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.

Age range10 Years – 21 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.

Medical Outcomes Trust SF-36

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

NCT IDNCT03573726

SponsorShriners Hospitals for Children

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-04-22

Who can participate

Age range10 Years – 21 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.