Context Urinary incontinence is a common health problem among women that negatively
impacts quality of life. Therefore, it is important that primary care physicians
have an understanding of how to manage urinary incontinence effectively.
Objective To review the most recent, high-quality evidence regarding the etiology
and management of urinary incontinence in women.
Data Sources and Study Selection Searches of MEDLINE, EMBASE, The Cochrane Library, and the ACP Journal Club were performed to identify English-language articles
published between 1998-2003 that focused on the etiology or treatment of urinary
incontinence in adult women. The references of each retrieved article were
reviewed and an expert in the field was contacted to identify additional relevant
articles.
Data Extraction Using a combination of more than 80 search terms, we included articles
of etiology that were cohort studies, case-control studies, cross-sectional
studies, or systematic reviews of cohort, case-control, and/or cross-sectional
studies. Studies of treatment had to be randomized controlled trials or systematic
reviews of randomized controlled trials. The quality of each article was assessed
independently by each author and inclusion (n = 66) was determined by consensus.
Data Synthesis Multiple factors have been found to be associated with urinary incontinence,
some of which are amenable to modification. Factors associated with incontinence
include age, white race, higher educational attainment, pregnancy-related
factors, gynecological factors, urological and gastrointestinal tract factors,
comorbid diseases, higher body mass index, medications, smoking, caffeine,
and functional impairment. There are several effective nonpharmacological
treatments including pelvic floor muscle training, electrical stimulation,
bladder training, and prompted voiding. Anticholinergic drugs are effective
in the treatment of urge urinary incontinence. Several surgical interventions
are effective in the management of stress incontinence, including open retropubic
colposuspension and suburethral sling procedure.
Conclusion Urinary incontinence in women is an important public health concern,
and effective treatment options exist.
Urinary incontinence, defined generally as
involuntary leakage of urine,1 is a common
health problem among women. The prevalence ranges from 3% to 55% depending
on the definition of incontinence used and the age of the population studied.2 The prevalence of urinary incontinence also increases
with advancing age.3 Between 17% to 55% of
older women report having experienced urinary incontinence at some point,
compared with 12% to 42% of younger women.2Quiz Ref IDThere are several different types of urinary incontinence, including
stress, urge, mixed, and overflow incontinence. Stress incontinence is involuntary leakage from effort or exertion, or from sneezing or
coughing,1 and it is usually related to increased
urethral mobility and/or poor intrinsic sphincter function. Urge incontinence is involuntary leakage accompanied or immediately
proceeded by urgency,1 and it usually indicates
detrusor overactivity. Mixed incontinence is the
complaint of involuntary leakage associated with urgency and also with exertion,
effort, sneezing, or coughing.1 A less common
form of urinary incontinence in women is overflow incontinence, which is associated with overdistension of the bladder and can be
caused by obstruction (eg, pelvic organ prolapse) or a neurological condition
(eg, spinal cord injury).
Urinary incontinence is associated with poor self-rated health,4 impairment in quality of life,5 social
isolation,6 and depressive symptoms.7 Many areas of a woman's life, including social, physical,
occupational, and leisure can be impacted by urinary incontinence.6 Therefore, an understanding of the etiology and effective
management options for urinary incontinence in women should be an important
consideration to the practicing physician. This article reviews the recent,
relevant literature.
Searches of MEDLINE, EMBASE, The Cochrane Library, and the ACP Journal Club were performed by using more than 80 relevant search
terms (available from the authors). We identified English-language articles
about the origin or treatment of urinary incontinence in adults, in which
the majority of the participants were women. We accepted the urinary incontinence
definitions used by the studies. To be included, studies of etiology had to
be cohort studies, case-control studies, cross-sectional studies, or systematic
reviews of cohort, case-control, and/or cross-sectional studies. Studies of
treatment had to be randomized controlled trials or systematic reviews of
randomized controlled trials. Given the recent results from the Women's Health
Initiative,8 we excluded treatment studies
of estrogen or hormone replacement therapy. The literature search focused
on recent evidence in the field (January 1998-March 2003). In addition, the
reference lists of retrieved articles were reviewed. A primary care physician
researcher, with research expertise in the field of urinary incontinence,
was also contacted in an attempt to retrieve additional articles. For this
review 236 articles were retrieved and 66 were included. Quiz Ref IDThe quality of each article was independently assessed by each author, and
inclusion was determined by consensus. The quality of studies of etiology
was assessed based on an evaluation of appropriate adjustment for confounders,
consistency of exposure and outcome measurements between groups, and completeness
of follow-up. The quality of treatment studies was assessed by evaluating
blinding, random allocation, and concealment; by the description of withdrawals;
by the presence of clinically relevant outcomes; and by determining whether
intention-to-treat analysis was performed. We focused on reporting clinical
outcomes instead of urodynamic outcomes.
