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Last Updated  Wednesday, 21. February 2007

Cambridge Study:

Journal of Paediatrics and Child Health

 Provisional citation Feb 2007 :Cutting DA, Pallant JF, Cutting FM. Nocturnal enuresis:
Application of evidence-based medicine in community practice. J Paed. Child Health. 43 (2007) 167–172

 Methods in Detail

Upon telephone request for a appointment information was given to parents via the telephone, clinic brochure and details mailed, and an appointment convenient to the parents was made.

The average waiting period was 2.1 weeks from booking time to appointment time. All children were seen for joint assessments and managements by the paediatrician (Dr D.A.Cutting) and the paediatric nurse. A full history was taken including that of the enuresis, day or bowel problems, information regarding age, sex, birth order and bedroom/housing situation. A general examination as well as specific examination of urogenital system was made. Investigations were generally limited to urine microscopy and culture. The paediatrician undertook an explanation regarding any historical or examination findings, a review of MNE in general and treatment options available including medication, alarm or "alternative medical" managements. The benefits or problems of each modality were discussed as well as outcome measures. The program overview was also given.

The child and parents were then reviewed jointly with the paediatrician and paediatric nurse where the salient features were reviewed, and discussion with parent and child made regarding management and choice of treatments. A decision regarding management was made as well as appropriate follow up and outcome measures. A high priority was given to gaining the child's confidence, maintaining rapport with the child and the use of many techniques of fun and humour. Apportioning age appropriate responsibility to the child was stressed.

The paediatric nurse spent an hour with further explanation and demystification of enuresis, education regarding body functions using diagrams and charts, and reviewed the family dynamics and sleep arrangements. The parents were recruited to help in the management of the enuresis program. The Malem (Malem Medical, Nottingham UK) body worn alarm was used either buzzer, electronic tone, or multi tone electronic alarm. Its use was explained, the alarm displayed and instructions given on its use it, its care daily check. All other managements were ceased including any medication or lifting, and the child was encouraged to have their normal drinks. A "dry run" with parent and child was undertaken with decision as to who would be responsible for which aspects of management. The child and parents were instructed that when the alarm sounded the child was to get up as quickly as possible, the child was to turn the alarm off and remove the sensor from the underwear/continence pad, to empty their bladder in the toilet, to remake the bed, reset the alarm, record the event on the charts and return to sleep. Parents were encouraged to supervise and facilitate the waking, toiletting and recording by their child. Spare batteries were supplied with the alarm with instructions on how to insert them, and same day replacement of the alarm was available for any breakdowns (breakdown rate 15%).

Contact was available during business hours with the nurse and for emergencies the paediatrician was available 24 hours a day, 7 days a week. Depending on progress and assessment of how well the child was aroused the alarm sound may have been changed to a multi tone or buzzer alarm, and for those who proved difficult to arouse with the body worn alarm the larger bell and pad alarm (Ramsay Coote Bell and Pad, Sandringham Melbourne Australia) was used (24 children - 4.8% ).

Each child was provided with a personalised bound book of instructions including educational material, a thorough explanation of alarm usage and instructions of its use, and detailed program record sheets. Sheets recorded frequency and time of wetting, size of wet, number of dry nights and any self-awakenings. The book provided contact telephone numbers during business hours and for emergency. Bladder exercises (retention control training) was also undertaken providing greater focus on bladder.

Overlearning of 250-500 mls at night was given to all children between March 1997 and December 2000 after they had achieved 14 dry nights with instructions to cease should there be two or more wet nights. This was ceased in December 2000 largely due to lack of acceptability and compliance.

The Australian Federal Government funded health rebate system (Medicare) provides a rebate of part of medical costs. Average out of pocket expense ran to approximately $100-150 Australian dollars per program. DDAVP (10 mcgs per actuation, 50 actuations), is available by government subsidy at a cost of AUD $21.90 (April 2002) for 1 bottle of 50 10mcg actuations, providing the child "is over 6 years and has failed to respond to an enuresis alarm".

Children were initially followed up by telephone call to the parents the day after commencing management, and subsequently every 2-3 weeks by visits to the clinic. Reviews included review of progress and continued supervision of parents and child regarding alarm use. Records were reviewed and a substantial amount of encouragement and support given re management and to the child. Various games and rewards are utilised. The children are sent a letter or e-mail subsequent to the visit reinforcing what had been said and continuing encouragement. A system of birthday and Christmas cards are also utilised.

