ADULT UROLOGY
SEXUAL FUNCTION AFTER MALE RADICAL CYSTECTOMY IN
CRAIG D. ZIPPE, RUPESH RAINA, ERIC Z. MASSANYI, ASHOK AGARWAL, J. STEPHEN JONES,
ABSTRACT Objectives. To assess sexual dysfunction in sexually active men after radical cystectomy (RC) and to determine whether sildenafil citrate can improve erectile dysfunction after surgery. Methods. The baseline and follow-up data from 49 sexually active male patients (mean age 57.8 Ϯ 9.1 years) undergoing RC (1995 to 2002) were obtained. Of the 49 patients, 16 (33%) had undergone nerve-sparing RC; 38 (78%) had undergone orthotopic diversion; 8 (16%) had undergone ileal conduit diversion; and 3 (6%) had undergone cutaneous continent diversion. The data were assessed using the abridged 5-item International Index of Erectile Function questionnaire, referred to as the Sexual Health Inventory for Men (SHIM). Results. At a mean follow-up of 47.6 Ϯ 22.7 months, the total mean SHIM score decreased from 22.08 Ϯ 3.96 to 4.33 Ϯ 5.72 after RC (P Ͻ0.05). Of the 49 patients, 42 (86%) did not have erections sufficient for vaginal penetration. Of these 42 patients, 22 (52%) tried sildenafil citrate. Of these 22 patients, only 2 (9%) responded positively, with a total mean SHIM score of 23.50 Ϯ 2.12. Although the mean SHIM score after orthotopic substitution (5.24 Ϯ 6.21) was statistically significant compared with that after ileal conduit (1.13
Ϯ 0.33) and cutaneous continent (1.33 Ϯ 0.58) diversions, this was not clinically significant. Conclusions. Male erectile dysfunction after RC is a prevalent problem. In our series, only 9 (14%) of 49 sexually active men were potent after surgery. Of these 9 potent patients, 8 (89%) had undergone nerve-sparing RC. Of concern, only 52% of the patients with erectile dysfunction sought treatment after RC.
UROLOGY 64: 682–686, Radicalcystectomy(RC)hasbeenthestandardfor otherquality-of-lifeissueafterRC.Wechoseasex-
treatment of aggressive superficial bladder can-
ually active population in whom erectile function
cer and invasive The endpoints after this
was an important quality-of-life issue before sur-
operation have focused on cure, urethral recurrence,
gery. We validated our responses in this subset,
using the abridged 5-item version of the Interna-
bundles are usually removed or damaged with re-
tional Index of Erectile Function (IIEF-5) ques-
moval of the Recent interest in quality-of-
tionnaire, referred to as the Sexual Health Inven-
life issues has stimulated the evolution of orthotopic
treatments they had sought and assessed their re-
has provided the momentum for assessing other
In this study, we addressed sexual function, an-
MATERIAL AND METHODS STUDY SUBJECTS AND DESIGN R. Raina and C. D. Zippe are members of the speakers bureau for
The Cleveland Clinic Institutional Review Board approved
this study, and all patients granted informed consent. Study
From the Center for Advanced Research in Human Reproduc-
participants were a self-selected, nonrandomized group who
tion, Infertility and Sexual Function and the Glickman Urological
had undergone RC, were alive in 2003, and had completed the
Institute, Cleveland Clinic Foundation, Cleveland, Ohio
necessary questionnaires. We obtained data on 49 male pa-
Reprint requests: Craig D. Zippe, M.D., Glickman Urological
tients (mean age 57.8 Ϯ 9.1 years) who were sexually active
Institute, Marymount, Cleveland Clinic Foundation, 1200
before surgery and had undergone RC at the Glickman Uro-
McCrackin Road, Suite 451, Garfield Heights, OH 44125
logical Institute from May 1995 to March 2002. These patients
Submitted: August 11, 2003, accepted (with revisions): May
completed the SHIM (IIEF-5) questionnaire or the IIEF-15
(before 1999) before surgery (4 months or less), after RC (1
SHIM (IIEF-5) analysis: baseline and after radical cystectomy Baseline Before RC SHIM (IIEF-5) Domains KEY: SHIM ϭ Sexual Health Inventory for Men; IIEF-5 ϭ 5-item (short form) International Index of Erectile Function; RC
ϭ radical cystectomy; Q ϭ question. Data presented as mean Ϯ SD. Wilcoxon rank-sum test used to compare preoperative and postoperative changes across study groups. Each IIEF-5 domain scored from 0 to 5; 0 ϭ did not attempt intercourse; 1 ϭ never/occasionally; 2 ϭ less than half the time;3 ϭ sometimes/half the time; 4 ϭ more than half the time; 5 ϭ almost always; total IIEF-5 score calculated by totaling andtaking the mean of the responses to all 5 domains of IIEF-5. * P Ͻ0.05 after RC vs. baseline.
