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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03573726
Recruitment Status : Completed
First Posted : June 29, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eric A Kurzrock, Shriners Hospitals for Children

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

Condition or disease Intervention/treatment Phase
Spina Bifida Neurogenic Bladder Other: Closed diurnal indwelling catheter (CDIC) Not Applicable

Detailed Description:

This is an interventional study examining the effects of indwelling diurnal catheter use in 10 to 21 year old individuals with neurogenic bladder due to Spina Bifida or spinal cord injury.Subject participation is expected to last up to 6 months.Eligible, interested patients will complete a pre-study visit for a clinical assessment by a pediatric urologist, informed consent completion and education regarding the diurnal use of indwelling foley catheters. Each patient will be screened to ensure that they have completed standard studies of urologic function within the last six months including a serum chemistry panel, renal ultrasound, KUB, and urodynamic studies. Within four weeks prior to study onset, a UA and culture, pad weighing test and voiding diary will be completed. After initiation of diurnal catheter use, weekly screening calls and adverse event screening will be completed by the study coordinator with involvement of a pediatric urologist for evaluation and management as required for all screens with responses concerning for either symptomatic urinary tract infection or adverse event. There will be clinical assessments at SHCNC by the nurse practitioner or pediatric urologist at Week 4, 12 and 24 of participation (adverse event assessment, quality of life questionnaire completion, pad weight tests, voiding diary completion and UA/ culture). At the Week 12 and 24 visits, a renal ultrasound will be completed.

The option that the investigators propose is novel and is the use of an indwelling urethral catheter placed in the morning, remaining in place for 8 hours ('diurnal' indwelling catheter). Bladder drainage will occur on a scheduled basis during the school day or workday by the simple opening of the closed catheter. After eight hours, each evening, the indwelling catheter will be removed with resumption of CIC. This would be a convenient and practical solution that could simultaneously avoid many of the risks associated with long-term indwelling urethral catheter use, while still allowing for the improved independence, convenience and privacy desired by youth with spina bifida or spinal cord injury.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life for Patients With Spina Bifida and Spinal Cord Injury
Actual Study Start Date : September 11, 2013
Actual Primary Completion Date : April 22, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spina Bifida

Arm Intervention/treatment
Technically N/A, Crossover Design
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)
Each participant underwent an evaluation during standard of care CIC use vs evaluations during use of the study intervention (CDIC).




Primary Outcome Measures :
  1. Medical Outcomes Trust SF-36 [ Time Frame: at baseline, week 4,12, and 24 ]
    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.


Secondary Outcome Measures :
  1. Urinary continence [ Time Frame: at baseline, week 4,12, and 24 ]
    Urinary specific quality of life will be assessed by the validated King's Health Questionnaire (KHQ). The King's Health Questionnaire (KHQ) consists of two portions, 21 questions total, which address general health and the impact of incontinence including limitations to roles, physical, emotional, social and personal domains, sleep disturbance and incontinence severity. Differences in component summary scores will be assessed at each endpoint weeks 4, 12, and 24 and compared to baseline scores as noted for the SF-36.

  2. PedsQL [ Time Frame: at baseline, week 4,12, and 24 ]
    Pediatric quality of life will be assessed by the PedsQL (pediatric quality of life) 4.0 Generic Core Scales includes scales that assess child self-report and parent proxy-report of generic core health outcomes from the physical, emotional, social and school domains. Outcome endpoints and analyses are as described for the SF-36 and KHQ above and will evaluate each summary domain score at 4, 12 and 24 weeks on trial in comparison to baseline evaluation.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 10 to 21 years at study entry
  2. 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.
  3. History of compliance with a CIC regimen.
  4. 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.

Exclusion Criteria:

  1. Age less than10 years and greater than 21 years at study entry
  2. 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.
  3. History of bladder augmentation
  4. History of prior urethral surgery
  5. History of urinary tract calculi
  6. 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.
  7. 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.
  8. Diminished renal function (GFR <60, consistent with CKD III) on pre-study laboratory assessment within 4 weeks prior to study onset.
  9. 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)
  10. Demonstrated lack of compliance with follow-up, with >2 missed urologic appointments in past year and/or lack of compliance with clean intermittent catheterization.
  11. Pregnant women (all female participants must have a negative pregnancy test within 4 weeks prior to study onset).
  12. Prisoners, institutionalized individuals or wards of the state.
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Responsible Party: Eric A Kurzrock, Professor of Urology and Pediatrics, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT03573726    
Other Study ID Numbers: 429063
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Spinal Dysraphism
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities