Incontinence Flashcards
(136 cards)
1
Q
What is the definition of incontinence?
A
any involuntary loss of urine which is a social or hygienic problem
2
Q
What proportion of women attending primary care clinics report incontinence?
A
46%
3
Q
What is the incidence of overactive bladder in institutionalised elderly females?
A
50% or more
4
Q
What are the 5 commonest types of urinary incontinence in women?
A
- Stress urinary incontinence (SUI)
- Urge incontinence/ Overactive bladder (OAB)
- Mixed incontinence (SUI and OAB)
- Retention with overflow
- Fistula
5
Q
What is the commonest cause of urinary incontinence?
A
stress urinary incontinence (40%)
6
Q
What is the definition of stress incontinence?
A
involuntary loss of urine on effort or physical exertion, including sporting activities, or on sneezing or coughing, in the absence of any detrusor contraction
7
Q
What term can sometimes be used to describe stress incontinence, to avoid confusion with psychological stress?
A
activity-related incontinence
8
Q
What proportion of cases of female urinary incontinence does OAB (aka urge incontinence) account for?
A
30%
9
Q
What are the symptoms of overactive bladder incontinence?
A
sudden, compeling desire to pass urine which is difficult to defer (urgency)
usually associated with daytime urinary frequency (more than previously deemed normal) and nocturia (interruption of sleep one or more times because of need to micturate)
in severe cases, enuresis (bed wetting)
10
Q
What distinguishes overactive bladder from urge urinary incontinence?
A
UUI is a severe form of OAB
11
Q
What is mixed urinary incontinence?
A
women complain of incontinence associated with both urgency and physical exertion (accounts for 30% of cases)
12
Q
In which group of patients is retention with overflow a common form of incontinence?
A
elderly female patients, with an underactive bladder or with a neurological problem
13
Q
What is the mechanism of retention with overflow?
A
bladder continues to fill until it spills over, resulting in leakage (due to underactive bladder or neurological problem)
14
Q
How can a fistula cause urinary incontinence?
A
it is an abnormal communication between two epithelial surface; any communication between the lower urinary tract (ureter, bladder or urethra) and the genital tract (uterus and vagina) will result in continuous dribbling
15
Q
What is the commonest cause of a fistula causing incontinence in 1. the UK and 2. in under-resourced countries?
A
- Complication of surgery
- Obstructed labour
16
Q
How common are fistulae as a cause of incontinence in the UK?
A
1 in 1000 cases of incontinence
17
Q
What are 4 structures/ features involved in the maintenance of continence?
A
- Proximal urethral sphincter mechanism
- Distal urethral sphincter mechanism
- Supporting tissues around urethra
- Bladder stability - detrusor action
18
Q
What role does the proximal urethral sphincter play in maintaining continence?
A
- present in the region of the bladder neck
- is a water-tight seal; maintains pressure in urethra greater than in the bladder.
- Anatomical basis of the seal is series of arteriovenous anastomoses within wall of proximal urethra, which allow degree of turgor pressure to be exerted circumferentially around urethra, which results in formation of hermetic seal by keeping urethra occluded
- if pressure exerted in numerous places around circumference of tube, it will close
19
Q
What role does the distal urethral sphincter play in the maintenance of continence?
A
- pressure in proximal urethra exceeds that in bladder; greatest pressure difference exists at mid-urethra
- this is made of striated muscle within wall of urethra and is innerved by nerve roots S2-4 via pudendal nerve
20
Q
What are the 2 key types of supporting tissues around the urethra that play a role in maintaining continence?
A
- pubourethral ligaments, derived from fascia of pelvic floor
- to lesser degree, the pelvic floor musculature, namely the levator ani muscle
21
Q
What is the innervation of the distal (external) urethral sphincter?
A
nerve roots S2-4 via pudendal nerve
22
Q
What role do the supporting tissues around the urethra pay in maintaining continence?
A
maintain proximal urethra in intra-abdominal position and any rise in intra-abdominal pressure is transmitted equally to bladder and proximal urethra - pressure difference will not change and continence will be maintained
23
Q
What can result from any weakness or damage to the supporting tissues around the urethra?
A
can make urethra hypermobile and any rise in intra-abdominal pressure makes it move outside the abdomen, leading to unequal distribution of pressure, which may predispose to SUI
24
Q
What is the role of bladder stability and the detrusor muscle in maintaining continence?
