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. 2016 Jan 20;2016(1):CD002117.
doi: 10.1002/14651858.CD002117.pub2.

Tricyclic and related drugs for nocturnal enuresis in children

Patrina H Y Caldwell  1 , Premala Sureshkumar, Wicky C F Wong
Affiliations

Tricyclic and related drugs for nocturnal enuresis in children

Patrina H Y Caldwell et al. Cochrane Database Syst Rev. .

Abstract

Background: Enuresis (bedwetting) affects up to 20% of five year-olds and 2% of adults. Although spontaneous remission often occurs, the social, emotional and psychological costs can be great. Tricyclics have been used to treat enuresis since the 1960s.

Objectives: To assess the effects of tricyclic and related drugs compared with other interventions for treating children with enuresis.

Search methods: We searched the Cochrane Incontinence Group Specialised Trials Register (containing trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings), on 30 November 2015, and reference lists of relevant articles.

Selection criteria: We included all randomised and quasi-randomised trials comparing a tricyclic or related drug with another intervention for treating enuresis. We also included combination therapies that included tricyclics. We excluded trials for treating daytime wetting.

Data collection and analysis: Two review authors independently assessed the quality of the eligible trials, and extracted data. We settled differences by discussion with a third review author.

Main results: Sixty-four trials met the inclusion criteria, involving 4071 children. The quality of many trials was poor, with comparisons addressed by single studies. Minor adverse effects were common, and reported in 30 trials. These included dizziness, headache, mood changes, gastrointestinal discomforts and neutropenia. More serious side-effects can occur but were not reported. Seven trials reported no adverse effects.Tricyclics are more effective than placebo, particularly for short-term outcomes. Compared to placebo, imipramine resulted in one fewer wet nights per week (mean difference (MD) -0.95, 95% confidence interval (CI) -1.40 to -0.50; 4 trials, 347 children), with fewer failing to achieve 14 consecutive dry nights (78% versus 95% for placebo, RR 0.74, 95% CI 0.61 to 0.90; 12 trials, 831 children). Amitriptyline and desipramine were more effective than placebo, but nortriptyline and mianserin showed no difference. Most tricyclics did not have a sustained effect after ceasing treatment, with 96% wetting at follow-up for imipramine versus 97% for placebo.Imipramine combined with oxybutynin is also more effective than placebo, with 33% failing to achieve 14 consecutive dry nights at the end of treatment versus 78% for placebo (RR 0.43, 95% CI 0.23 to 0.78; 1 trial, 47 children) and 45% wetting at follow-up versus 79% for placebo (RR 0.58, 95% CI 0.34 to 0.99; 1 trial, 36 children).There was insufficient evidence to judge the effect between different doses of tricyclics, and between different tricyclics. Treatment outcomes between tricyclic and desmopressin were similar, but were mixed when tricyclic was compared with an anticholinergic. However, when imipramine was compared