Reduction in lower urinary tract mucosal microtrauma as an effect of reducing eyelet sizes of intermittent urinary catheters.

Intermittent catheterization (IC) utilizing conventional eyelets catheters (CECs) for bladder drainage has long been the standard of care. However, when the tissue of the lower urinary tract comes in close proximity to the eyelets, mucosal suction often occurs, resulting in microtrauma. This study investigates the impact of replacing conventional eyelets with a drainage zone featuring multiple micro-holes, distributing pressure over a larger area. Lower pressures limit the suction of surrounding tissue into these micro-holes, significantly reducing tissue microtrauma. Using an ex vivo model replicating the intra-abdominal pressure conditions of the bladder, the intra-catheter pressure was measured during drainage. When mucosal suction occurred, intra-catheter images were recorded. Subsequently affected tissue samples were investigated histologically. The negative pressure peaks caused by mucosal suction were found to be very high for the CECs, leading to exfoliation of the bladder urothelium and breakage of the urothelial barrier. However, a micro-hole zone catheter (MHZC) with a multi-eyelet drainage zone showed significantly lower pressure peaks, with over 4 times lower peak intensity, thus inducing far less extensive microtraumas. Limiting or even eliminating mucosal suction and resulting tissue microtrauma may contribute to safer catheterizations in vivo and increased patient comfort and compliance.

Hydrophilic catheters for intermittent catheterization and occurrence of urinary tract infections. A retrospective comparative study in patients with spinal cord Injury.

BACKGROUND: Neurogenic bladder dysfunction is a major problem for spinal cord injury (SCI) patients not only due to the risk of serious complications but also because of the impact on quality of life. The main aim of this study is to compare the rate of urinary tract infection (UTI) associated with hydrophilic-coated catheters versus uncoated polyvinyl chloride (PVC) catheters among SCI patients presenting with functional neurogenic bladder sphincter disorders. METHODOLOGY: This was a retrospective cohort study from 2005 to 2020 including adult male or female patients who have an SCI at least more than 1 month ago with neurogenic bladder dysfunction and were using intermittent catheterization (single-use hydrophilic-coated or the standard-of-care polyvinyl chloride uncoated standard catheters) at least 3 times a day to maintain bladder emptying. RESULTS: A total of 1000 patients were selected and recruited through a stratified random sampling technique with 467 (47.60%) patients in the uncoated catheter arm and 524 (52.60%) in the coated catheter groups. The three outcome measures, namely: symptomatic UTI, Bacteriuria, and pyuria were significantly higher in the group using uncoated polyvinyl chloride (PVC) catheters compared to hydrophilic-coated catheters at the rate of 79.60% vs.46.60%, 81.10% vs. 64.69, and 53.57% versus 41.79% respectively. Males, elder patients, longer duration, and severity of SCI were associated with increased risk of symptomatic UTI. CONCLUSIONS: The results indicate a beneficial effect regarding clinical UTI when using hydrophilic-coated catheters in terms of fewer cases of symptomatic UTI. Bacteriuria is inevitable in patients with long-term catheterization, however, treatment should not be started unless the clinical symptoms exist. More attention should be given to the high-risk group for symptomatic UTIs.

Evaluating the effectiveness of early urethral catheter removal combined with intermittent catheterization for promoting early recovery of bladder function after laparoscopic radical hysterectomy: a study protocol for a randomized controlled trial.

