Promoting Continence: from research to clinical practice and everything in between

1
Promoting Continencefrom research to clinical
practice and everything in between
Kathryn Getliffe PhD, MSc, RN Professor of
Nursing
2
Outline

• Why study continence / incontinence UI ?
• what are the important research questions?
• does it make a difference?
• Designing and delivering meaningful continence
  research
• design issues challenges
• influencing clinical practice
• Some examples
• studies on long-term containment strategies

3
Why study continence and/orincontinence?

• a fundamental aspect of life
• a basic element of nursing care
• a common problem, but a low priority
• high costs to individuals and services

Nurses become very experienced at dealing with
episodes of incontinence from very early on in
their careers
4
What is Urinary Incontinence?

• the complaint of any involuntary
• leakage of urine
• (International Continence Society, Abrams et al.
  2005)

incontinence is a symptom with many causes
5
Urinary incontinence is a commonproblem, which
is often under-reported

gt 200M worldwide around 5 M in UK

• Male (living at home)
• 15-64 years 3
• gt 64 years 7-10

• Female (living at home)
• 15-44 years 5 - 7
• 45-64 years 8 - 15
• gt 64 years 10 -20

gt 40 years
20
gt 40 years
9
Prevalence figures (UK) DOH 2000
Perry 2000 (Leicester MRC study)
6
Problems of Bladder Control

• failure to store
• stress incontinence
• overactive bladder (wet or dry)
• failure to empty
• outflow obstruction
• neurological damage
• functional incontinence
• transient incontinence

7
Costs of incontinence

• high costs to individuals
• urinary incontinence shatters lives (CF 2000)
• nearly 1 of the total cost of the NHS (CF 2000)
• gt 153M on pads appliances
• gt 27M drug bill (prescription cost analysis)
• staff costs, surgery etc
• can be a major contributor to other problems
• 30 increased risk of falls (Brown 2000)
• 3 increased risk of fractures (Brown 2000)
• increased demand for residential care (Thom et
  al 1997)

8
Challenges for continence research

• Complexity of problems, scope of their impact
• Research design issues rigour and reality
• Funding
• low priority unattractive, neglected area
• non-life threatening
• poor recognition of impact and costs

9
Prevalence of UI compared toobesity, diabetes,
cancer in the UK
10
Research questions and design

• Questions from clinical practice
• expert professional knowledge/experience
• patient/carer experiences and preferences
• Questions from services
• effectiveness, efficiency, costs
• cost-effectiveness
• local context and environment
• Questions from industry
• product evaluation and new product development

11
Some issues

• interventions/treatments, largely dominated by
  surgical pharmacological treatments
• RCT gold standard
• the clinical nature of UI means that efficacy
  studies rarely follow Consort Statement
  guidelines (including power analysis,
  standardised outcome measures)
• lack of robust research instruments/tools
• particularly for conservative / behavioural care
  strategies
• impact on QoL (where symptoms of UI are
  unchanged)

12
Outcome measures

• precise, standardised, meaningful definitions and
  criteria
• ideally high clinical relevance high ease of
  use
• how do you measure urgency
• how do you measure catheter-associated urinary
  tract infection?
• need to establish and reuse standardised
  instruments to allow comparisons
• long-term follow-up
• high attrition

13
Recruitment and sample size

• accessing subjects
• reluctance to come forward
• target populations, often high proportion of
  older people
• sample selection
• co-morbid conditions
• heterogeneity v highly selective
• ethical issues, e.g. cognitive impairment
• high attrition
• unwilling to be reminded of UI problem
• co-morbidities and mortality in older population

14
The Continence Paradigm
Independent Continence (never having been wet or
dry as a result of treatment)
Controlled incontinence or dependent
continence (dry with behavioural treatments,
medications or with toileting assistance
Contained incontinence (urine contained in pads
or appliances)
Incontinence wet
Fonda et al 2005
15
Two studies on long-term containment strategies

• Long-term urinary catheters (LTC)
• infection and recurrent blockage
• Absorbent products for UI efficacy and
  product design

16
Catheters and bacterial biofilms

• major source of HAI over prescription of
  antibiotics
• bacteria adhere to catheter surfaces
• reduced susceptibility to host defences and
  antimicrobial agents
• chronic asymptomatic infection
• potential to progress to
• symptomatic infection
• bacteraemia
• linked to recurrent blockage

