III Methodology
Basic principles
The method used to prepare this guideline was determined by the class to which this
guideline was assigned. The AWMF Guidance Manual (version 1.0) has set out the respective
rules and
requirements for different classes of guidelines. Guidelines are differentiated into
lowest (S1), intermediate (S2), and highest (S3) class. The lowest class is defined
as consisting of a
set of recommendations for action compiled by a non-representative group of experts.
In 2004, the S2 class was divided into two subclasses: a systematic evidence-based
subclass (S2e) and a
structural consensus-based subclass (S2k). The highest S3 class combines both approaches.
This guideline was classified as: S2k
Grading of recommendations
The grading of evidence based on the systematic search, selection, evaluation, and
synthesis of an evidence base which is then used to grade the recommendations is not
envisaged for S2k
guidelines. The various individual statements and recommendations are only differentiated
by syntax, not by symbols ([Table 3 ]):
Table 3 Grading of recommendations (based on Lomotan et al., Qual Saf Health Care 2010).
Description of binding character
Expression
Strong recommendation with highly binding character
must/must not
Regular recommendation with moderately binding character
should/should not
Open recommendation with limited binding character
may/may not
Statements
Expositions or explanations of specific facts, circumstances, or problems without
any direct recommendations for action included in this guideline are referred to as
“statements.” It is
not possible to provide any information about the level of evidence for these statements.
Achieving consensus and level of consensus
At structured NIH-type consensus-based conferences (S2k/S3 level), authorized participants
attending the session vote on draft statements and recommendations. The process is
as follows. A
recommendation is presented, its contents are discussed, proposed changes are put
forward, and all proposed changes are voted on. If a consensus (> 75% of votes) is
not achieved, there is
another round of discussions, followed by a repeat vote. Finally, the extent of consensus
is determined, based on the number of participants ([Table 4 ]).
Table 4 Level of consensus based on extent of agreement.
Symbol
Level of consensus
Extent of agreement in percent
+++
Strong consensus
> 95% of participants agree
++
Consensus
> 75 – 95% of participants agree
+
Majority agreement
> 50 – 75% of participants agree
–
No consensus
< 51% of participants agree
Expert consensus
As the term already indicates, this refers to consensus decisions taken specifically
relating to recommendations/statements issued without a prior systematic search of
the literature (S2k)
or where evidence is lacking (S2e/S3). The term “expert consensus” (EC) used here
is synonymous with terms used in other guidelines such as “good clinical practice”
(GCP) or “clinical
consensus point” (CCP). The strength of the recommendation is graded as previously
described in the chapter Grading of recommendations but without the use of symbols; it is only
expressed semantically (“must”/“must not” or “should”/“should not” or “may”/“may not”).
IV Guideline
1 Introduction
The International Continence Society (ICS) defines urinary incontinence as any involuntary
loss of urine. Urinary incontinence is one of the most common symptoms raised during
visits to a
general practitioner, and it constitutes a severe health problem for women of all
ages. Urinary incontinence can have a severe negative impact on womenʼs quality of
life with physical,
psychological, social, and even economic consequences for affected women.
International studies report an incidence of 13.1%, but the rates reported in other
meta-analyses range from 4.4 – 44% (mean 23.5%). Urinary incontinence can occur at
any age, although the
prevalence and extent of urinary incontinence in women increases with increasing age.
The rates reported for Germany also vary. According to a statistical survey carried
out in 2005, the incidence of incontinence in women increased significantly with increasing
age, rising
from 7.8% in 18 to 40-year-old women to 11.3% in women aged between 41 and 60 and
27.1% in women aged over 60 years. This means that a total of 15% of the female population
report symptoms
of incontinence.
When considering female urinary incontinence, it is important to differentiate between
different pathophysiological forms:
Stress incontinence consists of involuntary loss of urine occurring during physical exertion (e.g., coughing,
sneezing, sports activities) without an urge to urinate.
Urge incontinence is characterized by involuntary loss of urine which is accompanied by an imperative
urge to urinate or which follows a strong urge to urinate. This can be
present with or without an overactive detrusor muscle.
The overarching syndrome known as overactive bladder (OAB) includes the symptoms of an imperative urge to urinate, which is often accompanied
by pollakisuria and nocturia, as
well as urge incontinence. The term should only be used if the patient has no urinary
tract infection or other disease which affects the lower urinary tract.
Nocturnal enuresis is characterized by (imperceptible) loss of urine during sleep (usually at night).
Mixed urinary incontinence presents with the symptoms of both stress incontinence and urge incontinence.
Incontinence in combination with chronic urinary retention (previously known as overflow incontinence) is caused by an increased volume of residual
urine, which can develop due
to detrusor underactivity or bladder outlet obstruction.
Neurogenic detrusor overactivity with urinary incontinence (formerly known as reflex incontinence) is the result of neurogenic detrusor overactivity
in patients with a known
neurological disease or an objective neurological deficit (e.g., congenital or acquired
spinal injury or neurological diseases such as Parkinsonʼs disease or multiple sclerosis).
Extraurethral urinary incontinence is present if there is a constant vaginal and/or rectal loss of urine without urge
symptoms or physical activity. This type of urinary
incontinence is caused by fistula formation or an ectopic ureter.