BACKGROUND: Bladder dysfunction, notably urinary retention, emerges as a significant complication for cervical cancer patients following radical hysterectomy, predominantly due to nerve damage, severely impacting their postoperative quality of life. The challenges to recovery include insufficient pelvic floor muscle training and the negative effects of prolonged postoperative indwelling urinary catheters. Intermittent catheterization represents the gold standard for neurogenic bladder management, facilitating bladder training, which is an important behavioral therapy aiming to enhance bladder function through the training of the external urethral sphincter and promoting the recovery of the micturition reflex. Nevertheless, gaps remain in current research regarding optimal timing for intermittent catheterization and the evaluation of subjective symptoms of bladder dysfunction. METHODS: Cervical cancer patients undergoing laparoscopic radical hysterectomy will be recruited to this randomized controlled trial. Participants will be randomly assigned to either early postoperative catheter removal combined with intermittent catheterization group or a control group receiving standard care with indwelling urinary catheters. All these patients will be followed for 3 months after surgery. The study's primary endpoint is the comparison of bladder function recovery rates (defined as achieving a Bladder Function Recovery Grade of II or higher) 2 weeks post-surgery. Secondary endpoints include the incidence of urinary tract infections, and changes in urodynamic parameters, and Mesure Du Handicap Urinaire scores within 1 month postoperatively. All analysis will adhere to the intention-to-treat principle. DISCUSSION: The findings from this trial are expected to refine clinical management strategies for enhancing postoperative recovery among cervical cancer patients undergoing radical hysterectomy. By providing robust evidence, this study aims to support patients and their families in informed decision-making regarding postoperative bladder management, potentially reducing the incidence of urinary complications and improving overall quality of life post-surgery. TRIAL REGISTRATION: ChiCTR2200064041, registered on 24th September, 2022.

Understanding the challenges faced by men learning to live with clean intermittent self-catheterisation.

Clean intermittent self-catheterisation (CISC) is considered the preferred option to an indwelling catheter for emptying the bladder in people with a range of voiding dysfunctions. CISC has a lower risk of complications and urinary tract infections. This narrative review of previous qualitative research explores the quality-of-life impacts and highlights the challenges that men face. It will provide nurses who teach CISC with some useful insights into the male experience and the issues of concordance and adherence. This will help to better inform and guide clinical practice in this specialist area of nursing practice.

Intermittent catheterisation.

When an individual has voiding difficulties, the person may require a urinary catheter. Enabling the person to choose an appropriate method of catheterisation and supporting them can have an enormous impact on the individual's health and wellbeing. Indwelling urethral catheters are suitable for some people but for others they can affect a person's lifestyle and lead to depression. Intermittent catheterisation can work well for some people. Intermittent self-catheterisation has been used to manage urinary retention for over 3500 years. It remains the 'gold standard' in terms of bladder drainage, but it is under-used and indwelling catheters remain more common. This article examines the history of intermittent catheterisation, indications for self-catheterisation and how to support people to use self-catheterisation.

Factors associated with symptomatic urinary tract infection in persons with spinal cord lesions who perform clean intermittent catheterization with single-use catheters.

OBJECTIVES: To investigate factors associated with symptomatic urinary tract infection (sUTI) in persons with chronic spinal cord lesion (SCL) who were using single-use catheters for intermittent self-catheterization (ISC). METHODS: Among respondents to an internet survey on the burden of illness on persons with SCL who were considered to be able to perform ISC, 111 persons using single-use catheters were included to examine factors associated with self-reported sUTI by univariate as well as multivariable analysis. RESULTS: The incidence of sUTI was significantly higher in males than in females (56.9% vs. 31.6%, p = .011), persons with stocks of antibiotics than those without it (82.9% vs. 28.6%, p < .011), and persons with more frequent bleeding during catheterization than those with less frequent bleeding (100% vs. 46.5%, p = .036). The incidence did not significantly differ between respective groups when various variables were evaluated by other characteristics of the participants, adherence to ISC procedures, and complications. On multivariable analysis, male gender and stocks of antibiotics were significant independent factors for sUTI. CONCLUSIONS: Male gender and stocks of antibiotics were associated with sUTI in persons with SCL who were performing ISC with single-use catheters.

Bladder Management and Continence in Girls With Cloacal Malformation After 3 Years of Age.

