CompletedNot Applicable

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

14 participantsStarted 2013-09-11

Plain-language summary

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

Who can participate

Age range

10 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Medical Outcomes Trust SF-36

Timeframe: at baseline, week 4,12, and 24

Trial details

NCT IDNCT03573726

SponsorShriners Hospitals for Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-22

View on ClinicalTrials.gov More Spina Bifida trials