with desmopressin plus oxybutynin (1 trial, 45 children), the combination therapy was more effective, with one fewer wet nights per week (MD 1.07, 95% CI 0.06 to 2.08) and 36% failing to achieve 14 consecutive dry nights versus 87% for imipramine (RR 2.39, 95% CI 1.35 to 4.25). Tricyclics were also more effective or showed no difference in response when compared to other drugs which are no longer used for enuresis.Tricyclics were less effective than alarms. Although there was no difference in the number of wet nights, 67% failed to achieve 14 consecutive dry nights for imipramine versus only 17% for alarms (RR 4.00, 95% CI 1.06 to 15.08; 1 trial, 24 children). Alarm therapy also had a more sustained effect after ceasing treatment with 100% on imipramine versus 58% on alarms wetting at follow-up (RR 1.67, 95% CI 1.03 to 2.69; 1 trial, 24 children).Imipramine was more effective than simple behavioural therapies during treatment, with one fewer wet nights per week compared with star chart plus placebo (MD -0.80, 95% CI -1.33 to -0.27; 1 trial, 250 children). At follow-up 40% were wet with imipramine versus 80% with fluids and avoiding punishment (RR 0.50, 95% CI 0.28 to 0.89; 1 trial, 40 children). However, imipramine was less effective than complex behavioural therapies, with 61% failing to achieve 14 consecutive dry nights for imipramine versus 33% for the three-step programme (RR 1.83, 95% CI 1.08 to 3.12; 1 trial, 72 children) and 16% for the three-step programme combined with motivational therapy and computer-led education (RR 3.91, 95% CI 2.30 to 6.66; 1 trial, 132 children) at the end of treatment, with similar results at follow-up.Tricyclics were more effective than restricted diet, with 99% failing to achieve 14 consecutive dry nights versus 84% for imipramine (RR 0.84, 95% CI 0.75 to 0.93; 1 trial, 147 children).There was insufficient evidence to judge the effect of tricyclics compared to the other miscellaneous interventions studied.At the end of treatment there were about two fewer wet nights for imipramine plus oxybutynin compared with imipramine monotherapy (MD -2.10, 95% CI -2.99 to -1.21; 1 trial, 63 children) and 48% on imipramine plus oxybutynin failed to achieve 14 consecutive dry nights compared with 74% on imipramine monotherapy (RR 0.68, 95% CI 0.50 to 0.92; 2 trials, 101 children). At follow-up, 45% on imipramine plus oxybutynin were wetting versus 83% on imipramine monotherapy (RR 0.55, 95% CI 0.32 to 0.92; 1 trial, 36 children).When imipramine combined with desmopressin was compared with imipramine monotherapy, there was no difference in outcomes. However, when imipramine plus desmopressin was compared with desmopressin monotherapy, the combination was more effective, with 15% not achieving 14 consecutive dry nights at the end of treatment for imipramine plus desmopressin versus 40% for desmopressin monotherapy (RR 0.38, 95% CI 0.17 to 0.83; 1 trial, 86 children). Tricyclics combined with alarm therapy were not more effective than alarm monotherapy, alarm combined with desmopressin or alarm combined with nortriptyline. The addition of a tricyclic to other behavioural therapies did not alter treatment response.