BACKGROUND: Multiple factors impact ability to achieve urinary continence in cloacal malformation including common channel (CC) and urethral length and presence of spinal cord abnormalities. Few publications describe continence rates and bladder management in this population. We evaluated our cohort of patients with cloacal malformation to describe the bladder management and continence outcomes. METHODS: We reviewed a prospectively collected database of patients with cloacal malformation managed at our institution. We included girls ≥3 years (y) of age and evaluated their bladder management methods and continence. Dryness was defined as <1 daytime accident per week. Incontinent diversions with both vesicostomy and enterovesicostomy were considered wet. RESULTS: A total of 152 patients were included. Overall, 93 (61.2%) are dry. Nearly half (47%) voided via urethra, 65% of whom were dry. Twenty patients (13.1%) had incontinent diversions. Over 40% of the cohort performed clean intermittent catheterization (CIC), approximately half via urethra and half via abdominal channel. Over 80% of those performing CIC were dry. In total, 12.5% (n = 19) required bladder augmentation (BA). CC length was not associated with dryness (p = 0.076), need for CIC (p = 0.253), or need for abdominal channel (p = 0.497). The presence of a spinal cord abnormality was associated with need for CIC (p = 0.0117) and normal spine associated with ability to void and be dry (p = 0.004) CONCLUSIONS: In girls ≥ 3 y of age with cloacal malformation, 61.2% are dry, 65% by voiding via urethra and 82% with CIC. 12.5% require BA. Further investigation is needed to determine anatomic findings associated with urinary outcomes. LEVEL OF EVIDENCE: IV.

Product evaluation of the Luja Micro-hole Zone Technology in clean intermittent self-catheterisation.

Clean intermittent self-catheterisation is a common procedure undertaken by people with bladder dysfunction. However, it is not without its complications, the main one being urinary tract infection. The most common causes of urinary tract infections are poor hygiene, technique and adherence, excessive post-void residual urine and bladder trauma. A catheter with new Micro-hole Zone Technology has been developed, which can potentially improve bladder emptying and minimise these complications. A case study is used to illustrate its effects in practice.

Prospective study of the epidemiology of urinary tract infections at short term and mid-term after initiation of intermittent self-catheterisation.

INTRODUCTION: Self-catheterisation (CIsC) is the gold standard treatment for bladder emptying disorders. A frequent complaint of patients undergoing CIsC is urinary tract infection (UTI). However, the epidemiology of UTIs remains poorly documented, particularly in the urological population. The aim of our study was to establish the epidemiology of infectious complications of CIsC. METHOD: A prospective, descriptive cohort study was carried out on a population educated in CIsC in a urology outpatient department of a university hospital. RESULTS: From January 1, 2019 to November 15, 2020, 411 patients completed a CIsC education session. Sixty patients could be included and integrated for analysis. The mean age was 58.6±16.3years. Among the patients, 68% had a neurological pathology. The most common bacteria found was Escherichia coli. The incidence of total UTIs within the first 6weeks was 18%. After a mean follow-up of 15±6.5months, the median number of UTIs was 0 [0; 4]. The mean interval between two infectious episodes was 9±6.7months. Only one patient met the criteria for recurrent UTI. Febrile UTIs affected 7% of patients. CONCLUSION: Self-catheterisation has a low infectious morbidity, occurring mainly in the first few weeks after its introduction.

The rationale for bladder washouts in children with neurogenic bladder.

Children with a neurogenic bladder are at risk of developing recurrent urinary tract infections and long-term kidney failure. Due to an altered lower urinary tract, children may be overtreated for simple bacteriuria or undertreated for a potentially severe urinary tract infection. This group of patients represent high users of healthcare, and are at risk of colonization and development of antibiotic resistance. Bladder washouts with non-antibiotic electrochemically activated solutions are a potential new prophylactic option for patients with bladder dysfunction when clean intermittent catheterization has resulted in chronic bacteriuria.

Perspectives on technology: Single-use catheters - evidence and environmental impact.

