Clinical Research Directory

Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)

People who rely on long-term indwelling urinary (Foley) catheters often experience recurrent urinary tract infections and catheter blockages that require unscheduled catheter changes, additional antibiotics, and emergency visits. These complications reduce quality of life and increase healthcare use. The NowCath Foley is an all-silicone indwelling urinary catheter with two additional drainage eyelets positioned below the retention balloon. A thin silicone skirt covers the eyelets to reduce suction against the bladder wall. The design is intended to improve bladder emptying and reduce mucosal contact, which may in turn lower the rate of catheter-associated urinary tract infections (CAUTIs) and blockages compared with a conventional all-silicone Foley catheter. The REDUCE study is a multi-centre, randomized, blinded, controlled crossover clinical investigation conducted in Denmark. The primary goal is to determine whether the NowCath Foley catheter can reduce incidence of CAUTI over 12 weeks compared to a conventional long-term indwelling Foley catheter in an adult population using indwelling urethral or suprapubic Foley catheters . The participants (n=160) are cared for and enrolled by community nursing services in the Ikast-Brande and Holstebro municipalities in collaboration with the coordinating site at Regional Hospital Gødstrup. Each participant will use both the NowCath Foley and a conventional all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) in a randomized sequence, for 12 weeks each (24 weeks total). The primary outcome is the rate of catheter changes per 100 catheter days. Secondary outcomes include CAUTI incidence, blockage incidence, residual urine volume, encrustation, antibiotic use, quality of life, patient comfort, safety, and cost-effectiveness. During phase 1, participants will be randomised to either NowCath or the conventional Foley catheter and will be seen at weeks 0 and 12. At week 12 participants will be crossed-over to phase 2, where they will receive the other catheter not allocated in phase 1 and will be seen at weeks 12 and 24. As the participants would default to the comparator catheter as part of standard of care, the wash-out period is minimal.

Anti-fouling Silicone Urinary Catheter for Adults Needing Long-term Catheterisation: a Pilot and Feasibility Study

This single-centre randomised pilot and feasibility study assessed whether an anti-fouling zwitterionic silicone urinary catheter can be deployed and evaluated in frail, elderly adults who require long-term indwelling catheterisation. In the experimental catheter, a zwitterionic polymer is blended into the silicone matrix rather than applied as a surface coating. Forty participants were randomly allocated to the anti-fouling catheter or a conventional commercial silicone catheter, with monthly catheter changes for up to eight cycles. The primary aim was to establish feasibility and acceptability (recruitment, retention, specimen completeness, safety and patient/family acceptability) and to obtain exploratory effect-size estimates (catheter-associated urinary tract infection, catheter-removal pain, urinalysis and urine culture) to inform the design of a future confirmatory trial. The study was not powered to test efficacy.

Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.

The CATHETERS trial is a multicenter, randomized, open-label superiority study comparing two methods of managing urinary retention before surgery for benign prostatic hyperplasia (BPH): clean intermittent self-catheterization (ICSC) versus indwelling catheter (IDC). The primary objective is to determine whether ICSC reduces the occurrence of infectious complications (urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis) compared to IDC in men awaiting BPH surgery. A total of 106 patients will be enrolled across multiple centers in France, with follow-up extending to three months after surgery.

Simulation-Based Training for Urinary Catheterization Skills in Nursing Students

The purpose of this study is to comparatively evaluate the effectiveness of two different simulation-based training methods on nursing students' knowledge and skills regarding urinary catheterization in male patients. Accordingly, the effects of hybrid simulation training using a wearable urinary catheter model on students' knowledge level, psychomotor skill acquisition, satisfaction, learning self-confidence, and communication skills will be revealed compared to standard training using traditional partial task instructional models.

Ureteral Stent Exchange Abstention in Urinary Tract Infections

The Committee of Infectiology of the French Association of Urology (CIAFU) provided, for the first time in 2020, comprehensive guidelines for ureteral stent-associated urinary tract infections (USAUTI) prevention, diagnosis and treatment. Since evidence lacked in terms of appropriate treatment, guidelines could not support systematic change of US in case of USAUTI. This study aims to evaluate whether "after guidelines group" patients treated for USAUTI had different occurrence of at least one relapse or recurrence than "before guidelines group".

Duration of Urinary Catheterization Following Cesarean Deliveries Under Neuraxial Anesthesia

In cesarean deliveries, urinary catheters are often used to help empty the bladder while patients have limited mobility. These catheters typically stay in during early recovery because certain pain medications can make it hard for patients to urinate. Recently, the Society of Obstetric Anesthesia and Perinatology (SOAP) recommended removing catheters within 6-12 hours after delivery to aid recovery. However, at BC Women's Hospital, a review found that catheters stayed in for an average of 19 to 19.4 hours, even when patients were mobile. Leaving catheters in too long can increase the risk of urinary tract infections (UTIs), pain, and urination issues, which can delay recovery and extend hospital stays. An internal review showed that factors like patient anxiety may affect when catheters are removed. Postpartum anxiety affects around 9.9% to 20.7% of new mothers in the first year and is an important factor in recovery after a cesarean delivery. The main goal of this study is to look at how long urinary catheters stay in patients who had a cesarean delivery under spinal or epidural anesthesia, and what the score is from a questionnaire used to measure anxiety called the State Trait Anxiety Inventory (STAI-S), to see if there is a link between them.