Table of Contents
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2. 1 NON-DRUG TREATMENTS
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2.1.1 - Regular training by
physiotherapist reduces urinary incontinence after radical
prostatectomy
2.1.2 - Vaginal pessaries provide some
relief from urinary and bowel symptoms with pelvic organ
prolapse
2.1.3 -
Behavioural training alongside medication improves urge
incontinence
2.1.4 -
How much do non-surgical treatments benefit incontinence
2.2. DRUG TREATMENTS
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2.2.1 -
Darifenacin improves symptoms of overactive bladder in women
and men
2.2.2 - Solifenacin in urge and mixed
urinary incontinence
2.2.3 - Drug therapy improves overactive
bladder symptoms better than bladder and pelvic floor
training alone
2.2.4 - DuloXetine (not available in
Canada) improves stress incontinence in some women
2.2.5 - Incontinence due to spinal cord
injury or multiple sclerosis may improve with Botox
injections
2.2.6 - The effectiveness of drug
treatment with duloxetine in men with stress incontinence
after radical prostatectomy
2.3. SURGICAL TREATMENTS
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2.3.1 - What complications can be expected
from sling procedure for stress urinary incontinence
2.3.2 - What determines success of
mid-urethral sling procedures in women with stress urinary
incontinence
2.3.3 - Results with sling procedure for
men with stress incontinence after prostate cancer surgery
2. 1 NON-DRUG TREATMENTS
2.1.1
Regular training by physiotherapist reduces urinary
incontinence after radical prostatectomy
Overgård M, Angelsen A, Lydersen S, Mørkved S. Does
physiotherapist-guided pelvic floor muscle training reduce
urinary incontinence after radical prostatectomy? A
randomised controlled trial. Eur Urol. 2008
Aug;54(2):438-48. Epub 2008 Apr 18.
Why they did the study
Urinary incontinence is a common problem after radical
prostatectomy. It is worst in the first six months after the
catheter is removed and improves somewhat between six months
and two years. But many men continue to suffer from
incontinence long after surgery. Pelvic floor training can
improve continence and men are generally instructed in the
technique while in hospital. The authors wondered whether
better results could be obtained if men were provided
regular follow-up pelvic floor training sessions with a
physiotherapist in the first year after surgery. Studies of
similar programs for women with stress urinary incontinence
showed promising results.
How they did it
The authors invited all men treated with radical
prostatectomy for prostate cancer at one hospital in Norway
over the course of a year to participate in the study. The
first 85 men to agree made up the study group. Half were
provided standard instruction in pelvic floor exercises. The
other half also attended weekly follow-up sessions with a
physiotherapist to reinforce pelvic floor training
techniques. All men reported on their continence status six
weeks, three months, six months and one year after starting
the study.
- What they found
After three months, there was no difference in continence
between the two groups, though the group receiving
physiotherapy follow-up reported milder problems than that
group not receiving follow-up.
- After six months, 79% of men in the follow-up group were
continent, compared to 58% of men in the control group.
- At one year, this difference was greater still, with 92%
of men in follow-up reporting continence versus 72% of men
in the control group.
Why it matters
Most hospitals provide one-time instruction in pelvic floor
training to men who have undergone radical prostatectomy and
then leave them to exercise on their own. This study makes
it clear that follow-up instruction by a physiotherapist
increases long-term adherence, improves exercise technique
and results in significantly improved continence rates over
time. It may be a good idea to make this sort of program
commonplace. If you are scheduled for radical prostatectomy,
you may want to find a physiotherapist to work with in the
months after your surgery.
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2.1.2
Vaginal pessaries provide some relief from urinary and bowel
symptoms with pelvic organ prolapse
Fernando RJ, Thakar R, Sultan AH, Shah SM, Jones PW.
Effect of vaginal pessaries on symptoms associated with
pelvic organ prolapse. Obstet Gynecol. 2006 Jul;108(1):93-9.
Why they did the study
Vaginal pessaries are an age-old mechanical means of
controlling pelvic organ prolapse (a dropping down of the
bladder into the vaginal vault, called a cystocele, or a
bulging of the rectum into the vaginal vault), which often
leads to problems with urinary and bowel incontinence.