With poor progress or failure, investigations including renal ultrasound and post micturition bladder ultrasound may have been performed. Children were discharged after 14 consecutive dry nights, or after repeated failures to attend or drop out. At discharge follow up arrangements were made should there have been any further difficulties, relapse was discussed and the parents were encouraged to call should there be a return of wetting.

At 6 and 24 months letters were sent to the parents requesting information as to whether the child is had remained continuously dry during the period, or whether there has been any relapse as defined in the preceding period. At what stage the child relapsed was also requested. Those who did not reply were contacted personally by the paediatrician by telephone.

Patient demographics, diagnostic classifications including nocturnal or diurnal enuresis and an assessment of the severity of the enuresis, constipation, and encopresis information was recorded. Prior alarm treatments and the initial managements was recorded. At discharge outcomes, failures, and drop outs were recorded, as well as duration of treatment. At 6 and 24 months outcome was recorded, whether dry, relapsed or partially dry and the time of relapse. Those who had dropped out were not followed up and once a relapse had been recorded no further formal follow up was made unless parents voluntarily returned for further management.

Results-  March 1997 - April 2002

Overview
Results In Detail

Overview

 

Results In Detail

Preliminary analyses were conducted to determine the overall success rate of treatment. These are summarized in Figure 1. Of the 505 patients commencing treatment, 399 (79%) achieved dryness (intention to treat), (defined as dry for 14 consecutive nights). Of the 106 patients who did not achieve total dryness 65 (61.3%) improved (reduced number of wet nights). Only 41 patients did not improve as a result of treatment.  The number of weeks taken to achieve dryness ranged from 3.1 to 35 weeks (mean=10.43, SD=6.0, Median=8.7), (includes one week of overlearning).

 

 
To determine relapse rates, patients who achieved dryness were followed up at both 6
months and 24 months post discharge.  368 patients reached 6 months after initial success.  Outcome data was obtained on all 368 (100%).  270 (73.4%) reported that they had remained dry with 98 (26.6%) relapsing.  266 patients reached 24 months after initial success. Outcome data was obtained 264 (99%).  171 of the 266 (64.3%) patients had remained dry, with 95 (35.7%) experiencing a relapse.
 

Exploration of factors affecting outcome


Previous research has suggested that there are a number of factors that may affect the success of treatment. Three factors were addressed in this study: gender, age of child, and initial severity of the problem.

Gender


There was a gender imbalance in patients presenting for treatment with the sample containing 65.1% males and 34.9% females. There was however no significant gender difference in the severity of presenting symptoms (in terms of percent wet nights) with 86.3% of males and 81.8% of females being classified as severe (6 or 7 wet nights per week)[X2=1.47, df=1, N=505, p=.23].


Initial success rates (dry/ not dry) were compared for males and females using Chi square test of independence with Yates Correction for Continuity. There was a statistically significant gender difference, with 74.8% of males and 86.9% of females achieving dryness [X2= 9.5, df=1, N=505, p=.002].


Gender differences in the overall success rate and the time taken to achieve dryness were explored using a Kaplan Meier Survival Analysis (see Figure 1). The log rank test revealed a significant gender difference (log rank =30.63, df=1, p<.0005). The average time taken to achieve dryness (adjusted for censored cases) in weeks for males was 14.78 (std error=.58, 95% CI 13.64, 15.93) with a median of 10.90 (std error=.42, 95% CI 10.08, 11.72). For females the average adjusted time in weeks was 10.35 (std error=.57, 95% CI 9.24, 11.47) with a median of 7.70  (std error=.61, 95% CI 6.51, 8.89).

 

Figure 1: Gender differences in weeks taken to achieve dryness 


Gender differences in relapse rates were considered at both 6-month and 24-month follow-
ups (see Table 1). There was no significant difference in the relapse rates at 6 months for males and females [ X2=.031, df=1, n=368, p=.86] or in the relapse rate at 24 months [X2=1.74, df=1, n=266, p=.19].

