Intermittent Catheter for Urinary Retention
(ConCaRe™ Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on understanding the experiences of people using intermittent catheters to manage urinary retention or incomplete bladder emptying. The goal is to gather information from participants about their current catheter use and any challenges or benefits they encounter. As an observational study, it records participants' experiences without altering their treatment. This trial suits adults who use intermittent catheters and are willing to share their experiences through regular online questionnaires. As an unphased trial, it offers participants the chance to contribute valuable insights that could enhance future care for catheter users.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on self-reporting about catheter use, so it's likely you can continue your medications, but you should confirm with the trial organizers.
What prior data suggests that intermittent catheters are safe for managing urinary retention?
Research shows that intermittent catheters are generally safe for adults needing assistance with urinary retention. Studies have found that these catheters reduce the risk of urinary tract infections compared to other methods. Some research suggests that specially coated catheters, such as prelubricated or hydrophilic ones, offer even greater safety for long-term use. Overall, patients using intermittent catheters report fewer changes in their urinary tract, indicating good safety.12345
Why are researchers excited about this trial?
Unlike traditional indwelling catheters that remain in the bladder, intermittent catheters are used temporarily and removed after each use, reducing the risk of infection and complications. Researchers are excited about intermittent catheters because they offer more control and comfort, allowing individuals to manage their bladder on their own schedule. This method also has the potential to improve quality of life by minimizing the need for continuous catheterization and healthcare support.
What evidence suggests that using an intermittent catheter is effective for managing urinary retention?
Studies have shown that intermittent catheters effectively manage urinary retention. One study found that patients using these catheters had significantly less residual urine in their bladders. Another study reported that normal bladder function returned in about 36% to 44% of patients using intermittent catheters. Over time, many patients improved their ability to empty their bladders, with some no longer needing catheters. This evidence suggests that intermittent catheters can be a reliable option for managing urinary retention.23467
Who Is on the Research Team?
Diane Newman, D.N.P. F.A.A.N. B.C.B.-P.M.D.
Principal Investigator
University of Pennsylvania
Jessica Simmons, DNP, APRN, FNP-C, CWON, DNC
Principal Investigator
Hollister Incorporated
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Participants self-report on attributes of their prescribed intermittent catheters and various aspects of using an intermittent catheter
Follow-up
Participants are monitored for safety and effectiveness after data collection
What Are the Treatments Tested in This Trial?
Interventions
- Intermittent Catheter
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Individuals using an intermittent catheter to void urine through the urethra. Participants use their currently prescribed intermittent catheter per their clinician's standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hollister Incorporated
Lead Sponsor
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Technomics Research
Industry Sponsor
Citations
Effects of clean intermittent catheterization and transurethral ...
The results revealed that the residual urine volume was markedly lower in patients with urinary retention who received intermittent ...
Effectiveness and safety of intermittent catheterisation for the ...
Normal voiding was restored in 25 (35.7%) patients in group I and 26 (44%) patients in group II. The point estimate of the probability of ...
A Real-world Data Analysis of Intermittent Catheterization ...
The primary outcome measures were the proportion of patients with at least one ssUTI (prescription of a nonspecific antibiotic with a UTI-related diagnosis, ...
Urinary Retention Evaluation and Catheterization ...
A UR evaluation and catheterization algorithm was developed to improve patient safety by increasing appropriate use of bladder scanners and catheterization.
Intermittent Catheters
The probability of bladder voiding function recovery and arrest of self-catheterization was 24.5%, 54%, 59%, 72%, and 77% at 4, 8, 12, 52, and 78 weeks, ...
Intermittent Catheters for Chronic Urinary Retention: A Health ...
This review evaluates the effectiveness, safety, patient preference, cost-effectiveness, and budget impact of different types of intermittent catheter (IC).
VIII. Evidence Review | Infection Control
Studies of patients with neurogenic bladder most consistently found a decreased risk of CAUTI with intermittent catheterization.
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