Pessaries can be used while waiting for surgery or as an
alternative to surgery. Previous studies of their
effectiveness failed to use standardized questionnaires. The
authors wanted to improve the quality of evidence around how
well pessaries work to control symptoms.
How they did it
203 women who chose to try a pessary when referred to a
uro-gynecologic specialist were included in the study. They
completed a questionnaire asking about the impact of
prolapse on urinary, bowel and sexual function and had a
pelvic exam. Different types of pessary (ring, cube or
doughnut) were inserted depending on factors such as whether
the woman was sexually active. Women returned for a visit at
two weeks and again after four months of using the pessary.
What they found
- 75% of women were still using the pessary at two weeks.
Women who did not keep it in were more likely to be of
higher parity (having had many past pregnancies) or have had
a hysterectomy.
- Among women who kept the pessary in over the four-month
follow-up, between 20% and 40% saw improvement in urinary
symptoms, including difficulty emptying bladder, urgency and
urge incontinence; about 20% of women reported improvements
in fecal urgency and incontinence. There was no real
improvement in stress urinary incontinence.
Why it matters
Surgery for pelvic organ prolapse is not possible for
everyone and those who do undergo surgery often need to have
it repeated. For some women, pessaries may provide relief
from urinary and bowel symptoms either while waiting for
surgery or instead of surgery.
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2.1.3
Behavioural training alongside medication improves urge
incontinence
Burgio KL, Kraus SR, Menefee S, et al. Behavioural
therapy to enable women with urge incontinence to
discontinue drug treatment: a randomized trial. Ann Intern
Med. 2008 Aug 5;149(3):161-9.
Why they did the study
Training in continence skills and the drug tolterodine (an
muscarinic-receptor antagonists drug that calm the
overactive bladder muscle) are both first-line treatments
for urge urinary incontinence. But many women do not achieve
complete continence on either therapy alone and a good
number stop taking antimuscarinic medications after a
certain amount of time. The authors wondered whether ongoing
behavioural training provided alongside medication would
improve continence during treatment and provide continued
improvements after medication was stopped.
How they did it
The authors recruited 237 women with urge incontinence in
outpatient clinics at clinical centres of the Urinary
Incontinence Treatment Network and randomly assigned them to
receive either antimuscarinic therapy (tolterodine) alone or
a combination of behavioural training and tolterodine for a
period of 10 weeks.
All women were seen four times over the 10 weeks to assess
whether they were taking the medication.
The women receiving behavioural training as well as drug
therapy had an initial session with a nurse practitioner or
physical therapist to instruct them on pelvic floor
strengthening exercises and behavioural strategies to reduce
urgency. At each of the four follow-up visits, pelvic floor
strength was measured and further instruction provided.
After 10 weeks, medication and behavioural training were
discontinued in all participants and women in the combined
treatment group were instructed to continue their
behavioural program. Women who requested a renewed drug
prescription were provided with it free of charge.
Continence was assessed at the start of the study, at 10
weeks and finally at eight months.
What they found
- After 10 weeks 69% of women in the combined drug and behavioural training group and 58% of women receiving drug
treatment alone had achieved at least 70% improvement in
continence. 21% of those in the combination therapy reported
being completely dry, against 17% of those receiving only
drug therapy.
- At the eight-month assessment, fewer women from the group
that had received combination therapy than women who had
received drug therapy alone had resumed taking medication
(29% vs 36%).
- The number of women in each group achieving a 70% or
greater reduction in incontinence at eight months was the
same.
Why it matters
Behavioural training can improve results of medication
therapy for urge incontinence but it provides no lasting
benefit after medication is discontinued. Patient
satisfaction and perceived improvement were better among
women receiving combination therapy at each assessment.
Next question
Future studies should compare the long-term effectiveness of
medications, surgeries and pessaries for stress urinary
incontinence.
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2.1.4
How much do non-surgical treatments benefit incontinence
Shamliyan TA, Kane RL, Wyman J, Wilt TJ. Systematic
review: randomized, controlled trials of nonsurgical
treatments for urinary incontinence in women. Ann Intern
Med. 2008 Mar 18;148(6):459-73. Epub 2008 Feb 11.