What Factors Increase the Risk of Developing Urinary
Incontinence? Multiple factors have been found to be associated with
urinary incontinence. Although many of these factors are not modifiable, some
are amenable to modification, so clinicians can focus on identifying and addressing
these.
Pregnancy, Mode of Delivery, and Parity. After
adjusting for the length of the second stage of delivery, episiotomy, vacuum
extraction, fetal weight, and sphincter rupture, the risk of having stress
incontinence 5 years postpartum was increased in women who developed stress
incontinence during the first pregnancy (odds ratio [OR], 3.8; 95% CI, 1.9-7.5)
and in women who developed stress incontinence during the first 6 weeks postpartum
(OR, 4.5; 95% CI, 1.5-13.2).9 Increased parity
also appears to be independently associated with urinary incontinence10-17 (OR,
1.62; 95% CI, 1.31-2.01).10 After adjusting
for age, parity was also associated with subsequent stress incontinence surgery.18
Mode of delivery is associated with development of urinary incontinence.
In 15 307 women enrolled in the EPINCONT study,19 age-adjusted
analysis found that both cesarean sections and vaginal deliveries, compared
with no deliveries, were associated with higher rates of stress incontinence
(OR, 1.4; 95% CI, 1.0-2.0 and OR, 3.0; 95% CI, 2.5-3.5, respectively) and
mixed incontinence (OR, 1.7; 95% CI, 1.2-2.5 and OR, 2.1; 95% CI, 1.7-2.6,
respectively). After adjustment for age, parity, years since last delivery,
and body mass index, the risk of stress incontinence was higher with vaginal
delivery than with cesarean delivery (OR, 2.4; 95% CI, 1.7-3.2). There was
no difference in the rates of mixed incontinence between vaginal delivery
and cesarean section, or in the risk of urge incontinence among nulliparous
women, women who had cesarean delivery, and women who had vaginal delivery.
This association between vaginal delivery and urinary incontinence has been
supported by other trials.20,21 The
association between vaginal delivery and stress urinary incontinence was present
regardless of the age of the patient at the time of childbirth.21
In a cohort study of 315 women, forceps delivery was associated with
a higher risk of stress incontinence compared with spontaneous vaginal delivery
(hazard ratio [HR], 3.5; 95% CI, 1.1-11.4) and compared with the combination
of spontaneous and vacuum deliveries (HR, 3.5; 95% CI, 1.2-9.8) after adjustment
for age, infant birth weight, and duration of labor.22 The
risk of stress incontinence was not significantly different between forceps
and vacuum delivery (HR, 3.5; 95% CI, 0.7-16.1) nor between vacuum and spontaneous
delivery (HR, 1.1; 95% CI, 0.2-3.7). These results are consistent with a case-control
study in which vacuum delivery, vaginal laceration or episiotomy, and length
of the second stage of labor were not found to be risk factors for developing
stress incontinence, whereas forceps delivery was an independent risk factor
(OR, 10.43; 95% CI, 1.17-93.42).23
A cohort study that looked at overall urinary incontinence rates in
491 women found no independent association between fetal weight and urinary
incontinence.24 Another cohort study of 549
women that adjusted for augmentation of labor, epidural usage, mode of delivery,
perineal trauma, duration of labor, and fetal head circumference found that
fetal birth weight was associated with stress incontinence 3 months postpartum
(OR, 2.5; 95% CI, 1.1-6.1) but was not associated with urge incontinence.25 There also appears to be an independent association
between high-birth weight and subsequent surgery for stress incontinence.18
Hysterectomy and Other Gynecological Factors. A
systematic review found that hysterectomy was associated with developing urinary
incontinence in women aged 60 years or older (OR, 1.6; 95% CI, 1.4-1.8) but
not in women younger than 60 years (OR 1.1; 95% CI, 0.9-1.3).26 These
results were supported by a large cohort study (n = 1299) that found, after
adjusting for race, income, and reason for hysterectomy, women 50 years or
older were less likely to experience improvement in urinary incontinence 2
years after hysterectomy than women younger than 50 years (OR, 0.7; 95% CI,
0.5-1.0).27 This age-related difference may
be explained by differing effects of hysterectomy on the development of different
types of incontinence. Urge and mixed incontinence predominate in older women,
whereas stress incontinence predominates in younger women.2 After
adjusting for age, parity, and educational level, a cross-sectional study
revealed that hysterectomy was associated with urge incontinence (OR, 1.93;
95% CI, 1.40-2.63) but not with stress incontinence (OR, 1.18; 95% CI, 0.88-1.59).28 There was no apparent association between mode of