Special variants of female urinary incontinence include positional incontinence (involuntary loss of urine occurring when changing from a sitting or recumbent position),
undetected urinary incontinence (affected women cannot provide any information about when or why the loss of urine
occurred), giggle incontinence (loss of urine while
laughing) or coital urinary incontinence (loss or urine during coital penetration and/or orgasm).
When treating stress urinary incontinence in women, it is important to differentiate
between uncomplicated and complicated stress incontinence.
Uncomplicated stress incontinence is characterized as follows:
symptoms of stress incontinence predominate
no history of an operation for incontinence or extended prolapse surgery
no neurological bladder function disorder
no accompanying symptomatic genital prolapse
the woman does not intend to have any (further) children
Complicated stress incontinence is characterized by:
previous failed incontinence operations
previous pelvic irradiation which affected the vaginal or urethral tissue
neurogenic bladder function disorders
simultaneous genital prolapse
the woman wishes to have (further) children
2 Diagnostics
2.1 Patient history and clinical examination
A careful and detailed inquiry into the patientʼs medical history is the first step
that must be taken to investigate urinary incontinence, even if there is no evidence
for it.
The urogynecological examination must be made with the patient in the lithotomy position,
and a Sims speculum must be used both when the patient is at rest and when straining.
It is
important to look for any changes to the external genitals (estrogen status, vulvar
atrophy, lichen sclerosus et atrophicans, etc.) and whether genital prolapse (uterus
or bladder
prolapse) is present. Direct observation of urinary excretion through the ureter during
a clinical cough stress test carried out with the patient in a supine or standing
position after
being requested to cough with a full bladder is an important part of the examination.
Palpation of the pelvic floor musculature which includes checking contractility is
an essential
examination and can be semi-quantified using the Oxford grading system.
Consensus-based recommendation E2-01
Expert consensus
Level of consensus +++
The investigation into the causes of urinary incontinence must be carried out systematically and must include the patientʼs general medical history,
her urogynecological
medical history, a physical examination and her expectations regarding the examination
and treatment (strong recommendation) .
Consensus-based recommendation E2-02
Expert consensus
Level of consensus +++
A history of the patientʼs current medications and dosages must be obtained for all female patients with urinary incontinence (strong recommendation) .
Consensus-based recommendation E2-03
Expert consensus
Level of consensus +++
All new medications which are associated with the development or worsening of urinary
incontinence should be reviewed (recommendation) .
Consensus-based recommendation E2-04
Expert consensus
Level of consensus +++
The following aspects should be considered: urine storage, bladder voiding, symptoms after micturition, type and
extent of incontinence and psychological stress for the
patient (strong recommendation) .
Consensus-based recommendation E2-05
Expert consensus
Level of consensus +++
The Oxford score may be used to evaluate pelvic floor contractility (open recommendation) .
2.2 Patient questionnaires
There are numerous questionnaires which include symptom scores, symptom-related questionnaires,
scales, indices, patient-reported outcomes (PROMs) and questionnaires focusing on
health-related quality of life. The latter two types also collect general data as
well as data related to specific problems. They should be validated for every language
used.
Consensus-based recommendation E2-06
Expert consensus
Level of consensus +++
If a standardized assessment is wanted, a validated and appropriate questionnaire
must be used (strong recommendation) .
2.3 Bladder diary
Obtaining an objective assessment of the functional symptoms affecting the lower urinary
tract (lower urinary tract symptoms, LUTS) is an important step in the management
of women with
disturbed bladder storage and/or voiding, including urinary incontinence. A bladder
diary is a semi-objective method to quantify symptoms and the incidence of incontinence
episodes.
Consensus-based recommendation E2-07
Expert consensus
Level of consensus +++
A micturition diary (bladder diary) must be kept by patients with urinary incontinence if a standardized investigation is
required (strong recommendation) .
Consensus-based recommendation E2-08
Expert consensus
Level of consensus ++
The micturition diary (bladder diary) should be kept for at least 3 days (recommendation) .
2.4 Pad test
Measuring urinary loss by weighing protective pads before and after use during a specific
period of time with the pads being used during protocolled physical activities can
demonstrate
the presence and severity of urinary incontinence as well as the effect of treatment.
A pad test provides an accurate diagnosis of urinary incontinence and quantifies urinary
loss.
Consensus-based recommendation E2-09
Expert consensus
Level of consensus +++
A pad test during a standardized period of time using protocolled activities must be carried out (strong recommendation) .
Consensus-based recommendation E2-10
Expert consensus
Level of consensus +++
A pad test should be carried out if it is necessary to quantify urinary incontinence (recommendation) .
2.5 Urine analysis and bladder infections
Urine analysis (urine strip test and, if necessary. urine microscopy [urine sediment]
and urine culture) must be routinely carried out to exclude infection as well as micro-hematuria,
proteinuria and glucosuria as part of the investigation into urinary incontinence.
The presence of a symptomatic urine infection worsens the symptoms of urinary incontinence
and must therefore be treated.
Consensus-based recommendation E2-11
Expert consensus
Level of consensus +++
A urine analysis must be carried out during the initial investigation of a female patient with urinary
incontinence (strong recommendation) .
Consensus-based recommendation E2-12
Expert consensus
Level of consensus +++
A re-evaluation after treatment of the urinary infection must be carried out in incontinent female patients with symptomatic urinary tract infection
(strong
recommendation) .