Why they did the study
There are many studies of non-surgical treatments for
urinary incontinence in women. The authors wanted to
synthesize the results to provide guidance on what
treatments work best.
How they did it
Research papers on all types of urinary incontinence
treatments published between 1990 and 2007 were considered
for inclusion in the analysis. Data from comparable studies
was pooled together to assess the consistency of results
with different incontinence treatments.
What they found
- Pelvic floor training, alone or alongside bladder
training, improves urinary incontinence. Individualized
training produces better results than group training or
training provided in a self-help booklet.
- Electrical stimulation did not produce better results
than pelvic floor muscle training.
- Injected bulking agents produce mixed results that are
similar for the different products used. Some studies of
bulking agents for stress incontinence report cure rates of
15-60%, but statistically significant benefit was only shown
in one clinical trial.
- Stress and mixed urinary incontinence were resolved for
some women by using intra-urethral or intra-vaginal devices
to block urine, but results did not differ significantly
among groups using vaginal cones, Hodge pessaries or
disposable intravaginal devices.
- There was strong evidence that oral hormone replacement
therapy worsens urinary incontinence.
- Vaginal and transdermal estrogen brings inconsistent
improvement.
- Adrenergic drugs (which liberate adrenaline) do not
improve continence compared with placebo or pelvic floor
training.
- Anticholinergic drugs (oxybutynin or tolterodine)
increase continence rates compared to placebo.
Why it matters
It is difficult to combine studies in urinary incontinence
because improvement is measured in different ways and over
different time periods. The authors wanted to provide
doctors and patients with an idea of the comparative
effectiveness of different treatment options. From the
analysis of studies accomplished to date, they can state
that for every 1000 women treated:
- pelvic floor muscle training would resolve 490 cases of SUI;
- magnetic stimulation therapy would resolve 390 cases of
urge incontinence;
- tolterodine would resolve 202 cases of urge incontinence;
- intensive llifestyle change would avoid 54 cases of
stress urinary incontinence.
Next question
Future studies should use long-term continence as a common
outcome to allow comparison of the benefits of different
therapies.
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2.2. DRUG TREATMENTS
2.2.1
Darifenacin improves symptoms of overactive bladder in women
and men
Chapple C, Steers W, Norton P, et al. A pooled analysis
of three phase III studies to investigate the efficacy,
tolerability and safety of darifenacin, a muscarinic M3
selective receptor antagonist, in the treatment of
overactive bladder. BJU Int. 2005 May;95(7):993-1001.
Why they did the study
Overactive bladder, which is a combination of urgency
(sometimes with urge incontinence), frequent urinating, and
having to urinate at night, is common in the general
population of both women and men.
Antimuscarinic drugs block the stimulation of muscarinic
receptors in the detrusor muscle of the bladder, but
existing drugs (such as oxybutinin and tolterodine) also
cause dry mouth and constipation. Darifenacin is a new
muscarinic M3 selective receptor antagonist, which appears
to target the bladder without producing the side effects of
less selective drugs.
Three Phase III studies (in which a new treatment, shown to
be safe and efficacious in Phase I and II studies, is
compared with results of standard treatment) were conducted
to assess the effectiveness of darifenacin and see what dose
worked best. The authors aimed to put the data from these
three trials together to evaluate the efficacy, safety and
tolerability of darifenacin.
How they did it
The authors took data from three studies of a total of 1059
adults (85% women) who had symptoms of overactive bladder
lasting at least six months and took darifenacin for 12
weeks. All participants completed diaries to record the
frequency and severity of incontinence episodes as well as
the frequency of urination. The study compared those taking
7.5 mg of darifenacin once a day, 15 mg twice a day, and
placebo.
Study visits were conducted two, six and 12 weeks after
starting treatment, at which point investigators looked at
participants' diaries, questioned them about improvement and
inquired about adverse events. Blood pressure, heart rate
and blood tests were taken at the beginning and end of the
study.
