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PCU2|2002: Craig
D. Zippe, MD
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Craig
D Zippe, MD |
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Co-director, Prostate Center, Urological
Institute
Cleveland Clinic Foundation |
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Edited comments by Dr Zippe
Postprostatectomy erectile dysfunction
I believe the average urologist, performing 50 or more bilateral
nerve-sparing procedures, has a 30 to 50% potency rate with at least
15 or 20% of that being medically assisted with Viagra® (sildenafil).
The long-term efficacy of sildenafil in maintaining erections, in
our study, was very good. About 70% of the patients, who responded
to sildenafil at one year, were still obtaining a good response
at three years. The best predictor of response to sildenafil is
the quality of the initial nerve-sparing prostatectomy, measured
by some partial function following surgery. Partial function would
be reflected by an International Index of Erectile Function (IIEF)
abridged score of at least 15. The other predictive factors for
a response to sildenafil include bilateral compared to unilateral
nerve-sparing surgery and, of course, age.
Nerve-sparing radical prostatectomy
I perform bilateral nerve-sparing prostatectomy in 90% of my patients.
In the community three or four years ago, ten percent of the prostatectomies
were nerve-sparing and 90% were non-nerve-sparing. That ratio is
slowly changing.
We have looked at whether our positive margin rates were higher
with bilateral nerve-sparing prostatectomy. I initially thought
so when I was more inexperienced. But the more experienced one becomes,
the easier it is to do bilateral nerve-sparing surgery with most
tumors.
Technical caveats when performing a nerve-sparing prostatectomy
include achieving excellent hemostasis of the dorsal vein and obtaining
precise visualization at the apex. I have improved my vision by
wearing 2.5 magnification loops, which help me see a little better.
However, the ability to control hemostasis allows perfection of
the nerve-sparing technique. The actual handling of the nerve bundle
is also very important. Many nerves are dysfunctional not because
you cut them, but because you traumatize them. We should be operating
more like neurosurgeons, compared to urologists or pelvic surgeons.
Postoperative management of erectile function
I am very aggressive with penile rehabilitation. Typically in
the past, there was a neuropraxia period after surgery that lasted
nine to 12 months — where patients were not getting nocturnal
erections. We used to just let this period endure. After one year,
we would then become aggressive and start treatment.
My current practice is very different than that. Now two weeks
after surgery, patients start either oral sildenafil with a vacuum
constriction device (VCD) or an early injection program with papaverine
and phentolamine without any PGE1. We are using sildenafil to both
prime the vasculature and try to induce erections. I have patients
take it an hour or two before they use their VCD. Those men who
are sexually active feel the sildenafil enhances the sexual experience
from the VCD.
The year after prostatectomy is very important to these men in
terms of keeping a relationship with their spouse. One of the advantages
to an early rehabilitation program is that no physical or emotional
separation occurs between the couple. It is really hard for many
couples to re-establish physical intimacy 12 to 18 months after
surgery. That physical and emotional separation may be a reason
many of these patients are not interested in becoming sexually active
again.
I have a nurse who specializes in sexual dysfunction who works
with the patients. I also spend a lot of time discussing sexual
function both before and after surgery. One to two years after surgery,
most of us become impotence doctors. One year after surgery, 90%
of my patients have an undetectable PSA and are continent without
pads. Meanwhile, we are dealing with 75 or 80% of the patients who
are still unhappy with their erections.
Therapeutic options for erectile dysfunction
Initially, I give patients all the options. In the same visit,
I typically ask patients to come for injection training as well
as prescribe a VCD and MUSE® (alprostadil). In any patient,
the efficacy or long-term compliance with each option is not predictable.
The long-term compliance with many of these options is only 50%.
However, 50% of the men are happy with them. So, I give patients
all the options as early as possible. Each individual patient —
or couple, I should say, because the wife has to be satisfied as
well — will narrow down what they prefer.
Sildenafil has been a marvelous addition to our armamentarium.
Two other new drugs with at least equal, if not greater, efficacy
are vardenafil by Bayer and Cialis® (tadalafil) by ICOS-Lily.