hysterectomy (vaginal or abdominal) and urge incontinence or between mode
of hysterectomy and stress incontinence.29
Urinary incontinence has been found to be independently associated with
the presence of a cystocele and/or the absence of urethrovesical crease (OR,
2.49; 95% CI, 1.48-4.18),15 and with uterine
prolapse (OR, 4.11; 95% CI, 2.15-7.86).30 However,
prolapse surgery with and without hysterectomy has also been independently
associated with urinary incontinence.14,31 Other
factors independently associated with urinary incontinence include a not-normal
gynecological examination (OR, 2.86; P = .001),31 and poor pelvic floor muscle contraction15,31 (OR, 3.48; P<.001).31
Urological and Gastrointestinal Factors. Recurrent
urinary tract infection appears to be independently associated with urinary
incontinence.12,16,30,32,33 In
one study, recurrent urinary tract infection was associated with urge incontinence
(OR, 1.98; 95% CI, 1.10-3.57) and mixed incontinence (OR, 2.44; 95% CI, 1.51-3.92)
but not with stress incontinence (OR, 1.51; 95% CI, 0.77-2.97).33 Another
study found that, after adjustment for confounders, women with urinary incontinence
were more likely to report having experienced dysuria in the past 12 months.14 This study, however, does not report what percentage
of women reporting dysuria had also been given a diagnosis of urinary tract
infection. Childhood enuresis has also been found to be independently associated
with urge urinary incontinence in middle-aged women (OR, 2.7; 95% CI, 1.3-5.6).21 Urinary incontinence is independently associated
with fecal incontinence32,34 (OR,
10.4; 95% CI, 1.40-20.2),32 which may be because
both can be caused by the same process. Constipation and other bowel problems
were also independently associated with urinary incontinence.14,16,34 The
relationship between constipation and urinary incontinence may also be bidirectional,
and may be associated with pelvic organ prolapse.
Medications, Smoking, Alcohol, and Caffeine.Quiz Ref IDSeveral medications have been independently associated with urinary
incontinence in women including: diuretics (OR, 2.2; 95% CI, 1.2-3.9),11 estrogen (OR, 2.91; 95% CI, 1.44-5.89),15,24 benzodiazepines
(OR, 1.44; 95% CI, 1.12-1.83),35 tranquilizers
(OR, 1.65; 95% CI, 1.06-2.57), antidepressants (OR, 1.75; 95% CI, 1.04-2.94),
hypnotics (OR, 1.52; 95% CI, 1.07-2.16), laxatives (OR, 1.67; 95% CI, 1.18-2.37),
and antibiotics (OR, 1.64; 95% CI, 1.25-2.16).36 Although
study results are somewhat inconsistent, being either a current or an ex-smoker
may be independently associated with urinary incontinence.13,15,37 The
association between alcohol and urinary incontinence is less clear.13,37 One study reported an association
between daily alcohol intake and urinary incontinence (age-adjusted RR, 1.83;
95% CI, 1.27-2.63).13 However, when stratified
by incontinence frequency, another study did not find an association between
daily alcohol intake and urinary incontinence.37 After
controlling for age and smoking, high caffeine intake (>400 mg/d) was associated
with urge incontinence (OR, 2.4; 95% CI, 1.1-6.5).38
Comorbid Diseases. The presence of 2 or more
diseases has been associated with urinary incontinence (OR, 4.38; 95% CI,
2.50-7.68).30 Poor overall health status has
also been independently associated with mixed incontinence (OR, 1.43; 95%
CI, 1.14-1.79).33 Women with stress urinary
incontinence had visited their general physician more frequently in the past
year, even after adjusting for confounders (OR, 1.4; 95% CI, 1.0-1.9).21 Specific diseases found to be independently associated
with urinary incontinence in women include diabetes,10,33,36 stroke,34,36,37elevated systolic
blood pressure,13 cognitive impairment,32,34 Parkinsonism,39 arthritis,16,36 back problems,36 hearing
and/or visual impairment,34,37 and
possibly chronic obstructive pulmonary disease.36,39 Vitamin
B12 level has not been found to affect continence.40
Age. Advancing age is associated with urinary
incontinence10,15,30,32,39;
however, this may not be true for all types of urinary incontinence. A large
cross-sectional study of 2763 women found that the prevalence of urge incontinence
increased slightly with age (adjusted OR per 5-year interval, 1.19; 95% CI,
1.09-1.31), as did the prevalence of mixed incontinence (adjusted OR per 5-year
interval, 1.10; 95% CI, 1.02-1.18).33 However,
no association between age and stress incontinence was found (adjusted OR
per 5-year interval, 0.93; 95% CI, 0.85-1.03). This would suggest that with
age the prevalence of urge incontinence increases while the prevalence of
stress incontinence remains unchanged.
