflammatory: prostatitis can inhibit ejaculatory function


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Retrograde Ejaculation

  • Medical Causes:

    • Anatomical/Surgical: TURP (resection of the bladder neck)

    • Medications: certain alpha-blockers for benign prostatic hyperplasia (BPH)—e.g., tamsulosin (Flomax®)


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Premature Ejaculation

  • Ejaculation which occurs within 15 seconds of beginning of intercourse (ICD-10)

  • Ejaculation occurs with minimal sexual stimulation before, on, or shortly after penetration…before the person wishes (DSM-IV)

  • Recent reviews place prevalence between 22-38%

  • Etiology: psychogenic (anxiety, frequency, conflicts, etc), pelvic nerve damage, prostatitis, withdrawl from narcotics, possibly genetic, penile hypersensitivity…


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Premature Ejaculation Treatment

  • Psychological: - Squeeze technique (Masters and Johnson) - Sensate focus - “Quiet vagina”

  • Self Help: multiple condoms, desensitizing creams, distraction, etc

  • Pharmacologic treatment - MAO-inhibitors - Tricyclic antidepressants - SSRIs (especially sertraline and clomipramine)


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Dapoxetine for Premature Ejaculation

  • Oral tablet (Alza; Johnson & Johnson) in Ph III trials

  • Inhibits seratonin reuptake at multiple levels

  • Rapid onset of action, quickly eliminated: prn use and fewer side effects (rare nausea, nervousness)


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ED and EjD: Summary

  • ED is very common, particularly in diabetics, and fairly easy to evaluate

  • Many (not all) patients respond to PDE-5 inhibitors; urologists can help the rest

  • Anejaculation is rare but may be treatable

  • Retrograde ejaculation is almost never treatable

  • Options for premature ejaculation are improving



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