Consensus-based recommendation E2-13
Expert consensus
Level of consensus +++
Asymptomatic bacteriuria must not be routinely treated with antibiotics in geriatric female patients with urinary
incontinence (strong recommendation) .
2.6 Post-void residual urine
Residual urine, i.e., the volume of urine remaining in the bladder at the end of micturition,
can have varying causes. Increased bladder outlet resistance and detrusor wall weakness
(detrusor hypocontractility or acontractility) – or a combination of both disorders
– may be responsible for post-void residual urine. Residual urine can worsen the symptoms
of
incontinence and in rare cases be accompanied by urinary tract infection or a dilatation
of the upper urinary tract as well as renal failure. The volume of residual urine
can be determined
by one-time urethral catheterization or ultrasound examination.
Consensus-based recommendation E2-14
Expert consensus
Level of consensus +++
Residual urine must be determined using ultrasound (strong recommendation) .
Consensus-based recommendation E2-15
Expert consensus
Level of consensus +++
Residual urine must be determined in female patients with urinary incontinence and micturition difficulties
(strong recommendation) .
Consensus-based recommendation E2-16
Expert consensus
Level of consensus +++
The volume of residual urine must be determined in female patients with complicated urinary incontinence (strong recommendation) .
Consensus-based recommendation E2-17
Expert consensus
Level of consensus +++
Residual urine must be determined in female patients before, during and after therapy which causes or
worsens bladder voiding disorders – including incontinence surgery
(strong recommendation) .
2.7 Urodynamics
Diagnosing urinary incontinence using only a urodynamic study is not possible as urodynamics
must be evaluated in the context of symptoms and clinical findings. The general rule
is that
clinical symptoms do not necessarily correlate with urodynamic findings.
A routine urodynamic study is not indicated before starting conservative treatment
of uncomplicated urinary incontinence and untreated overactive bladder and should
not be carried out.
But if the findings are not clear or if the urodynamic findings could affect the treatment
decision, then a urodynamic study must be carried out.
Recent studies have shown that if the patient presents with uncomplicated stress urinary
incontinence, a preoperative urodynamic study can neither predict the success of surgery
nor
predict possible complications of surgery. But many cases do not have uncomplicated
stress urinary incontinence and in up to 60% of cases, the clinical assessment is
incorrect.
If there is a suspicion of mixed incontinence or of a neurogenic component, if there
is a discrepancy between the clinical findings and the patientʼs medical history,
or if the patient
has a bladder voiding disorder, a urodynamic study should be carried out prior to
invasive treatment in cases with complicated stress urinary incontinence and prior
to carrying repeat
surgery in order to support the treatment decision and offer the patient the best
possible advice.
Consensus-based recommendation E2-18
Expert consensus
Level of consensus +++
A urodynamic study should be carried out if the cause of the symptoms or the pathophysiology is not clear (recommendation) .
Consensus-based recommendation E2-19
Expert consensus
Level of consensus +++
A urodynamic study must only be carried out if the results will have consequences for the subsequent therapy
(strong recommendation) .
Consensus-based recommendation E2-20
Expert consensus
Level of consensus +++
Urine status should be determined prior to any urodynamic study to exclude urinary tract infection, and
any infection detected must be treated first
(recommendation) .
Consensus-based recommendation E2-21
Expert consensus
Level of consensus +++
A routine urodynamic study is not indicated prior to starting conservative treatment
for uncomplicated stress urinary incontinence or untreated overactive bladder and
should
not be carried out (recommendation) .
Consensus-based recommendation E2-22
Expert consensus
Level of consensus +++
A urodynamic study must be carried out preoperatively in female patients with complicated stress urinary
incontinence (strong recommendation) .
Consensus-based recommendation E2-23
Expert consensus
Level of consensus +++
A video-based urodynamic study should not be routinely carried out in cases with non-neurogenic urinary incontinence (recommendation) .
2.8 Urethrocystoscopy
Indications to carry out this further investigative procedure are:
questioning the patient elicits a work-related history positive for suspected urothelial
bladder carcinoma
micro- and macro-hematuria
positive urine cytology results
recurrent urinary tract infections
bladder pain
de novo urge symptoms after surgery for urinary incontinence
(suspicion of) bladder empty disorder
patient is status post unsuccessful conservative therapy (physiotherapy, drug therapy)
Consensus-based recommendation E2-24
Expert consensus
Level of consensus +++
A urethrocystoscopy should be carried out in patients with complicated stress urinary incontinence (recommendation) .
Consensus-based recommendation E2-25
Expert consensus
Level of consensus +++
A urethrocystoscopy must be carried out in female patients with treatment-resistant urge incontinence to ensure
that another potential pathology has not been overlooked
(strong recommendation) .
3 Diagnostic imaging for female urinary incontinence
3.1 Sonography
Ultrasound (US) is the most important imaging procedure for the diagnostic workup
of female urinary incontinence as it provides the most information and can be used
in all patients. There
are numerous established US parameters ([Table 5 ]).
Table 5 Ultrasound parameters.
