Question 11What is the clinical and cost effectiveness of dry bed training for children and young people under 19 years old who have nocturnal enuresis?

Grading:1+Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias
Reference number 360Study TypeRandomised Controlled TrialRID: 445
Bennett GA;Walkden VJ;Curtis RH;Burns LE;Rees. J.;Gosling JA;
Pad-and-buzzer training, dry-bed training, and stop-start training in the treatment of primary nocturnal enuresis
198513pgs 309 19
Number of subjects40 in total, 18 in group A, 23 in group B and 20 in group C and 12 in group D
Inclusion/Exclusion Criteria:Inclusion: primary NE, not dry for more than 4 weeks, at least 6 wet night during 14 night baseline, negligilbe day time wetting
Exclusion: encopresis, previous behavioural intervention, gross psychopathology
Characteristics of subjects or envirmonment/prognostic factor63% were boys, the mean age was 8.5 (3.2 SD) years, the age range was 5–12 years
Recruitment:Referred from GP
Setting:At home, Rochdale UK
Interventions/Test/Factor being investigatedGroup A: alarm (pad and buzzer)
Group B: stop-start training (sphincter muscle exercises)
Group C: DBT with alarm
Group D: Control group - waiting list were given star chart after first dry night
ComparitorsBetween treatment groups
Length of Study/Follow-up0 months
Outcome measures studies14 consecutive dry nights, mean wet nights at end of treatment, drop out
ResultsDry bed training included: waking schedule, retention control training, positive practice and cleanliness training
Stop start training was sphincter muscle exercises
12 weeks treatment
Results:
Dry for 14 consecutive nights:
In group A (alarm) 4 out of 9 children, became dry for 14 nights compared to 2 out of 12 in group B (stop start training), 5 out of 10 children, in group C (DBT with alarm) and 0 out of 9 children, in group D (control).
Drop out:
32 children in total dropped out. In group A (alarm) 9 children, dropped out compared to 11 children in group B (stop start training) 10 children in group C (DBT with alarm) and 3 children in group D (control). All drop outs were after the first assessment before treatment was started
Mean number of wet nights:
The mean number of wet nights per week at end of treatment for the alarm group was 1 (SD 1.95) compared to 3.25 (SD 3.55) in the stop start training group, 1.4 (SD 4.65) for the dry bed training group and 5.15 (SD 1.5) for the no treatment alarm group.
FundingNone reported
Does the study answer the question?Both alarm alone and DBT with alarm gave good results for achieving 14 dry nights (44% and 50%) and were moer effective than the stop start training and no treatment. There was no significant difference in the number of drop outs in each group
Effect due to factor in study?Yes (NB there is a 15% spontaneous cure rate)
Consistency of results with other studies?Similar results with other studies
How directly applicable to population of the guideline?Yes the age range was 5–12 years old
Internal ValidityThere is a high drop out rate, unclear allocation concealment
Reference number 1754Study TypeRandomised Controlled TrialRID: 391
Bollard J;Nettelbeck T;Roxbee L;
Dry-bed training for childhood bedwetting: a comparison of group with individually administered parent instruction
198220Behav Res Therpgs 209 217
Number of subjects30 in total: 10 in each group (Group A: DBT with alarm, Group B: DBT without alarm, and Group C: Waiting list)
Inclusion/Exclusion Criteria:Inclusion: wet at least 1 night a week, no underlying pathology, and no current treatment.
Exclusion: organic causes of NE.
Characteristics of subjects or envirmonment/prognostic factor18 were male. In group A (DBT and alarm) the mean age was 8 years and 5 months, the mean baseline wetting was 4.9 nights per week. In group B (DBT without alarm) the mean age was 9 years and 4 months, the mean baseline wetting was 5.0 nights per week. In group C (waiting list) the mean age was 9 years and 5 months, the mean baseline wetting was 5.3 nights per week.
Recruitment:Selected from outpatients list, Adelaide Children's Hospital, Australia.
Setting:Outpatients, Adelaide Children's Hospital.
Interventions/Test/Factor being investigatedGroup A: DBT with alarm
Group B: DBT without alarm
Group C: Waiting list
ComparitorsBetween treatment groups.
