Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism: A retrospective, multicenter, observational study

Jung Hoon Lee, Kyoung Rok Kim, Yong Seung Lee, Sang Won Han, Kun Suk Kim, Sang Hoon Song, Minki Baek, Kwanjin Park

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Purpose: Anticholinergics are a key element in treating neurogenic detrusor overactivity, but only limited data are available in the pediatric population, thus limiting the application to children even for oxybutynin chloride (OC), a prototype drug. This retrospective study was designed to provide data regarding the efficacy, tolerability, and safety of OC in the pediatric population (0–15 years old) with spinal dysraphism (SD).

Materials and Methods: Records relevant to OC use for neurogenic bladder were gathered and scrutinized from four specialized clinics for pediatric urology. The primary efficacy outcomes were maximal cystometric capacity (MCC) and end filling pressure (EFP). Data on tolerability, compliance, and adverse events (AEs) were also analyzed.

Results: Of the 121 patient records analyzed, 41 patients (34%) received OC at less than 5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatment duration was 19 months (range, 0.3–111 months). Significant improvement of both primary efficacy outcomes was noted following OC treatment. MCC increased about 8% even after adjustment for age-related increases in MCC. Likewise, mean EFP was reduced from 33 to 21 cm H2O. More than 80% of patients showed compliance above 70%, and approximately 50% of patients used OC for more than 1 year. No serious AEs were reported; constipation and facial flushing consisted of the major AEs.

Conclusions: OC is safe and efficacious in treating pediatric neurogenic bladder associated with SD. The drug is also tolerable and the safety profile suggests that adjustment of dosage for age may not be strictly observed.

Original languageEnglish
Pages (from-to)828-833
Number of pages6
JournalKorean Journal of Urology
Volume55
Issue number12
DOIs
Publication statusPublished - 2014 Dec 1

Fingerprint

Neurogenic Urinary Bladder
Spinal Dysraphism
Multicenter Studies
Observational Studies
Pediatrics
Safety
Social Adjustment
Pressure
Cholinergic Antagonists
Urology
Constipation
Patient Compliance
oxybutynin
Pharmaceutical Preparations
Population
Compliance
Retrospective Studies
Therapeutics

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

Lee, Jung Hoon ; Kim, Kyoung Rok ; Lee, Yong Seung ; Han, Sang Won ; Kim, Kun Suk ; Song, Sang Hoon ; Baek, Minki ; Park, Kwanjin. / Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism : A retrospective, multicenter, observational study. In: Korean Journal of Urology. 2014 ; Vol. 55, No. 12. pp. 828-833.
@article{aae4d53c4567420f92b32efc4f2c9565,
title = "Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism: A retrospective, multicenter, observational study",
abstract = "Purpose: Anticholinergics are a key element in treating neurogenic detrusor overactivity, but only limited data are available in the pediatric population, thus limiting the application to children even for oxybutynin chloride (OC), a prototype drug. This retrospective study was designed to provide data regarding the efficacy, tolerability, and safety of OC in the pediatric population (0–15 years old) with spinal dysraphism (SD).Materials and Methods: Records relevant to OC use for neurogenic bladder were gathered and scrutinized from four specialized clinics for pediatric urology. The primary efficacy outcomes were maximal cystometric capacity (MCC) and end filling pressure (EFP). Data on tolerability, compliance, and adverse events (AEs) were also analyzed.Results: Of the 121 patient records analyzed, 41 patients (34{\%}) received OC at less than 5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatment duration was 19 months (range, 0.3–111 months). Significant improvement of both primary efficacy outcomes was noted following OC treatment. MCC increased about 8{\%} even after adjustment for age-related increases in MCC. Likewise, mean EFP was reduced from 33 to 21 cm H2O. More than 80{\%} of patients showed compliance above 70{\%}, and approximately 50{\%} of patients used OC for more than 1 year. No serious AEs were reported; constipation and facial flushing consisted of the major AEs.Conclusions: OC is safe and efficacious in treating pediatric neurogenic bladder associated with SD. The drug is also tolerable and the safety profile suggests that adjustment of dosage for age may not be strictly observed.",
author = "Lee, {Jung Hoon} and Kim, {Kyoung Rok} and Lee, {Yong Seung} and Han, {Sang Won} and Kim, {Kun Suk} and Song, {Sang Hoon} and Minki Baek and Kwanjin Park",
year = "2014",
month = "12",
day = "1",
doi = "10.4111/kju.2014.55.12.828",
language = "English",
volume = "55",
pages = "828--833",
journal = "Korean Journal of Urology",
issn = "2005-6737",
publisher = "Korean Urological Association",
number = "12",

}

Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism : A retrospective, multicenter, observational study. / Lee, Jung Hoon; Kim, Kyoung Rok; Lee, Yong Seung; Han, Sang Won; Kim, Kun Suk; Song, Sang Hoon; Baek, Minki; Park, Kwanjin.