Participants were not excluded if they took other
medications for health conditions, but were required to be
on a stable dose with no plans to change during the study.
What they found
- The average decrease in weekly incontinence was -8.8
among participants taking 7.5 mg of darifenacin, and -10.6
for those taking 15 mg.
- The proportion of people who achieved a 70% or greater
reduction in number of incontinence episodes after 12 weeks
was 48% in the group taking 7.5 mg of darifenacin and 57%
for those taking 15 mg, compared with 33% to 39% in the
placebo groups.
- 34% of those taking 7.5 mg of darifenacin and 35% of
those taking 15 mg attained normal urination frequency
(eight or fewer times per day), compared to 27% of those on
placebo.
- 24% of patients on the 15 mg dose achieved seven or more
consecutive dry days, compared with 16% of those taking the
7.5 mg dose.
- 27% and 28% of those taking darifenacin saw a 90% or
greater reduction in incontinence episodes, compared with
17% on placebo.
- Treatment-related adverse events occurred in 37.1% and
52.1% of people given 7.5 mg or 15 mg compared to 20.9% of
those taking placebo. The most common were dry mouth and
constipation, which sometimes required laxative use. No
other adverse events were more common in the treatment group
than in the placebo group.
Why it matters
There is currently no cure for overactive bladder. However,
darifenacin can reduce symptoms to almost normal for more
than a quarter of those taking it. The poor tolerability of
existing drugs makes it difficult for people to comply with
therapy over the long term. Darifenacin did produce dry
mouth and constipation in some people, but the need for
laxatives and the withdrawal rate were not significantly
different than in the placebo group. Increasing concerns
about the cognitive effects of less selective muscarinic
inhibitors make a new alternative even more welcome.
Next question
- What is the additive effect of combining pelvic floor
exercises and pharmacologic treatment in overactive bladder?
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2.2.2
Solifenacin in urge and mixed urinary incontinence
Kelleher C, Cardozo L, Kobashi K, et al. Solifenacin: as
effective in mixed urinary incontinence as in urge urinary
incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2006
Jun;17(4):382-8. Epub 2005 Nov 8.
Why they did the study
Treatments for mixed and urge urinary incontinence are
generally tested in much larger groups of people with any
form of overactive bladder, many of whom do not experience
incontinence. The authors wanted to see what results were
achieved with the drug solifenacin for the subset of people
in previous studies who had mixed and urge incontinence.
How they did it
The authors extracted data on the efficacy of solifenacin in
mixed and urge incontinence from four international studies
on people with overactive bladder to see results for this
more specific population. Study methodology and patient
selection criteria were close enough to permit combining
data. Each study compared solifenacin to placebo.
Participants were assessed at regular intervals through
diaries that recorded incontinence episodes and other
information over a period of at least 12 weeks. Over 1800
participants taking either 5 mg or 10 mg of solifenacin once
a day were available for analysis, as were 1200 who took
placebo.
What they found
- Among people with mixed and urge urinary incontinence,
decreases in the number of incontinence episodes per day
were seen in 84% to 100% of the study subjects taking solifenacin, compared to 64% of those of placebo.
- Decreases in the number of urgency episodes per day were
seen in between 63-70% of those on solifenacin and 39% of
those on placebo
- Side effects of dry mouth occurred in 28% of patients on
the 10 mg dose, but only 11% of those on the 5 mg dose.
- Constipation was also more common at the higher dose (13% vs 5%)
- 8% of people at the higher dose discontinued treatment
because of side effects, compared to 4% of those on the 5 mg
dose.
Why it matters
This analysis showed that solifenacin is an appropriate
choice of antimuscarinic agent for the treatment of urge and
mixed urinary incontinence.
Next question
We need to look at combination drug therapy alongside
behavioural therapy with pelvic floor muscle training to see
which is more effective.
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2.2.3
Drug therapy improves overactive bladder symptoms better
than bladder and pelvic floor training alone
Alhasso AA, McKinlay J, Patrick K, Stewart L.
Anticholinergic drugs versus non-drug active therapies for
overactive bladder syndrome in adults. Cochrane Database
Syst Rev. 2006 Oct 18;(4):CD003193.
