PATIENT-ORIENTED EVIDENCE THAT MATTERS (POEMS) FOR MEN
From the Scott & White Symposium on the Adult Patient: Male and Female Issues
Jeffrey Waxman, MD, Assistant Professor, Department of Surgery, Division of Urology, Texas A&M University
System Health Science Center College of Medicine, Temple
| “InfoPOEMS”: database founded by 3 practitioners; taken from journal articles; qualitative point of view (ie, how good is
evidence?); 20 to 30 pearls each month; levels of evidence—5 levels; higher number indicates poorer quality of evidence
(best study has level 1A)
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False-Positive Prostate-Specific Antigen (PSA) and Patient Fears
| Elevated PSA and negative prostate biopsy: fear not alleviated by learning they have no cancer; 167 men compared to
233 men who had normal PSA; 6 wk after tests, 49% of PSA-positive men thought of prostate cancer frequently or some,
vs 18% of control group; 40% worried that they might get prostate cancer, vs 8% in control group; both groups worried
equally about dying soon; 62% in control group felt reassured about prostate cancer as result of recent biopsy or PSA;
more men in positive-PSA group felt better because of recent biopsy or PSA than those with normal blood tests; 36% of
elevated-PSA men thought they had increased chance of getting prostate cancer someday than did those in control group
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| Psychologic impact: false-positive PSA not benign because of psychologic cost; work-up not going to change, but study
helps practitioner understand mindset of patients and gain empathy
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Alcohol and Sildenafil (Viagra)
| Red wine and sildenafil: each of 8 healthy college students randomly participated in all 4 study arms; in first study arm,
student took 100 mg of sildenafil; in second study arm, student drank 1 bottle of red wine; in third arm, student had
sildenafil and drank red wine at same time; in fourth arm, student took sildenafil, waited 1 hr, then drank wine over 1 hr;
placebo group had neither; study measured students’ cardiac index, heart rate, and arterial blood pressure (BP) every 3 hr;
heart rate—unaffected by sildenafil alone; 27% increase with red wine with or without sildenafil; BP—reduced by 7%
with sildenafil alone; with wine, increased by 6%, then fell 7%; no difference with combination; cardiac index—no
change with sildenafil alone; maximum 15% increase with red wine alone; combination no different from alcohol alone;
peripheral vascular resistance (PVR)—24% lower with sildenafil alone; no change with red wine; combination same
as with alcohol alone
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| Conclusion: sildenafil with red wine has no more effect on young men’s parameters than alcohol alone; more research
needed, especially on older men who are exercising; results suggest alcohol plus sildenafil may not cause patients harm
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Quality of Life: Radiation vs Prostatectomy
| Side effects of external-beam radiation therapy vs those of radical prostatectomy: men 55 to 74 yr of age who received
radical prostatectomy or radiation therapy for localized prostate cancer; surveys filled out 5 yr after therapy; urinary
incontinence—defined as no control or frequently leaking urine; more likely in men who had surgery; erectile dysfunction
(ED)—more prevalent after radical prostatectomy, but not by much; bowel function—more problems with bowel
urgency or painful hemorrhoids after radiation therapy; radiation treatments cause loss of elasticity in rectal wall, so capacity
reduced
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| Limits of study: follow-up incomplete; disproportionate number of survey responses, depending on treatment received;
data from 1994 to 1995, and therapeutic techniques have evolved; does not take treatment success rates into account
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| Conclusions: men with clinically localized prostate cancer treated with radical prostatectomy from 1994 to 1995 more likely
to experience incontinence and ED than men who received radiation treatment; these men less likely to experience problems
with bowel function
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ED and Cycling
| ED and long-distance cycling: some men have ED after long-distance cycling; compression of neurovascular bundle that supplies
message to corpus cavernosum to produce erection (neurapraxia)
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| Bicycle seat study: premise—bicycle seat with grooves to reduce pressure would lessen ED; anatomy—nerves run from
pelvic plexus, alongside prostate, below urethra, as they travel to corpus cavernosum; this area could be susceptible to pressure,
causing ED; study—463 cyclists rode minimum 320 km, maximum 820 km; men in prime of life, 21 yr of age, sexually
active, and did not have ED; data collected 1 wk before, 1 wk after, and 1 mo after bike ride; type of bicycle—
