Download treatment of erectile dysfunction following therapy for

0022-5347/05/1742-0646/0
THE JOURNAL OF UROLOGY®
Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 174, 646 – 650, August 2005
Printed in U.S.A.
DOI: 10.1097/01.ju.0000165342.85300.14
TREATMENT OF ERECTILE DYSFUNCTION FOLLOWING THERAPY FOR
CLINICALLY LOCALIZED PROSTATE CANCER: PATIENT REPORTED USE
AND OUTCOMES FROM THE SURVEILLANCE, EPIDEMIOLOGY, AND END
RESULTS PROSTATE CANCER OUTCOMES STUDY
ROBERT A. STEPHENSON,* MOTOMI MORI, YI-CHING HSIEH, TOMASZ M. BEER,
JANET L. STANFORD, FRANK D. GILLILAND, RICHARD M. HOFFMAN AND ARNOLD L. POTOSKY
From the Division of Urology, University of Utah School of Medicine (RAS), Salt Lake City, Utah, Biostatistics Shared Resource, Cancer
Institute (MM, Y-CH) and Division of Hematology and Medical Oncology (TMB), Oregon Health and Science University, Portland Oregon,
Department of Epidemiology, Fred Hutchinson Cancer Research Center, University of Washington (JLS), Seattle, Washington, Department
of Preventive Medicine, Keck School of Medicine, University of Southern California (FDG), Los Angeles, California, Medicine Service, New
Mexico Veterans Affairs Health Care System (RMH), Albuquerque, New Mexico, and Division of Cancer Control and Population Sciences,
National Cancer Institute (ALP), Bethesda, Maryland
ABSTRACT
Purpose: Erectile dysfunction (ED) persists for years following curative therapies for clinically
localized prostate cancer. We report use and treatment outcomes in a 5-year interval in a
population based cohort from the Surveillance, Epidemiology, and End Results Prostate Cancer
Outcomes Study.
Materials and Methods: A sample of 1,977 men with localized prostate cancer who received
external beam radiation therapy or radical prostatectomy in 1994 to 1995 were surveyed for 5
outcome measures of ED treatment, namely treatment, perceived helpfulness, erectile sufficiency, sexual activity frequency and erection maintenance. Subjects were surveyed 6, 12, 24 and
60 months after prostate cancer diagnosis.
Results: Overall 50.5% of men ever used ED treatment. The use of ED treatments increased
during the study course. Subject age, regular sexual partner and baseline sexual activity were
factors positively associated with ED treatments. While it was used uncommonly (1.9%), a penile
prosthesis was perceived as the most helpful ED treatment (helped a lot in 52% of respondents).
Sildenafil helped a lot in 12% of respondents. Erectile fullness, erection maintenance and sexual
activity frequency were modestly improved in men using ED treatment compared with those in
men not using ED treatment.
Conclusions: Approximately half of the patients in this population based cohort of men used ED
treatment during the 5 years following prostate cancer diagnosis. Men using ED treatments had
modest improvement in sexual function compared with men that in who did not receive ED
treatment at 60 months. More effective treatments for ED following local therapy for prostate
cancer are needed.