Why they did the study
Overactive bladder, which is defined as urinary urgency,
with or without incontinence, is treated with either
anticholinergic drugs or bladder and pelvic floor muscle
training. The authors wanted to review existing trials of
each type of therapy to see which had the best results.
How they did it
The authors included all randomized controlled clinical
trials of treatment with anticholinergic drugs for
overactive bladder in which one group of patients received a
non-drug therapy. Data were extracted and reviewed all
together.
What they found
- Symptom improvement of overactive bladder, with or
without incontinence, is more common among those taking anticholinergic drugs than those using non-drug treatment.
- A combination of bladder and pelvic floor training with anticholinergic drugs may be better than drugs alone.
- Adverse effects such as dry mouth were reported by about
a third of people taking anticholinergic drugs.
Why it matters
Anticholinergic drugs produce the best symptom relief for
people with overactive bladder. And there effectiveness
improves in combination with pelvic floor muscle training.
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2.2.4
DuloXetine (not available in Canada) improves stress
incontinence in some women
van Kerrebroeck P, Abrams P, Lange R, et al. Duloxetine
versus placebo in the treatment of European and Canadian
women with stress urinary incontinence. BJOG. 2004
Mar;111(3):249-57.
Why they did the study
Existing treatments for stress urinary incontinence are less
than satisfactory. Continence surgery is undergone by only
about 5% of American women with bothersome stress urinary
incontinence. Pelvic floor exercises are used by an
undetermined number of women but often not for long enough
or regularly enough to significantly improve continence.
Animal studies have shown that serotonin and norepinephrine
improve lower urinary tract function. They increase bladder
storage by relaxing the bladder and increasing bladder
outlet (the bladder neck area) resistance. Decreasing the
uptake of serotonin and norepinephrine were therefore though
to have potential in improving stress urinary incontinence.
Animal studies using the uptake inhibitor duloxetine
hydrochloride showed that it significantly increased bladder
capacity and sphincter muscle activity. A phase II study in
women with stress urinary incontinence showed improvement.
Phase II studies include more people than Phase I studies
and are intended to evaluate the efficacy of a treatment for
the condition it is intended to treat as well as monitor for
side effects.
The authors felt that earlier phase studies were promising
enough to warrant a Phase III trial of duloxetine in women
with stress urinary incontinence. A Phase III trial is meant
to prove effectiveness of a drug compared to placebo or
standard treatment.
How they did it
The authors recruited 494 women aged 24 to 83 in seven
European countries and Canada who had bothersome stress
urinary incontinence lasting at least three months. The
severity of incontinence ranged from two or three pads per
day to 10 pads per day, meaning that these women would be
considered candidates for incontinence surgery.
All women were given a placebo (sugar pill) for two weeks,
after which half the group was given duloxetine and the
other half continued on placebo. Neither the women, nor the
researchers performing the assessments knew who was taking
the active drug and who was taking placebo.
Women were seen at four-week intervals throughout the
12-week study and completed surveys about the frequency of
incontinence episodes based on diaries they kept every day.
Women also completed incontinence-related quality of life
surveys at each visit. Drug safety was assessed through
questions about adverse events and investigations of
discontinuations.
What they found
- Fewer women in the duloxetine group (73%) completed the
12-week study than women in the placebo group (92%). The
difference was due to more frequent side effects. The
discontinuations occurred in the first four weeks of taking
the drug, after which none of the women taking duloxetine
discontinued for adverse events.
- 51.9% of women in the duloxetine group had a 50% to 100%
decrease in incontinence episode frequency compared with
33.5% of those in the placebo group. The improvements were
apparent four weeks after starting the drug and continued
throughout the 12-week study period. Improvements were
greater in women with severe incontinence.
- Differences in health-related quality of life were not
significant, though at the 12-week assessment 64.8% of women
on duloxetine considered their urinary tract condition to be
very much, much or a little better, compared with 48.2% of
women on placebo.
- The most common adverse effects of duloxetine were
nausea, dry mouth, constipation, fatigue, insomnia,
dizziness, headache and sweating. Each of these either
occurred in more than 5% of women taking duloxetine or
occurred significantly more often with duloxetine than with
placebo.
