Clinical trials: Urinary Catheter
Urinary Incontinence
Clinical Trial of New Intermittent Single-use Catheter
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home.
- Trial name
- NCT05814211
- Testing
- Investigational device - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve, Comparator device #2 - SpeediCath Compact Plus Female
- Where
- 11 sites in Denmark, France and 1 more
- Volunteers
- 82 people
- Sponsor
- Coloplast A/S
Urinary Catheterization
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator.
- Trial name
- NCT00753298
- Testing
- LoFric Primo (POBE) single-use urinary catheter, LoFric Primo (PVC) single-use urinary catheter
- Where
- 13 sites in Austria, Germany and 4 more
- Volunteers
- 195 people
- Sponsor
- Wellspect HealthCare
Urinary Incontinence
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT06850259)
- Testing
- PureWick® Urine Collection System, UltraFlex™ Self-Adhering Male External Catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- C. R. Bard
Catheter-Associated Urinary Tract Infection
Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.
- Trial name
- NCT03645967
- Testing
- ReadyCleanse Cloths
- Where
- 4 sites in United States
- Volunteers
- 9,891 people, healthy volunteers welcome
- Sponsor
- Medline Industries
Urinary Tract Infection
Preventing Urinary Tract Infection Post-Surgery
Approximately 10-27% of patients undergoing gynecologic surgeries develop a catheter associated urinary tract infection (CAUTI) in the post operatory period, as bladder catheterization is a common practice in gynecologic surgery.
- Trial name
- PUPS (NCT01346774)
- Testing
- Cranberry powder capsules
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Betsy Foxman
Pelvic Organ Prolapse
Nitrofurantoin Prophylaxis During Catheter-managed Acute Urinary Retention After Pelvic Reconstructive Surgery
The specific aim of this randomized double-blind placebo-controlled trial is to determine if extended release nitrofurantoin antibiotic prophylaxis decreases the incidence of symptomatic urinary tract infection (UTI) compared…
- Trial name
- NCT02727322
- Testing
- Nitrofurantoin
- Where
- 2 sites in United States
- Volunteers
- 154 people
- Sponsor
- Halina M Zyczynski, MD
Infection Due to Indwelling Urinary Catheter, Asymptomatic Bacteriuria
Asymptomatic Bacteriuria Guideline Implementation Study
Overtreatment of asymptomatic bacteriuria (ABU) is a quality, safety, and cost issue, particularly as unnecessary antibiotics lead to emergence of resistant pathogens.
- Trial name
- ABU (NCT01052545)
- Testing
- Audit-Feedback
- Where
- United States
- Volunteers
- 1,598 people
- Sponsor
- VA Office of Research and Development
Urinary Retention
A Confirmatory Study Confirming Performance of a New Intermittent Catheter
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks.
- Trial name
- NCT05485935
- Testing
- Investigational device - intermittent catheter with micro-hole zone, Comparator - standard intermittent catheter
- Where
- 6 sites in Denmark, France and 2 more
- Volunteers
- 73 people
- Sponsor
- Coloplast A/S
Urinary Retention
Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men
The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.
- Trial name
- NCT02643849
- Testing
- The Spanner Temporary Prostatic Stent
- Where
- 6 sites in United States
- Volunteers
- 107 people
- Sponsor
- SRS Medical
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Retention, Urinary
Investigation of New Intermittent Catheters in Healthy Volunteers
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
- Trial name
- NCT04445051
- Testing
- SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Infection Associated With Catheter, Urinary Tract Infection
Silver-impregnated Suprapubic Catheters (SPC) in Urogynecology
The purpose of this study is to compare urinary tract infection rates among women undergoing urogynecological procedures with a silver-alloy suprapubic catheter compared to the standard suprapubic catheter.
- Trial name
- NCT01359046
- Testing
- silver SPC, standard SPC
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- Mayo Clinic
Catheterization (Clean, Intermittent Urinary Catheterization)
Evaluation of a New Catheter Material for Intermittent Catheterization
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e.
- Trial name
- NCT01295281
- Testing
- LoFric POBE 2.0, LoFric PVC
- Where
- 6 sites in Sweden
- Volunteers
- 107 people
- Sponsor
- Wellspect HealthCare
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters.
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
- Trial name
- NCT04543136
- Testing
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- Coloplast A/S
Bladder Dysfunction, Urinary Retention
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which…
- Trial name
- NCT01460303
- Testing
- Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag, Transurethral catheter with leg bag
- Volunteers
- 49 people
- Sponsor
- University of Massachusetts, Worcester
Spinal Cord Injury, Urinary Tract Infection
Colonizing Neurogenic Bladders With Benign Flora
The purpose of the research is to determine whether we can get harmless bacteria to live in the bladders of persons with spinal cord injury who practice intermittent bladder catheterization.
- Trial name
- NCT00371631
- Testing
- Insertion of urinary catheters coated with E. coli 83972
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- US Department of Veterans Affairs
Postoperative Urinary Retention, Total Hip Arthroplasty
RCT Foley Catheter Study for Elective TJA
Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension.
- Conditions
- Postoperative Urinary Retention, Total Hip Arthroplasty, Total Knee Arthroplasty
- Trial name
- NCT05428020
- Testing
- Indwelling foley catheter, No foley catheter
- Where
- United States
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Cross Infection, Pneumonia, Ventilator-associated
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit
This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and…
- Conditions
- Cross Infection, Pneumonia, Ventilator-associated, Catheter-related Infections, Infection Due to Indwelling Urinary Catheter
- Trial name
- NCT01640925
- Testing
- Chlorhexidine gluconate, Standard bathing
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Joshua Swan
Urinary Retention
Comparison of Two Intermittent Urinary Catheters
This is an unblinded, multi-center, randomized, controlled, cross-over study assessing wheel-chair bound, male user preference and catheter characteristics of two intermittent urinary catheters.
- Trial name
- NCT01284361
- Testing
- 30 cm Intermittent Catheter, 40 cm Intermittent Catheter
- Where
- 4 sites in United States
- Volunteers
- 91 people
- Sponsor
- Hollister Incorporated
Transforaminal Lumbar Interbody Fusion
Effect of Catheter on Postoperative Urinary Retention
To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after…
- Trial name
- NCT04645264
- Testing
- Foley Catheter
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center