A
detrusor should relax during bladder filling and contract during micturition; involves complex interaction between structural anatomic parts of the urinary tract + between nervous control systems
25
What is one of the possible causes of overactive bladder and how does this work?
involuntary bladder i.e. detrusor contraction: if contraction is modest, woman will appreciate contraction as urinary urgency, but if contraction is strong enough to elevate pressure inside bladder above urethra, there will be urge urinary incontinence
26
What is the aetiology of stress urinary incontinence?
degree of weakness of one or both of the proximal and distal urethral sphincter mechanisms and/or supporting tissues around the urethra
27
What are 5 predisposing factors to stress urinary incontinence?
1. Pregnancy and vaginal delivery
2. Prolapse
3. Menopause
4. Collagen disorder
5. Obesity
28
What type of delivery after pregnancy particularly predisposes to stress urinary incontinence?
vaginal delivery
29
How can pregnancy itself cause stress incontinence?
* can cause some irreversible pelvic floor damage
* during pregnancy, raised intra-abdominal pressure related to uterine contents together with smooth muscle-relaxant effect of progesterone
30
How can vaginal delivery contribute to stress UI?
* may cause direct damage of pelvic floor or denervation of the pudendal nerve (pudendal neuropathy)
* first vaginal delivery causes maximum damage to the pelvic floor and all subsequent vaginal births can worsen the damage
31
What is a possible protective factor against stress urinary incontinence?
elective caesarean section
32
Why is prolapse a risk factor for stress urinary incontinence?
they co-exist in over 50% of cases; relationship relates to pelvic floor dysfunction which is the main aetiology of both conditions
33
What is the link between menopause and stress urinary incontinence?
lack of oestrogen **weakens urethral sphincter complex** and **reduces maximal urethral closure pressure** (intrinsic sphincter deficiency)
effect of this pressure reduction is that a smaller rise in intra-abdominal pressure will result in SUI
34
How can collagen disorders lead to stress urinary incontinence?
collagen is a major component of the pubo-urethral ligament
several different types of collagen within body, different types of collagen in varying proportions in the puboruethral ligaments of women who become incontinent compared with those who do not
35
What are 3 types of aetiology of overactive bladder?
1. Idiopathic (most cases)
2. Neurological conditions e.g. multiple sclerosis, stroke or spinal cord injury
3. Psychological upset (higher incidence of anxiety and neuroses)
36
What are 2 causes of voiding difficulty?
1. Underactive detrusor - hypotonia, 90% of cases
2. Anatomical obstruction - 10%
37
What are 2 possible causes of anatomical obstruction leading to voiding difficulty?
1. previous surgery
2. increased urethral sphincter activity (e.g. neurological disease)
38
What are 4 possible causes of detrusor hypotonia leading to voiding difficulty?
1. Ageing - natural reduction in muscle fibres and strength
2. Pregnancy and childbirth causing nerve damage (pudendal neuropathy)
3. Infrequent voiders as young women - more prone
4. Neurological disease - detrusor hypotonia (or obstruction)
39
How can neurological disease lead to voiding difficulty through obstruction (as well as detrusor hypotonia)?
**inappropriate** **contraction** of urethral sphincter or incoordination (**dyssynergia**) between bladder and urethral sphincter complex
40
What are 5 symptoms of overactive bladder?
1. Frequency
2. Urgency
3. Nocturia
4. Urge incontinence
5. Enuresis
41
What are 5 **voiding** symptoms to ask about when women report incontinence?
1. Hesitancy
2. Straining to void
3. Poor or intermittent urinary stream
4. Sensation of incomplete emptying
5. Post-micturition dribbling
42
What are 3 red flag urinary symptoms to rule out?
1. Haematuria
2. Persistent bladder or urethral pain
3. Recurrent urinary traction infection (UTI)
43
If any red flag symptom is present with urinary symptoms (haematuria, persistent bladder/urethral pain, recurrent UTI) what is warranted?
urological assessment of lower and upper urinary tracts
44
What proportion of women with stress urinar incontinence have coexisting pelvic organ prolapse?