directly linked to likelihood of ED; if riding mountain bike, 4.1 times more likely to complain of ED after ride than if
riding road bike; height of handlebars—if parallel to or higher than bicycle saddle, more problems with ED than if lower
than saddle; risk 3 times greater; perineal numbness—if present during ride, problems with ED more likely; reported by
one third of riders; if present, saddles with cutouts increased risk for ED; if not present, saddles with cutouts decreased risk
for ED
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| Conclusions: long-distance cyclists who wish to minimize risk for ED should ride road bike; keep handlebar height lower
than saddle height; use saddle that does not have cutout if experiencing problems with perineal numbness, with cutout if
no perineal numbness
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PSA Velocity and Outcome of Radical Prostatectomy
| PSA velocity: rate of change in PSA over time (1 yr); example—if PSA 2.5 ng/mL, and 1 yr later 3.5 ng/mL, PSA velocity
1 ng/mL per year
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| Study: >1800 men in prospective prostate cancer screening study who ultimately went to radical prostatectomy; 1100 men had
PSA data at time of diagnosis and 1 yr before diagnosis; no confounding factors (eg, adjuvant hormonal therapy, radiation
treatment); at time of diagnosis, 43% had PSA <4 ng/mL, 52% had 4 to 10 ng/mL, remainder had higher; Gleason score of
biopsy specimen—indicator of disease aggressiveness; range 2 to 10; 2 to 6 indicates moderately differentiated cancer,
smaller propensity to metastasize, and much greater likelihood of being localized; 84% of subjects had low Gleason score; with
score of 7, tumor found in 12% of biopsies, and more aggressive cancer in 4%; clinical tumor stage—at time of diagnosis,
71% had stage 1C (palpably normal prostate gland; cancer found only because of biopsy performed after abnormal PSA); 24%
had prostate cancer clinically localized to gland or one half of gland by digital rectal examination (DRE); 4% had bilateral disease;
follow-up—subjects followed for 5 yr; data available on 97% of patients
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| Results: graph shows likelihood of disease recurrence (measured by abnormal PSA) in years after radical prostatectomy;
stratified by PSA velocity (<0.5, 0.5-1.0, 1-2, or >2 ng/mL per year) before diagnosis; significant difference between >2
ng/mL per year and all others; likelihood of dying from prostate cancer—dramatically increased if PSA velocity >2
ng/mL per year before diagnosis; death from any cause—group with higher PSA velocity statistically different from
others; of 833 men with lower PSA velocity, only 3 died; of 262 men with higher PSA velocity, 9.2% died; conclusion—
PSA velocity strong independent predictor of outcome after radical prostatectomy for men thought to have localized
prostate cancer
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Analgesia for Renal Colic: Nonsteroidal Anti-inflammatory Drugs (NSAIDs) vs Opioids
| Intravenous (IV) NSAIDs vs narcotics: pain evaluated at fixed time after therapy given, allowing greater degrees of comparison;
with parenteral ketorolac (Toradol) vs opioids, no difference in analog pain scale; with parenteral NSAIDs other
than ketoralac, difference significant (ie, worked better than IV morphine or IV meperidine [Demerol]); 30 to 60 min after
administration—either agent’s ability to achieve complete pain relief similar; pain recurrence—need for additional
analgesics within 4 hr of being pain free less if NSAIDs given; emesis—less frequent with NSAIDs; risk highest
with meperidine; limits of study—did not look at effect of medications on duration of colic pain; did not examine role of
NSAIDs’ inhibition of prostaglandins, which cause ureteral spasm
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| Conclusions: NSAIDs produce equivalent or better analgesia than opioids; NSAIDs reduce need for additional analgesia
and result in fewer problems with emesis; not known whether NSAIDs reduce total duration of colic; possible that
NSAIDs may hasten stone passage
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Prostate Cancer Risk with PSA 4 ng/mL
| Prostate cancer and PSA: PSA 4 ng/mL considered normal range; data from National Prostate Cancer Prevention Trial; 7-
yr, randomized, double-blind, placebo-controlled study to see whether finasteride (Proscar) diminishes risk for cancer;
dose 5 mg/day (standard dose to treat benign prostatic enlargement); 18800 men randomized to finasteride or placebo received
PSA and DRE each year; if either not normal, prostate biopsy recommended; at end of study, sextant prostate biopsy
recommended for all participants; prostate cancer—almost 3000 participants, ages 62 to 91, with normal PSA and
prostate examinations; 8.8% with PSA <1 ng/mL, 17% with PSA 1 to 2 ng/mL, 23.9% with PSA 2 to 3 ng/mL, and
26.9% with PSA 3 to 4 ng/mL had prostate cancer at end-of-study biopsy; high-grade prostate cancer—0.9% of those
with normal PSA and DRE had high-grade tumor; increased incidence of Gleason score-7 prostate cancer (6.7% of 3000
