Ramsey Coote In Instruments Bell and Pad System Overview Some - - PowerPoint PPT Presentation

Ramsey Coote In Instruments

Bell and Pad System

Overview

• Some History– Bell & Pad
• RCI Research
• RCI Approach – include Validation
• f Cleaning Bed-pad
• Conclusion & Questions

Ramsey Coote In Instruments Background

• Established in 1956 – over 60 years old
• Manufactured & Developed in Australia
• Leading practitioner based treatment in ANZ
• Since then have had many innovations
• Voucher Grant from Victorian State Government to assist Research project

2012

• TGA approved - Class One Device ARTG No:164989
• FDA approved late 2010, CE Mark 2014
• Attended The Simon Foundation Engineering Challenge April 2013- First Prize

for Abstract of interim results

• Presentation of interim results at 2014 CFA/ICCS meeting in Cairns, 2016 Kyoto,

2016 ERIC UK –won scientific prize in Kyoto and top 3 presentation at ERIC

• Publication in Journal of Pediatrics Feb 2018, 211-216 Apos Et al.
• Here to collaborate with practitioners and sell Ramsey Coote Systems to help

children become dry at night

The bir irth of f Bell and Pad

• First reported in 1904 by a

German physician Pfaundler

• Earliest patent recorded in

1905

• 1938 Prof Mowrer (Harvard

University) and his wife developed the first “elegant” bedwetting alarm which consisted of a bell and mat and was run on a simple battery

• Early design of the pad caused

patients to develop rashes on buttocks and thighs, in severe cases ulceration from contact with the pad.

Meanwhile back in in Australia some years la later.. ....

• The Bell and Pad was first developed by Peter Coote in 1952-4

(His wife was a nurse and her maiden name Ramsey) They had a family of 4 children all with bed wetting!! Didn’t like design of international products so worked on redesigning and innovating the bell and pad

• Further innovated by Gordon Marshall to the current Ramsey

Coote – around 20 versions (K models to PB models).

• Ramsey Coote Bed Pad was very different from the other bed

pads and was adopted locally by practitioners

• Used extensively by Aus and NZ practitioners but not much
• verseas.

Bell and Pad alarms elsewhere UK etc …..

• In the UK, in the 70’s and 80’s a variety of bell and pad

alarms available; most randomized controlled studies carried out using these alarms1

• Efficacy (success = less than 4 wet nights in a 28 day period)
• f 9 UK bell and pad alarms said to be comparable (~50%

effective) but the bed pads and battery were not long lasting1.

• 1. Goel KM, Thomson RB, Gibb EM, McAinsh TF. Evaluation of nine different types of enuresis
• alarms. Arch Dis Child 1984;59: 748-53.

• 1. Meadow R. Help for bedwetting. Edinburgh:Churchill Livingstone,1980.
• 2. Fordham KE, Meadow SR. Controlled trial of standard pad and bell alarm

against mini alarm for nocturnal enuresis. Arch Dis Child. 1989;64(5):651- 656.

Bell and Pad alarms elsewhere UK etc …..

Ala larm rm Th Therapy In Internatio ionall lly– not t well accepted…

• Although devices were

available in the UK, Canada and US, reports in the 60s indicated they were not widely accepted by the medical fraternity and were considered a “barbarous contraption”

• Considered “the last ditch

effort for treating bedwetting” (Werry, 1966)

• Late 80s, only 3% of US

practitioners were using alarms (Foxman et al, 1986)

Body Worn Alarms

• Early 1980s
• Considered to be a ”revolution to

the treatment of bedwetting”.

• Only one randomized controlled

study comparing the efficacy of a body worn alarm with a bell and pad (Fordham & Meadow, 1989)

• Compared the Eastleigh alarm

with Mini Dri Night

• Efficacy using both alarms over a 4

month treatment period was similar (<50%)

Fordham KE, Meadow SR. Controlled trial of standard pad and bell alarm against mini alarm for nocturnal enuresis. Arch Dis

• Child. 1989;64(5):651-656.

n = 27 n = 29

Body worn Alarms (cont’d)

• Body Worn Alarms can be purchased directly by

families usually for one treatment use

• Caldwell et al 2015 - A randomised controlled trial of a

code-word enuresis alarm

• Of the 353 participants, 176 were assigned to the

code-word alarm and 177 to control.