50%
45
What must you always ask about when women present with urinary problems?
quality of life impact
can limit physical or social activity, cause depression/loss of self esteem/anxiety, sex life - incontinence during intercourse
nocturia can affect concentration and working
nocturia carries risk of falls in elderly e.g. #NOF
46
What other organ can be impacted in urinary problems?
bowel dysfunction can be associated
47
What are 6 overall ways urinary incontinence can affect quality of life?
1. Emotions - stigma and humiliation, social and recreational withdrawal, anxiety
2. Relationships - reduced intimacy, affection and physical proximity. Marriage breakdown
3. Employment - absence from work, loss of concentration, interruption for toilet breaks
4. Sleep - tiredness, risk of falls in elderly
5. Exercise and sport - barrier to exercise
6. Travel and holidays - relucant to visit new places, need to pack protective materials
48
What are 7 types of investigations which may be performed in cases of urinary incontinence?
1. Clinical examination
2. Urinalysis
3. Frequency-volume chart (bladder diary)
4. Cystoscopy
5. Ultrasound measurement of post-void residual volume
6. Quality-of-life questionnaires
7. Urodynamic studies
49
What type of clinical examination should be performed in cases of urinary incontinence?
abdominal and pelvic examination
50
What might 1. abdominal and 2. pelvic examination reveal in a woman suffering from incontinence?
1. Palpable bladder - urinary retention, pelvic mass
2. Pelvic organ prolapse, vaginal atrophy
51
What are 4 possible additional observations when performing abdominal and pelvic examinations to look for?
1. Stress UI - clinical stress leakage: observed involuntary leakage from urethra synchronous with effort or physical exertion, or sneezing or coughing
2. Extra-urethral incontinence: urine leakage through channels other than urethral meatus e.g. fistula or ectopic ureter
3. Focus neurological examination: if appropriate e.g. cognitive function, ambulation, mobility, hand function, lumbar and sacral spinal segment function
4. PR exam: if symptoms of anal incontinence, anal sphincter tone should be determined
52
When should you perform urinalysis in the workup for incontinence?
every woman presenting with LUTS should have urinalysis performed
53
What are 3 things to look for on urinalysis?
1. Leucocytes and nitrites suggests **UTI**
2. Recurrent UTI or haematuria - cystoscopy and USS of upper renal tracts for **malignancy**
3. Glycosuria - **diabetes** (can cause recurrent UTI and frequency)
54
What is the management if UTI is detected on urinalysis?
* broad-spectrum antbiotic started
* mid-stream specimen of urine sent
55
What is the management of recurrent UTI and presence of haematuria?
* cystoscopy
* ultrasound of upper renal tracts
56
When should a frequency-volume chart (bladder diary) be used?
should be used in initial assessment for minimum of 3 days
57
For how long should a bladder diary be completed as part of the initial assessment of incontinence?
minimum of 3 days
58
What should be included in a bladder diary for initial assessment of urinary incontinence? 4 key aspects
1. variations in usual activities such as working and leisure days
2. amount, type and timing of fluid intake
3. timing and amount of voiding
4. episodes of UI/ pad changes
59
In addition to initial assessment, what else can a bladder diary be useful for?
monitoring effects of treatment and act as feedback
60
How might the bladder diary of a patient with stress incontinence appear?
normal frequency but incontinence when not needing toilet
61
How might the bladder diary of a person with OAB appear?
normal bladder capacity (400ml), emptying with small amounts e.g. 50ml, incontinence when going to toilet
62
How would the bladder diary of someone with a small capacity bladder appear and what is the likely cause?
voiding smaller amounts e.g. 150ml at regular intervals; probably inflammatory in nature
63
When is cystoscopy indicated for incontinence?
if haematuria or recurrent UTIs
64
What are 3 situations when US measurement of post-void residual volume should be performed?
1. Incomplete emptying
2. Voiding dysfunction
3. Recurrent UTI
65
When is pelvic ultrasound useful for incontinence?
limited role other than if pelvic masses suspected
66
When should quality of life questionnaires be carried out for incontinence?
for every woman both before and after treatment, along with impression of what she expects from treatment - shared goals to improve patient satisfaction
67
What are 5 negatives of urodynamiC studies?
1. Invasive
2. Expensive
3. Time-consuming
4. Some women find them embarrassing
5. Not foolproof in providing diagnosis
68
What are 4 indications for urodynamic studies?