patients)
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| Conclusion: prostate cancer, even high-grade disease, can be found in older men who have normal PSA; interpretation
open to question; patient education vital; normal PSA no guarantee
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Frequency of Ejaculation and Risk for Prostate Cancer
| Impact of sexuality on prostate cancer: theories—more sexual activity means higher androgen levels, and prostate cancer
androgen-dependent; more sex indicates more partners and more exposure to infectious agents, and prostate cancer
may have infectious etiology; less sex builds up prostatic fluids and carcinogens in prostatic acini, increasing likelihood
of prostate cancer; men with prostate cancer have greater sex drive but sexually repressed
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| Data from Health Professionals Follow-up Study: 30,000 men 46 to 81 yr of age; looked at number of ejaculations in 3
age groups; findings—no link between increased risk for prostate cancer and any category of ejaculation frequency; risk
decreased in men with high ejaculation frequency (>21/mo); no statistically significant association between frequency of
ejaculation and risk for advanced prostate cancer; conclusion—ejaculation frequency not associated with increased risk
for prostate cancer; high ejaculation frequency might reduce risk for prostate cancer
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Behavioral Treatment for Urinary Incontinence
| Treating incontinence in elderly patients: 3 studies comparing medication to behavioral treatments; 5 studies looking at
behavioral treatments alone; biofeedback—anorectal biofeedback helps patients sense pelvic floor musculature; teaches
patients to contract and relax muscles selectively while relaxing abdominal muscles; pearl—to teach woman Kegel exercises,
have her squeeze practitioner’s finger during vaginal exam; have her pretend to prevent passing gas; behavior
modification—patients taught not to rush to bathroom when feeling urgency; told to relax whole body while contracting
pelvic floor musculature; information reinforced twice weekly
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| Other studies: oxybutinin—used in medication arms of study; 2.5 mg tid or placebo; findings—in biofeedback group,
80.7% reduction in number of incontinent episodes; in oxybutinin group, 68.5% reduction; in placebo group, 39.4% reduction;
subset of patients from first study—not completely dry after first study; if in biofeedback group, received oxybutinin;
if oxybutinin first, got biofeedback; improvement in both groups; pelvic floor exercises without biofeedback vs
phenylpropanolamine—similar reduction in incontinent episodes; behavior therapy alone—bladder-sphincter biofeedback,
bladder training without biofeedback, or pelvic floor exercises without biofeedback; found behavioral techniques
effective for urge and stress incontinence
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| Importance of studies: show that behavioral treatments work; bladder-sphincter biofeedback works and can be done in
office without machinery; bladder training can work; pelvic floor exercises can work, and at least as effective as drugs
in treating incontinence; regular reinforcement required for effectiveness
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Daily Valacyclovir and Herpes Simplex Virus 2 (HSV-2) Transmission
| Reducing risk for transmission to uninfected sexual partners: 1500 immunocompetent heterosexual monogamous couples;
one of each pair documented to have HSV infection, partner shown uninfected by serology; half of infected patients
took valacyclovir qd, other half took placebo; each month for 8 mo, uninfected partner tested, and couple counseled on
value of condom use in reducing likelihood of virus transmission; findings—large number of couples withdrew from
study; despite monthly counseling, 20% of couples always used condoms, 37% never used condoms; if symptomatic and
valacyclovir used daily, likelihood of transmitting infection to partner only 0.5%; with placebo, likelihood 2.2%; valacyclovir
reduced risk by 25%; if asymptomatic but serology positive, likelihood of virus transmission (at least serologically)
1.9% with valacyclovir, 3.6% with placebo
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| Conclusion: valacyclovir reduces chance of HSV transmission by 50%; valacyclovir slightly reduces risk for HSV transmission
to uninfected partners; number needed to treat (NNT)—59 patients must take valacyclovir daily for 8 mo to
prevent one infection
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Educational Objectives
| The purpose of this program is to educate the listener about several evidence-based studies on urologic issues. After hearing
and assimilating this program, the clinician will be better able to:
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 | 1. Apply recent data on prostate-specific antigen (PSA) results to treatment practices.
