Evidence-based product

selection – what

information is available

Alan Cottenden

Department Medical Physics &

Biomedical Engineering

Nikola Network Conference, Stockholm, 23 Oct 2014

Products for managing toileting, urinary

retention, UI and FI

Urinals

Toileting aids

Pads Catheters

Body-worn

urinalsFI devices

Sheaths

BagsMech. devices

Skincare &

odour products ?

Background

• Are unable to be (fully) cured.

• Are awaiting treatment.

• Can not access treatment.

• Are waiting for treatment to take effect.

• Elect not to pursue cure options.

Continence products find an essential role in enhancing the quality of life of those who:

The challenge of evidence-

based product selection

• There is a fairly extensive literature, but little hard data.

• Very few currently available products have associated published clinical evaluations (Products tend to be modified often).

• There is much published generic wisdom which applies to product categories or broad patient groups.

• International Consultation on Incontinence strategy is to capture this generic wisdom and make it accessible to practitioners.

Continence Products in the

International Consultations

ICI5 published in 2013

Adjunct website (part of ICS website) at:

http://www.continenceproductadvisor.org/

Company contacts to come….

The Bladder & Bowel Foundation

For information and advice on bladder and bowel problems:

http://www.bladderandbowelfoundation.org/

? Connect to www.continenceproductadvisor.org, giving local information for Swedes.

? Translate www.continenceproductadvisor.org into Swedish, to help Swedes.

Products for managing toileting, urinary

retention, UI and FI

Urinals

Toileting aids

Pads Catheters

Body-worn

urinalsFI devices

Sheaths

BagsMech. devices

Skincare &

odour products ?

Containment products for urinary

incontinence

Catheters

Body-worn

urinals

Sheaths

Bags

Mech. devices

?Pads

Containment products for urinary

incontinence

Catheters

Body-worn

urinals

Sheaths

Bags

Mech. devices

?Pads

Product user groups

• Females with light UI.

• Males with light UI.

• Females with moderate / heavy UI.

• Males with moderate / heavy UI.

Women, light UI, Main product categories

PadsMechanical devices

?

Women, light UI, Main product categories

PadsMechanical devices

?

Top 5 pad characteristics for lightly

incontinent women

Top 5

characteristics

(day)

% of women

(N=99)

Top 5

characteristics

(night)

% of women

(N=81)

To hold urine

without leakage 84To hold urine

without leakage 94

To contain smell 76 To stay in place 78

To stay in place 54 To contain smell 54

To be discrete 41To be comfortable

when wet 54

To be comfortable

when wet 40 To keep skin dry 48

Women, light UI, Pad categories

Disposable inserts

Menstrual pads

Washable inserts

Washable pants

?

0

20

40

60

80

100

Menstrual pad Disposable

insert

Washable

pant

Washable

insert

Ac

ce

pta

bil

ity

(%

)

Home

Out

Women, light UI: pads

Potential for mix and match

Characteristics / priorities / contexts that:

Favour use Discourage use

Disposable

Insert

• Reliable leakage prevention

is a priority (B)

• Low cost is a priority

• Discretion is a priority (B)

Disposable

ST/MP

• Low cost is a priority (B) • Incontinence is heavy LIGHT

(B)

Washable

Pants

• Low cost is a priority (B)

• The concept is acceptable /

preferred (B)

• Incontinence is light LIGHT

(B/C)

• Adequate laundry facilities are

not available (C)

• The concept is unacceptable (C)

• Carrying used pads when out is

an issue (C)

• Incontinence is heavy LIGHT

(B/C)

Washable

Inserts

• As for washable pants, but

prefer separate pad (B/C)

• As for washable pants (B/C)

Women, light UI:pads Recommendations

NB Mix and match

Women, light UI, Main product categories

PadsMechanical devices

?