1. Symptoms of OAB leading to clinical suspicion of **detrusor** **overactivity**
2. Symptoms suggestive of **voiding** **dysfunction**
3. Anterior compartment **prolapse**
4. Previous **surgery** for stress incontinence
69
What is the approach to initial treatment of incontinence?
rule out red flags, categorise predominant symptoms e.g. SUI vs OAB predominant
70
What approach to management should be taken if a patient is thought to have mixed urinary incontinence?
direct treatment towards the predominant symptom
71
What are 6 differences between the symptoms of stress vs urge incontinence?
1. Urgency in OAB not SUI
2. Frequency with urgency (\>8 times /24h) with OAB not SUI
3. Leaking during physical activity e.g. coughing, sneezing, lifting - in SUI
4. Amount of urinary leakage with each episode of incontinence large with urge, small with stress
5. Ability to reach toilet in time following urge to void often not present in OAB, but present in SUI
6. Waking to pass urine at night seldom in SI
72
What are 3 aspects of management of urge and stress incontinence?
1. Conservative - lifestyle and bladder retraining
2. Medical therapy
3. Surgery
73
What are the 3 aspects of conservative management of incontinence?
1. Lifestyle interventions
2. Bladder retraining by continence advisor or clinical nurse specialist
3. Physiotherapy
74
What are 6 forms of lifestyle interventions for the management of incontinence?
1. Normalise fluid intake (1.5L per day) - shouldn't drink too much, or over-restrict
2. Cut down alcohol and restrict caffeine - should be no more than a third of total daily fluid intake
3. Lose weight if BMI \>30
4. Stop smoking
5. Avoid carbonated drinks
6. Treat chronic constipation and chronic cough
75
Why is it important not to over-restrict fluids in incontinence?
this can increase the risk of bladder irritation
76
What is bladder retraining?
* involves analysis and alteration of patient's behaviour and environment to alter maladaptive voiding pattern
* aims to re-establish cortical control over voiding
* bladder diary reviewed and based on this, time interval between voids increased to achieve normal micturition pattern
77
What is the minimum period of time that bladder re-training is offered for?
6 weeks
78
What are 3 types of techniques which may be used alongside bladder retraining to aid it?
1. Distraction techniques
2. Doing something that requires concentration
3. Pelvic floor squeezes
79
What is the first-line treatment for both stress and mixed urinary incontinence?
pelvic floor muscle training by physiotherapist for at least 3 months
80
What is the minimum amount of time which physiotherapy should be tried in stress and mixed incontinence?
3 months
81
What does pelvic floor muscle training for incontinence involve?
Muscle training using pelvic floor exercises - **Kegel exercises**
repetitive voluntary contractions and relaxations of the pelvic floor muscles, to increase strength of voluntary pelvic floor muscle contraction and teach voluntary contraction of muscles before increases in abdominal presure (**counter brace**)
82
What are 2 types of techniques which can be used to enhance pelvic floor exercises for stress or mixed incontinence?
1. Biofeedback - verbal feedback on palpation or electromyogenic with electrodes
2. Cones - inserted vaginally, contractions produced to retain
83
How can biofeedback be used to enhance pelvic floor exercises for stress or mixed incontinence?
2 techniques, to allow patient to recognise strength of an appropriate contraction
* verbal feedback on digital palpation
* electromyogenic feedback from contractions using vaginal electrodes
84
How can intravaginal cones be used to enhance pelvic floor muscle exercises?
inserted for short periods to produce contractions to retain them
exercise daily with increasing weights, retaining for 10-20 min each time
85
What is the benefit of using biofeedback or cones as conservative measures for stress or mixed urinary incontinence?
no evidence it's better than pelvic floor exercises but in women who cannot actively contract pelvic floor muscles, may aid motivation and adherence to treatment
86
What class of medication is the mainstay of medical treatment for OAB/ urge incontinence?
anticholinergics
87
What are 7 examples of anticholinergic medications that can be used to treat OAB/urge incontinence?
1. **Oxybutynin** (Lyrinel XL, Ditropan, Kentera)
2. **Darifenacin** (Emselex)
3. **Tolterodine** (Detrusitol and Detrusitol XL)
4. Fesoterodine (Toviaz)
5. Solifenacin (Vesicare)
6. Trospium (Regurin XL)
7. Propiverine (Detrunorm XL)
88
In what proportion of women are anticholinergic medications effective to treat OAB and how effective are they?