US scanner/frequencies
Introital ultrasound
Perineal ultrasound
Vaginal US, 2 – 10 MHz
Sector scanner, 5 – 9 MHz
Pelvic floor sonography
Curved array scanner, 3.5 – 5.0 MHz
and its combinations, evaluation of all compartments
Positioning of the probe
Introital ultrasound
Introitus (high resolution despite minimum possible contact pressure, transducer is
held perpendicular to the body axis)
Vaginal introitus
Perineal ultrasound
Pelvic floor sonography
Vaginal introitus
The position of the scanner must be moved. Changing the entry angle and rotating or
elevating the vaginal scanner offers the opportunity to view the organs being examined
in
three different planes (sagittal, frontal and axial).
Examination technique
2D or 3D technique
2D sonography is the standard approach (captures rapid changes in movement), 3D sonography
is used to obtain images of the levator ani and sphincter ani muscles
Imaging
cranial – at the top of the image; caudal – at the bottom of the image
right – on the left side of the image; left – on the right side of the image
ventral – on the right side of the image; dorsal – on the left side of the image (for
publications)
Computed tomography image in the transverse plane
cranial – at the top of the image; caudal – at the bottom of the image
right – on the left side of the image; left – on the right side of the image
ventral – on the right side of the image; dorsal – on the left side of the image (for
publications)
urethra above, rectum below
Patient position during examination
Lithotomy position is usually sufficient.
Bladder filling
Diagnostic workup for incontinence must be done with a moderately filled bladder
affects funneling/urethral length, position of the bladder neck
must be recorded in scientific studies to allow results to be compared (optimal filling
volume is 300 ml)
Analyzed parameters (descriptive)
Determination of residual urine volume
sonomorphological urethral length
Urethral mobility (rigid, hypermobile)
Position of the bladder neck at rest, during compression and when straining/coughing
Funneling: description of funnel formation
Evaluation of periurethral tissue (e.g., diverticula or cysts)
Assessment of coordination and elevation of levator ani muscle complex
Detrusor wall thickness
postoperative imaging of the tape, bulking agent depots, or hematoma
Consensus-based recommendation E3-01
Expert consensus
Level of consensus ++
Pelvic floor sonography should be used as part of conservative treatment to document improvements over the course
of treatment and to obtain biofeedback
(recommendation) .
Consensus-based recommendation E3-02
Expert consensus
Level of consensus +++
The volume of residual urine must be determined preoperatively and postoperatively; because US is non-invasive, sonography
is the preferred method used to measure
residual urine (strong recommendation) .
Consensus-based recommendation E3-03
Expert consensus
Level of consensus +++
Pelvic floor sonography should be used to obtain a morphological correlate to clinical information and to exclude
possible clinically occult risk factors
(recommendation) .
Consensus-based recommendation E3-04
Expert consensus
Level of consensus +++
A control sonography to check the proper placement of vaginal tape or mesh can be
carried out in cases with an unremarkable postoperative course. To manage complications,
diagnostic ultrasound must be part of the primary workup in addition to the clinical examination (strong recommendation) .
3.2 Requirements for diagnostic US
Consensus-based recommendation E3-05
Expert consensus
Level of consensus +++
2D ultrasound must be the standard technique used for diagnostic US of all compartments (strong recommendation) .
Consensus-based recommendation E3-06
Expert consensus
Level of consensus +++
3D sonography may be used as a supplementary procedure for the morphological assessment of the levator
muscles and pelvic organs (open recommendation) .
Patient position during examination
Consensus-based statement S3-01
Expert consensus
Level of consensus ++
Based on current studies, it is not possible to issue a general recommendation on
how the patient must be positioned during US examinations.
Consensus-based recommendation E3-07
Expert consensus
Level of consensus +++
The position of the patient during the examination must always be recorded when carrying out a diagnostic workup in the context of a study
(strong
recommendation) .
Bladder filling
Consensus-based recommendation E3-08
Expert consensus
Level of consensus +++
To better compare findings and for studies carried out as part of the diagnostic workup
for bladder incontinence, bladder filling should be around 300 ml because the
volume of urine in the bladder affects imaging of the bladder trigone and the position
of the bladder neck (recommendation) .
Using the probe
Consensus-based recommendation E3-09
Expert consensus
Level of consensus +++
The ultrasound examination should be carried out with as little pressure exerted as possible (recommendation) .
Ultrasound probes
A curved array scanner is used for perineal ultrasound with the probe placed at the
introitus. The broad surface of the transducer makes orientation relatively easy.
The ultrasound
frequencies usually range between 3.5 and 5 MHz.
A vaginal transducer is used for introital ultrasound examinations with the probe
also placed in the introital area. The ultrasound frequencies used with this type
of sonography are
higher, ranging from 5 – 9 MHz.
Imaging
For studies and publications, DEGUM recommends that cranial structures are shown at
the top and caudal structures at the bottom of images. Ventral structures must be
shown on the right
side and dorsal structures on the left side of the image. It is possible to deviate
from the recommendation in clinical practice.
3.3 Use of sonomorphology in the diagnostic workup of urinary incontinence
Bladder filling
Measurement of bladder filling volume is a prerequisite for every examination and
should be done at the beginning of the examination. The residual urine volume is an
important criterion
to differentiate simple stress incontinence from complicated incontinence such as
overflow incontinence or neurogenic incontinence.