Race. After adjustment for educational attainment,
financial assets, age, functional status, vision and hearing capability, stroke,
body mass index, smoking, alcohol use, parity, and proxy respondent, a large
cross-sectional study of 3991 women found that compared with black women white
women had higher rates of moderate (OR, 2.06; 95% CI, 1.10-3.89) and severe
urinary incontinence (OR, 2.10; 95% CI, 1.49-2.96).37 A
second study of 2763 women similarly found that white race was associated
with higher rates of stress incontinence (OR, 2.84; 95% CI, 1.60-5.05) and
mixed incontinence (OR, 2.14; 95% CI, 1.48-3.08) but was not so for urge incontinence
(OR, 1.26; 95% CI, 0.83-1.91).33
Socioeconomic Status. Higher levels of educational
attainment appear to be associated with urinary incontinence, particularly
mild incontinence and stress incontinence.10,21,37 Although
the reason for this association is unclear, it remains present even after
adjustment for factors such as age, race, assets, comorbidity, and obstetrical
and gynecological factors. There is no clear association between a person's
financial assets and urinary incontinence.37
Body Mass Index. Many studies have found that
increasing body mass index (BMI) is associated with increasing rates of urinary
incontinence10-14,16,21,30,31,33,37 (OR
per unit increase, 1.05; 95% CI, 1.04-1.07).10
Functional Status. Functional impairment appears
to be independently associated with urinary incontinence.30,32,34,37,39 The
presence of trunk restraints has also been found to be independently associated
with urinary incontinence.34 Prevalence rates
of stress incontinence and urge incontinence are not significantly different
between elite athletes and control participants.41
What Nonpharmacological Management Strategies Are
Effective? There are several nonpharmacological treatments for urinary
incontinence. These include the physical therapy techniques of pelvic floor
muscle training, weighted vaginal cones, and electrical stimulation. Pelvic
floor muscle training, or Kegel exercise, is a program of repeated voluntary
pelvic floor muscle contraction. Pelvic floor muscle training can be done
with or without biofeedback techniques to help an individual isolate the relevant
muscles. Weighted vaginal cones are weights that theoretically require contraction
of the pelvic floor muscles to prevent the cones from slipping out of the
vagina. Electrical stimulation can be used to improve pelvic floor musculature
or to inhibit detrusor overactivity. Other nonpharmacological techniques include
bladder training, which aims to increase the time interval between voiding,
and prompted voiding, which teaches dependent individuals when and how to
initiate their own toileting or to respond when prompted to toilet.
Pelvic Floor Muscle Training. Studies of pelvic
floor muscle training varied in terms of the duration of each contraction,
the number of contractions performed per session, the number of sessions performed
per day, and the type of instruction provided. A Cochrane systematic review
that included studies of stress, urge, and mixed incontinence, found that
pelvic floor muscle training was more effective than no treatment or placebo
(Table 1).42 The
placebo intervention used in the different trials varied and included placebo
drug, sham electrical stimulation, and placebo pelvic floor training (ie,
having the participant perform exercises that will not alter the pelvic floor
musculature). Patients allocated to placebo groups in these studies showed
improvement in symptoms. The health status of participants in randomized trials
can improve during the course of the trial, independent of the intervention.
The improvement may be due to a number of factors (eg, natural history of
the disease), but the placebo effect might have a small effect on this outcome.
A recent systematic review found that use of a placebo (compared with no treatment)
had a moderate effect on subjective, continuous outcomes.43
A recent trial of 200 women, all of whom had stress or mixed incontinence,
found that pelvic floor muscle training using a comprehensive clinic-based
program was more effective at reducing the frequency of incontinent episodes
than using a self-help booklet.44Quiz Ref IDThere were no significant differences between pelvic floor muscle
training alone and other physical therapy regimens, except for a significant
reduction in urinary leakage with pelvic floor muscle training compared with
vaginal cones.42,45 Of note, more
adverse events (such as difficulty using the devise and maintaining motivation)
were reported with electrical stimulation and with vaginal cones than with
pelvic floor muscle training.42 Trials
published subsequent to the Cochrane review that included women with stress
incontinence have confirmed that there does not appear to be any clear advantage
to combining pelvic floor muscle training with biofeedback over pelvic floor
muscle training alone.46,47 Another
recent trial of 222 women 55 years or older, all of whom had urge or mixed
incontinence, also found that pelvic floor muscle training with biofeedback
was no more effective than pelvic floor muscle training with verbal feedback
or than pelvic floor muscle training using a self-help booklet.48 However,
biofeedback may be helpful for women who have difficulty isolating their pelvic
floor muscles during pelvic floor muscle training.