Authors' conclusions: There was evidence that tricyclics are effective at reducing the number of wet nights during treatment, but do not have a sustained effect after treatment stops, with most children relapsing. In contrast, there was evidence that alarm therapy has better short- and long-term outcomes. There was some evidence that tricyclics combined with anticholinergics may be more effective that tricyclic monotherapy.

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Conflict of interest statement

Patrina HY Caldwell has a non‐personal indirect financial conflict of interest. She invented an enuresis alarm in year 2009. The Children's Hospital at Westmead and the University of Sydney jointly own the patent and rights, and have sole control and benefits from any income if it were to successfully commercialise. PC will not benefit financially. Commercialisation is not assured.

Premala Sureshkumar ‐ none known

Wicky CF Wong ‐ none known

Figures

1
1
PRISMA study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Funnel plot of comparison: 1 TRICYCLIC DRUG vs PLACEBO, outcome: 1.3 Number not achieving 14 consecutive dry nights at the end of treatment.
1.1
1.1. Analysis
Comparison 1 TRICYCLIC DRUG vs PLACEBO, Outcome 1 Number of wet nights per week at the end of treatment.
1.3
1.3. Analysis
Comparison 1 TRICYCLIC DRUG vs PLACEBO, Outcome 3 Number not achieving 14 consecutive dry nights at the end of treatment.
1.4
1.4. Analysis
Comparison 1 TRICYCLIC DRUG vs PLACEBO, Outcome 4 Number of wet nights per week at follow‐up.
1.6
1.6. Analysis
Comparison 1 TRICYCLIC DRUG vs PLACEBO, Outcome 6 Number not achieving 14 consecutive dry nights or relapsing at follow‐up.
3.1
3.1. Analysis
Comparison 3 DRUG‐DRUG COMPARISONS, Outcome 1 Number of wet nights per week at the end of treatment.
3.3
3.3. Analysis
Comparison 3 DRUG‐DRUG COMPARISONS, Outcome 3 Number not achieving 14 consecutive dry nights at the end of treatment.
3.4
3.4. Analysis
Comparison 3 DRUG‐DRUG COMPARISONS, Outcome 4 Number of wet nights per week at follow‐up.
3.5
3.5. Analysis
Comparison 3 DRUG‐DRUG COMPARISONS, Outcome 5 Number not achieving 14 consecutive dry nights or relapsing at follow‐up.
4.1
4.1. Analysis
Comparison 4 DRUGS vs BEHAVIOURAL INTERVENTIONS, Outcome 1 Number of wet nights per week at the end of treatment.
4.3
4.3. Analysis
Comparison 4 DRUGS vs BEHAVIOURAL INTERVENTIONS, Outcome 3 Number not achieving 14 consecutive dry nights at the end of treatment.
4.5
4.5. Analysis
Comparison 4 DRUGS vs BEHAVIOURAL INTERVENTIONS, Outcome 5 Number not achieving 14 consecutive dry nights or relapsing at follow‐up.
5.1
5.1. Analysis
Comparison 5 DRUGS VS COMPLEMENTARY / MISCELLANEOUS INTERVENTIONS, Outcome 1 Number not achieving 14 dry night at the end of treatment.
6.1
6.1. Analysis
Comparison 6 COMBINATION THERAPY INVOLVING TRICYCLICS VS OTHER, Outcome 1 Number of wet nights per week at the end of treatment.
6.3
6.3. Analysis
Comparison 6 COMBINATION THERAPY INVOLVING TRICYCLICS VS OTHER, Outcome 3 Number not achieving 14 consecutive dry nights at the end of treatment.
6.4
6.4. Analysis
Comparison 6 COMBINATION THERAPY INVOLVING TRICYCLICS VS OTHER, Outcome 4 Number of wet nights per week at follow‐up.
6.5
6.5. Analysis
Comparison 6 COMBINATION THERAPY INVOLVING TRICYCLICS VS OTHER, Outcome 5 Number not achieving 14 consecutive dry nights or relapsing at follow‐up.
See this image and copyright information in PMC

Update of

References

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References to studies excluded from this review

