Sleep Architecture in Valproate-induced Nocturnal Enuresis in Primary School and Preschool Children.

NCT04191863 | Completed

• 1 other identifier: Mansoura University Hospital 8
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Our study, retrospectively evaluate the characteristics of and the risk factors for the occurrence of nocturnal enuresis in epileptic children kept on valproate monotherapy. Epileptic children with the age ranged 5 up to 15 years who were started and kept up on valproate monotherapy. In this study, a child determined to have nocturnal enuresis based on the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, fourth edition: "an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged 5 years or older, in the absence of congenital or acquired defects of the nervous system."

Conditions

Epilepsy; Nocturnal Enuresis

Keywords

Valproic acid, enuresis, epilepsy.

Outcome Measures

Primary Outcomes (1)

• Nocturnal enuresis

  Follow-up at least monthly interval for 6 month for the children kept on valproate monotherapy. The incidence of nocturnal enuresis and its frequency were reported

  6 months

Secondary Outcomes (1)

• Side effects of valproic acid

  6 month

Study Arms (2)

Children with enuresis

28 epileptic children with induced secondary nocturnal enuresis in valproate monotherapy.

Other: Clinical, EEG and laboratory assessment at presentation; Drug: Valproate

Children without enuresis

232 epileptic children without induced secondary nocturnal enuresis in valproate monotherapy.

Other: Clinical, EEG and laboratory assessment at presentation; Drug: Valproate

Interventions

Clinical, EEG and laboratory assessment at presentation OTHER

* The patients' history, clinical, demographic, and laboratory data were acquired. * The following tests and imaging studies are routinely done for epilepsy patients receiving valproate treatment and developed nocturnal enuresis, blood urea nitrogen (BUN), serum creatinine (Cr), urinary pH (before and after valproate therapy beginning and at enuresis onset), serum levels and therapeutic doses of valproate. * Urinary tract ultrasonography (with full and void bladder). * CT brain and EEG.

Children with enuresis; Children without enuresis

Valproate DRUG

valproate monotherapy

Also known as: valprioc acid

Children with enuresis; Children without enuresis

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study was conducted on 260 children with epilepsy receiving valproate monotherapy aged 5-15 years who attended the outpatient clinic of neurology departments, Mansoura University Hospital, Egypt during the period Sep 2019 to Aug 2019.

You may qualify if:

• Epileptic children kept up on valproate monotherapy and developed nocturnal enuresis.
• Age ranged 5 up to 15 years.

You may not qualify if:

• Combined therapy with other antiepileptic drugs,
• Abnormal cerebral imaging,
• Poor seizure control,
• Primary nocturnal enuresis (a child didn't accomplish any times of evening dryness -over a time of 6 successive months).
• Congenital or acquired defects of the nervous system.
• Urinary system anomalies, or
• Intellectual disability.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

Related Publications (12)

• Clayton-Smith J, Bromley R, Dean J, Journel H, Odent S, Wood A, Williams J, Cuthbert V, Hackett L, Aslam N, Malm H, James G, Westbom L, Day R, Ladusans E, Jackson A, Bruce I, Walker R, Sidhu S, Dyer C, Ashworth J, Hindley D, Diaz GA, Rawson M, Turnpenny P. Diagnosis and management of individuals with Fetal Valproate Spectrum Disorder; a consensus statement from the European Reference Network for Congenital Malformations and Intellectual Disability. Orphanet J Rare Dis. 2019 Jul 19;14(1):180. doi: 10.1186/s13023-019-1064-y.

  PMID: 31324220 BACKGROUND

• Tomson T, Battino D, Perucca E. Valproic acid after five decades of use in epilepsy: time to reconsider the indications of a time-honoured drug. Lancet Neurol. 2016 Feb;15(2):210-218. doi: 10.1016/S1474-4422(15)00314-2. Epub 2015 Dec 5.