One trial involving 204 women has suggested that there is no difference
between pelvic floor muscle training and bladder training for the treatment
of stress, urge, or mixed incontinence.49 However,
pelvic floor muscle training combined with bladder training is better than
pelvic floor training alone (relative risk [RR] for self-reported cure or
improvement, 1.20; 95% CI, 1.02-1.42) or bladder training alone (RR for self-reported
cure or improvement, 1.43; 95% CI, 1.17-1.74).42,49 The
combination of pelvic floor muscle training and bladder training was equally
effective when administered as individual therapy or as group therapy.50 Among cognitively intact individuals, a nurse practitioner-administered
home-based therapy program that combined pelvic floor muscle training with
biofeedback and bladder training was significantly better than regular social
visits by a nurse practitioner (median percentage reduction in incontinent
episodes per day: treatment group, 75.0; controls, 6.4; P<.001).51
Among participants with urge incontinence with or without stress incontinence,
there was no difference in self-reported cure rates between pelvic floor muscle
training and anticholinergic medications.42,52 However,
compared with anticholinergic medications, the combined subjective cure or
improvement rates were marginally better with pelvic floor muscle training
(RR, 1.18; 95% CI, 1.01-1.37) and pelvic floor muscle training significantly
reduced the number of leakage episodes in 24 hours (weighted mean difference
[WMD], −0.41; 95% CI, −0.79 to −0.03). Significantly more
women receiving anticholinergic medications experienced dry mouth and inability
to void. Assuming that dropouts from the study were treatment failures, investigators
found that more women reported subjective cure or improvement with α-adrenergic
drugs (phenypropanolamine) than with pelvic floor muscle training (RR, 1.41;
95% CI, 1.09-1.81).53 However, there was no
significant difference in objective outcomes among those remaining in the
study.
A trial of 50 women that compared pelvic floor muscle training to surgery
(open retropubic colposuspension, vaginal repair, or a combination) for stress
incontinence found no significant difference in the rates of self-reported
cure or improvement, but it did find that pelvic floor muscle training resulted
in fewer self-reported cures (RR, 0.20; 95% CI, 0.07-0.61).42 Both
groups had a significant reduction in the number of leakage episodes, but
the surgery group had a significantly greater reduction (P<.01). All reported adverse events were postsurgical complications.
Electrical Stimulation. Electrical stimulation
consists of brief electrical impulses administered via needle or surface electrodes
and is used to inhibit detrusor overactivity or to improve pelvic floor musculature.
The effectiveness of electrical stimulation may depend on the type of urinary
incontinence. A study of 68 participants comparing electrical stimulation
with sham stimulation in persons with urge incontinence revealed a number
needed to treat (NNT) of 5 (95% CI, 3-42) for cure (no incontinence episodes
and no detrusor overactivity on cystometry) and an NNT of 2 (95% CI, 1-4)
for improvement (a reduction in the frequency of incontinence by >50% or a
cystometric bladder capacity increase >50 mL).54 There
was no significant difference in adverse events between the 2 groups.