17
Causes of catheter blockage
urine normally slightly acidic
infection with urease-producers
urine pH alkaline
urease splits urea to release ammonia
struvite and calcium phosphates precipitate
encrustation and blockage
18
Recurrent catheter encrustation blockage
19
Scanning electron micrograph of biofilm
20
Struvite crystal embedded in calcium phosphate
deposits
21
Managing recurrent blockage

• Blockers and non-blockers - pro-active care
• planned catheter change based on catheter life
• acidic catheter maintenance solutions - is there
  a role?
• Suby G (3.23 citric acid pH 4, with magnesium
  oxide)
• do they work ? laboratory studies
• how much solution?
• how often?
• how long to retain in the catheter /bladder?
• clinical evidence?

22
Model of the catheterised bladder
urine from reservoir
water circulating through outer water jacket
catheter
urine drainage
23
Cross-sections of two catheters (I and II - both
subjected to a conditions which cause
encrustation). Following instillation of an
acidic washout to one
I Suby G II No washout
24
Clinical evidence

• Not much mostly anecdotal
• but people have strong views!
• Recent RCT to compare weekly catheter flushes
  with saline or an acidic solution, with no
  flushes
• reported the mean time until catheter removal was
  very similar between groups.
• however subjects were only followed for a maximum
  of 8 weeks and the study was underpowered.
• there were considerable difficulties with
  recruitment of patients and target numbers fell
  short within each group
• (Moore et al 2007).

25
Absorbent products for UI efficacy and product
design

• Aims
• to examine how absorbent pad use impacts on the
  lives of women with incontinence
• to identify the pad characteristics which are
  most important to users, and should influence new
  product design and evaluations.
• to determine key domains for inclusion in the
  development of QOL measure for people using
  absorbent products

26
Design

• Four modules to the study
• Three clinical trials cross-over designs
• Women with light incontinence
• Adults with mod/heavy incontinence in nursing
  homes
• Adults with mod/heavy incontinence in the
  community
• 3 products of each design, order randomised, 3
  weeks
• QoL measure early development

27
Methodological issues

• product representation
• no firm evidence for product selection
• providing a control product
• products and product practice has changed over
  the last 10-15 years
• study design (RCT or multiple crossover)
• multiple comparisons
• selection of primary outcome variable
• no appropriate QoL tool

28
Absorbent products for light incontinence
29
Data collection (99 women)

• Test each product for 3 weeks
• diary and questionnaire at end of week 3
• pad weighing (sample of 10-15 pads)
• Outcome measures
• Primary - overall opinion (questionnaire)
• leakage performance (diary data)
• pad consumption (diary data)
• consumer-generated product performance items
  (questionnaire)

30
Overall performance
MP Menstrual Pad DI Disposable Insert WP
Washable pants WI Washable Insert
DI
WI
WP
MP
31
Acceptability of designs
32
Ranking exercise
33
Analysis of interview data
CONTAINING THE PROBLEM
PSYCHOLOGICAL SOCIAL FUNCTIONING
PHYSICAL IMPACT
Holding urine
Perception of self
General comfort
Hiding the problem
Inter-personal relationships
Skin health
Ease of use
Coping with incontinence
Sleep
34
Study conclusions

• Although these results were limited to women with
  light incontinence findings suggest
• One product does not fit all
• pad-users need a range of products for different
  circumstances
• day/night, home / going out
• a need for a sensitive, patient-oriented, QOL
  measure for users
• aid product selection, new product development
  and inform future evaluations
• This study was funded by the HTA

35
..from research to clinical practice

• asking the important questions
• expert professional knowledge/experience
• patient/carer experiences and preferences
• local context and environment
• pragmatic issues
• affecting research design limit clarity/impact of
  research outcomes
• imprecise outcome measures
• use established robust tools to allow comparisons
• knowledge gained from
• quantitative and qualitative research

36
does it make a difference?

• awareness of research evidence?
• research evidence does not tell practitioners how
  to adapt and apply it to individual clients or
  contexts
• the evidence-base for a decision usually
  comprises a balance between rigour, expedience
  and local contexts
• patients views

37
Your patients are as serious about their
incontinence as you are !