These new drugs need to be compared to sildenafil and evaluated
for their side-effect potential. It is an exciting time, because
we will have more options when these new oral treatments are approved.
However, these drugs only work with good neurovascular preservation.
Each of us who performs prostate cancer surgery, especially on
younger patients, must continue to work on our nerve-preservation
techniques. However, we still try sildenafil in patients with nonnerve-sparing
surgery, because about 10% of them will respond.
There are several university centers in the United States using
sural nerve grafts. This procedure is slowly growing throughout
the country. In sexually active young patients who require resection
of both neurovascular bundles, we perform sural nerve grafting.
Since two nerves are always better than one, especially when you
consider the response to sildenafil, we have also started using
it when we take out one nerve. The nerve grafts appear to respond
to oral therapy as well as the native nerves. It takes 18 to 24
months to see a response from the transplanted nerve. Usually, a
plastic surgeon helps to harvest the nerve and also sutures the
nerve graft.
Evaluation of erectile function
In the past, good measures for erectile function were not available.
Physician-assisted data collection was highly biased and probably
inaccurate. Great strides were made with the implementation of validated
questionnaires. Some of the earlier questionnaires were too complicated;
they required the patient take them home and a statistician to input
the data into a computer. I think the best questionnaire is the
five-question Sexual Health Inventory for Men (SHIM). It consists
of five questions that quantitate frequency of erections, maintenance
of erections and sexual satisfaction. The SHIM is easy to complete
and put in the patient’s chart. In my clinic, men fill out
the SHIM in the waiting room. It is reproducible and should probably
be the gold standard for any specialty evaluating sexual function
outcomes. To compare perineal and laparoscopic prostatectomy with
retropubic prostatectomy, we all need to use the same instrument
to assess erectile function. There are no reports in the radiation
therapy literature using the SHIM questionnaire.
Challenging Case 1:
76-year-old man in excellent health
with Gleason 7 prostate cancer in 2/10 core biopsy
Clinical history
This very active and healthy man, with a history of diverticulitis
and rectal polyp removal, presented with a PSA of 10.5 ng/mL. Two
years earlier, his PSA was 4.3 ng/mL, and a biopsy was not performed.
On physical exam, there were no palpable nodules, and he seemed
to have a fairly large prostate (approximately 60 grams).
A 10-core biopsy revealed that the left side was normal, but the
right side had two positive cores with Gleason 7 (3+4) adenocarcinoma.
His bone scan was negative, and a CAT scan was not done. He did
not want to receive any form of radiation. At the same time, he
did not want to be observed.
Key management question
Which hormonal therapy options should be presented to this man?
Follow-up
The patient elected bicalutamide 150 mg monotherapy. He has been
on it for nearly three years, and he is very happy with his treatment
plan. His PSA is stable around 1.4 to 1.6 ng/mL. He has not experienced
any toxicity, such as gynecomastia or hot flashes.
Case discussion
While I-125 seeds might have been an option, this patient did
not want to have any radiation. At the same time, he did not want
to be observed either. In a situation like this, a 76-year-old man
with a Gleason 7 tumor probably has an 89% chance of survival at
ten years with observation. However, he also has a 42% chance of
developing metastatic disease with observation.
Healthy 76-year-old men will not accept observation with that
kind of risk of developing metastatic disease. They will usually
elect treatment. Most of my patients do not choose observation when
presented with the statistics about the risk of developing metastatic
disease.
So, we discussed hormonal options. One option was combined androgen
ablation, which I think was too aggressive for this patient’s
tumor. The other hormonal therapy options included intermittent
LHRH agonist therapy and bicalutamide monotherapy. I believed his
tumor could be controlled without much androgen deprivation, and
that he did not need castration or to suffer from its side effects.
He chose bicalutamide monotherapy. The mean decrease in PSA with
bicalutamide monotherapy is around 76 to 80%. Although about 30%
of patients may become refractory to bicalutamide in two years,
according to our small series of patients, this man did not. In
our series, we have been able to use an LHRH agonist to rescue all
of the patients with antiandrogenrefractory PSAs. I am comfortable
with bicalutamide monotherapy in delaying PSA progression. This
patient’s quality of life was not compromised by treatment.
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