In a small trial of 27 women with stress incontinence, electrical stimulation
was not significantly different from sham stimulation based on an incontinence
impact questionnaire or on changes in urinary leakages per week.55 Electrical
stimulation alone or in combination with other therapies was also not significantly
different from other physical therapy regiments in the treatment of stress
incontinence.42,45 A recent trial
of 200 women, all of whom had stress or mixed incontinence, found that the
addition of pelvic floor electrical stimulation to an extensive pelvic floor
muscle training program did not significantly reduce the frequency of incontinent
episodes.44
Vaginal Cones. Use of weighted vaginal cones
theoretically requires that the pelvic floor muscles must be contracted, but
factors other than contraction of the pelvic floor muscles may contribute
to the cones' remaining in place. The weights are generally used twice a day
for 15 minutes per session, and the weight is increased as tolerated.45 The majority of trials evaluating use of vaginal
cones enrolled women with stress incontinence. Participants receiving vaginal
cones were more likely to be subjectively cured compared with those who received
control interventions that did not involve the pelvic floor musculature (RR
for failure to cure incontinence, 0.74; 95% CI, 0.59-0.93).45 However,
there were no differences in objective outcomes such as leakage episodes,
pad test, or pelvic floor muscle strength. There were no significant differences
between vaginal cones alone and electrical stimulation. Therapy with vaginal
cones appears to be inferior to pelvic floor muscle training.42,45
Bladder Training. Bladder training techniques
varied between studies, but all involved strategies to increase the time interval
between voids using progressive voiding schedules. In 2 small trials (n =
78), the bladder training groups had fewer individuals who failed to experience
a subjective cure vs those who did not receive bladder training (OR for failure,
0.07; 95% CI, 0.03-0.19).56 However, as outlined
above, bladder training was not significantly better than pelvic floor muscle
training, and the combination of bladder training with pelvic floor muscle
training was more effective than either alone.42,49 Bladder
training in combination with drug therapy (eg, calcium antagonists and anticholinergic
agents) did not demonstrate significant subjective improvement rates over
bladder training alone.56
Prompted Voiding. There are a number of randomized
trials that have examined the role of prompted voiding initiated by caregivers
at regular time intervals. Several of these trials (including both cognitively
intact and impaired participants) have revealed that prompted voiding is better
than usual incontinence-related care. Usual incontinence-related care includes
regular checking and changing of wet garments and bedding. Compared with participants
in the control groups, there was a suggestion that fewer participants who
received prompted voiding experienced no improvement in the number of wet
episodes (OR for no improvement, 0.59; 95% CI, 0.31-1.14) while more in the
intervention groups had significantly fewer incontinent episodes in 24 hours
(WMD, −0.93; 95% CI, −1.32 to −0.53).57 One
trial found a statistically significant increase in independent requests for
the toilet as a result of the prompted voiding intervention, in persons who
on cognitive screening could correctly identify at least 1 object out of 2
on 3 separate occasions (OR, 1.9; 95% CI, 1.51-2.29).57
What Are the Risks and Benefits of Pharmacological Therapies?
There are a variety of pharmacological therapies that have been studied
in the treatment of urinary incontinence (Table 2).
Anticholinergic Drugs.Quiz Ref IDAnticholinergic
drugs are used in the treatment of urge incontinence to inhibit involuntary
detrusor contractions. A Cochrane systematic review of anticholinergics
for urge incontinence found anticholinergic medications were better than placebo
in subjective cure or improvement rates (RR, 1.41; 95% CI, 1.29-1.54) and
in the improvement in leakage episodes in 24 hours (WMD, −0.56; 95%
CI, −0.73 to −0.39).58 The most
common adverse effect was dry mouth, and compared with placebo, the risk of
dry mouth was 3 times higher with tolterodine (RR, 3.02; 95% CI, 2.45-3.71)
and with oxybutynin (RR, 3.23; 95% CI, 2.48-4.20).
A subsequent controlled trial of extended-release tolterodine in older
(≥65 years) vs younger (<65 years) patients found no significant age-related
difference in incontinent episodes per week or in adverse events (except for
headache, which was more common among younger participants).59 The
overall benefit of tolterodine compared with placebo was not different between
the 2 age groups.
In direct comparison trials, tolterodine and oxybutynin did not differ
in outcomes.60-62 However,
oxybutynin was more commonly associated with the occurrence of at least 1
adverse event (eg, dry mouth, dyspepsia, headache) in 2 trials, with a number
needed to harm (NNH) of 8 (95% CI, 5-30) in a trial of 378 participants62 and an NNH of 4 (95% CI, 3-7) in the second trial
of 228 participants.61 In particular, the risk
of dry mouth was higher with oxybutynin than with tolterodine (NNH, 4; 95%
CI, 3-6).61,62 A comparison of
extended-release oxybutynin and tolterodine demonstrated that extended-release
oxybutynin was associated with a significantly lower mean number of weekly
incontinent episodes, and there was no difference in adverse events between
the extended-release oxybutynin and tolterodine groups.63 Transdermal
and oral oxybutynin did not differ significantly in the reduction in average
daily incontinent episodes.64 However, dry
mouth occurred more often with oral oxybutynin (NNH, 2; 95% CI, 2-4).
Adrenergic Drugs. α-Adrenoceptor agonists
have been used in the treatment of stress incontinence because α-1A
adrenoceptors have been found to mediate the contractile response of the urethra
and bladder neck. β-Adrenergic drugs have also been studied. However,
many of the studied drugs are not available in the United States. Phenylpropanolamine
has been removed from the US market by the US Food and Drug Administration
(FDA) because of its association with hemorrhagic stroke.65 Clenbuterol
has anabolic steroid properties and is not an FDA approved medication.