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| 2. Advise patients on the safety of combining alcohol and sildenafil.
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| 3. Set up a regimen for a patient having difficulty with erectile dysfunction (ED) after long-distance bicycle rides.
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| 4. Evaluate analgesia options for a patient with renal colic.
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| 5. Instruct elderly patients about behavior modification and biofeedback in the treatment of incontinence.
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Discussed on This Program
Finasteride [Propecia, Proscar]
Ketorolac tromethamine [Acular, Acular LS, Toradol]
Meperidine HCl [Demerol]
Morphine sulfate (many trade names)
Oxybutynin chloride [Ditropan, Ditropan XL, Osytrol]
Phenylpropanolamine HCl (withdrawn)
Sildenafil citrate [Viagra]
Valacyclovir HCl [Valtrex]
Suggested Reading
Corey L et al: Once-daily valacyclovir to reduce the risk of transmission of genital herpes. N Engl J Med 350:11, 2004;
D'Amico AV et al: Preoperative PSA velocity and the risk of death from prostate cancer after radical prostatectomy. N Engl
J Med 351:125, 2004; Dettori JR et al: Erectile dysfunction after a long-distance cycling event: associations with bicycle
characteristics. J Urol 172:637, 2004; Holdgate A, Pollock T: Systematic review of the relative efficacy of non-steroidal
anti-inflammatory drugs and opioids in the treatment of acute renal colic. BMJ 328:1401, 2004; Jackson G et al: Effects of
sildenafil citrate on human hemodynamics. Am J Cardiol 83:13C, 1999; Leitzmann MF et al: Ejaculation frequency and
subsequent risk of prostate cancer. JAMA 291:1578, 2004; Leslie SJ et al: No adverse hemodynamic interaction between
sildenafil and red wine. Clin Pharmacol Ther 76:365, 2004; McNaughton-Collins M et al: Psychological effects of a suspicious
prostate cancer screening test followed by a benign biopsy result. Am J Med 117:719, 2004; Schwartz K et al:
Complications from treatment for prostate carcinoma among men in the Detroit area. Cancer 95:82, 2002; Taylor JA 3rd et
al: Bicycle riding and its relationship to the development of erectile dysfunction. J Urol 172:1028, 2004; Teunissen TA et
al: Prevalence of urinary, fecal and double incontinence in the elderly living at home. Int Urogynecol J Pelvic Floor Dysfunct
15:10, 2004; Teunissen TA et al: Treating urinary incontinence in the elderly--conservative therapies that work: a
systematic review. J Fam Pract 53:25, 2004; Thompson IM, et al: Prevalence of prostate cancer among men with a prostate-specific
antigen level < or =4.0 ng per milliliter. N Engl J Med 350:2239, 2004; Thompson KE et al: Prognostic features
in men who died of prostate cancer. J Urol 174:553, 2005; Wang AC: Bladder-sphincter biofeedback as treatment of
detrusor instability in women who failed to respond to oxybutynin. Chang Gung Med J 23:590, 2000
Faculty Disclosure
In adherence to ACCME guidelines, the Audio-Digest Foundation requests all lecturers to disclose any significant financial
relationship with the manufacturer or provider of any commercial product or service discussed. For this issue there is nothing
to report.
Dr. Waxman was recorded in South Padre Island, Texas, at The Adult Patient: Male and Female Issues, held June 20-24,
2005, and sponsored by the Scott & White Clinic and the Texas A&M University System Health Science Center. The Audio-Digest
Foundation thanks Dr. Waxman and the sponsors for their cooperation in the production of this program.
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