year or longer), and after the use of sildenafil citrate or any
used to assess changes from baseline. Wilcoxon rank sum
erectile aid for erectile dysfunction (ED). Medical records
tests were used to compare the preoperative and postoper-
were obtained and reviewed to assess the baseline medical data
ative changes across study groups. Statistical significance
and social history, as well as the type of urinary diversion and
was assessed with a two-tailed test at P Ͻ0.05. Computa-
nerve-sparing surgery. When the operative report did not
tions used Statistical Analysis Systems, version 8.1, soft-
specify any consideration or protection of the neurovascular
bundles, the procedure was deemed a non-nerve-sparing pro-cedure.
The mean level of preoperative sexual activity before surgery
was 2.0 Ϯ 1.2 per week. Of these 49 patients, 38 (78%) had
At a mean follow-up of 47.6 Ϯ 22.7 months, 42
undergone orthotopic urinary diversion (Studer pouch), 8 (16%)had undergone ileal conduit diversion, and 3 (6%) had under-
(86%) of the 49 patients were unable to achieve
gone cutaneous continent diversion (Indiana). Only 16 (33%) of
vaginal penetration after surgery. The mean total
the 49 patients had undergone nerve-sparing procedures. Of the
SHIM (IIEF-5) score of the 49 patients at baseline
16 patients who had undergone nerve-sparing RC, 6 had patho-
was 22.1 Ϯ 4.0. After surgery, the mean total SHIM
logic Stage T1, 2 had Stage T2a, and 8 had Stage T2b, and all had
score for the entire group was 4.33 Ϯ 5.72
negative surgical margins. The mean follow-up interval was 47.6
Ϯ 22.7 months after surgery. Of these 49 patients, 2 developed
Of these 49 patients, 7 had erections sufficient
recurrent cancer. When comorbidities were assessed in the 49
for vaginal penetration at a mean of 17.1 Ϯ 4.1
patients, hypertension was found in 35%, diabetes in 6%, and
months after surgery. Those 7 patients had a mean
total baseline SHIM score of 21.1 Ϯ 4.1 and a meantotal postoperative score of 16.6 Ϯ 4.9 at a mean
SURVEYS AND DATA ASSESSMENT
follow-up of 44.4 Ϯ 25.1 months. When analyzing
Sexual function was assessed at baseline (preoperative), af-
these 7 patients for common denominators to ex-
ter RC, and after treatment using the abridged 5-item IIEF-5questionnaire, referred to as the This questionnaire
plain their potency, 6 (86%) of the patients had
was used to define and validate the degree of sexual dysfunc-
undergone a nerve-sparing procedure. Although
tion in our surgical population. Specific domains analyzed in
this subgroup’s mean age of 51.0 Ϯ 10.9 years was
the SHIM questionnaire include erection confidence, erection
lower than the remaining 42 patients’ mean age
firmness, ability to maintain an erection, maintenance fre-
(58.9 Ϯ 8.4 years), the difference was not statisti-
quency, and intercourse satisfaction. This questionnaire pro-vided us with a comprehensive assessment of baseline, post-
cally significant (P ϭ 0.055). Additionally, the in-
operative, and post-treatment sexual function in this pop-
cidence of comorbid disorders (hypertension, dia-
ulation of patients. Responses were scored from 0 to 5. The
betes, coronary artery disease) was similar in both
total SHIM score was calculated by adding responses from all
the sexually active and impotent subgroups, with a
five domains. The mean baseline scores to the questions were
rate of 43% (3 of 7) and 48% (20 of 42), respec-
calculated and compared with the postoperative scores to as-sess the change in response.
