title: New device for intermittent emptying of the bladder in female children and adolescents: A pilot study.
abstract: BACKGROUND
  Urinary incontinence (UI) is a challenging problem for the urological community. Clean intermittent catheterization (CIC) is the most commonly used method to restore bladder emptying to the state close to the physiological condition. This procedure can cause negative aspects such as pain and possible urethral injury. In addition, there is a negative impact on self-image and decline in quality of patient's life. The aim of the present study was to evaluate the safety and efficacy of a new intraurethral self-retaining device (ISRD), in female children and adolescents, as an attractive alternative to CIC.
  
  
  METHODS
  A prospective clinical pilot study was performed, in a single-institution, including female children and adolescent patients with urinary incontinence secondary to myelomeningocele who were already in an intermittent bladder catheterization program. Assessments included the use of a visual analogue scale in diagnosis of UI, reported adverse events, and the King's Health Questionnaire (KHQ) to evaluate quality of life, which was answered by patients and the caregivers of younger patients before and 6 months after enrolment.
  
  
  CONCLUSIONS
  The device was efficient and well tolerated by most patients (84%). The ISRD significantly improved quality of life in children and adolescents (p<0.0001 for both) (Table). The safe insertion and removal of the ISRD can be considered an advantage compared with CIC as eventual urethral trauma is significantly minimized. It was found that one of the main advantages of the ISRD is the possibility of management as an outpatient procedure both for initial insertion and replacement. The autonomy of patients to perform the bladder emptying process by themselves indicates the importance of this study, especially for school life and social interaction. ISRD use showed a tendency to improve the QoL.
  
  
  CONCLUSIONS
  This new bladder-draining device (ISRD) was effective and secure in terms of insertion technique, and improved QoL of patients with urinary retention and incontinence, according to domains evaluated in the KHQ.
authors.affiliation: Department of Surgery, Center for Health Sciences, Federal University of Pernambuco, UFPE, Brazil. Electronic address: urology@salvador.net.
authors.forename: Salvador V C
authors.initials: SVC
authors.lastname: Lima
authors.affiliation: Graduate Medical School, Federal University of Pernambuco, UFPE, Brazil.
authors.forename: Fábio O
authors.initials: FO
authors.lastname: Vilar
authors.affiliation: Clinical Hospital, Federal University of Pernambuco, UFPE, Brazil.
authors.forename: Eugênio S
authors.initials: ES
authors.lastname: Lustosa
authors.affiliation: Clinical Hospital, Federal University of Pernambuco, UFPE, Brazil.
authors.forename: Daniel C C
authors.initials: DCC
authors.lastname: Aragão
authors.affiliation: Department of Surgery, Center for Health Sciences, Federal University of Pernambuco, UFPE, Brazil.
authors.forename: Fernanda C F S
authors.initials: FCFS
authors.lastname: Calisto
authors.affiliation: Department of Surgery, Center for Health Sciences, Federal University of Pernambuco, UFPE, Brazil.
authors.forename: Flávia C M
authors.initials: FCM
authors.lastname: Pinto
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D057928:Intermittent Urethral Catheterization / Q000295:instrumentation*; D008591:Meningomyelocele / Q000150:complications; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014549:Urinary Incontinence / Q000209:etiology / Q000628:therapy*; D016055:Urinary Retention / Q000209:etiology / Q000628:therapy*
keywords: Clean intermittent catheterization; New device; Quality of life; Urinary incontinence