50% of women, who will have up to 50% improvement
89
What are 4 examples of side effects of anticholinergic medication for OAB?
1. Dry mouth
2. Dizziness (risk of falls in elderly)
3. Nausea
4. Constipation
90
What are 4 options if a woman is taking an anticholinergic medication but it is not effective or not tolerated?
1. Change dose
2. Offer alternative anticholinergic drug
3. Administer drug transdermally
4. Mirabegron, beta-3 adrenoceptor agonist used instead
91
What is the mechanism of Mirabegron to treat OAB?
beta-3 adrenoceptor agonist, relaxes bladder and helps bladder to fill and store more urine
92
What are 3 situations when mirabegron is indicated for OAB?
when anticholinergics are
1. Contraindicated
2. Ineffective
3. Unacceptable side effects
93
What are the 2 aspects of medical management of stress urinary incontinence?
1. Vaginal topical oestrogen
2. Duloxetine
94
When should vaginal oestrogens be prescribed in urinary incontinence?
all women with UI who are **postmenopausal** and have signs of **vaginal** **atrophy**, even if they are taking a systemic hormone replacement therapy
95
What class of drug is duloxetine?
combined serotonin and noradrenaline reuptake inhibitor
96
When should duloxetine be used to treat stress urinary incontinence?
moderate to severe UI. after PFME have been tried for at least 3 months, and surgery contraindicated
97
What is the mechanism of action of duloxetine to treat stress incontinence?
* blockade of serotonin and noradrenaline reuptake in the **spinal cord** stimulates **pudendal motor neurons**, increasing **stimulation of urethral striated muscles** in the sphincter and enhancing contraction
* increases urethral closure pressure and electrical activity of the sphincter
98
What are 4 side effects of duloxetine?
1. Gastrointestinal disturbances
2. Dry mouth
3. Headache
4. Suicidal ideology
Due to increases in noradrenaline and serotonin
99
How do the types of surgery for SUI and OAB differ?
SUI usually responds to minimally invasive procedures but OAB requires major surgery with significant risks - so surgery is a last resort for OAB
100
What are 4 types of surgery recommended by NICE for SUI?
1. Mid-urethral sling (tension-free transvaginal tape)
2. Open Burch colposuspension
3. Autologous (biological) fascial sling
4. Bladder neck injections
101
What are 3 types of mid-urethral sling (MUS) as surgery for SUI?
1. Retropubic tape (tension-free vaginal tape, TVT)
2. Trans-obturator tape (trans-obturator tape iside out TVT-O/ transobturator tape outside in TOT)
3. Mini-sling - single incision tapes
102
What is mid-urethral sling surgery?
minimal access surgery that involves the passage of a small strip of tape (e.g. polypropylene mesh) through either the retropubic or obturator space, with entry or exit points at the lower abdomen or groin
103
What do the different types of mid-urethral sling surgery depend on?
depends on entry and exit wounds
104
What is the tape which is used in mid-urethral sling surgery?
artificial, non-absorbable synthetic material made of polypropylene and is microporous
105
What is the common mechanism in all types of mid-urethral sling surgery?
the tape is left under the mid-urethra (between the urethra and the vagina) without tension, being held by its serrated polypropylene edges into one or other part of the patient's connective tissue
106
How long does it take before the mid-urethral sling tape is effective?
effective frmo day 1 but takes several weeks before it is invaded by fibroblasts then connective tissue is laid down in and around the tape, making it permanently fixed to the tissues
107
What is the long term effect of a mid-urethral sling?
forms a hammock which then prevents urethral hypermoblity with increase in abdominal pressure, thus preventing leakage
108
What must a patient do following MUS surgery for stress incontinence and for how long?
Avoid any straining, heavy lifting or any other causes of increased intra-abdominal pressure for up to 10-12 weeks
109
What was the first type of mid-urethral sling to be used?
retropubic tape
110
How does the **retropubic** **tape** type of MUS work to treat stress incontinence?
tape is inserted vaginally, bypasses the bladder neck and bladder in the retropubic space and exits suprapubically
111
What is the other name for retropubic tape?
tension-free vaginal tape (TVT)
112
How does the trans-obturator tape (TVTO inside out or TOT outside in) type of MUS work to treat stress incontinence?
tape is passed through the obturator membrane on either side and out towards the adipose tissue of the thigh
113
What is 1 advantage and 1 disadvantage of the trans-obturator type of MUS?