A recent Cochrane systematic review found that compared with placebo
adrenergic drugs were associated with marginally higher combined cure or improvement
rates (RR for midodrine, 1.55; 95% CI, 1.02-2.35; RR for phenylpropanolamine,
1.58; 95% CI, 0.87-2.85; RR for clenbuterol, 1.96; 95% CI, 1.26-3.05).53 More adverse events were also reported with adrenergic
drugs (eg, insomnia, restlessness, and vasomotor stimulation) and, although
statistical significance was not reached in any single adverse-effect category,
the adverse effects were severe enough for 14 women in 6 trials (n = 339)
to discontinue the treatment or study.
Other Drug Treatments. Because of their smooth
muscle relaxant properties, calcium channel blockers are a potential treatment
for urge incontinence, but to date no trials have shown their benefit.66 A recently published placebo-controlled trial of
nimodipine (n = 86) revealed no significant difference in the number of incontinent
episodes with this medication.67
Magnesium hydroxide may also be an effective treatment for urge incontinence,
by reducing spontaneous detrusor contractions. A small placebo-controlled
study (n = 40) of women with sensory urgency or detrusor instability found
that oral magnesium hydroxide resulted in subjective improvement of urinary
symptoms (NNT, 3; 95% CI, 2-91).68 The only
reported adverse effect was transient diarrhea (2/20, treatment group vs 1/20,
control group).
Doxepin, a tricyclic antidepressant, has also been studied in women
with detrusor instability or urinary incontinence. Doxepin as been found to
result in subjective improvement compared with placebo (OR, 23.80; 95% CI,
3.99-141.97) but not in objective improvement in bladder stability.66
Serotonin and norepinephrine agonists also have putative continence-promoting
properties through parasympathetic suppression and through enhancement of
sympathetic and somatic activity. A controlled trial of duloxetine (a selective
serotonin and norepinephrine reuptake inhibitor) for treatment of stress incontinence
revealed a significant dose response in the median decrease in incontinence
frequency, compared with placebo (median decrease in incontinence frequency:
placebo, 40%; 20 mg, 44%; P = .6; 40 mg, 59%; P = .02; 80 mg, 58%; P = .04).69 However, there was no significant difference in cure
rates, and there was a dose response increase in discontinuations because
of adverse events. The most common adverse effect was nausea.
What Are the Risks and Benefits of Surgical Interventions?
Knowledge of the different surgical procedures is important for primary
care clinicians when discussing management options with their patients. For
the individual patient, the choice of procedure can also be influenced by
coexisting urogenital problems, bladder outlet anatomy, health status, and
by the surgeon's preference and experience performing the various procedures.
Surgical procedures to treat stress incontinence are designed to correct urethral
closure deficiencies and to improve support of the urethrovesical junction.
There are a variety of surgical techniques that have been evaluated including
open retropubic colposuspension, bladder neck needle suspension, anterior
vaginal repair, laparoscopic retropubic colposuspension, suburethral sling
procedure, and periurethral injections. The potential adverse outcomes of
surgery include perioperative complications (eg, infection, hemorrhage, pain,
and urinary retention), de novo urgency and urge incontinence, voiding difficulties,
recurrent or new pelvic organ prolapse, and need for repeat anti-incontinence
surgery. Although there are clinical trials comparing the different surgical
procedures, there is insufficient evidence to fully compare surgery with either
pharmacological or nonpharmacological interventions. Nearly all patients should
be considered for a trial of nonsurgical therapy first.
Open Retropubic Colposuspension. Open retropubic
colposuspension involves making an incision over the lower abdomen and lifting
the tissues near the bladder neck and proximal urethra in the pelvic area
behind the anterior pubic bones.70 Three variations
of the procedure are Burch, Marshall-Marchetti-Krantz, and Paravaginal defect
repair or Vagina-obturator shelf repair. Based on results from a Cochrane
systematic review, open retropubic colposuspension had lower failure rates
than bladder neck needle suspension, anterior vaginal repair, and laparoscopic
colposuspension (Table 3).70 Open retropubic colposuspension was associated with
a lower risk of perioperative complications compared with anterior vaginal
repair and with bladder neck needle suspension. Compared with anterior vaginal
repair, open retropubic colposuspension resulted in higher rates of new or
recurrent prolapse, no difference in de novo urge symptoms and urge incontinence
rates, and lower rates of repeat anti-incontinence surgery. There was insufficient
evidence to judge whether open retropubic colposuspension and bladder neck
needle suspension differed in the rates of repeat surgery, de novo urge symptoms,
or new prolapse. There were no differences between open retropubic colposuspension
and laparoscopic colposuspension in adverse event rates.