- There was an increase in average heart rate in women
taking duloxetine, but it generally stayed within normal
range, and there were no significant changes in blood
pressure.
Why it matters
The study supports the beneficial effect of duloxetine found
in other studies. Duloxetine appears as a pharmacologic
option for the treatment of stress urinary incontinence.
Side effects are a consideration, but these do not appear to
include cardiovascular changes other than slight increase in
heart rate.
Next question
Do side effects bother some women and not others, or do they
diminish with time?
Does effectiveness persist beyond 12 weeks?
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2.2.5
Incontinence due to spinal cord injury or multiple sclerosis
may improve with Botox injections
Schurch B, Denys P, Kozma CM, et al. Botulinum toxin A
improves the quality of life of patients with neurogenic
urinary incontinence. Eur Urol. 2007 Sep;52(3):850-8. Epub
2007 Apr 19.
Why they did the study
Urinary incontinence has a negative impact on quality of
life for people with spinal cord injury and multiple
sclerosis. It can restrict activities and impede
rehabilitation exercises. The authors wanted to see whether
Botox injections could improve quality of life related to
urinary incontinence.
How they did it
The authors recruited 59 patients with urinary incontinence
caused by neurogenic detrusor overactivity (when the bladder
muscle becomes overactive) secondary to spinal cord injury
(53 patients) or multiple sclerosis (6 patients). All
patients were performing regular catheterizations but had
urinary incontinence between catheterizations for more than
six weeks and inadequate improvement with anticholinergic
drugs.
Half the group were given Botox injections (Botulinum Toxin
A). Two different dosages, 200U and 300U were tried. The
other half was given placebo.
Incontinence-related quality of life scores were calculated
based on a 22 item questionnaire
What they found
- After two weeks of treatment, the Botox groups had
quality of life scores of 65 and 68, compared to 35 in those
who received placebo.
- By 12 weeks, the Botox groups reached quality of life
scores of 71 and 89, compared to 30 in the placebo group.
- After week 12, scores levelled off and even dropped a
little in the Botox groups, reaching 76 and 68 at 24 weeks,
but were still much higher than the score of 40 among
patients who received placebo.
Why it matters
The study showed that Botox injections could produce a
significant improvement in health-related quality of life
for patients with neurogenic incontinence compared to
placebo. Patients were less worried about rushing to the
toilet, sneezing or drinking too much, and were also less
likely to feel depressed, frustrated, helpless or
embarrassed.
Previous studies of Botox in patients with non-neurogenic
urge incontinence have shown improvements in continence over
placebo and good tolerability. This study shows that these
improvements increase health-related quality of life in
patients with incontinence related to spinal cord injury and
multiple sclerosis.
Next question
Longer term studies with larger patient numbers for
recruitment need to be conducted.
Return to Table of Contents
2.2.6
The effectiveness of drug treatment with duloxetine in men
with stress incontinence after radical prostatectomy
Filocamo MT, Li Marzi V, Del Popolo G, Pharmacologic
treatment in postprostatectomy stress urinary incontinence.
Eur Urol. 2007 Jun;51(6):1559-64. Epub 2006 Aug 15.
Why they did the study
Even with the improvements in surgical technique seen in
recent years, many men who undergo radical prostatectomy (an
operation to remove the prostate gland for the purpose of
treating prostate cancer) suffer from stress urinary
incontinence after their surgery. Pelvic floor muscle
training is the primary treatment recommended to improve
continence after surgery. As well, many men will gradually
recover continence as the urinary sphincter heals naturally
in the year after surgery. The authors wondered whether
duloxetine, a relatively new drug treatment approved for use
in women with stress incontinence in many countries (though
not Canada) could help men recover continence earlier in the
post-operative period when used alongside pelvic muscle
training.
How they did it
After undergoing radical prostatectomy, 112 men who had
symptoms of stress incontinence after their catheter was
removed were randomly assigned to receive either pelvic
muscle training alone or training along with duloxetine (40
mg twice daily). Men were examined and questioned at four,
10, 16, 20 and 24 weeks for improvements in continence and
medication side effects. At 16 weeks, duloxetine was
stopped.