OBJECTIVE: To explore the data comparing single- vs multi-use catheters for clean intermittent catheterisation (CIC), consider if the widespread use of single-use catheters is warranted given the cost and environmental impact, and put forth ideas for future consideration. METHODS: A primary literature review was performed in PubMed over the past 50 years. Studies that performed comparative analysis of single- and multi-use catheters were included in our review. All studies that reported on primary data were narratively summarised. RESULTS: A total of 11 studies were identified that reported on primary data comparing single- and multi-use catheters. There was no appreciable evidence suggesting reusable multi-use catheters were inferior to single-use catheters from an infection or usability standpoint. In addition, the environmental and monetary burden of single-use catheters is significant. CONCLUSIONS: The intermittent catheter landscape in the USA has a complex past: defined by policy, shaped by industry, yet characterised by a paucity of data demonstrating superiority of single-use over multi-use catheters. We believe that the aversion to reusable catheters by many patients and healthcare professionals is unwarranted, especially given the cost and environmental impact. Moving forward, better comparative data and more sustainable practices are needed.

Factors affecting clean intermittent catheterization compliance among children and adolescents with neurogenic bladder due to spina bifida and caudal regression syndrome.

INTRODUCTION: Children and adolescents with neurogenic bladder often need clean intermittent catheterization (CIC) over a long period. Our study aimed to identify factors that affect CIC compliance and to determine if CIC compliance affected short-term urological outcomes among patients in Malaysia. STUDY DESIGN: 50 patients aged 2-18 years who perform CIC were included in this cohort study. Patient compliance with CIC was evaluated using the validated Intermittent Catheterization Adherence Scale (ICAS). CIC difficulties were assessed using the validated Intermittent Catheterization Difficulty Questionnaire (ICDQ). Data was obtained on patients' co-morbidity, caregiver factors, socio-economic factors, CIC technique, access to catheters and facilities, urinary tract infections, incontinence, urology tests and treatment. Statistical analysis was performed. RESULTS: Mean age was 6.68 ± 4.34 years. 32 (64%) patients commenced CIC within the first month of life. Mean daily CIC frequency was 4.70 ± 1.33.30 (60%) participants showed strong adherence to CIC. 39 (78%) participants were able to catheterize with no or minor difficulties. Pain (6, 12%), transient blocking sensation (6.12%), and urinary incontinence (3, 6%) were the predominant difficulties encountered. CIC performed by caregiver was associated with improved adherence compared to patient self-catheterization (p = 0.039). The mean age of participants who self-catheterized was 10.7 ± 3.7 years. Strong adherence was also observed among patients who purchased their own CIC catheters (p = 0.007). Participants with lower ICDQ score were more likely to be compliant with CIC (p = 0.007). CIC adherence was not affected by patient's age, gender, co-morbidity, mobility, caregiver factors, socio-economic factors, and age at initiation of CIC. There was no significant association between CIC adherence and febrile urinary tract infections, upper tract deterioration, and bladder stones at 6 months follow-up. DISCUSSION: There is lower CIC adherence when a child begins to self-catheterize and healthcare providers should be alert during this period of transition. Though most patients with spina bifida have decreased urethral sensation, some patients do experience significant pain during CIC which may impact their compliance. These patients would need a review of their catheterization techniques to improve adherence. The limitations of our study are its modest sample size from a single center and short study period. Our study provides insights into the feasibility of instituting CIC in developing countries. CONCLUSION: Strong CIC adherence was observed among patients who were catheterized by their caregiver, purchased their own CIC catheters, and encountered minimal difficulties during catheterization. CIC adherence had no effect on short-term urological outcomes.

New micro-hole zone catheter reduces residual urine and mucosal microtrauma in a lower urinary tract model.