Length of Study/Follow-up3 months of follow up.
Outcome measures studiesNumber of children achieving 14 consecutive dry nights, mean number of wet nights per week in the last week of treatment, and number of children relapsing or failed.
ResultsResults from Cochrane review, presented in graphs in paper.
Dry bed training included: waking schedule, retention control training, positive practice and cleanliness training and weekly meetings for parents and children.
Treatment was until 14 consecutive dry nights were achieved or 8 weeks.
14 consecutive dry nights:
In Group A (DBT with alarm) 9 out of 10 children achieved 14 consecutive dry nights compared to 2 out of 10 in Group B (DBT without alarm) and 0 out of 10 in Group C (waiting list).
Mean number of wet nights per week in the last week of treatment:
In Group A (DBT with alarm) the mean number of wet nights was 0.2 compared to 3.25 in Group B (DBT without alarm) and 5.3 in Group C (waiting list).
Number of children relapsing or failed:
In Group A (DBT with alarm) 3 out of 10 children relapsed compared to 4 out of 10 in Group B (DBT without alarm) and there were no results for Group C (waiting list).
Funding
Does the study answer the question?The study shows children treated with DTB and alarm were more likely to achieve 14 consecutive dry nights and have fewer wet nights compared to children treated with DBT without alarm or no treatment.
Effect due to factor in study?Yes.
Consistency of results with other studies?Similar results with other studies comparing DBT without an alarm to a control group.
How directly applicable to population of the guideline?Children had mean ages of 8 years and 5 months to 9 years and 5 months.
Internal ValidityResults presented from Cochrane as presented in graph in paper. Unclear allocation concealment.
Reference number 54Study TypeRandomised Controlled TrialRID: 450
Nawaz S;Griffiths P;Tappin D;
Parent-administered modified dry-bed training for childhood nocturnal enuresis: Evidence for superiority over urine-alarm conditioning when delivery factors are controlled
200217Behavioral Interventionspgs 247 260
Number of subjects36 in total, 12 in each group
Inclusion/Exclusion Criteria:Inclusion: functional NE defined in DSM-IV (aged over 5 years, wet at least 2 times a week for 3 months, NE not due to primary medical or physiological pathology), aged between 7–12 years, attending a mainstream school, wetting 4 or more nights a week, no forseen domestic distruption during treatment time, readiness to be involved in trial
Exclusion: diurnal enuresis or encopresis, bedwetting secondary to organic or psychiatric disorder and those unwilling to cooperate
Characteristics of subjects or envirmonment/prognostic factorIn group A (DBT with alarm) the mean age was 9.93 years (1.81 SD), 50% were male, the mena baseline number of wet nights per week was 5.58 (1.31 SD), The mean deprivation category (0–7) was 4.67 (2.15 SD)
In group B (alarm) the mean age was 9.93 years (1.99 SD), 50% were male, the mena baseline number of wet nights per week was 5.50 (1.45 SD), The mean deprivation category (0–7) was 4.75 (1.91 SD)
In group C (control) the mean age was 9.84 years (1.84 SD), 50% were male, the mena baseline number of wet nights per week was 5.92 (1.08 SD), The mean deprivation category (0–7) was 5.75 (1.71 SD)
Recruitment:From nine health centres (GPs, GP nurses, health visitors, community paediatricians)
Setting:Scotland, UK, treatment at home
Interventions/Test/Factor being investigatedGroup A: DBT with alarm
Group B: alarm
Grou C: control group - no treatment
ComparitorsBetween groups A, B and C
Length of Study/Follow-up6 months
Outcome measures studiesdry for 14 consecutive nights, mean number of wet nights, relapse
ResultsDry bed training included: waking schedule, retention control training, positive practice and cleanliness training
Patients were treated for 16 weeks or until dry
Dry for 14 consecutive nights:
In group A (DBT with alarm) 8 out of 12 children (67%) became dry for 14 nights compared to 3 out of 12 children (25%) in group B (alarm) and 1 out of 12 children (8%) in group C (control). This difference was significant (p<0.01)
Mean number of wet nights:
The mean number of wet nights per week at the end of treatment was 0.83 (sd 1.4) for children who had DBT with an alarm; for children who had an alarm the mean number of wet nights was 3.25 (sd 2.67) and for children in the control group (waiting list) the mean number of wet nights was 5 (sd 2.26)
Relapse:
At 3 month follow up, no children had relapsed. At 6 month follow up 1 out of 4 children in group A (DBT with alarm) and 1 out of 9 children in group B (alarm) had relapsed), both children were wetting 3 nights a week.