KEY WORDS: penis, prostate, impotence, prostatic neoplasms, treatment outcome
Several recent studies have described patient reported
quality of life outcomes following treatment for localized
prostate cancer.1⫺4 These studies demonstrate that overall
quality of life is uniformly good after treatment with radical
prostatectomy (RP) or external beam radiation therapy (RT)
for localized prostate cancer.1⫺3 However, sexual function
and sexual satisfaction decrease significantly in patients subsequent to treatment with RP or RT.4⫺9
While published studies have documented improved sexual
function with erectile dysfunction (ED) treatment following
localized prostate cancer treatment, there has been little
information on the population wide prevalence of ED treatment or on the comparative results achieved with the various
forms of ED treatment. We used data on a population based,
randomly sampled group of men treated in diverse clinical
settings to examine the prevalence and results of treatment
for ED following treatment for clinically localized prostate
cancer.10
MATERIALS AND METHODS
Prostate Cancer Outcomes Study (PCOS). In 1994 the National Cancer Institute initiated the PCOS to obtain longitudinal, population based estimates of health outcomes in men
diagnosed with prostate cancer using self-administered questionnaires and abstracted medical records. The study was
based on men diagnosed with prostate cancer who were randomly selected from the regions of 6 Surveillance, Epidemiology, and End Results cancer registries (Connecticut, Utah,
New Mexico, metropolitan Atlanta, Los Angeles County and
Seattle, King County) from October 1, 1994 through October
31, 1995. A total of 3,533 men were initially enrolled from a
sample of 5,672 and they were surveyed 6, 12, 24 and 60
months after diagnosis. The survey instrument included general and disease specific measures of health related quality of
life. The rationale, objectives and methods have been previously reported in more detail.10
In the current study we focused on ED treatment, includ-
Submitted for publication December 2, 2004.
Supported by Contracts NO1-PC-67000, NO1-PC-67005, NO1-PC67006, NO1-PC-67007, NO1-PC-67009 and NO1-PC-67010 from the
National Cancer Institute, National Institutes of Health, Bethesda,
Maryland to participating SEER institutions.
* Correspondence: Division of Urology, 50 North Medical Dr.,
Room 3B420, Salt Lake City, Utah 84132 (telephone: 801-581-4705;
FAX: 801-585-2891; e-mail: [email protected]).
646
ERECTILE DYSFUNCTION TREATMENT OUTCOMES AFTER PROSTATE CANCER THERAPY
ing the type and use of ED treatment (vacuum erection
devices, penile injections, psychosexual counseling, penile
prosthesis, nonsildenafil medications and sildenafil), the perceived helpfulness of ED treatments and sexual function
measures (erectile fullness, erection maintenance and sexual
frequency activity).
Study population. A total of 3,486 men completed a 6
and/or 12-month survey and underwent RP or RT within
year 1 of diagnosis in PCOS. We restricted our analysis to
patients diagnosed with clinically localized disease (2,176)
who completed a 6-month survey (1,977). Of these study
patients 1,753 (89%) completed a 12-month survey, 1,643
(83%) completed a 24-month survey, 1,462 (74%) completed a
60-month survey and 1,282 (65%) completed all 4 surveys.
Definition of outcome variables. We examined ED treatment use, perceived helpfulness, erectile fullness, erection
maintenance and sexual activity frequency. The use of ED
treatment was defined as a series of binary variables indicating the use of each of 5 treatments (ie vacuum erection
device, penile injection, psychological/sexual counseling, penile prosthesis and nonsildenafil medication) on the 6, 12, 24
and 60-month surveys. Sildenafil became available as a
treatment for ED in 1997 and it was included as an ED
treatment option in the 60-month survey. Use of treatments
for ED was based on the question, “In the past 6 months, did
you try any of the following to help with problems with sexual
function?” This means that the survey could not distinguish
between concurrent and serial use of ED treatments. The
perceived helpfulness of each ED treatment was based on the
question, “How much did it help?” (ie helped a lot vs helped
somewhat vs helped not at all). Sexual function in the last
month was assessed using the 3 questions, “Have you had
any erections firm enough for sexual intercourse? ” (full vs
partial or none), “How often have you engaged in sexual
activity? ” (any vs none at all) and “How much difficulty did
you have keeping an erect penis during sexual activity?”
(some/little/or no difficulty vs no erections/a lot of difficulty).
Statistical methods. All analyses were performed using
SUDAAN.11 We specified stratified random sampling with
replacement and the Horvitz-Thompson weight, which is the
inverse of the sampling fraction for each stratum, defined by
patient age, race and study area, to obtain unbiased estimates of proportion and regression parameters. All estimates
presented were weighted according to the sampling fraction.
