Impotence from Drug Treatment

Dr.Joe's Data Base

Review of the literature reveals no evidence that use of alpha blocker
drugs is a risk factor for impotence. Finasteride, however, produces sexual
dysfunction in a small number of patients.

Of patients taking 5 mg of finasteride per day, 3.3 percent reported
decreased libido compared with 1.6 percent on placebo; 2.5 to 3.7 percent reported
erectile dysfunction compared with 1.1 percent on placebo. The etiology of this
small, but statistically significant effect of finasteride is unclear, since
the drug does not lower serum testosterone levels, and since testosterone is
presumed to primarily mediate libido and sexual function.

Retrograde Ejaculation After BPH Treatment

The pathophysiology of retrograde ejaculation is that the bladder neck
fails to close during ejaculation, allowing the semen to flow back into the
bladder. Other than potential infertility, retrograde ejaculation has no serious
medical consequences. Patients may not find retrograde ejaculation troublesome,
but it is important that they understand the risk before surgery. In patients
not informed preoperatively, more significant sexual dysfunction may occur secondary
to the anxiety produced.

Although relatively uncommon, alpha blocker therapy may cause retrograde
ejaculation due to relaxation of the bladder neck. This effect is reversible.
Among surgical options, as shown in Table 19, TUIP
has the lowest probability of producing retrograde ejaculation and should be
the operation of choice in men with prostates <30 grams (of resectable tissue
as estimated by DRE) who wish to maintain antegrade ejaculation.

Finasteride does not cause retrograde ejaculation. In clinical trials,
however, 2.9 percent of patients on finasteride (5 mg per day) complained of
a "decrease or abnormality" in ejaculation. The drug can reduce the
ejaculate volume to some degree, and some patients may find this change a problem.

12. Direct Treatment Outcomes -- Urinary Incontinence

Although infrequent, total urinary incontinence is a serious complication
of prostate surgery. The risk of incontinence appears to be lower after open
prostatectomy than after TURP, although this may be due to reporting bias. The
risk of incontinence is lower following TUIP than following TURP.

Urinary incontinence is defined as the involuntary loss of urine.
Data were abstracted from a variety of BPH treatment outcome studies to determine
risk of stress urinary incontinence, urge urinary incontinence, and total urinary
incontinence (complete loss of voluntary control over micturition).

Stress Urinary Incontinence

Stress incontinence refers to the involuntary loss of urine during physical
activity such as coughing, sneezing, and lifting. Stress incontinence often
follows surgical intervention for BPH and is usually temporary. Most studies
reporting the incidence of stress urinary incontinence following treatment do
not report exactly at what time point during followup the patient was assessed
in regard to this particular symptom.

Urge Urinary Incontinence

Urge incontinence refers to the involuntary loss of urine associated
with an uncontrollable urge to void. Urge incontinence may be a symptom of severe
bladder obstruction. It is recognized as the most extreme manifestation of the
irritative symptom of urgency, which is very common in patients with prostatism.

Although an attempt was made to abstract data on urge urinary incontinence,
very few studies report this particular outcome. Consequently, the panel did
not perform a formal statistical calculation of the mean risk of urge incontinence
following treatment.

Total Urinary Incontinence

The risk of total incontinence, defined as the complete loss of voluntary
control over micturition, is of great concern to patients facing a treatment
decision for BPH. In an overall ranking of 15 different outcomes, the panel's
proxy judges (see chapter 18) ranked total incontinence
of urine as the fourth most important outcome influencing a treatment decision.

Treatment Comparisons

Urinary incontinence has not been reported following alpha blocker treatment,
finasteride treatment, or placebo treatment. Also, in none of the papers reporting
on balloon dilation was a patient found to suffer from stress, urge, or total
urinary incontinence following treatment. In the panel's opinion, incontinence
is possible following balloon dilation but rare.

Studies reviewed show stress incontinence for 1.9 percent and urge incontinence
for 0.5 percent of patients following open prostatectomy. The average for total
urinary incontinence was 0.5 percent. Following TUIP, 0.8 percent of patients
experienced stress incontinence. Urge urinary incontinence was not reported
in any TUIP study, and only one patient was reported to have experienced total
urinary incontinence following TUIP. The probability for total incontinence
following TUIP is less than 0.1 percent. After TURP, 2.1 percent of patients
experienced stress incontinence, 1.9 percent had urge urinary incontinence,
and 1.0 percent were reported to have total incontinence.