In addition to the SHIM questionnaire, we asked patients to
In the other 42 patients who had no potency
estimate their approximate frequency of sexual intercourse at
sufficient for vaginal penetration, 4 were able to
baseline, after surgery, and after treatment. Patients’ spouses
achieve erections with an erectile aid or medical
or partners were also asked to rate their level of satisfaction,
therapy (sildenafil citrate). Two patients re-
sponded successfully to sildenafil citrate. Two
S
other patients were using erectile aids to achieve
TATISTICAL ANALYSIS
The mean and standard deviation were calculated for all
erections, one with a vacuum constriction device
the domains of the SHIM questionnaire. Paired t tests were
and one using intracavernosal injection therapy. In
UROLOGY 64 (4), 2004 TABLE II. SHIM (IIEF-5) analysis: treatment with sildenafil citrate and erectile aids Baseline Before Treatment Response and Type After Treatment
Negative response to sildenafil (n ϭ 20)
Positive response to erectile aids (n ϭ 2)
Abbreviations as in Data presented as mean Ϯ SD. Wilcoxon rank sum test used to compare preoperative and postoperative changes across study groups. Each IIEF-5 domain scored from 0 to 5; 0 ϭ did not attempt intercourse; 1 ϭ never/occasionally; 2 ϭ less than half the time; 3 ϭ sometimes/half the time; 4 ϭ more than halfthe time; 5 ϭ almost always; total IIEF-5 score calculated by totaling and taking the mean of the responses to all 5 domains of IIEF-5. * P Ͻ0.05 after RC vs. baseline.
† P Ͻ0.05 after RC vs. after treatment.TABLE III. SHIM (IIEF-5) analysis: stratified by type of urinary diversion Baseline Before Urinary Diversion Abbreviations as in Data presented as mean Ϯ SD. Wilcoxon rank sum test used to compare preoperative and postoperative changes across study groups. Each IIEF-5 domain scored from 0 to 5; 0 ϭ did not attempt intercourse; 1 ϭ never/occasionally; 2 ϭ less than half the time;3 ϭ sometimes/half the time; 4 ϭ more than half the time; 5 ϭ almost always; total IIEF-5 score calculated by totaling andtaking the mean of the responses to all 5 domains of IIEF-5. * P Ͻ0.05, after RC vs. baseline.
† P Ͻ0.05, orthotopic substitution vs. ileal conduit/continent cutaneous.
the 42 patients who were impotent, our data indi-
age of 58.9 Ϯ 8.4 years. Seven (14%) of the 49
cated that 22 (52%) attempted sildenafil citrate,
patients were naturally potent after surgery, and
with only 2 (9%) having responses sufficient for
6 of those 7 (86%) had undergone a nerve-spar-
ing procedure. Of concern, only 52% of this sex-
We stratified the degree of ED (using SHIM
ually active series sought treatment for their ED.
scores) by the type of urinary diversion. The differ-
This study also points out the important impact
ence in the mean total SHIM score of 5.24 Ϯ 6.21
of the postoperative treatment of patients with ED.
after orthotopic substitution was statistically sig-
Of the 42 patients with ED after RC, 20 (47%) did
nificant (P Ͻ0.05) compared with that after ileal
not seek treatment. This fact emphasizes the im-
conduit (mean total SHIM score 1.13 Ϯ 0.33) and
portance of preoperative counseling and earlier ag-
cutaneous continent (mean total SHIM score 1.33
gressive treatment and consultation after surgery.
Currently, these patients often have a discussion
ference was not as clinically significant, because
regarding their ED 12 to 18 months after surgery.
the difference between “almost never or never”
This delay in addressing this issue after RC may
does not differ in the SHIM questionnaire from
discourage patients and may explain why many
sexually active patients in our study did not seektreatment after RC.
In our series, only 2 (9%) of 22 patients re-
The results of this study have important signif-
sponded to sildenafil citrate as defined by success-
icance in the treatment of bladder cancer. Al-
ful vaginal penetration. It is well known that pres-
though RC has focused primarily on cure, recur-
ervation of the neurovascular bundles is vital for
the success of sildenafil Sildenafil citrate
our results suggest that ED is an important com-
does not work as a phosphodiesterase type 5 inhib-
plication after this procedure that has not been
itor when nitric oxide is not released from the neu-
well recognized. ED was a prevalent problem in
rovascular bundle. The 2 patients who responded
our study, occurring in 42 (86%) of 49 sexually
to sildenafil citrate had preservation of neurovas-
active men after RC. These 42 patients were sex-
cular bundles. It is unclear from the operative re-
ually active before surgery, with a mean fre-
ports how many of the other 20 patients had un-
quency of 2.0 Ϯ 1.3 times per week and a mean
dergone nerve-sparing RC. It appears that most
UROLOGY 64 (4), 2004
were non-nerve-sparing procedures, explaining
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Only 9 (18%) of these 49 men were able to achieve erections
UROLOGY 64 (4), 2004
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