Simple cross-tabulations were used to estimate proportions
for demographic and clinical characteristics, use of ED treatment with time and perceived helpfulness. Logistic regression analysis was performed to evaluate the association between baseline sexual characteristics (regular sexual
partner, interest in sex, sexual activity, change in impotency
status and perception of a problem) and ED treatment at 60
months, adjusted for patient cancer treatment and demographic characteristics. Logistic regression analysis was performed to evaluate the effects of ED treatment on erectile
sufficiency, sexual activity frequency and erection maintenance at 60 months. Predicted percents were obtained using
the method of predicted margins.12
RESULTS
Table 1 shows the distribution of selected clinical and
sociodemographic characteristics of the study cohort, that is
1,977 men who completed the 6 and/or 12-month surveys. Of
this patient cohort 68% men underwent RP and 32% received
RT.
Overall 50.5% of the men used some form of treatment for
ED during the 60 months following the prostate cancer diagnosis (table 2). Prior to the introduction of sildenafil (6, 12
and 24-month surveys) the most commonly used treatment
was vacuum erection devices, followed by penile injections.
Penile prostheses were the least used form of ED treatment.
647
TABLE 1. Select demographic characteristics
Level
Treatment:
RP
RT
Age group:
Younger than 55
55–59
60–64
65–69
70–74
Older than 74
Registry:
Seattle
Connecticut
New Mexico
Utah
Atlanta
Los Angeles
Race:
Hispanic
Black
White
Education:
Advanced
College graduate
Some college
High school or less
Marital status:
Yes
No/unknown
Based on 1,977 patients and adjusted for sampling fractions.
%
68
32
9
13
23
26
21
8
5
23
10
11
16
35
10
13
77
22
16
44
18
83
17
Use of ED treatment increased steadily during the study
duration with the largest increase at 60 months after the introduction of sildenafil. At 60 months 16.7% of respondents used
sildenafil alone and 20.9% used sildenafil and other treatments
for ED. Of those using sildenafil and other ED treatments at 60
months 33.1% also used a vacuum erection device, 22.6% used
penile injections and 33.3% used more than 1 additional ED
treatment. More than half of the men using vacuum erection
devices and penile injections at 24 months changed to sildenafil
alone or sildenafil plus an additional ED treatment, generally
the same ED treatment that they were using at 24 months.
We next examined which factors were associated with treatment use for ED 60 months after diagnosis (table 3). After
adjustment for multiple sociodemographic and health status
variables (race, education and cancer treatment) younger age at
diagnosis, having a sexual partner prior to prostate cancer and
higher sexual activity frequency prior to prostate cancer were
statistically significantly associated with reported ED treatment use 60 months after diagnosis.
We examined cases in which only 1 ED treatment was used
to assess the perceived helpfulness of individual ED therapies. Perceived helpfulness at 60 months varied by ED treatment type (see figure). The proportion of users who believed
that the treatment helped a lot was highest for penile prostheses (52%) and lowest for psychosexual counseling (7%).
Notably only 12% of men using sildenafil reported that the
treatment helped a lot. The level of helpfulness was stable
for all nonsildenafil treatments from 6 to 60 months except
for penile injections, which decreased from 43% (helped a
lot) to 30%. The proportion of users at 60 months who
believed that treatment helped a lot or helped somewhat
was 71% for penile prostheses, 71% for vacuum erection
devices, 69% for penile injection, 61% for nonsildenafil
medication, 47% for sildenafil and 40% for psychosexual
counseling. Respondents who reported using more than 1
ED treatment reported less helpfulness than respondents
who used only 1 ED treatment (data not shown).
We then examined the association of individual ED therapies with sexual function in patients who used only a single
ED therapy (table 4). At 60 months full erections were reported in less than half of patients using any ED treatments.