Urinary tract infections (UTIs) are the main complication associated with clean intermittent catheterization (CIC) and are facilitated by post-void residual urine and trauma to the mucosa during voiding. The risk of UTI may be diminished by reducing the residual volumes and preventing microtrauma caused by mucosal suction through the eyelets of conventional eyelet catheters (CEC). A new micro-hole zone catheter (MHZC) was developed and tested in an ex vivo porcine lower urinary tract model and in vivo, in pigs, against a CEC. It was shown that, irrespective of the micro-hole diameter, the new catheter ensured increased flowrates and significantly lower residual volumes at the first flow-stop. Furthermore, with a micro-hole diameter of 0.4 mm, mucosal suction was virtually eliminated, regardless of the insertion depth or simulated intra-abdominal pressure mimicking sitting or standing humans. Pressure profile experiments and endoscopy studies indicated that the bladder gradually folds against the drainage tip of the new catheter, without blocking the flow, and, unlike with the CEC, sharp pressure variations and flow-stops did not occur during voiding. The MHZC outperformed the CEC in all tested scenarios and decreased residual volumes, thus potentially decreasing the risk of UTIs.

Investigation of anxiety levels in caregivers who perform clean intermittent catheterization on their children and affecting factors.

PURPOSE: The study aimed to determine the anxiety levels of caregivers who performed clean intermittent catheterization (CIC) on their children and the factors affecting them. METHODS: This descriptive study was conducted between January 6, and May 29, 2023 with caregivers of 42 patients who were followed up by the pediatric nephrology outpatient clinic of a university for CIC. The study data were collected using the "Participant Information Form" and the "State and Trait Anxiety Scale." RESULTS: According to the results, of the children included in the study, 73.8% were female, 64.3% were diagnosed with spina bifida (SB), and 76.2% received CIC applications 4-6 times a day. All the caregivers were mothers, and 76.2% received CIC training from a doctor. However, 78.6% of them found the training insufficient, leading them to rely on self-experimentation when applying CIC to their own children. None of the caregivers received information or training on the CIC application from nurses, and there were no home visits or telephone counseling provided after the hospital discharge. The mean score for the state anxiety scale among the caregivers was 45.90 ± 10.57, while the mean score for the trait anxiety scale was 46.92 ± 8.43. Significantly higher mean trait anxiety scores were observed among caregivers with chronic diseases who did not receive training on the CIC application (p < 0.05). Additionally, caregivers of children who experienced 3-4 urinary tract infections (UTIs) within the last 3 months also had significantly higher mean trait anxiety scores (p < 0.05). The mean trait anxiety level scores of caregivers of children who had 3-4 UTIs in the last 3 months were significantly higher (p < 0.05). CONCLUSIONS: It was concluded that caregivers' lack of training on CIC implementation, having chronic disease, and having frequent UTIs in their children were effective on anxiety levels.

Improved emptying performance with a new micro-hole zone catheter in adult male intermittent catheter users: A comparative multi-center randomized controlled cross-over study.

AIMS: To confirm the improved performance of the micro-hole zone catheter (MHZC) compared to a conventional eyelet catheter (CEC) in male users of clean intermittent catheterizations (CICs). METHODS: Male self-catheterizing subjects, who used hydrophilic sleeved soft/flexible CIC as the only bladder emptying method, were enrolled into a multi-center, randomized, cross-over study performed across six European sites. Subjects tested the MHZC, featuring a drainage zone with 120 micro-holes and a CEC with two eyelets. The study consisted of four study visits (V0-V3), during which endpoints related to catheter performance (urinary flow-stops, bladder emptying, and intra-catheter pressure) were measured and two 4-week test periods at home (T1 and T2) where dipstick hematuria and user perception between catheters were evaluated. RESULTS: Seventy-three male subjects with non-neurogenic and neurogenic bladder dysfunction (3:2) were enrolled. On average, catheterizations with the MHZC led to close to mean zero flow-stops compared to ≥1 flow-stops with the CEC, during both HCP- and self-led catheterizations (both p < 0.001). Residual urine at first flow-stop was significantly reduced for the MHZC compared to CEC (p = 0.001 and p = 0.004, for HCP- and self-led catheterizations, respectively). This was substantiated by a significantly smaller pressure peak at first flow-stop, a proxy for minimized mucosal suction (both HCP- and self-led catheterizations, p < 0.001). After home-use catheterizations, dipstick hematuria was comparable between catheters, whereas catheterizations were associated with significantly improved perception in favor of MHZC regarding bladder emptying, less blocking sensation, and improved hygienic catheterization compared to the CEC. CONCLUSION: This study confirmed the evidence of improved bladder emptying with the MHZC compared to a CEC without the need to reposition the catheter. The MHZC therefore offers an enhanced benefit for the dependent CIC user securing complete bladder emptying in an uninterrupted free flow and reducing the need to reposition the catheter during emptying.