Comparing the risk of incontinence after open prostatectomy with the
risk after TUIP and TURP reveals significant differences (Table
20). The probability of total incontinence following TURP is 1.0 percent
(90-percent CI 0.7-1.4 percent). This is significantly higher than the 0.5-percent
risk of total incontinence following open prostatectomy. The calculated probability
of suffering total incontinence following TUIP is 0.1 percent (90-percent CI
0.02-0.5 percent). This may be an overestimation, since only 1 of 1,200 patients
in 7 TUIP studies experienced total urinary incontinence after treatment.

13. Direct Treatment Outcomes -- Late Complications

Surgery may produce scarring in the urethra (stricture) or at the
bladder neck (contracture), which may lead to persistent or recurrent urinary
symptoms. Urethral stricture and bladder neck contracture often necessitate
secondary invasive procedures. The probability for the development of a urethral
stricture or a bladder neck contracture, requiring a secondary surgical intervention,
ranges from 0.6 to 14.1 percent of patients after open prostatectomy, from 0.65
to 10.1 percent of patients following TURP, and from 2.1 to 4.1 percent of patients
following TUIP.

Two late complications that may result from surgical treatment of BPH are
clearly defined and reported in many of the series found in the literature.
These are urethral stricture and bladder neck contracture (BNC), following either
open or transurethral surgery on the prostate (Table 21).
The risk of urethral stricture or BNC following balloon dilation has not been
reported. The percentage of patients experiencing these complications who required
treatment was calculated based on the total number of patients in each series.
This may, in some cases, be either an underestimation or an overestimation because
of reporting bias. The time interval is highly variable in these studies. However,
fibrotic complications are usually evident within 2 to 24 months.

Treatments for the two conditions include repeated dilation of the urethral
stricture or the BNC, surgical treatment such as visual internal urethrotomy
of the urethral stricture or the BNC, or open surgical repair of the complication.

Urethral Stricture After Open Surgery

There are 18 studies reporting the incidence of urethral stricture and/or
BNC following open surgical enucleation of the prostate (Attachment
D). These studies comprise a total of 8,634 patients. Patients treated
by retropubic prostatectomy numbered 5,271, and 3,080 patients were treated
by suprapubic prostatectomy. Although men with smaller prostates are thought
to be more susceptible to the two complications, no meaningful conclusion can
be drawn from these studies regarding correlations between weight of the prostate
and incidence of the complications. Only 3 of the 18 studies reported the mean
weight, and the mean weight ranges only from 42 to 51 grams in those studies
in which it was reported.

Overall, open surgical enucleation resulted in urethral stricture disease
in 181 out of 8,634 patients for an incidence of 2.1 percent and a mean of 2.6
percent (Table 21) (90-percent CI 2.8-9.4 percent).
The higher risk
following suprapubic (mean 5.1 percent), as opposed to retropubic prostatectomy
(mean 1.0 percent), cannot be explained. Given the small number of cases reported,
it may be artifactual.

Urethral Stricture After TUIP

Nine studies report the incidence of urethral stricture disease following
TUIP (see Attachment D). The risk is 2.65 percent (Table 21) (90-percent CI 1.85-3.8 percent). Of 1,218 patients
reported, 21 had the complication. The overall risk of urethral stricture following
TUIP does not appear to be markedly lower than that seen following TURP, notwithstanding
the shorter operating time of the former.

Urethral Stricture After TURP

The incidence of urethral stricture disease following TURP is reported in
17 studies with a total of 12,003 patients, with an average age of 67.6 years
(Attachment D). Of this total, 269 patients developed
urethral stricture disease. The combined analysis indicates the estimated risk
to be 3.1 percent (90-percent CI 0.5-9.7 percent). Three studies report an especially
high rate of stricture: 16 percent (Nielsen, 1988),
16 percent (Meyhoff, Nordling, and Hald, 1984), and
12 percent (Meyhoff and Nordling, 1986). Although these
studies report a much higher incidence of urethral stricture disease, the complications
are carefully documented and the studies are contemporary. In 6 of the 17 studies,
the average weight of the removed tissue is reported (mean 21.1 grams, range
7-57 grams). There is no correlation between the weight of tissue resected and
the incidence of stricture formation evident in these studies.

Regarding such potential predictors of subsequent strictures as resected
weight, the panel reviewed a large body of evidence on the correlation between
perioperative parameters and the subsequent probability of scar tissue formation.
Individual studies have found positive correlations between urethral stricture
or BNC and the resected weight, the operating time, the catheter size and site,
the type of instrumentation, and other factors. Unfortunately, the studies conflict
with one another. Based on a synthesis of these studies, the panel cannot make
any evidence-based recommendations on prevention of the two complications by
modifications of operative or perioperative management.