648
ERECTILE DYSFUNCTION TREATMENT OUTCOMES AFTER PROSTATE CANCER THERAPY
TABLE 2. ED treatment during 60 months following prostate cancer diagnosis and before RP or RT
% Cell Entries ⫾ SE
At Any Time
6 Mos
12 Mos
No. pts
1,977
1,977
Any ED treatment
50.5 ⫾ 1.30
14.0 ⫾ 0.87
Vacuum erection device only
16.5 ⫾ 0.94
4.5 ⫾ 0.57
Penile injection only
11.1 ⫾ 0.79
2.7 ⫾ 0.37
Nonsildenafil medication only
5.0 ⫾ 0.54
1.7 ⫾ 0.32
Psychosexual counseling only
4.5 ⫾ 0.55
1.5 ⫾ 0.29
Penile prosthesis only
1.9 ⫾ 0.34
0.6 ⫾ 0.19
Sildenafil only
—
—
Sildenafil ⫹ others
—
—
Other multiple treatments
11.6 ⫾ 0.80
2.9 ⫾ 0.44
No ED treatment
49.5 ⫾ 1.30
86.0 ⫾ 0.87
Question did not distinguish between concurrent and serial ED treatments during 6-month
than 1 form of therapy (percent adjusted for sampling fractions).
24 Mos
60 Mos
1,753
1,642
25.4 ⫾ 1.19
32.7 ⫾ 1.31
9.8 ⫾ 0.82
11.9 ⫾ 0.89
6.6 ⫾ 0.68
7.4 ⫾ 0.74
1.6 ⫾ 0.32
2.1 ⫾ 0.39
2.0 ⫾ 0.44
1.9 ⫾ 0.42
1.1 ⫾ 0.30
1.3 ⫾ 0.32
—
—
—
—
4.3 ⫾ 0.55
8.0 ⫾ 0.74
74.6 ⫾ 1.19
67.3 ⫾ 1.31
interval preceding each questionnaire in men
1,462
50.8 ⫾ 1.53
5.7 ⫾ 0.69
2.0 ⫾ 0.43
0.8 ⫾ 0.25
0.8 ⫾ 0.25
1.6 ⫾ 0.35
16.7 ⫾ 1.18
20.9 ⫾ 1.21
2.3 ⫾ 0.47
49.2 ⫾ 1.53
who used more
TABLE 3. Multivariate analysis of characteristics associated with ED treatments 60 months after localized prostate cancer diagnosis
Level
OR
95% CI
p Value
Treatment:
RP
1.19
0.81–1.73
0.38
RT
1.00
Age group:
Younger than 60
3.05
2.04–4.55
⬍0.0001
60–64
2.46
1.60–3.78
65–69
1.22
0.81–1.84
70 or Older
1.00
Race:
Hispanic
0.87
0.58–1.29
0.31
NonHispanic black
1.23
0.85–1.78
NonHispanic white
1.00
Education:
Advanced
1.19
0.73–1.93
0.85
College graduate
1.22
0.72–2.07
Some college
1.19
0.79–1.80
Less high school
1.00
Baseline regular sexual partner:
Yes
2.14
1.32–3.48
0.0021
No/unknown
1.00
Baseline sex interest:
A lot
1.78
0.82–3.86
0.34
Somewhat/only little
1.64
0.80–3.40
Not at all
1.00
Baseline sexual activity:
At least 1/wk
2.91
1.65–5.13
0.0003
At least 1/mo
1.79
1.04–3.07
Not at all
1.00
Baseline-6-mo impotency status change:
Potent to impotent
1.35
0.97–1.88
0.07
No change
1.00
Predicted percent of each covariate was obtained using predicted margin method and it was adjusted for all other table covariates.
