Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life

NCT03573726 | Completed

• 1 other identifier: 429063
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an interventional study examining the effects of closed diurnal indwelling catheterization (CDIC) for neurogenic bladder management.

Conditions

Spina Bifida; Neurogenic Bladder

Outcome Measures

Primary Outcomes (1)

• Medical Outcomes Trust SF-36

  Quality of Life is measured by questionnaire Medical Outcomes Trust SF-36. The physical component and mental component summary measures were selected from the SF-36 questionnaire. It measures change from baseline on CIC to week 4 of CDIC use in health related quality of life. We obtained the SF-36 site license from Quality Metric (Lincoln, RI) and are utilizing the proprietary software for all composite analyses.

  at baseline, week 4,12, and 24

Secondary Outcomes (2)

• Urinary continence

  at baseline, week 4,12, and 24

• PedsQL

  at baseline, week 4,12, and 24

Study Arms (1)

Technically N/A, Crossover Design

OTHER

Each participant underwent an evaluation during standard of care CIC use vs evaluations during use of the study intervention (CDIC).

Other: Closed diurnal indwelling catheter (CDIC)

Interventions

Closed diurnal indwelling catheter (CDIC) OTHER

Each participant underwent an evaluation during standard of care CIC use vs evaluations during use of the study intervention (CDIC).

Technically N/A, Crossover Design

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 10 to 21 years at study entry
• Primary diagnosis of Spina Bifida or Spinal Cord Injury with neurogenic bladder and established patients of a pediatric urologist in the Shriners Hospitals for Children multidisciplinary spina bifida clinic.
• History of compliance with a CIC regimen.
• Ability to understand and the willingness to sign a written informed consent document on the part of both the subject and guardian. A signed assent will be required, on the part of the subject, for all youth aged 10 to 17 years at the onset of study participation. In these cases, a parent or legal guardian must additionally sign a provision of informed consent. For subjects 18 years of age and older at the onset of study participation, only the subject must sign a provision of informed consent and HIPAA compliant research authorization.

You may not qualify if:

• Age less than10 years and greater than 21 years at study entry
• Greater than 2 diagnosed UTIs within last 12 months or symptomatic UTI at trial onset (UTI defined as the presence or ≥104 cfu/ml of a single bacterial strain in the presence of identified symptoms including but not limited to fever, flank or abdominal pain, change in urinary pattern or dysuria). Potential screened subjects with a symptomatic UTI at time of screening may be included after treatment of the UTI, followed by verification of symptom resolution and a negative culture result.
• History of bladder augmentation
• History of prior urethral surgery
• History of urinary tract calculi
• Diagnosis of high volume vesicoureteral reflux (grade 3 to 5) or moderate to severe (grade 3-4) hydronephrosis on pre-study imaging within 6 months of trial onset.
• Diagnosis on urodynamics of \>40mmHg detrusor end fill pressure (consistent with a poorly compliant bladder) on pre-study urodynamics within 6 months of trial onset.
• Diminished renal function (GFR \<60, consistent with CKD III) on pre-study laboratory assessment within 4 weeks prior to study onset.
• Lack of a 5th grade minimum reading/writing level by the subject (and parent or guardian providing informed consent of \<18 years of age at time of study onset)
• Demonstrated lack of compliance with follow-up, with \>2 missed urologic appointments in past year and/or lack of compliance with clean intermittent catheterization.
• Pregnant women (all female participants must have a negative pregnancy test within 4 weeks prior to study onset).
• Prisoners, institutionalized individuals or wards of the state.

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

MeSH Terms

Conditions

Spinal Dysraphism; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Pediatrics

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 29, 2018
• Study Start: September 11, 2013
• Primary Completion: April 22, 2016
• Study Completion: December 31, 2016
• Last Updated: June 29, 2018

Record last verified: 2018-06