Spina BifidaNCT03573726
Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life
A study testing Closed diurnal indwelling catheter (CDIC) in people with Spina Bifida and Neurogenic Bladder, run by Shriners Hospitals for Children.
Trial summary
This is an interventional study examining the effects of closed diurnal indwelling catheterization (CDIC) for neurogenic bladder management. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Spina Bifida, Neurogenic Bladder
- What is being tested?
- Closed diurnal indwelling catheter (CDIC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2013to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life for Patients With Spina Bifida and Spinal Cord Injury
This is an interventional study examining the effects of closed diurnal indwelling catheterization (CDIC) for neurogenic bladder management.
Read the 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.
- Conditions
- Spina Bifida, Neurogenic Bladder
- Being tested
- Closed diurnal indwelling catheter (CDIC)
- Medical subject headings
- Spinal Dysraphism, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Closed diurnal indwelling catheter (CDIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, week 4,12, and 24
Secondary outcomes (2)
Urinary continence
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.
Measured: at baseline, week 4,12, and 24
PedsQL
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.
Measured: at baseline, week 4,12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start11 Sep 2013
- Primary completion22 Apr 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric A Kurzrock, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573726
- Sponsor's protocol ID
- 429063
- Status last verified
- Jun 2018
- First submitted
- 8 May 2018
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life for Patients With Spina Bifida and Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03573726
- Acronym / sponsor ID
- 429063
- Conditions
- Spina Bifida, Neurogenic Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- 11 Sep 2013 (actual)
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an interventional study examining the effects of closed diurnal indwelling catheterization (CDIC) for neurogenic bladder management.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Technically N/A, Crossover Design | Other | 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). |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Technically N/A, Crossover Design |
Primary outcome
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.
2 secondary outcomes
Urinary continence
Time frame: at baseline, week 4,12, and 24
PedsQL
Time frame: at baseline, week 4,12, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Closed diurnal indwelling catheter (CDIC) in people with Spina Bifida and Neurogenic Bladder, run by Shriners Hospitals for Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Outcomes Trust SF-36 (time frame: at baseline, week 4,12, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.