Predicted % ⫾ SE
53 ⫾ 2
49 ⫾ 3
64 ⫾ 3
60 ⫾ 3
44 ⫾ 3
40 ⫾ 3
48 ⫾ 4
56 ⫾ 4
51 ⫾ 2
52 ⫾ 3
53 ⫾ 4
52 ⫾ 2
48 ⫾ 4
53 ⫾ 2
37 ⫾ 5
53 ⫾ 3
51 ⫾ 2
41 ⫾ 8
59 ⫾ 3
48 ⫾ 3
36 ⫾ 5
54 ⫾ 2
48 ⫾ 3
erection maintenance. Adjustments for potential clinical and
sociodemographic confounders in multivariate models did
not materially alter these results, and so we report only
unadjusted percents (table 4). For purposes of comparison
table 4 also shows recalled baseline sexual function prior to
the diagnosis of prostate cancer.
DISCUSSION
Perceived helpfulness of ED treatments at 60 months in men using
only 1 ED treatment.
Full erections were reported by 42% of men using penile
prostheses, 39% using penile injections and 39% using sildenafil alone. Men using penile prostheses reported the greatest success in maintaining erections (67%). Sexual activity
frequency was similarly high in men using vacuum erection
devices, penile injection, penile prostheses, sildenafil alone
and sildenafil with other ED treatments (67% to 73%). Men
who used no ED treatment reported low sexual success, as
reflected by erectile ability, sexual activity frequency and
In a prior report we noted substantial decreases in sexual
potency in patients treated with RT and RP (61.5% and
79.6% at 2 years, respectively).1 Others have reported similar
effects of RP and RT on sexual function.2⫺9 Many men consider that sexual dysfunction is a substantial problem following treatment for prostate cancer with RP and RT.1 Those
experiencing the largest amount of dysfunction relating to
sexual function also have decrements in overall quality of
life.13 The substantial decrease in sexual function and general health related quality of life observed in these studies
suggests the need for effective treatment for ED in many
patients following RT and RP.
It is notable that half of the patients in the current study
did not receive ED treatment in the 5 years following the
ERECTILE DYSFUNCTION TREATMENT OUTCOMES AFTER PROSTATE CANCER THERAPY
TABLE 4. Predicted effect of each treatment 60 months after
prostate cancer diagnosis
Predicted % ⫾ SE
Treatment
Erectile
ability
Sexual
Activity
Frequency
Erection
Maintenance
Vacuum erection device
21 ⫾ 5
68 ⫾ 6
24 ⫾ 5
only
Penile injection only
39 ⫾ 12
72 ⫾ 9
42 ⫾ 11
Nonsildenafil (yohimbine,
25 ⫾ 12
44 ⫾ 14
31 ⫾ 13
etc) medication only
Psychosexual counseling
16 ⫾ 9
40 ⫾ 14
11 ⫾ 8
only
Penile prosthesis only
42 ⫾ 11
73 ⫾ 11
67 ⫾ 10
Sildenafil only
39 ⫾ 4
69 ⫾ 4
41 ⫾ 4
Sildenafil ⫹ others
26 ⫾ 3
67 ⫾ 3
28 ⫾ 3
Other multiple treatments
13 ⫾ 6
43 ⫾ 10
29 ⫾ 9
No ED treatment
23 ⫾ 2
36 ⫾ 2
24 ⫾ 2
Overall baseline
74 ⫾ 1.2
80 ⫾ 1.1
75 ⫾ 1.2
Values were obtained by the method of predicted margin method, representing percents unadjusted for other covariates and confounders since
adjustment did little to change predicted margin magnitude (erectile ability—full vs partial or none, frequency—any vs not at all and maintenance—
some/little/no difficulty vs no erection/a lot of difficulty).
diagnosis. Since those who did not receive ED therapy had
generally low sexual function (table 4), adequate sexual function does not appear to account for low levels of ED treatment
use in these men. It is possible that a combination of patient
reluctance and failure of physicians to offer therapy accounts
for the large number of men who did not receive ED therapy.