In: Korean Journal of Urology, Vol. 55, No. 12, 01.12.2014, p. 828-833.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy, tolerability, and safety of oxybutynin chloride in pediatric neurogenic bladder with spinal dysraphism

T2 - A retrospective, multicenter, observational study

AU - Lee, Jung Hoon

AU - Kim, Kyoung Rok

AU - Lee, Yong Seung

AU - Han, Sang Won

AU - Kim, Kun Suk

AU - Song, Sang Hoon

AU - Baek, Minki

AU - Park, Kwanjin

PY - 2014/12/1

Y1 - 2014/12/1

N2 - Purpose: Anticholinergics are a key element in treating neurogenic detrusor overactivity, but only limited data are available in the pediatric population, thus limiting the application to children even for oxybutynin chloride (OC), a prototype drug. This retrospective study was designed to provide data regarding the efficacy, tolerability, and safety of OC in the pediatric population (0–15 years old) with spinal dysraphism (SD).Materials and Methods: Records relevant to OC use for neurogenic bladder were gathered and scrutinized from four specialized clinics for pediatric urology. The primary efficacy outcomes were maximal cystometric capacity (MCC) and end filling pressure (EFP). Data on tolerability, compliance, and adverse events (AEs) were also analyzed.Results: Of the 121 patient records analyzed, 41 patients (34%) received OC at less than 5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatment duration was 19 months (range, 0.3–111 months). Significant improvement of both primary efficacy outcomes was noted following OC treatment. MCC increased about 8% even after adjustment for age-related increases in MCC. Likewise, mean EFP was reduced from 33 to 21 cm H2O. More than 80% of patients showed compliance above 70%, and approximately 50% of patients used OC for more than 1 year. No serious AEs were reported; constipation and facial flushing consisted of the major AEs.Conclusions: OC is safe and efficacious in treating pediatric neurogenic bladder associated with SD. The drug is also tolerable and the safety profile suggests that adjustment of dosage for age may not be strictly observed.

AB - Purpose: Anticholinergics are a key element in treating neurogenic detrusor overactivity, but only limited data are available in the pediatric population, thus limiting the application to children even for oxybutynin chloride (OC), a prototype drug. This retrospective study was designed to provide data regarding the efficacy, tolerability, and safety of OC in the pediatric population (0–15 years old) with spinal dysraphism (SD).Materials and Methods: Records relevant to OC use for neurogenic bladder were gathered and scrutinized from four specialized clinics for pediatric urology. The primary efficacy outcomes were maximal cystometric capacity (MCC) and end filling pressure (EFP). Data on tolerability, compliance, and adverse events (AEs) were also analyzed.Results: Of the 121 patient records analyzed, 41 patients (34%) received OC at less than 5 years of age. The range of prescribed doses varied from 3 to 24 mg/d. The median treatment duration was 19 months (range, 0.3–111 months). Significant improvement of both primary efficacy outcomes was noted following OC treatment. MCC increased about 8% even after adjustment for age-related increases in MCC. Likewise, mean EFP was reduced from 33 to 21 cm H2O. More than 80% of patients showed compliance above 70%, and approximately 50% of patients used OC for more than 1 year. No serious AEs were reported; constipation and facial flushing consisted of the major AEs.Conclusions: OC is safe and efficacious in treating pediatric neurogenic bladder associated with SD. The drug is also tolerable and the safety profile suggests that adjustment of dosage for age may not be strictly observed.

UR - http://www.scopus.com/inward/record.url?scp=84916631844&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84916631844&partnerID=8YFLogxK

U2 - 10.4111/kju.2014.55.12.828

DO - 10.4111/kju.2014.55.12.828

M3 - Article

C2 - 25512818

AN - SCOPUS:84916631844

VL - 55

SP - 828

EP - 833

JO - Korean Journal of Urology

JF - Korean Journal of Urology

SN - 2005-6737

IS - 12

ER -