• At 16 weeks, 54% in the experimental group and 47%

in the control group had achieved a full response ( p=0.22)

• (full response: ≥ 14 days dry)

Rese search: Enuresis is management in in Australi lian child ildren

A retrospective review of 2861 patients treated with bell and pad alarm

Enuresis management in Australian children

Dr S Gibb Royal Children’s Hospital Melbourne RCH Ms S Whitaker Ballarat Health Service BHS Dr S Schuster & Dr E Apos Division of Health Sciences RMIT University RMIT Ms K Murphy Princess Margaret Hospital Perth PMH Dr John Golder Redlands Clinic, Brisbane Red Clinic Ms Beverley Leiper Craigieburn Community Health Service CHS Ms Linda Sullivan A Dry Bed – Private Nurse Practice ADB

• Prof. J Reece

Australian College of Applied Psychology

Study Design

• Retrospective multi-centre medical chart review
• The study was approved by 4 HREC/IRBs (Primary HREC No:

HREC/12/BHSSSJOG/111)

• 7 clinical settings
• 2 tertiary hospital outpatient clinics
• 2 community continence clinics
• a general practice
• a private continence nurse practice
• a university psychology teaching clinic

Study Design (cont’d)

Population Study Outcomes

• Healthy, developmentally normal

children (male and female) between the ages of 6 and 15 years 11 months of age who:

• Have no chronic medical

conditions,

• Have no structural or neurological

bladder disorders, and

• Have been treated for nocturnal

enuresis using the Ramsey Coote bell and pad alarm treatment system.

• Primary outcome measure:
• Time taken for children with

either primary or secondary NE to be dry for 14 consecutive nights. This measure is based on the ICCS guidelines.

• Secondary outcome measure:
• Determination of relapse rates

Results

• 72% of patients reported some

hereditary link to NE.

• Mean age at first treatment =

8.21 years. Boys slightly older than girls, but not significantly.

Results

• Only 6% of patients reported some type of co-morbidity (ADD,

autism, intellectual disability, conduct disorder).

• Very few patients reported more than one co-morbidity

Results

• Average number of days of

alarm treatment across all 3671 treatments = 62.1 days

• range 1 – 361 days
• 8.8 weeks +/- 4.4weeks

SUCCESS RATE OVER MULTIPLE TREATMENTS

• No. of Patients

with Outcome Data Treatment Success

2nd Treatment 278 80% 3rd Treatment 48 85.5% 4th Treatment 11 54.6% 5th Treatment 5

Results

SUCCESS RATE AND RELAPSE

• 77% reported successful treatment after

their first treatment

• 23% relapse rate
• Treatment time 8.8weeks +/- 4.4weeks
• Can retreat using this system

Limitations of the Study

• Retrospective so incomplete follow up with some

patients.

• Missing data from clinical records ~7% missing.
• Assumption that families would return to the same

clinic for treatment.

• More research for base line treatment is required

Take Home Mess ssages for r Treatment with ith Ramsey Coote In Instruments Bell ll and Pad system

• Very effective with no detrimental

side effects

• Worth persisting if 1st treatment not

successful

• Not associated with age
• Can be used effectively with children

with LUTs and co morbidities

Conclusions fr from Research

• The pad and bell conditioning alarm is widely used

successfully in Australia

• Large retrospective cohort study provides evidence for its

efficacy in routine clinical practice.

• Clinical guidelines will help to reduce variation in care

pathways for alarm treatment for NE

• Opportunity for international practitioners in NZ, USA, UK,

IRE and others to purchase this proven treatment

Ramsey Coote Instruments Approach

• For a successful treatment outcome the practitioner

activities include:

–Familiarisation with the alarm –Child-centered consultations –Using the alarm –Routine maintenance of alarm and bed-pad (cleaning) –Manufacturers repairs and servicing

Familiarisation of f Ramsey Coote System

• Bell Control Unit – monitors the pad to

detect the wetting by urine, the bell rings and the lights illuminate the bell’s position in the bedroom.

• The PB timer also starts counting in

seconds and minutes so will give the time it takes for the child to turn off the alarm. It is an objective outcome as the time decreases over the period

• f use of the alarm, until the child has

dry nights.

• The Bed-pad has braided nichrome wires and is the sensor

for the bell.

• The Battery charger is there to charge the batteries at least
• nce a week.
• Packaging – the box for the alarm control unit and battery

charger and cover for the bed-pad.