Abrams 1963 {published data only}
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Cupalova‐Naglova 1970 {published data only}
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D'Hollander 1967 {published data only}
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De Jonge 1972 {published data only}
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Dorison 1962 {published data only}
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Esperanca 1969 {published data only}
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Fisher 1963 {published data only}
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Fritz 1994 {published data only}
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Heising 1978 {published data only}
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Hicks 1964 {published data only}
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Höfler 1978 {published data only}
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Jorgensen 1980 {published data only}
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Kales 1977 {published data only}
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Kardash 1968 {published data only}
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Kelly 1974 {published data only}
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Kim 2001 {published data only}
    1. Kim KM, Kang J, Ha IS, Chung HI. Therapeutic effects of imipramine and DDAVP in the children with primary monosymptomatic nocturnal enuresis: a randomised prospective study. Neurourology and Urodynamics 2001;20(4):379‐80.
Korczyn 1979 {published data only}
    1. Korczyn AD, Kish I. The mechanism of imipramine in enuresis nocturna. Clinical and Experimental Pharmacology and Physiology 1979;6(1):31‐5. - PubMed
Kurokawa 1963 {published data only}
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Lake 1979 {published data only}
    1. Lake CR, Mikkelsen EJ, Rapoport JL, Zavadil AP 3rd, Kopin IJ. Effect of imipramine on norepinephrine and blood pressure in enuretic boys. Clinical Pharmacology and Therapeutics 1979;26(5):647‐53. - PubMed
Laybourne 1968 {published data only}
    1. Laybourne PC Jr, Roach NE, Ebbesson B, Edwards S. Double‐blind study of the use of imipramine (Tofranil) in enuresis. Psychosomatics 1968;9(5):282‐5. - PubMed
Libert 1991 {published data only}
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Manglick 1992 {published data only}
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Mariuz 1963 {published data only}
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McConaghy 1969 {published data only}
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Meadow 1982 {published data only}
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Meijer 1965 {published data only}
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Miller 1968 {published data only}
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Milner 1968 {published data only}
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Mishra 1980 {published data only}
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Monda 1995 {published data only}
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Nigam 1973 {published data only}
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Noack 1964 {published data only}
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Philpott 1970 {published data only}
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Polak 1981 {published data only}
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Rapoport 1980 {published data only}
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Rett 1968 {published data only}
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Saeedalzakerin 2000 {published data only}
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Schjetne 1970 {published data only}
    1. Schjetne OB, Uri O. Nocturnal enuresis. Treatment with an antidepressive (Tofranil) controlled by a placebo in a double‐blind trial on 28 children. Tidsskrift for Den Norse Laegeforening 1970;90(9):873‐6. - PubMed
Simeon 1981 {published data only}
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Site 1974 {published data only}
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Smith 1967 {published data only}
    1. Smith EH, Gonzalez R. Nortriptyline hydrochloride in the treatment of enuresis in mentally retarded boys. American Journal of Mental Deficiency 1967;71:825‐7.
Soulayrol 1970 {published data only}
    1. Soulayrol R, Julien D. Note on the comparative effect of 2 drugs recommended for enuresis. [French]. Revue de Neuropsychiatrie Infantile et D'Hygiene Mentale de L'Enfance 1970;18(12):933‐42. - PubMed
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    1. Steinicke O. Imipramine therapy of enuresis ‐‐ a material from Julemaerkehjemmene. Nordisk Medicin 1971;85(3):89. - PubMed
    1. Steinicke O. Imipramine treatment of enuresis. A material from Christmas Seal Homes. Acta Paediatrica Scandinavica 1971;60(2):244‐5. - PubMed
Tamburello 1971 {published data only}
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Tong 2001 {published data only}
    1. Tong ZS, Du WJ, Lu XB, Zheng. Amitriptyline in the treatment of enuresis induced by clozapine. Sichuan Mental Health 2001;14(2):92‐3.
Valentine 1968 {published data only}
    1. Valentine AA, Maxwell C. Enuresis in severely subnormal children: a clinical trial of imipramine. Journal of Mental Subnormality 1968;12(2):84‐90.
Werry 1975 {published data only}
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References to studies awaiting assessment

Cheng 2008 {published data only}
    1. Cheng K. Vitamin B12 injection on acupoints versus imipramine monotherapy in treatment of nocturnal enuresis. Guangming Journal of Chinese Medicine 2008;23(10):1552. [sr‐incont40703]
Chertin 2007 {published data only}
    1. Chertin B, Koulikov D, Abu‐Arafeh W, Mor Y, Shenfled O. Treatment of nocturnal enuresis in children with attention deficit hyperactivity disorder. Journal of Urology 2007;178(4):1744‐7. [DOI: 10.1016/j.juro.2007.03.171; sr‐incont26984] - DOI - PubMed
Cupalova‐Naglova 1968 {published data only}
    1. Cupalova‐Naglova R. Therapeutic effect of imipramine, chloridzaepoxide and placebo in enuretic children [Czech]. Activitas Nervosa Superior 1968;10(3):265‐6. [sr‐incont1636] - PubMed
GP Research Grp 1969 {published data only}
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Hoseinzadeh 1997 NEW {published data only}
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Houts 2003 {published data only}
    1. Houts AC. Behavioral treatment for enuresis. In: Kazdin AE, Weisz JR editor(s). Evidence‐based psychotherapies for children and adolescents. New York: Guilford Press, 2003:389‐406. [sr‐incont68812]
Ice 1966 {published data only}
    1. Ice JF, Daus AT, Smith R. Imipramine (Tofranil‐Geigy) in the treatment of enuresis in institutionalized adolescents. Proceedings of the 4th World Congress in Psychiatry, Madrid 1966:236‐7. [sr‐incont5750]

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References to other published versions of this review

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