There was no significant difference in failure rates between open colposuspension
and suburethral sling procedure. There were also no differences in perioperative
complication rates. However, open colposuspension was associated with an increased
risk for new or recurrent prolapse (NNH, 12; 95% CI, 8-27).70 There
was insufficient evidence to identify differences in rates of de novo urge
symptoms, urge incontinence, or voiding difficulties.
Bladder Neck Needle Suspension. Bladder neck
needle suspensions are performed using a vaginal or abdominal approach.71 A long needle is used to thread sutures from the
vagina to the anterior abdominal fascia, looping the sutures through to the
paraurethral tissue on each side of the bladder neck to support it. There
are 3 main types (Pereyra, Stamey, Raz) and several modified versions. As
outlined above, bladder neck needle suspension appears to be inferior to open
retropubic colposuspension.70 Although there
is a paucity of data, there does not appear to be a difference in failure
rates between bladder neck needle suspension and anterior vaginal repair.71 There was insufficient evidence to compare bladder
neck needle suspension with laparoscopic colposuspension or suburethral sling
procedure.
Anterior Vaginal Repair. During anterior vaginal
repair, or anterior colporrhaphy, the vaginal mucosa below the urethra is
dissected and suture(s) are placed in the periurethral tissue and pubocervical
fascia to elevate and support the bladder neck.72 Excess
vaginal tissue is removed and the dissected area is closed. A variety of techniques
have been described, and examples include the Bologna procedure and Kelly
plication. As already outlined, anterior vaginal repair appears inferior to
open retropubic colposuspension and equivalent to bladder neck needle suspension.70,72 No studies were identified that compared
anterior vaginal repair with laparoscopic colposuspension or suburethral sling
procedure.
Laparoscopic Colposuspension. Laparoscopic
colposuspension is similar to open colposuspension; however, there are technical
differences including that a laparoscopic approach is used.73 Laparoscopic
colposuspension appears inferior to open colposuspension, as outlined above.70 In a recent Cochrane systematic review, there were
no eligible studies identified that compared laparoscopic colposuspension
with other surgical procedures,70,73 nor
were any studies found in our subsequent literature search.
Suburethral Sling Procedure. Suburethral sling
procedure uses a combined abdominal and vaginal approach.74 Strips
of material are tunneled under the urethra and attached to either the rectus
muscle or ileopectineal ligaments resulting in tightening of the sling and
increased bladder support every time the woman contracts her rectus muscles.
Tension-free vaginal tape is a modification of the suburethral sling procedure
and is considered within a Cochrane review of suburethral sling procedures.74 There was insufficient evidence to compare suburethral
sling procedure with any procedure other than open retropubic colposuspension.70,74 As outlined previously, suburethral
sling procedure appears equivalent to open colposuspension.
Periurethral Injections. The injection of bulking
agents into the urethral submucosa is designed to create artificial urethral
cushions that can help to restore continence.75 A
recent Cochrane systematic review found 1 eligible study (n = 68) comparing
periurethral injection (injection of autologous fat) with placebo (injection
of saline). There were no differences in subjective cure or improvement rates
(RR, 0.98; 95% CI, 0.75-1.29), and complication rates were higher with periurethral
injection (NNH, 5; 95% CI, 3-11).75,76 There
was also a death in the treatment group from a fat pulmonary embolism. Another
study (n = 133) compared periurethral injection (collagen injection) with
open surgery (open retropubic colposuspension, sling procedure, or bladder
neck suspension).75 There was no difference
in patient satisfaction (RR, 1.45; 95% CI, 0.92-2.29), but the number not
cured based on objective criteria (24-hour pad test results) was higher with
periurethral injection (RR, 1.69; 95% CI, 1.02-2.79).
Urinary incontinence is common in women and has a tremendous impact
on their quality of life. Therefore, it is important that primary care clinicians
work with their patients to identify and manage it. Several potentially modifiable
factors are associated with urinary incontinence and clinicians can explore
these with their patients. There are several nonpharmacological, pharmacological,
and surgical treatments available that are effective in managing the symptoms
of urinary incontinence. However, it is generally agreed that the first treatment
choice should be the least invasive option with the lowest risk for adverse
complications. Generally, nonpharmacological options should be considered
before pharmacological or surgical options.
We have provided a brief overview of some of the recent developments
in this field in an attempt to bridge the gap between research evidence and
clinical practice. Part 2 of this series will focus on how clinicians can
use this evidence in practice.
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