  PMID: 26655849 BACKGROUND

• Glauser T, Shinnar S, Gloss D, Alldredge B, Arya R, Bainbridge J, Bare M, Bleck T, Dodson WE, Garrity L, Jagoda A, Lowenstein D, Pellock J, Riviello J, Sloan E, Treiman DM. Evidence-Based Guideline: Treatment of Convulsive Status Epilepticus in Children and Adults: Report of the Guideline Committee of the American Epilepsy Society. Epilepsy Curr. 2016 Jan-Feb;16(1):48-61. doi: 10.5698/1535-7597-16.1.48.

  PMID: 26900382 BACKGROUND

• Romoli M, Mazzocchetti P, D'Alonzo R, Siliquini S, Rinaldi VE, Verrotti A, Calabresi P, Costa C. Valproic Acid and Epilepsy: From Molecular Mechanisms to Clinical Evidences. Curr Neuropharmacol. 2019;17(10):926-946. doi: 10.2174/1570159X17666181227165722.

  PMID: 30592252 BACKGROUND

• Cattaneo CI, Ressico F, Valsesia R, D'Innella P, Ballabio M, Fornaro M. Sudden valproate-induced hyperammonemia managed with L-carnitine in a medically healthy bipolar patient: Essential review of the literature and case report. Medicine (Baltimore). 2017 Sep;96(39):e8117. doi: 10.1097/MD.0000000000008117.

  PMID: 28953637 BACKGROUND

• Badv R S, Abbasi A, Ashrafi M R, Shariatmadari F, Bayat O. The Effect of Sodium Valproate on Urinary Frequency and Enuresis Compared to Carbamazepine in Children with Epilepsy, Iran J Pediatr. 2018 ; 28(6):e66083. doi: 10.5812/ijp.66083.

  BACKGROUND

• Alshahrani A, Selim M, Abbas M. Prevalence of nocturnal enuresis among children in Primary Health Care Centers of Family and Community Medicine, PSMMC, Riyadh City, KSA. J Family Med Prim Care. 2018 Sep-Oct;7(5):937-941. doi: 10.4103/jfmpc.jfmpc_32_18.

  PMID: 30598936 BACKGROUND

• Hamed A, Yousf F, Hussein MM. Prevalence of nocturnal enuresis and related risk factors in school-age children in Egypt: an epidemiological study. World J Urol. 2017 Mar;35(3):459-465. doi: 10.1007/s00345-016-1879-2. Epub 2016 Jun 15.

  PMID: 27306687 BACKGROUND

• Kanemura H, Sano F, Ohyama T, Sugita K, Aihara M. The relationship between nocturnal enuresis and sequential changes of NAG/morning urine gravity in epileptic children treated with valproate sodium. J Pediatr Epilepsy 2015;4:61-6.

  BACKGROUND

• Yamak WR, Hmaimess G, Makke Y, Sabbagh S, Arabi M, Beydoun A, Nasreddine W. Valproate-induced enuresis: a prospective study. Dev Med Child Neurol. 2015 Aug;57(8):737-41. doi: 10.1111/dmcn.12737. Epub 2015 Mar 25.

  PMID: 25808512 BACKGROUND

• Fritz G, Rockney R, Bernet W, Arnold V, Beitchman J, Benson RS, Bukstein O, Kinlan J, McClellan J, Rue D, Shaw JA, Stock S, Kroeger Ptakowski K; Work Group on Quality Issues; AACAP. Practice parameter for the assessment and treatment of children and adolescents with enuresis. J Am Acad Child Adolesc Psychiatry. 2004 Dec;43(12):1540-50. doi: 10.1097/01.chi.0000142196.41215.cc.

  PMID: 15564822 BACKGROUND

• Esmael A, Elsherief M, Abdelsalam M, Bendary L, Egila H. Sleep Architecture in Valproate-Induced Nocturnal Enuresis in Primary School and Preschool Children. J Child Neurol. 2020 Dec;35(14):975-982. doi: 10.1177/0883073820944051. Epub 2020 Aug 7.

  PMID: 32762394 DERIVED

MeSH Terms

Conditions

Epilepsy; Nocturnal Enuresis; Enuresis

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Esmael M Ahmed, MD

  Assistant Prof of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Neurology

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 10, 2019
• Study Start: September 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

EG (1)