Characteristics / priorities / contexts that:

Favour use Discourage use• Incontinence is predominantly stress

(C)

• Manual dexterity is good (C)

• Sound cognition (C)

• Device concept is acceptable /

preferred (C)

• Preventing leakage rather than

containing it is attractive (C)

• Incontinence has a significant urge

component (C)

• Concerns over risks of UTI are high

(intra-urethral devices) (C)

Women, light UI: mechanical devices

Recommendations

Men: light UI, Main product categories

Dribble

containers

Mechanical

devicesPads

?

Men, heavy UI: mechanical devices

Characteristics / priorities / contexts that:

Favour use Discourage use

• Highly motivated (C)

• Periodic / intermittent use (C)

• Incontinence is predominantly stress

(C)

• Device concept is acceptable (C)

• Preventing leakage rather than

containing it is attractive (C)

• Incontinence has a significant urge

element (C)

• Doubtful level of cognition (C)

• If risk of skin damage.

• If bladder sensation poor (C)

• Poor dexterity (C)

Recommendations

Characteristics / priorities / contexts that:

Favour use Discourage use

• Device concept is acceptable /

preferred (C)

• ? Other

• ?

Men, light UI: dribble containers

Recommendations

Men, light UI, Pad categories

Disposable insertDisposable leaf

Disposable pouch

Washable pants?

Characteristics / priorities / contexts that:

Favour use Discourage use

Disposable

Pouch

• Discretion is a priority (B/C)

• Male-specific product needed (C)

• Penis is retracted (C)

• Incontinence is heavy LIGHT (B/C)

Disposable

Leaf *

• In general (B/C)

Disposable

Insert *

• Low cost is a priority (B/C)

•Male-specific product needed (C)

Washables

*

• Incontinence is light LIGHT (B/C)

• Low cost is a priority (B/C)

• Concept is acceptable / preferred

(C)

• User mobile & active (B/C)

• Inadequate laundry facilities (B/C)

• Concept is unacceptable (B/C)

• Carrying used pads when out is an

issue (B/C)

• Incontinence is heavy LIGHT (B/C)

Men, light UI:pads

Recommendations

* Appropriate whether or not penis is retracted.

Women, heavy UI, Main product categories

Indwelling catheters

Pads

?

Men, heavy UI, Main product categories

Mechanical

devices

Indwelling catheters

Pads

Body-worn

urinalsSheaths & bags

?

Men, heavy UI, Main product categories

Mechanical

devices

Indwelling catheters

Pads

Body-worn

urinalsSheaths & bags

?

Men & women, heavy UI, Pad categories

Washable productsDisposable insert

Disposable

diaper/AIODisposable T-

shaped diaper

Disposable

pull-ups

?

Preferences for different designs (community)

Men & women, heavy UI: pads

Fader et al. 2008

All-in-

one (%)

T-shape

(%)

Wash-

able (%)

Pull-up

(%)

Insert

(%)

Men 43 24 6 20 6

Women 11 11 0 61 16

Men 24 10 53 8 4

Women 8 8 11 53 22

Day

Night

Men: 49

Women: 36

Preferences for different designs (community)

Men & women, heavy UI: pads

Fader et al. 2008

All-in-

one (%)

T-shape

(%)

Wash-

able (%)

Pull-up

(%)

Insert

(%)

Men 43 24 6 20 6

Women 11 11 0 61 16

Men 24 10 53 8 4

Women 8 8 11 53 22

Day

Night

Men: 49

Women: 36

Recommendations

Characteristics / priorities / contexts that:

Favour use Discourage use

Disposable

Insert

• Carer is needed for pad change

and user can stand (B/C)

• Discretion is a priority (B/C)

• Ease of putting on is a priority (B/C)

• Female (B/C)

• Incontinence is heavy HEAVY

(B/C)

•Mobile and active (C)

Disposable

Pull-ups

• Carer is needed for pad change

and user can stand (B/C)

• Reliable containment of leakage is

a priority (B/C)

• Ease of putting on is a priority (B/C)

• Discretion is a priority (B/C)

• Female (B/C)

• Removal of clothing for pad

changing is an issue (B/C)

• Low cost is a priority (B/C)