What they found
- Nine men stopped duloxetine early because of adverse
events (mainly nausea).
- After four weeks, 30% of men receiving medication and
training were completely dry, compared to 11.5% of men on
training alone. After 10 weeks, these numbers climbed to
57.6% and 26.9%, respectively. By 16 weeks, 78% of men on
medication and training were dry, compared to 51.9% on
training alone.
- At 20 weeks, four weeks after medication was stopped
(while training continued for everyone), results switched:
only 46% of men who started out on medication and training
were dry, compared to 73% of men who started out on training
alone. After 24 weeks, the first group improved to the point
that 62% were dry, as were 78% of the training alone group.
Why it matters
Pelvic muscle training produces slow and steady improvements
in continence in the six months after surgery. But even this
duration of incontinence can have very negative psychosocial
effects on men after prostate cancer surgery. The authors
found that it was possible to improve continence earlier by
using duloxetine alongside muscle training but that once the
medication was stopped, these men had worse continence than
men who had only received training. This could be due to the
fact that men on muscle training alone had more incentive to
work hard at the exercises. Eight weeks after the stop of
drug therapy, continence improved to levels similar to,
though still lower than, men who had been on training alone.
Return to Table of Contents
SURGICAL TREATMENTS
2.3.1
What complications can be expected from sling procedure for
stress urinary incontinence
Novara G, Galfano A, Boscolo-Berto R, Secco S, Cavalleri
S, Ficarra V, Artibani W. Complication rates of tension-free
midurethral slings in the treatment of female stress urinary
incontinence: a systematic review and meta-analysis of
randomized controlled trials comparing tension-free
midurethral tapes to other surgical procedures and different
devices. Eur Urol. 2008 Feb;53(2):288-308. Epub 2007 Nov 8.
Why they did the study
Options for surgical treatment of stress urinary have
expanded from the traditional Burch colosuspension surgery
since about 1995. Mid-urethral tension-free vaginal tape
(TVT) gained popularity for its ease of use and
effectiveness (continence rates of 70-80%), and more than 1
million surgeries have been performed worldwide to date.
Further efforts were made to make the mid-urethral sling
procedure less invasive and reduce complication rates,
bringing another set of slings and techniques into the mix.
Complications with surgical treatments can include bladder
perforation, nerve injuries and bleeding during surgery, as
well as urinary tract infections, voiding dysfunction and
vaginal or bladder erosion following surgery. Further, the
need for re-operation several years after the initial
surgery is not uncommon.
The authors wanted to review the studies available on
complication rates with TVT and other surgical procedures
for stress urinary incontinence to provide better guidance
in physician and patient choice.
How they did it
The authors reviewed all studies of surgical treatment of
stress urinary incontinence and found 169 of high enough
quality to include in their metanalysis, including 33
randomized controlled trials with data on complication
rates.
What they found
- Complication rates were similar after TVT and Burch
colosuspension, except for bladder perforation, which was
more common after TVT, and reoperation, which was more
common after Burch colosuspension.
- TVT and pubovaginal sling had similar post-operative
complication rates
- Suprapubic arc sling (SPARC) led to more voiding lower
urinary tract symptoms and reoperations than TVT.
- Transobdurator tape procedures had less bladder
perforation, pelvic bruising and urinary storage
complications than retropubic tape procedures.
Why it matters
With a greater number of surgical procedures for stress
urinary incontinence available, awareness of the
complication rates associated with each may help women and
their doctors make informed choices. The authors caution
that many studies were of limited quality and that long-term
follow-up data was seldom available.
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2.3.2
What determines success of mid-urethral sling procedures in
women with stress urinary incontinence
Novara G, Ficarra V, Boscolo-Berto R, et al. Tension-free
midurethral slings in the treatment of female stress urinary
incontinence: a systematic review and meta-analysis of
randomized controlled trials of effectiveness. Eur Urol.