In the first 2 years following diagnosis and prior to the
introduction of sildenafil only about a third of men used some
form of ED treatment. This proportion increased to half of
patients at 5 years. Most of the increase at 5 years was due
to sildenafil use. Because sildenafil is a convenient oral treatment, it has become the preferred initial treatment for erectile dysfunction.14 However, the drug is not generally effective in men with complete loss of erectile function.15
Furthermore, sildenafil appears to be associated with decreasing efficacy with time, it is not uniformly effective in
men with milder forms of ED and it is associated with side
effects that induce some men to discontinue its use.16 Our
results indicate that sildenafil and other newer, related
agents have become the most widely used form of treatment
for ED following prostate cancer treatment but sildenafil was
not considered to be as helpful by users as penile prostheses,
vacuum erection devices or penile injection therapy. Based on
these findings it appears that these other methods to treat
ED will continue to have an important role in many patients.17
Of non-oral ED treatments it is notable that penile prostheses were associated with similar or better sexual function
and perception of helpfulness and yet penile prostheses were
the least used form of ED therapy. The substantially lower
use despite similar or better outcomes of penile prostheses
may be related to the greater risk, expense, inconvenience
and discomfort associated with surgically placed penile prostheses compared with those of other, less invasive forms of
ED treatment.18
Our results demonstrate that the effectiveness of currently
available ED treatments is at best modest. Similar to the
findings of Schover et al,18 our results indicate substantial
room for improvement in the use, effectiveness and acceptability of therapy for ED following treatment for localized
prostate cancer.
To our knowledge the current study is the first to describe
the prevalence and effectiveness of ED treatment in a population based cohort of men following treatment for localized
prostate cancer. The major strengths of this series are derived from its large sample size and the use of a population
based cohort. Population based data should be less affected
649
by the selection bias seen in institutional series and, therefore, they should be more reflective of outcomes in the population at large.
An important potential limitation of this nonrandomized
study is related to the introduction of sildenafil late in the study
course. Patients who were highly satisfied with pre-sildenafil
sexual function may have been less likely to try sildenafil. As a
result, the sildenafil cohort may have been enriched for individuals with poorer sexual function and a lower probability of
response to sildenafil, thereby, leading to falsely low sexual
function outcomes in sildenafil treated patients.
Other limitations are related to the possibility of recall bias
of baseline sexual function because it was recalled by patients 6 months after diagnosis at the time of the 6-month
questionnaire. However, a validation study of men in PCOS
assessing 6-month recall did not reveal any large, systematic
biases in the recall of pretreatment sexual function.19 Using
a longer period of recall others have noted that men may
overestimate sexual function before therapy.20 Bias may also
be introduced due to differences between those who responded to the questionnaire and nonrespondents, especially
when there is loss to followup at each survey. Nonrespondents to the questionnaire may have had poorer functional
status, leading to underestimation of functional loss due to
exclusion of the poorer outcomes of nonrespondents from the
analysis.
CONCLUSIONS
The use and effectiveness of ED treatment was limited in
this population based cohort subsequent to definitive local
therapy for localized prostate cancer. After it became available the convenient oral medication sildenafil was the most
commonly chosen treatment for ED. Penile prostheses, penile
injections and vacuum erection devices were more effective
treatments for ED than sildenafil. However, these more intrusive ED treatments were only modestly effective. Our
results indicate that there is substantial room for improvement in the use, helpfulness and functional sexual outcome
of ED treatments in men following therapy for prostate cancer.
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EDITORIAL COMMENT
This is an important report because it highlights the modest improvements in sexual function noted with the use of various interventions in men treated for prostate cancer. The study is strengthened by its large sample size and use of a population based cohort.
The domain of sexual function is clearly the one most affected by
prostate cancer treatment. It is also the one most affected by age and
comorbidity independent of prostate cancer. Although many men
with prostate cancer have significant limitations in this domain
before treatment, those who are the most sexually active are most at
risk (i.e. those who have the most to lose, lose the most). Although I
fully agree with the authors that better interventions are necessary;
more immediate gains may be made by improved pre-treatment
counseling, active surveillance rather than immediate treatment in
some men, better case selection, and improved surgical and radiation
technique.
Peter R. Carroll
Department of Urology
University of California-San Francisco
San Francisco, California