Urethral length
Consensus-based recommendation E3-10
Expert consensus
Level of consensus ++
Sonomorphology to determine urethral length should be done preoperatively to plan the correct placement of the tape (recommendation) .
Position of the bladder neck
Consensus-based recommendation E3-11
Expert consensus
Level of consensus +++
The position of the bladder neck should be verified under three different conditions: at rest, during Valsalva maneuver and
during pelvic floor contraction
(recommendation) .
Urethral mobility
Urethral mobility is evaluated based on the position of the bladder neck during different
states of motion.
Consensus-based statement S3-02
Expert consensus
Level of consensus ++
Urethral mobility is evaluated to identify pathologies such as hypermobile or rigid
urethra. This is important because it affects the chances of success of surgical
interventions.
Funneling
Consensus-based statement S3-03
Expert consensus
Level of consensus ++
Funneling is a typical sonomorphological correlate of stress urinary incontinence.
Funneling describes funneling of the bladder neck during stress. Funneling can also
occur
when the urethra is unstable or in cases with overactive bladder.
Periurethral tissue
Consensus-based recommendation E3-12
Expert consensus
Level of consensus +++
Evaluation of the anterior compartment should include periurethral tissue (recommendation) .
Evaluation of the bladder wall
Bladder wall hypertrophy due to increased detrusor activity can be confirmed by transvaginal,
translabial or suprapubic positioning of the ultrasound probe.
Consensus-based recommendation E3-13
Expert consensus
Level of consensus +++
The bladder wall should be assessed using ultrasonography in female patients with urge incontinence symptoms
to preclude local pathologies as the cause of incontinence.
Pathological thickening of the bladder wall requires further investigation (recommendation) .
Urogenital fistula/ectopic ureter
Consensus-based recommendation E3-14
Expert consensus
Level of consensus +++
Pelvic floor sonography may be additionally used to detect urethral or bladder wall defects, particularly when
investigating possible fistula formation (open
recommendation) .
3.4 Use of diagnostic sonography after incontinence surgery, use of sonography after
tension-free tape placement
Ultrasound is the method of choice to diagnose complications after suburethral sling
procedure. The most common complications are de novo urge incontinence, bladder voiding
disorder with
residual urine, and unsatisfactory surgical outcome. A tape positioned in the proximal
third of the urethra or at the level of the bladder neck is often associated with
bladder voiding
disorder, increased residual urine volume and the necessity for surgical revision.
Consensus-based recommendation E3-15
Expert consensus
Level of consensus +++
Ultrasound must be used in cases with postoperative bladder voiding disorder after tape placement
to exclude incorrect positioning or retropubic/paravesical hematoma
(strong recommendation) .
Sonography after colposuspension
Ultrasound imaging can be used to show stabilization of the bladder neck following
colposuspension. Hypermobility of the bladder neck which persists postoperatively
may be correlated
with recurrent urinary incontinence.
Consensus-based recommendation E3-16
Expert consensus
Level of consensus +++
An ultrasound examination should be carried out in cases with postoperative bladder voiding disorder following colposuspension
to exclude overcorrection
(recommendation) .
Sonography after injection of bulking agents
The use of sonography to assess the shape and localization of bulking agents has been
confirmed in the literature. Ultrasound assessment of bulking agent depots can be
useful to
determine the mechanism of action and detect complications.
Consensus-based statement S3-04
Expert consensus
Level of consensus +++
Imaging of the morphology, size and localization of bulking agents is possible with
ultrasound.
3.5 Use of X-ray procedures and magnetic resonance imaging in the diagnostic workup
of female urinary incontinence
Starting with the lumen and moving outwards, the cross-sectional anatomical continence
mechanism of the urethra consists of the urothelium, the submucosa, the longitudinal
smooth muscles,
the circular smooth muscles, the external striated urethral sphincter, and the serosa.
All these structures can be visualized with MRI, and the quality of imaging is constantly
improving.
If there is a suspicion that the cause of urinary incontinence could be urogenital
malformations, then a pelvic MRI which includes imaging of the upper urinary tract
provides the most
sensitive diagnostic imaging with the greatest soft tissue contrast.
Consensus-based statement S3-05
Expert consensus
Level of consensus ++
X-ray and MRI play only a marginal role in the routine diagnostic workup of uncomplicated
urinary incontinence.
Consensus-based recommendation E3-17
Expert consensus
Level of consensus +++
Diagnostic X-ray or MRI may be indicated in selected cases with congenital or postoperative
urinary incontinence and unclear clinical and sonomorphological diagnosis.
[Fig. 1 ] shows the algorithm used for the diagnostic workup and for the conservative and
surgical treatment of different forms of urinary incontinence.
Fig. 1 Flow chart for the diagnosis and treatment of female urinary incontinence. [rerif]
4 Conservative therapy of urinary incontinence
4.1 Simple clinical measures
It is standard clinical practice to start treatment by trying non-surgical therapies
as they are usually associated with the lowest risk of injury. Non-surgical therapies
are often used
combined, making it difficult to determine which components are effective. Incontinence
pads play a particularly important role for those who prefer to avoid the risks of
interventional
procedures or for whom active treatment is not possible for some reason.
Primary disease/cognitive impairment
Consensus-based recommendation E4-01
Expert consensus
Level of consensus +++
Female patients with urinary incontinence who develop comorbidities must always receive appropriate treatment for their comorbidity in line with good medical
practice
(strong recommendation) .
