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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Ghanizadeh 2012.

Methods Double‐blind, placebo controlled parallel trial
  1. Methylphenidate + nortriptyline

  2. Methylphenidate + placebo


Investigating the efficacy, tolerability, and adverse effects of nortriptyline for treating enuresis in children with ADHD.
No control/no‐intervention group
Participants Number of patients screened: 45
Number included in trial: 43
Number included in placebo group: 16
First follow‐up in placebo group: 13
Number of withdrawals in placebo group: 3
Second follow‐up in placebo group: 13
Lost to final evaluation in placebo group: 1
Final evaluation in placebo group: 12
 Diagnosis of ADHD: DSM‐IV‐TR (subtype: not stated)
Age: mean: 8.9, range: 5‐14 years old
IQ: above 70
Sex: 34 males, 9 females
Methylphenidate‐naïve: not stated
Ethnicity: not stated
Country: Iran
Comorbidity: primary enuresis (100%)
Comedication: not stated
Sociodemographics: not stated
Inclusion criteria
  1. Children diagnosed with both ADHD and primary enuresis

  2. 5‐14 years old

  3. Both genders

  4. Written consent from parents


Exclusion criteria
  1. Any major psychosocial stressors

  2. Urinary complaints

  3. Concurrent behaviour therapy for enuresis (desmopressin or carbamazepine)

  4. Enuresis alarms

  5. Concurrent behaviour therapy for enuresis

  6. Fluid‐intake restriction during the clinical trial

  7. Clinically estimated mental retardation

  8. Active medical problems such as hepatic, renal, cardiac, or pulmonary dysfunction

  9. Urinary tract infection in the last month

  10. Urinary urgency and frequency

  11. Enuresis due to an underlying condition, such as diabetes

Interventions Methylphenidate type: not stated
Methylphenidate dosage: 20 mg/day (< 30 kg), 30 mg/day (> 30 kg)
Administration schedule: not stated
Duration of intervention: 45 days
Treatment compliance: not stated
Outcomes Spontaneously reported adverse events
Systematically reported using a checklist, at baseline and 2 weeks and 4 weeks after onset of interventions, and 2 weeks after stopping the interventions
Bedwetting, parent rated, daily
Notes Sample calculation: not stated
Ethics approval: yes, Shiraz University of Medical Sciences
Funding: the author received a grant
Vested interest/authors' affiliations: not stated
 Key conclusions from study authors: nortriptyline decreases the frequency of enuresis in the children with ADHD and its effect disappears after the discontinuation of treatment
 Comments from the study authors: the sample size was relatively small and may result in type II errors. In addition, all children were diagnosed with ADHD and formed a clinical sample. Therefore, the results of this study cannot be generalised to other settings, such as a community sample. There was a predominantly higher number of boys than girls, and also it is not clear whether these results can be generalised to other age groups. In the literature there are contradictory reports about the relationship between enuresis and sociodemographic factors. Therefore, it is questionable whether the findings of this study can be applied to other cultures. This current trial was short‐term, and the children had not received an enuresis alarm or desmopressin. Therefore, they were not therapy‐resistant children.
Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: not stated
Supplemental information received through personal email correspondence with the authors in June 2014 (Ghanizadeh 2014 [pers comm])