2007 Sep;52(3):663-78.
Why they did the study
Tension free vaginal tape (TVT) surgery was introduced in
1995 and has now replaced most other forms of urinary
incontinence surgery. And results are good: after seven
years, 81% of patients are completely continent and a
further 16% experience improvement. But complications do
occur and the authors wanted to find out whether certain
specific factors influenced the efficacy and safety of the
TVT procedure in a teaching hospital.
How they did it
The authors reviewed the medical records of women who
underwent TVT surgery over a three-year period for stress or
mixed incontinence and combined this with information on
continence status collected in a follow-up questionnaire
sent to these women. Characteristics of the women and of the
surgery were entered into the analysis to see if any
particular ones affected complication rates.
What they found
- Complications occurred in 19% of all TVT procedures,
including prolonged catheterisation in 9.6% and bladder
perforation in 4%.
- The only significant risk factor for complications
(mainly prolonged catheterization) was having prolapse
surgery at the same time as the TVT surgery.
Why it matters
The authors recommend separating the two surgeries. A woman
with both pelvic organ prolapse and stress urinary
incontinence should have the prolapse surgery first. If
urinary continence is not much improved afterwards,
physiotherapy to improve pelvic floor strength should be
provided and only if this fails to produce improvement
should TVT surgery be proposed.
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2.3.3
Results with sling procedure for men with stress
incontinence after prostate cancer surgery
Guimarães M, Oliveira R, Pinto R. Intermediate-term
results, up to 4 years, of a bone-anchored male perineal
sling for treating male stress urinary incontinence after
prostate surgery. BJU Int. 2008 Sep 8.
Why they did the study
Stress urinary incontinence is a frequent complication after
prostatectomy. The bone-anchored InVance sling was developed
as a more widely acceptable option than artificial urinary
sphincter and bulking agents, and more effective than other
sling models. The authors wanted to see how much the sling
improved stress urinary incontinence four years following
prostate surgery.
How they did it
The authors followed 62 men who had the InVance sling
inserted between 2003 and 2007. All men had stress urinary
incontinence; 58 after undergoing radical prostatectomy and
four after surgery for benign prostatic hyperplasia (BPH,
which is a common enlargement of the prostate that usually
happens after age 50). Follow-up assessments were conducted
at one, three, six and 12 months, and then every year until
year four. Treatment was considered successful if the
patient stopped wearing continence pads altogether or the
number of pads used decreased by at least half. Men were
also asked about any complications resulting from the sling
procedure.
What they found
- At one month, urinary incontinence was cured in 67% of
men and improved in 25%. Cure rates were higher (88%) in men
who had used less than five pads per day before the sling
procedure and in men who did not have adjuvant radiation
therapy (combined surgery and radiation treatment) for their
prostate cancer.
- The procedure failed to improve continence in 8% of men.
- Failures were generally apparent immediately after the
catheter was removed.
- Cure and improvement rates remained about the same out to
three years after the procedure was performed.
- Too few men were available for four-year follow-up to
obtain meaningful results.
- The most frequent complication associated with the InVance sling was localized occasional pain in the scrotum,
perineum or thighs, which was relieved with non-opioid
analgesics such as Tylenol etc. Infections occurred in two
men.
Why it matters
This study showed improvements in urinary incontinence
similar to previous studies of the InVance sling, but
further indicated that these results could be maintained up
to three or four years after the procedure. The InVance
sling therefore appears superior to the earlier Kauffman
sling, which produced cure rates of 56% at four years with
an additional 8% of men showing improvement. In 27% of men
with the Kauffman sling, strings needed to be re-tightened
after a time. The authors believe the InVance sling's better
performance has to do with the durable anchorage provided by
the six screws inserted into the public bone.
The InVance sling also produces better results than
alternative urinary incontinence treatments such as bulking
agents, which produce good initial improvements but have
one-year success rates below 20%. The sling offers
comparable advantages to artificial urinary sphincter and
liberates men from having to fiddle with the artifical
sphincter.
The authors feel that the InVance sling should be considered
a first choice in men with less severe stress urinary
incontinence who have not undergone radiation therapy.
Next question
Longer-term studies need to be conducted.
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