Adaptation of other (non-incontinence) medication
It can be difficult or even impossible to differentiate between the different factors
affecting urinary incontinence in patients with existing urinary incontinence, particularly
if the
patients are elderly. Potential factors which may additionally affect urinary incontinence
can include medication, comorbidities, or ageing.
Constipation
Consensus-based recommendation E4-02
Expert consensus
Level of consensus ++
Female patients with urinary incontinence who also suffer from constipation must receive counseling in line with good medical practice about the appropriate bowel
treatment (strong recommendation) .
Aids
Aids are important for people with urinary incontinence if active treatment is unable
to solve the problem or another treatment is not possible. Some people may prefer
using aids rather
than receiving active treatment with its associated risks. Aids can consist of incontinence
pads, catheters, or external diversion.
Consensus-based recommendation E4-03
Expert consensus
Level of consensus +++
Female patients with urinary incontinence and/or their carers must be informed about the available treatment options before they decide to only use aids
(strong
recommendation) .
Consensus-based recommendation E4-04
Expert consensus
Level of consensus ++
Patients must be offered incontinence pads and/or additional aids to treat urinary incontinence
(strong recommendation) .
4.2 Lifestyle-related interventions
Examples of lifestyle factors which have been associated with incontinence include
obesity, smoking, physical activity, and nutrition. Changing these factors may also
improve urinary
continence.
Consensus-based recommendation E4-05
Expert consensus
Level of consensus ++
Overweight or obese female patients with urinary incontinence must be motivated to reduce their weight and maintain their reduced weight (strong
recommendation) .
Consensus-based recommendation E4-06
Expert consensus
Level of consensus +++
Female patients with urinary incontinence must be informed that reducing their caffeine intake may reduce the symptoms of urge incontinence
and their frequency of
urination but will not reduce stress urinary incontinence (strong recommendation) .
Consensus-based recommendation E4-07
Expert consensus
Level of consensus +++
The type and amount of the liquid intake of female patients with urinary incontinence
must be verified and modified if necessary (strong recommendation) .
Behavioral therapy and physiotherapy
Consensus-based recommendation E4-08
Expert consensus
Level of consensus +++
Patients with urinary incontinence and cognitive impairment must be offered prompted voiding (strong recommendation) .
Consensus-based recommendation E4-09
Expert consensus
Level of consensus +++
Bladder training should be the first-choice therapy for female patients with urge incontinence or mixed incontinence
(recommendation) .
Consensus-based recommendation E4-10
Expert consensus
Level of consensus ++
Pelvic floor training must be offered to patients with stress urinary incontinence and mixed urinary incontinence
(including elderly female patients or women who have
given birth). Pelvic floor strength should be monitored and pelvic floor training
should be continued for at least 3 months (strong recommendation) .
Consensus-based recommendation E4-11
Expert consensus
Level of consensus ++
The pelvic floor training program must involve strength training principles (strong recommendation) .
Consensus-based recommendation E4-12
Expert consensus
Level of consensus +++
Electrostimulation (skin, vaginal, anal) may be used in addition to pelvic floor training to treat urinary incontinence (open recommendation) .
Consensus-based recommendation E4-13
Expert consensus
Level of consensus ++
Electromagnetic stimulation may be considered to treat urinary incontinence or overactive bladder in adult women
(open recommendation) .
Consensus-based recommendation E4-14
Expert consensus
Level of consensus ++
In female patients with mixed urinary incontinence, the clinically dominant symptom
should be treated first (recommendation) .
4.4 Laser therapy for stress incontinence
Numerous reviews and guidelines issued by various committees have concluded that the
data on the efficacy and safety of laser therapy is still insufficient, despite a
huge improvement in
the amount of data in the last two years about the use of laser therapy as a routine
treatment for stress incontinence. Because of this new evidence, laser therapy may
now be recommended
to treat a selected group of women with stress incontinence.
Three laser modalities have been described for the intravaginal treatment of stress
incontinence
microablative fractional carbon dioxide (CO2 ) laser therapy (10 600 nm),
biphasic erbium:YAG laser therapy (2940 nm), a combination of fractional cold ablation
and thermal ablation, and
non-ablative erbium:YAG laser therapy (2940 nm) with SMOOTH mode technology, the most
commonly used laser therapy.
Consensus-based statement S4-01
Expert consensus
Level of consensus +++
There is no randomized controlled study yet which has directly compared the three
laser modalities used to treat stress incontinence head-to-head.
Consensus-based statement S4-02
Expert consensus
Level of consensus ++
Two randomized controlled studies with a short follow-up period of up to 3 months
have shown a subjective superiority of laser treatment compared to placebo/control
treatment.
Prospective observational studies with follow-up of up to 36 months have been published.
Consensus-based statement S3-03
Expert consensus
Level of consensus +++
Laser therapy can be topped up.
Consensus-based recommendation E4-15
Expert consensus
Level of consensus ++
* Laser therapy has not yet been approved for use by the statutory health insurance
companies in Germany, Switzerland and Austria.
Intravaginal laser therapy may be a therapeutic option to treat mild or moderate stress incontinence (open recommendation) .*
4.5 Pessary therapy for urinary incontinence
Consensus-based recommendation E4-16
Expert consensus
Level of consensus ++
Pessary therapy should be offered to female patients with stress urinary incontinence as a therapeutic option
(recommendation) .