A consensus statement on when to start clean intermittent self-catheterization: An untapped resource?

BACKGROUND: Clean intermittent self-catheterisation (CISC or ISC) is used by patients/carers to empty the bladder if needed. Sometimes the urethral lumen leading out of the bladder is blocked; sometimes, the bladder (detrusor) muscle itself or the autonomic motor nerves innervating the bladder are damaged, resulting in a failure of the detrusor muscle to work, leading to a failure of the bladder being able to empty adequately. Prior consensus as to the indications and timing of CISC has yet to be provided. This article aims to provide a multidisciplinary consensus view on this subject. CONCLUSION: It is evident that every patient needs to be considered individually, bearing in mind the symptoms and investigations to be considered. We emphasise the importance of considering the term Bladder Voiding Efficiency (BVE). One group of patients who might find CISC helpful are those with a neurological disorder; these include spinal injury patients, multiple sclerosis, Parkinson's, and a condition called cauda equina. Sometimes bladder problems are treated with anticholinergics, and others may be treated with Botox. These may cause the bladder not to empty at all, which is good for leaks but needs self-catheterisation to empty the bladder. In the past, hospitals used a permanent catheter called an 'indwelling' or a 'suprapubic' catheter. These can have side effects, including infections, stones, and pain. For CISC, disposable catheters are the best option for patients as they come in different sizes and styles to provide individualised care. In conclusion, we would like hospitals to consider each patient separately and not use a general 'one-size-fits-all' bladder function for these patients.

Advances in clean intermittent self-catheterisation: impact on trauma and urinary tract infections.

Intermittent self-catheterisation with hydrophilic coated catheters carries the risk of trauma, bleeding and infection. However, evidence suggest that these risks can be minimised with a new generation of catheters that stay lubricated over time, allowing for comfortable and safe insertion and withdrawal.

Evaluation of Quality of Life and Self-reported Complications in Patients With Clean Intermittent Catheterization: An Observational Study.

PURPOSE: This study sought to determine health-related quality of life and self-reported complications associated with clean intermittent catheterization (CIC). DESIGN: Observational, cross-sectional study. SUBJECTS AND SETTING: The target population was patients cared for by the urology department at Hospital 12 de Octubre in Madrid, Spain, undergoing CIC for chronic urinary retention of any etiology (neurogenic bladder dysfunction, neobladder, and other). The sample comprised 50 respondents with a mean age of 49 years; a majority (66%, n = 33) were female. Participants performed an average of 4 CICs. METHODS: All participants completed the ISC-Q (Intermittent Self-Catheterization Questionnaire) and a questionnaire about CIC-associated complications. Data were collected in February 2019. RESULTS: A vast majority of respondents (98%, n = 49) indicated preparation for catheterization was simple, and 76% (n = 38) indicated the catheter was easy to insert. One in 5 (20%, n = 10) considered carrying catheters and supplies inconvenient, though 58% (n = 29) indicated it was easy to dispose of the catheters outside the home. Most respondents (98%, n = 49) indicated they felt self-conscious about their need to self-catheterize, and 16% (n = 8) felt that CIC created limitations when visiting friends and family. The most frequent complication was symptomatic urinary tract infections (UTIs); participants reported an average of 1.7 UTIs in the last year. Additional complications, such as epididymo-orchitis, urethral stenosis, and urethral bleeding, were reported by less than 5% (n = 2) of participants. CONCLUSIONS: Participants managed by CIC for chronic urinary retention of any cause reported acceptable levels of satisfaction with the procedure. The reported incidence of complications was low, except for UTIs.