FundingNone reported
Does the study answer the question?The study showed that DBT with alarm was significantly more effective at achieving 14 dry nights compared to alarm alone and no treatment. The study also showed that DBT with alarm had a greater reduction in the mean number of wet nights compared to alarm alone and no treatment.
Effect due to factor in study?Yes (NB there is a 15% spontaneous cure rate assoicated with NE)
Consistency of results with other studies?Similar results to other studies comparing DBT with alarm alarm to alarms and control group
How directly applicable to population of the guideline?The age range was 7–12 years
Internal ValidityUnclear allocation concealment
Grading:1−Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias*
Reference number 371Study TypeRandomised Controlled TrialRID: 446
Bollard J;Nettelbeck T;
A comparison of dry-bed training and standard urine-alarm conditioning treatment of childhood bedwetting
198119Behav Res Therpgs 215 226
Number of subjects120 children, 82 males and 38 females. 20 in each group
Inclusion/Exclusion Criteria:Inclusion: through medical examination, wet at least 1 night a week, no other treatment during study
Exclusion: organic causes of NE
Characteristics of subjects or envirmonment/prognostic factorIn group A (DBT with therapist in home) had a mean age of 9.3 years and 14 were male, the baseline mean number of wet nights was 5.8.
In group B (DBT with therapist in hospital) had a mean age of 8.11 years and 13 were male, the baseline mean number of wet nights was 5.2.
In group C (DBT with parents as therapist in home) had a mean age of 9.7 years and 16 were male, the baseline mean number of wet nights was 6.0.
In group D (DBT with parents as therapist in home without alarm) had a mean age of 8.6 years and 14 were male, the baseline mean number of wet nights was 5.7.
In group E (alarm) had a mean age of 8.8 years and 14 were male, the baseline mean number of wet nights was 6.0.
In group F (waiting list) had a mean age of 8.1 years and 1 were male, the baseline mean number of wet nights was 4.7.
Recruitment:Children who were outpatients of the Adelaide Children's Hospital.
Setting:Outpatient service of Adelaide Children's Hospital
Interventions/Test/Factor being investigatedGroup A: DBT with therapist in home
Group B: DBT with therapist in hospital
Group C: DBT with parents as therapist in home
Group D: DBT with parents as therapist in home without alarm
Group E: Alarm
Group F: Waiting list
ComparitorsBetween treatment groups
Length of Study/Follow-upFollowup at 3, 6 and 12 months
Outcome measures studies14 consecutive dry nights, mean number of wet nights per week at the end of week 20, relapses
ResultsDry bed training included: waking schedule, retention control training, positive practice and cleanliness training
Treatment was until patient achieved 14 consecutive dry nights or for 20 weeks
14 consecutive dry nights:
In group A (DBT with therapist in home) 20 out of 20 achieved 14 consecutive dry nights compared to 20 out of 20 in group B (DBT with therapist in hospital), 20 out of 20 in group C (DBT with parents as therapist in home), 5 out of 20 in group D (DBT with parents as therapist in home without alarm), 16 out of 20 in group E (alarm) and 2 out of 20 in group F (waiting list).
Mean number of wet nights per week at the end of week 20:
In group A (DBT with therapist in home) the mean number of wet nights was 0 compared to 0 in group B (DBT with therapist in hospital), 0 in group C (DBT with parents as therapist in home), 3.8 in group D (DBT with parents as therapist in home without alarm), 0.6 in group E (alarm) and 4.4 in group F (waiting list).
Number of children who relapsed:
In group A (DBT with therapist in home) 5 out of 20 relapsed compared to 6 out of 20 in group B (DBT with therapist in hospital), 4 out of 20 in group C (DBT with parents as therapist in home), 2 out of 5 in group D (DBT with parents as therapist in home without alarm), 6 out of 16 in group E (alarm) and 2 out of 2 in group F (waiting list).