* Adv: less risk of damage to internal organs and voiding dysfunction
* Disadv: high incidence of thigh pain
114
What is the proposed benefit of single incision aka mini-tapes (type of MUS) when introduced?
less likely to damage vessels, nerves and pelvic organs, as passage through tissues was less
115
How do single incision/mini tapes work to treat stress incontinence?
inserted through vaginal incision but then anchored into patient's tissues without exiting through the skin, hence name single incision
116
What should be done to help women who are worried about the safety of tape devices to treat stress incontinence?
offer women all the options and appropriate treatment (tape and non-tape) and appropriate PIL to make informed choices
117
What is the best approach when surgery that involves the use of a tape is contemplated for stress incontinence?
retropubic approach
118
What is an open (Burch) colposuspension?
abdominal operation (open or laparoscopic) where bladder neck and base are elevated by suturing the upper lateral vaginal walls to the iliopectineal ligaments (Cooper's ligament)
119
What is the success rate of mid-urethral sling tapes vs open colposuspension?
similar for both - 85-90%
120
What are 4 disavtanges of open colposuspension to treat stress incontinence?
higher complication rates than MUS;
1. mainly short-term morbidity with a longer hospital stay and longer recovery
2. higher voiding difficulties
3. detrusor overactivity
4. genitourinary prolapse - posterior vaginal wall
121
How commonly is open colposuspension performed to treat stress UI?
common before MUS introduced, but with recent controversies regarding use of mesh, more women opting to have open colposuspension
122
What are 2 ways that biological sling surgery can be performed?
Autologous (yourself) or allograft (someone else) material
123
How does an autologous fascial sling/ biological sling surgery work to treat stress incontinence?
strip of rectus fascia harvested from **abdominal** **wall** or **fascia** **lata** **from** **thigh**, and is placed in a sling under the bladder neck, causing urethral closure when the sling is stretched
124
What do bladder neck injections to treat stress incontinence involve?
injecting bulking agents composed of synthetic materials, bovine collagen, or autologous substances to **augment the urethral wall** at the level of the **proximal urethra** to achieve better coaptation of urethral mucosa to **increase urethral resistance to urinary flow**
125
What are 3 types of materials that can be used as bulking agents for bladder neck injections?
1. Synthetic materials
2. Bovine collagen
3. Autologous substances
126
What type of procedure are bladder neck injections i.e. day case or major?
minimally invasive, can be performed under local as day case
127
What is the success rate of bladder neck injections to treat stress incontinence?
66% - less effective than other definitive procedures
128
How often are bladder neck injections given to a patient with stress incontinence?
need to be repeated after a few months as only give temporary improvement
129
What are 3 groups of patients for whom bladder neck injections are a good treatment choice?
1. Young women who have not yet completed their family
2. Women not keen for definitive surgery
3. Older women with several comorbidities who might not be fit for anaesthetic
130
What are 9 complications associated with mid-urethral sling surgery for stress incontinence?
1. Failure to cure SUI
2. De novo OAB
3. Voiding difficulty (retropubic)
4. Urinary infection
5. Vaginal tape exposure
6. Thigh pain (transobturator)
7. Operative blood loss (retropubic)
8. Bladder injury (retropubic)
9. Urethral trauma
131
When would a patient be offered surgery for OAB?
if medical treatment fails
132
What are 3 types of surgical procedures for overactive bladder?
1. Intravesical Botox (botulinum toxin type A)
2. Sacral nerve root stimulation
3. Extensive surgery e.g. urinary diversion, detrusor myomectomy or augmentation cystoplasty
133
Why might a patient with OAB require extensive surgery?
small-capacity neurogenic bladder
134
What are 3 types of more extensive surgery that might be needed for patients with small capacity neurogenic bladder?
1. Urinary diversion
2. Detrusor myomectomy
3. Augmentation cystoplasty
135
What is the treatment for voiding difficult irrespective of underlying cause?
Clean intermittent self-catheterisation (CISC) or an indwelling catheter (urethral or suprapubic) in women unable to perform CISC
136
What is the treatment of genitourinary fistulae?
use **indwelling** catheterisation; if fails to close fistula, surgical correction will be required