4.6 Prevention of urinary incontinence
Consensus-based recommendation E4-17
Expert consensus
Level of consensus ++
Women should be informed about the association between being overweight and urinary incontinence,
especially about the benefits of having a normal weight prior to
conception (recommendation) .
Consensus-based recommendation E4-18
Expert consensus
Level of consensus +++
Prepartum physiotherapy may reduce the risk of developing urinary incontinence and
should therefore be offered to all pregnant women (recommendation) .
Consensus-based recommendation E4-19
Expert consensus
Level of consensus ++/+++
Because of the risk-benefit constellation, elective caesarean section to reduce the
risk of urinary incontinence must not be recommended (++). Nevertheless, pregnant
women with a higher risk of postpartum pelvic floor insufficiency must be offered specific information to allow them to weigh up the benefits and risks
of primary
caesarean section (strong recommendation) (+++).
Consensus-based recommendation E4-20
Expert consensus
Level of consensus +++
Preventive substitution of vitamin D to reduce the risk of urinary incontinence may not be currently generally recommended during pregnancy because the data is
insufficient (open recommendation) .
Consensus-based recommendation E4-21
Expert consensus
Level of consensus ++
Women should be informed postpartum about the risk of pelvic floor insufficiency which increases
with age (recommendation) .
5 Drug therapy for urinary incontinence
5.1 Antimuscarinic agents
The oral antimuscarinic agents currently approved for use in Germany, Austria and
Switzerland and the brand names of the preparations used in Germany, their pharmacokinetic
properties,
and the recommended daily dosages are listed in [Table 6 ].
Table 6 Approved antimuscarinic drugs.
Generic name
Brand name in Germany
tmax [hours]
t½ [hours]
Recommended daily dosage
Darifencacin
Emselex
7
12
1 × 7.5 – 15 mg
Fesoterodin
Toviaz
5
7
1 × 4 – 8 mg
Oxybutynin IR
Oxybutynin
Dridase
Oxybugamma
Oxybutin
Spasyt
0.5 – 1
2 – 4
3 – 4 × 2.5 – 5 mg
Oxybutynin ER
5
16
2 – 3 × 5 mg
Propiverin
Propiverin
Mictonetten
Mictonorm
Propimedac
Propiver
2.5
13
2 – 3 × 15 mg
Propiverin ER
10
20
1 × 30 mg
Solifenacin
Vesikur
3 – 8
45 – 68
1 × 5 – 10 mg
Tolterodin IR
Tolterodon
Detrusitol
1 – 3
2 – 10
2 × 1 – 2 mg
Tolterodin ER
4
6 – 10
1 × 4 mg
Trospium IR
Trospium
Spasmolyt
Spasmex
Urivesc
Spasmo-Urgenin
Trospi
5
18
3 × 10 – 15 mg
2 × 10 – 20 mg
Trospium ER
5
36
1 × 60 mg
Consensus-based statement S5-01
Expert consensus
Level of consensus +++
Antimuscarinic agents are an effective oral treatment option for urge incontinence.
Consensus-based statement S5-02
Expert consensus
Level of consensus +++
There is no consistent evidence that any antimuscarinic agent is more effective than
another.
Consensus-based statement S5-03
Expert consensus
Level of consensus +++
The side effects of immediate-release formulations are higher than those of extended-release
formulations.
Consensus-based statement S5-04
Expert consensus
Level of consensus ++
If a formulation is ineffective or not sufficiently effective, changing the medication
or the form of delivery may be considered.
Consensus-based statement S5-05
Expert consensus
Level of consensus ++
With the exception of oxybutynin IR, antimuscarinic agents are safe to use in older
patients, but it is important to be aware of potential interactions with other medications
and possible intolerances.
Consensus-based statement S5-06
Expert consensus
Level of consensus ++
(Oral) oxybutynin has a significantly negative effect on cognitive functioning.
Consensus-based recommendation E5-01
Expert consensus
Level of consensus ++
If conservative non-drug therapy fails in adults with overactive bladder or urge incontinence,
then antimuscarinic agents must be additionally offered to patients
(strong recommendation) .
Consensus-based recommendation E5-02
Expert consensus
Level of consensus ++
ER formulations must be given priority over IR formulations (strong recommendation) .
Consensus-based recommendation E5-03
Expert consensus
Level of consensus ++
Oxybutynin oral must be avoided because of its high side effects profile (strong recommendation) .
Consensus-based recommendation E5-04
Expert consensus
Level of consensus ++
If treatment with an antimuscarinic agent is unsuccessful, escalating the dose, changing
the medication within the same group of medications, or even a combination of
antimuscarinic drugs may be considered (open recommendation) .
Consensus-based recommendation E5-05
Expert consensus
Level of consensus ++
If patients (especially geriatric patients) are receiving polymedication, the (total)
anticholinergic burden must be considered and interactions with other medications
must be reviewed (strong recommendation).
5.2 β3-adrenergic agonists (mirabegron) for overactive bladder, urge incontinence
or mixed urinary incontinence
Consensus-based statement S5-07
Expert consensus
Level of consensus +++
β3-adrenergic agonists (mirabegron) are superior to placebo and the effect of administration
is equivalent to the administration of antimuscarinic agents in terms of improving
the symptoms of overactive bladder but without impairing bladder contractility (residual
urine).