Fundingresearch undertaken as part requirement for the degree of doctor of philosophy.
Does the study answer the question?Study showed children treated wtith DBT and an alarm were more likely to achieve 14 consecutive dry nights and have fewer wet nights compared to children treated with DBT and no alarm, alarm or no treatment.
Effect due to factor in study?Yes
Consistency of results with other studies?Similar results with other studies comparing DBT with an alarm to an alarm and control groups
How directly applicable to population of the guideline?Children had mean ages from 8.1 to 9.7
Internal ValidityNo Blinding, unclear allocation concealment
Reference number 467Study TypeRandomised Controlled TrialRID: 451
Keating JCJ;Butz RA;Burke E;Heimberg RG;
Dry bed training without a urine alarm: lack of effect of setting and therapist contact with child
198314pgs 109 115
Number of subjects30 in total, 7 in group A (DBT with hospital training for parents and child), 9 in group B (DBT with home training for parent and child), 7 in group C (DBT with hospital training for parents), 7 in group D (waiting list)
Inclusion/Exclusion Criteria:Include: diurnally continent, child must be able to follow intructions, wet at least 50% of nights
Exclude: organic causes of Ne, day time wetting
Characteristics of subjects or envirmonment/prognostic factorThe mean age is 8.1 years, the age range was 4 to 14 years. Children were wet at least 50% of nights
Recruitment:Newspaper adverts, referred from friends, peadiatric urologist, psychologist
Setting:Hospital or home, Albany, USA
Interventions/Test/Factor being investigatedGroup A: DBT (no alarm) with hospital training for parents and child; 7 children
Group B: DBT (no alarm) with home training for parent and child; 9 children
Group C: DBT (no alarm) with hospital training for parents; 7 children
Group D: waiting list; 7 children
ComparitorsBetween treatment groups
Length of Study/Follow-up5 months follow up
Outcome measures studiesnumber of children who achieved 14 consecutive dry nights, mean number of wet nights in the final week of treatment, number of children who relapsed.
ResultsDry bed training included: waking schedule, retention control training, positive practice and cleanliness training
Data taken from Cochrane as presented in graphical form in paper
5 weeks of treatment
14 consecutive dry nights:
In group A (DBT (no alarm) with hospital training for parents and child) 7 out of 7 children achieved 14 consecutive dry nights compared to 5 out of 9 in group B (DBT (no alarm) with home training for parent and child) and 6 out of 7 in group C (DBT (no alarm) with hospital training for parents). No results for group D (waiting list).
Mean number of wet nights in final week of treatment:
In group A (DBT (no alarm) with hospital training for parents and child) children had a mean number of wet nights of 2.7 compared to 2.5 in group B (DBT (no alarm) with home training for parent and child), 1.9 in group C (DBT (no alarm) with hospital training for parents) and 2 in group D (waiting list).
Relapse:
In group A (DBT (no alarm) with hospital training for parents and child) 2 out of 7 children relapsed compared to 2 out of 5 in group B (DBT (no alarm) with home training for parent and child) and 2 out of 6 in group C (DBT (no alarm) with hospital training for parents). No results for group D (waiting list).
Funding
Does the study answer the question?Study shows children treated with dry bed training where training is given in a hospital were more likely to achieve 14 conseuctive dry nights compared to no treatment or training at home. Children who had DBT where only parents had training in a hosptial had fewer wet nights per week at the end of treatment compared to other dry bed training or no treatment.
Effect due to factor in study?Yes
Consistency of results with other studies?Study shows similar results to other studies comparing DBT with an alarm and DBT without an alarm nad waiting list group
How directly applicable to population of the guideline?Children had an age range of 4 to 14 years
Internal ValidityNo blinding, unclear allocation concealment

From: Appendix C, Clinical Evidence Extractions

Cover of Nocturnal Enuresis
Nocturnal Enuresis: The Management of Bedwetting in Children and Young People.
NICE Clinical Guidelines, No. 111.
National Clinical Guideline Centre (UK).
Copyright © 2010, National Clinical Guideline Centre.

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