• Night time user, with a carer

(B/C)

Men & women, heavy UI: pads

Recommendations

Characteristics / priorities / contexts that:

Favour use Discourage useDisposable

Diaper

• Incontinence is heavy HEAVY

(B/C)

• User can not stand for a pad

change (B/C)

• Male (B/C)

• Discretion is a priority (B/C)

Disposable

T-shaped

• Reliable containment of

leakage is a priority (B/C)

• Male (B/C)

Washable

Designs

• At night, if incontinence is

heavy HEAVY (B/C)

• Male (B/C)

• Adequate laundry facilities are not

available (B/C)

• The concept is unacceptable (B/C)

• Discretion and appearance is not a

priority (B/C)

Men & women, heavy UI: pads

Men, heavy UI, Main product categories

Mechanical

devices

Indwelling catheters

Pads

Body-worn

urinalsSheaths & bags

?

Men, heavy UI: sheaths

Two piece system

Retracted penis

featuresDifferent sizes Anti-kinking

features

One piece system

With applicator

?

Characteristics / priorities / contexts that:

Favour use Discourage use• Less risk of bacteruria, recurrent UTI’s or

death than indwelling catheters (C)

• More comfortable than indwelling

catheters (C)

• Acceptable / preferred to pads (C)

• Minimal physical intervention is a priority

(C)

• Good dexterity (C)

• Sound cognition (C)

• Carrying out CIC (C)

• Local skin breakdown (C)

• Bacteruria, UTI (C)

• Carer / user unable or reluctant to

apply (C)

Sheath with integral adhesive more popular than sheath with separate adhesive.

Sheath applicators are often ineffective and unpopular

Recommendations

Men, heavy UI: sheaths

Men, heavy UI, Main product categories

Mechanical

devices

Indwelling catheters

Pads

Body-worn

urinalsSheaths & bags

?

Men and women, heavy UI: drainage bags

Leg bags

Free-standing bags

Body worn bags?

Men and women: drainage bags

Pay attention to taps (discretion vs ease of use) and straps.

Issues

• bag sterility requirement for acute care settings - ? Requirement for

community settings

• research to provide evidence to underpin practice (bag change

frequency, use of antiseptic agents, bag position,…)

Recommendations

Men, heavy UI, Main product categories

Mechanical

devices

Indwelling catheters

Pads

Body-worn

urinalsSheaths & bags

?

Characteristics / priorities / contexts that:

Favour use Discourage use

• Desire to avoid absorbent pads (C)

• Concept acceptable/preferred (C)

• Mobile (not wheelchair user) (C)

• Latex / materials allergy (C)

• ? Recurrent skin problems

Men, heavy UI: bodyworn urinals

Recommendations

A trial of male urinary devices for intractable

incontinence after treatment for prostate cancer

(University of Southampton & Prostate Cancer Charity)

• Randomized crossover trial, 80 men (56 completed)

• Try out each design for three weeks

• Inclusion criteria: Hx prostate cancer followed by urinary

incontinence ≥12 months

• Exclusion criteria: latex sensitivity, faecal incontinence

requiring pads

Sheath ClampBody-worn urinal

Urinary drainage sheath (sheaths)

Body-worn urinals (BWU)

Penile compression device (clamp)

Cunningham clamp

Men’s overall opinion rating for day use

N = 53-56

Men’s overall opinion rating for night use

Men’s product combination preferences 3m after trial (day use)

Pad * * * * * * 91

Sheath * * * * * 36

BWU * * * 11

Clamp * * * * 33

% Men > 36 18 16 11 7 6 2 2 2 ^ % any

1 product: 42%

2 products: 45% N = 55

3 products: 13%

? Connect to www.continenceproductadvisor.org, giving local information for Swedes.

? Translate www.continenceproductadvisor.org into Swedish, to help Swedes.

Evidence-based product

selection – what

information is available

Alan Cottenden

Department Medical Physics &

Biomedical Engineering

Nikola Network Conference, Stockholm, 23 Oct 2014