Table 1: Impact of Gender on relapse rates at 6 months and 24 months

 

6 month follow up

24 month followup

 

 

Dry

Not dry

Dry

Not dry

 

Males

169 (72.8%)

63 (27.2%)

116 (67.4%)

56 (32.6%)

 

Females

101 (74.3%)

35 (25.7%)

55 (58.5%)

39 (41.5%)


Age of Child

Children were divided into categories according to their age (under 6, 6.1 to 7, 7.1 to 8, 8.1 to 9, 9.1 to 10, 10.1+yrs). Comparison of pre-treatment severity for each age group using a Chi Square test of Independence revealed a significant result [X2=29.19, df=5, N=505, p<.0005] with the younger age groups recording high percentages of severe cases (6,7 wet nights per week).  (Table 2) 

Table 2: Age differences in initial severity 

Age group (yrs)

More severe
(6,7 wet nights per week)

Less severe
(5 or less nights per week)

 

6 or less

98 (93.3%)

7 (6.7%)

 

6.1 to 7

106 (89.8%)

12 (10.2%)

 

7.1 to 8

63 (87.5%)

9 (12.5%)

 

8.1 to 9

65 (85.5%)

11 (14.5%)

 

9.1 to 10

34 (65.4%)

18 (34.6%)

 

10.1 +

62(75.6%)

20 (24.4%)


The impact of the age of the child on treatment success rates (dry/ not dry) was assessed
using Chi Square Test of Independence.  Success rates (% to achieve dryness) ranged from 76.3% for children aged 8.1 to 9yrs, to 81.4% for children age 6.1 to 7yrs. There was no statistically significant effect for age (X2, =1.05, df=5, N=505, p=.96). (Table 3) 

Table 3: Impact of age group on treatment success 

Age group (yrs)

Dry

Not dry

 

6 or less

83        (79%)

22        (21%)

 

6.1 to 7

96        (81.4%)

22        (18.6%)

 

7.1 to 8

57        (79.2%)

15        (20.8%)

 

8.1 to 9

58        (76.3%)

18        (23.7%)

 

9.1 to 10

42        (80.8%)

10        (19.2%)

 

10.1 +

63        (76.8%)

19        (23.2%)


Relapse rates were also investigated for each group at the 6 month and 24 month time points. There was no significant difference in relapse rates among the age groups (see Table 4).

Table 4: Impact of age group on relapse rates at 6 months and 24 months
 

Age group (yrs)

6 month follow-up

24 month follow-up

 

 

Dry

Not dry

Dry

Not dry

 

6 or less

56 (75.7%)

18 (24.3%)

31 (58.5%)

22 (41.5%)

 

6.1 to 7

73 (82.0%)

16 (18.0%)

44 (71.0%)

18 (29.0%)

 

7.1 to 8

37 (69.8%)

16 (30.2%)

26 (65.0%)

14 (35.0%)

 

8.1 to 9

36 (65.5%)

19 (34.5%)

24 (54.5%)

20 (45.5%)

 

9.1 to 10

28 (73.7%)

10 (26.3%)

21 (75.0%)

7 (25.0%)

 

10.1 +

40 (67.8%)

19 (32.2%)

25 (64.1%)

14 (35.9%)

 

  

Severity


The impact of initial severity on success of treatment was assessed (see Table X). There was no significant difference in outcome (dry/not dry) for patients classified as more severe (6, 7 wet nights per week) or less severe (5 or less nights per week). For the more severe group 79.7% of patients achieved dryness, while 75.3% of the less severe group achieved dryness.  (Table 5) 

Table 5: Impact of initial severity on treatment outcome

 

Dry

Not dry

 

More severe
(6,7 wet nights per week)

 341 (79.7%)

87 (20.3%)

 

Less severe
(5 or less wet nights per week)

58 (75.3%)

 19 (24.7%)


A Kaplan-Meier Survival Analysis revealed no significant difference between the more
severe and less severe group in the number of weeks taken to achieve dryness.  The log rank test did not reach statistical significance (log rank =.09, df=1, p=.76). The average time taken to achieve dryness (adjusted for censored cases) in weeks for the more severe group was 13.16 (std error=.47, 95% CI 12.23, 14.09 ) with a median of 9.90 (std error=.31, 95% CI 9.29, 10.51). For the less severe group the average adjusted time in weeks was 13.53 (std error=1.14, 95% CI 11.29, 15.77 ) with a median of 9.6  (std error=1.34, 95% CI 6.97, 12.23). 

Relapse rates were also investigated for the more severe and less severe group at the 6 month and 24 month time points. There was no significant difference in relapse rates among the age groups (see Table 6).  

Table 6: Impact of severity on relapse rates at 6 months and 24 months

Severity

6 month follow-up

24 month follow-up

 

 

Dry

Not dry

Dry

Not dry

 

 

Less severe

45 (83.3%)

9 (16.7%)

30 (78.9%)

8 (21.1%)

 

More severe

225 (71.7%)

89 (28.3%)

141 (61.8%)

87 (38.2%)

 

 

 

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