Familiarisation of f Ramsey Coote System

Safety Rules

▪Adult takes responsibility for charging the Alarm control unit. This can be done during the day for a period of up to 16 hours once a week. ▪The charger be kept away from the child’s bedroom. ▪The alarm will work once charged with out the charger attached. ▪These rules ensure that the Alarm has no connection to electricity supply when in use

Familiarisation of f Ramsey Coote System

• Set up of system in the child’s room. Make sure the lead is kept away so there is no

tripping hazard and the alarm unit is a meter or 3 feet away from the bed, so the child will get out of bed to switch it off

Child Centered Consultations

An Approach – important that the child is motivated ▪Treatment will teach the child to sense the full bladder during sleep ▪The teaching aid is the bell-and-pad alarm ▪Designed so that child can take away from the consultation either the alarm or the bed-pad – “empower and motivate the child” ▪Parents need to support and coach the child, especially in the first two weeks

Review of key actions for Treatment

• 1. Do a dummy run with the child. Testing the alarm with the

child, using a paper clip to close the circuit teaches the child that they will not be electrocuted.

• 2. Let the child do all the work but the parents should
• supervise. Help the child to wake to the alarm. Only the

child should switch it off.

• 3. Keep a diary each day.
• 4. Don’t restrict fluids – make sure they are hydrated

through out the day.

Harari MD Moulden A: J. Paediatr. Child Health (2000) 36, 78–81

Review of key actions for Treatment

• 5. Wear light underpants rather than pyjamas to bed. The alarm should sound as

soon as possible after the child begins to wet. If pyjamas, boxer shorts or a nightie are worn these must first absorb a considerable amount of urine before it dribbles

• n to the sensor. If the child wears only underpants then urine triggers the alarm

sooner.

• 6. Get the child to test the alarm with a paper clip each night before bed and run

through in their mind or out loud what they will do when the alarm sounds at night.

• 7. Overlearning. If dry for 2 weeks give the child a glass of water to drink before
• bed. This further challenges the bladder and makes wetting more likely giving the

alarm more of a chance to have an effect.

• 8. Praise and encouragement. A positive attitude on the part of the therapist and

parents is vital.

Harari MD Moulden A: J. Paediatr. Child Health (2000) 36, 78–81

Summary of Treatment Guideline

• Follow-up weekly for first 2-3 weeks to track how the child is

progressing and sort any issues.

• When child has 14 dry nights then they are successful but

suggest that they keep alarm and continue with overlearning.

• Overlearning can be used to help the child stay dry longer

and help minimise relapses1.

• Once they complete this time, they can return the alarm

system back to the practitioner.

• 1. Robertson B, et al., Effectiveness of an alarm intervention with overlearning for primary nocturnal

enuresis, Journal of Pediatric Urology (2013), http://dx.doi.org/10.1016/j.jpurol.2013.08.008

Cleaning Validation for bed-pad

Cleaning of Bed-pads - Validation

Introduction

• The report presents the validation of the Ramsey Coote Instruments

cleaning protocol which is provided to practitioners who purchase Ramsey Coote Instruments bell and pad systems.

• The bed-pads are non-critical items as identified by AS/NZS

4187:2014 so they need to be cleaned but not sterilised.

• The protocol was tested by examining the bioburden on bed-pads

sourced from 6 individual health practices around Melbourne.

• Validation criteria were determined using FDA guidelines.

Cleaning of Bed-pads – Materials & Method

Materials

• As specified in RCI SOP
• For validation a minimum of 30 bed-pads required – a total of 34 bed-pads

were sourced.

Video on Ramsey Coote YouTube channel

Cleaning of Bed-pads - Results

0.00 0.01 0.10 1.00 10.00 100.00 1000.00 10000.00 cfu / cm2 (logaritmic scale) Ramsey Coote Instruments 2015

Microbial count in clean Ramsey Coote pads

Standards Practice A Practice B Practice C Practice D Practice E Practice F

.

Clean pads: Satisfactory range (microbial load ≤ 10 cfu/cm2)

Alert range (10 cfu/cm2 < microbial load ≤ 100 cfu/cm2)

Unsatisfactory/ unacceptable range (microbial load > 100 cfu/cm2) Figure 1: Microbial counts (cfu/cm2) obtained from RCI bed pads according to each practice investigated

Conclusions

• When practices adhere to the

RCI cleaning protocol the bed- pads pose no risk to children’s health or become a public health issue

Ramsey Coote In Instruments Thanks for the tim ime

• We collaborate with you for a successful treatment
• utcome - activities include:
• Familiarisation with the alarm
• Child-centered consultations
• Using the alarm
• Routine maintenance of alarm and bed-pad

(cleaning)

• Research will help fine tune a “Pathway to Care”
• Questions???Please contact us to help children

become dry at night We can arrange a Zoom meeting with you Email:info@ramseycoote.com.au