Consensus-based statement S5-08
Expert consensus
Level of consensus +++
It is important to be aware that one undesirable side effect of β3-adrenergic agonists
(mirabegron) can be an increase in blood pressure.
Consensus-based statement S5-09
Expert consensus
Level of consensus +++
Female patients who received insufficient treatment with antimuscarinic agents may
benefit more from the addition of β3-adrenergic agonists (mirabegron) than from escalating
the
dose of the antimuscarinic agent.
Consensus-based recommendation E5-06
Expert consensus
Level of consensus +++
β3-adrenergic agonists (mirabegron) should be offered to female patients for whom
conservative non-drug therapy did not lead to any improvement and who cannot tolerate
antimuscarinic drugs or in whom antimuscarinic drugs are ineffective or contraindicated
(recommendation) .
5.3 Duloxetine for stress incontinence or urge urinary incontinence
Consensus-based statement S5-10
Expert consensus
Level of consensus ++
Duloxetine may improve stress urinary incontinence.
Consensus-based statement S5-11
Expert consensus
Level of consensus ++
Especially during the initial weeks, duloxetine may affect the central nervous system
and have gastrointestinal side effects which lead to high rates of therapy
discontinuation.
Consensus-based recommendation E5-07
Expert consensus
Level of consensus ++
* It is not approved for use in Austria and Switzerland.
Patients receiving conservative treatment who have moderately severe stress urinary
incontinence must be informed about duloxetine as a treatment option (strong
recommendation) .*
Consensus-based recommendation E5-08
Expert consensus
Level of consensus +++
Female patients must be informed about continence rates and side effects before starting treatment with
duloxetine (strong recommendation) .
Consensus-based recommendation E5-09
Expert consensus
Level of consensus ++
To reduce the rate of side effects, duloxetine therapy must be started at low doses which are then gradually increased; if therapy is discontinued,
the doses must be
gradually reduced again (strong recommendation) .
Consensus-based recommendation E5-10
Expert consensus
Level of consensus ++
A combination of duloxetine and pelvic floor training may be recommended (open recommendation) .
5.4 Estrogens for stress incontinence, urge incontinence and mixed urinary incontinence
In addition to vaginal dryness, pruritus, burning, reduced or lack of vaginal lubrication,
dyspareunia and dysuria, estrogen deficiency-related changes to the female genitals
may also
manifest as incontinence symptoms including an imperative urge to urinate and increased
urination frequency or recurrent urinary tract infections.
Consensus-based recommendation E5-13
Expert consensus
Level of consensus +++
Vaginal estriol administration must be carried out in postmenopausal women with urinary incontinence (particularly urge
incontinence) and vulvovaginal atrophy. The
administration of estriol must be continued for a longer period of time (strong recommendation) .
Consensus-based recommendation E5-14
Expert consensus
Level of consensus +++
Ultra-low dose local estriol therapy may be used to treat female patients who are status post breast cancer after they have
been informed about the lack of data regarding
its oncological safety (open recommendation) .
Consensus-based recommendation E5-15
Expert consensus
Level of consensus +
* Conjugated estrogens are currently no longer approved for use in Austria and Switzerland.
Alternative hormone therapies must be discussed for women receiving oral hormone replacement therapy with conjugate
equine estrogens who develop urinary incontinence or
experience a worsening of urinary incontinence (strong recommendation) *.
Consensus-based statement S5-12
Expert consensus
Level of consensus +++
It is unlikely that the urinary incontinence of incontinent women will improve after
terminating systemic estradiol therapy.
5.5 Desmopressin for nocturia due to nocturnal polyuria
Consensus-based recommendation E5-16
Expert consensus
Level of consensus +++
Nocturia due to nocturnal polyuria caused an arginine-vasopressin deficit must be treated with desmopressin if the patient is upset by the nocturia (strong
recommendation) .
Consensus-based recommendation E5-17
Expert consensus
Level of consensus +++
Female patients with overactive bladder and nocturia (but no evidence of nocturnal
polyuria) must not be treated with an anti-muscarinic agent in combination with
desmopressin (strong recommendation) .
Consensus-based recommendation E5-18
Expert consensus
Level of consensus +++
Serum sodium concentrations must be monitored before and during desmopressin therapy with measurements carried out
after at least one week and after one month (strong
recommendation) .
5.6 Complementary medicine for stress, urge and mixed urinary incontinence
Complementary medicine and empirical medicine procedures are also used to treat female
urinary incontinence.
Interesting treatment options include phytotherapeutic agents and homeopathic remedies.
Other possible approaches are specific nutrition, orthomolecular therapy, supplements
using various
vitamins, especially vitamin D or the vitamin D analog elocalcitol. There are numerous
studies in the literature which have investigated the efficacy of acupuncture to treat
overactive
bladder and stress urinary incontinence.
Consensus-based statement S5-13
Expert consensus
Level of consensus ++
There is currently insufficient evidence about complementary medicine which would
allow an explicit recommendation to be made about the use of homeopathy, phytotherapy,
treatment with supplements and other therapeutic complementary medicine agents.
