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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03573726
Study type	Interventional
Source	Shriners Hospitals for Children
Contact
Status	Completed
Phase	N/A
Start date	September 11, 2013
Completion date	December 31, 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Enrolling by invitation	`NCT06429631` - The Effect of CIC Education on QOL and Compliance With Mobile Application in Individuals With Spinal Cord Injury.	N/A
Recruiting	`NCT06059066` - Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction	N/A
Completed	`NCT01429090` - Bioavailability of Vagantin® Coated Tablets Relative to an Oral Methantheline Bromide Solution	Phase 1
Recruiting	`NCT05587101` - Neurogenic Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Terminated	`NCT03843073` - Connected Catheter- Safety and Effectiveness Study	N/A
Terminated	`NCT04059159` - Connected Catheter - Safety and Effectiveness Study	N/A
Completed	`NCT05861024` - Urinary Calculi After Bladder Augmentation in Children
Completed	`NCT05858840` - Urinary Artificial Sphincter in Children
Completed	`NCT04074616` - Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation	N/A
Completed	`NCT05683938` - GentleCath™ Air Intermittent Catheter Smartwatch Real Life Pilot Study
Completed	`NCT04543552` - A Comparative Analysis of Portable Bladder Scanner to Determine Age/ Volume Specific Accuracy in 0-6 Years of Children
Active, not recruiting	`NCT06247033` - Efficacies of Different Managements in Patients With Overactive Bladder With Stroke	N/A
Withdrawn	`NCT01305681` - Bacterial Properties With LoFric® Catheters During Clean Intermittent Catheterization	Phase 1/Phase 2
Recruiting	`NCT04248322` - Qualitative Assessment of the Impact of TTNS on QOL and Participation
Recruiting	`NCT05301335` - Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study	N/A
Recruiting	`NCT04924569` - Continence Care Registry
Completed	`NCT01716624` - Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder	Phase 3
Completed	`NCT01297647` - Incidence of Urinary Tract Infection After Urodynamic Investigation	N/A
Recruiting	`NCT04373512` - Intravesical Lactobacillus to Reduce Urinary Symptoms After Spinal Cord Injury	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.