Medical Affairs: Continence Care

Medical Affairs Continence Care

Introduction to Continence Care

Bladder emptying (or urine retention) is a problem for some patient groups, including patients suffering from lower urinary tract dysfunctions (LUTD). The affected bladder is characterized as either a neurogenic bladder (NLUTD, typically seen in clinical conditions such as spinal cord injury (SCI), spina bifida (SB), multiple sclerosis (MS) or other neuro degenerative diseases) or a non-NLUTD (caused by non-urological causes such as anatomical malformations, prostatic or bladder cancer or benign prostate hypertrophy). In these populations, bladder emptying can be performed by various methods such as indwelling catheter, suprapubic catheter, reflex voiding or by clean intermittent catheterization (CIC) as introduced by Lapideset al 1978.¹ Intermittent catheterization is recommended for people who are able to self-catheterize.³ Several different techniques and types of catheters exist.⁴

Impact of Catheter Features on Clinical Outcomes

Access to the right intermittent catheter can be critical for clinical success; however, choosing the right intermittent catheter is complex.^4-7 Figure 1 reflects the number of considerations to make the right catheter choice. These include clinical condition, patient factors, and catheter features.^4-7

Figure 1. Complexity of Catheter Choice

Intermittent catheter choice is individualized to meet the needs of the patient’s clinical condition. For instance, patients with a spinal cord injury have various intermittent catheter needs, related to the level and completeness of injury, presence of spasticity, and need for a wheelchair. Therefore, features that should be considered could be greater firmness, ready-to-use, collection bag attached, packaging that is easy to open, a gripper and/or protective sleeve, and hydrophilic coating or pre-lubrication. These features are related to the possibility of reduced or impaired hand function and mobility and an increase of infections. Table 1 lists patient needs for specific catheter features with the clinical rationale.

Table 1. Individualized patient needs correlate to specific catheter features supported by clinical rationale.

Clinical Condition

Patient Needs

Clinical Rationale

Catheter Feature

Spinal Cord Injury

Personalized based on level and completeness of injury
Accessibility from wheelchair in multiple scenarios
Difficult passing catheters due to spasticity
Increased risk of infection, such as UTI/urosepsis

Reduced/impaired hand function and mobility
Increase risk of infections

Greater firmness
Ready-to-use (no activation)
Attached to collection bag
Easy to open packaging
Gripper and/or protective sleeve
Hydrophilic coating or pre-lubricated

Spina Bifida

Compliance with catheterization schedule as they transition into adulthood, including college/work/family life

Minimizing adverse events and maintaining urethral integrity to support lifelong catheterization

Discreet
Hydrophilic coating or pre-lubricated

Multiple Sclerosis

Bladder management needs fluctuate with disease progression
Prevent negative sequalae associated with poor bladder management

Reduced or impaired mobility
Impact neurological functions, including hand dexterity and body instability

Discreet
Ready-to-use (no activation)
Protective sleeve
Hydrophilic coating or pre-lubricated

Benign Prostatic Hyperplasia

Accessibility through narrowed urethra and enlarged prostate
Possible spastic sphincters

Prostate enlargement narrows urethra

Coudé tip with flexibility
Protective sleeve
Hydrophilic coating or pre-lubricated

Diabetes

Enhance compliance
Reduce risk of infection, such as UTI/renal failure/urosepsis

More ambulatory
Increased risk of infections
Multiple neuro comorbidities with advancing hand dexterity

Discreet
Introducer tips
Hydrophilic coating
Sterile kit (attached to collection bag)

Parkinson's

Decreased bladder control with disease progression
Tangential loss of dexterity
At risk of falls (most commonly in the bathrooms)

Hand tremors and reduced dexterity
Declining stability and mobility

Greater firmness
Ready-to-use (no activation)
Attached to collection bag
Easy to open packaging
Hydrophilic coating or pre-lubricated

Bladder Cancer

Increased risk of infection, such as UTI/urosepsis
Easy to catheterize in multiple situations

Active chemotherapy reduces immune system
More ambulatory

Discreet
Sterile closed kits
Ready-to-use (no activation)
Attached to collection bag
Hydrophilic coating

Clinical complications associated with clean intermittent catheterization (CIC)

Long term users of CIC are at a risk for potential complications. Factors such as improper hygiene, incomplete bladder emptying, non-compliance with bladder management regimen, inappropriate catheter choice, insufficient lubrication may contribute to increased risk of complications.⁸ These complications could arise in the urethra (such as bleeding, false passage) or the bladder itself (such as stones). A comprehensive list of potential complications is outlined below. Despite potential for these complications, CIC is the preferred method of bladder emptying for long term bladder management.

Table 2. Complications Associated with Clean Intermittent Catheterization

Anatomical structure	Complication	Causes
Urethra	Urethral bleeding or hematuria	Tears or injury of the urethra that are seen during the first months of intermittent catheterization due to lack of technical expertise⁹; bleeding in long-term patients may be a sign of other issues, including UTI
	Urethral strictures	Repeated catheterization may result in inflammation and secondary, traumatic strictures¹⁰
	False passage	Tract that is created when a catheter is inserted through the urethral wall rather than the lumen
Scrotum or testes	Epididymitis (Epididymorchitis)	A rare inflammation or infection of the epididymis of testes; common in men with urethral strictures
Bladder	Bladder stones	Residual urine is the primary cause of bladder stone; kidney stones entering the bladder; introduction of pubic hair, or loss of the catheter, perforation, residual urine, or necrosis of the bladder that surrounded by salt crystals to create a stone¹¹
	Urinary tract infections (UTIs)	Bacteria introduced into the urinary tract and bladder with catheter insertion; urethral or bladder trauma from catheter; post-void residual urine from early catheter removal or catheter inserted too far into the bladder³

Urethral Trauma

One of the key outcomes, where hydrophilic catheters are speculated to make a difference, is in relation to urethral trauma and microhematuria. The hydrophilic technology adds a smooth wetted surface to the catheter and the ability to impose lower friction force during catheterization, designed to reduce risk of micro strictures and to protect the fragile mucosal lining of the urethra.

One of the main challenges in evaluating urethral microtrauma is the lack of standardization of the outcomes, although the most common being hematuria. Indication of blood in urine, urethral inflammatory response (such as leukocyte counts) are other outcome measures. Even within the measured outcomes, varying methodology and threshold levels across studies pose an ongoing challenge. Here, we present the individual study data focused on friction force and hematuria.

Table 3. Literature associated with urethral trauma and associated hematuria.

*Click on the quote for further study analysis and the reference for connection to PubMed.*
“Use of the hydrophilic coated catheter by patients on intermittent catheterization is associated with less hematuria…”	Vapnek et al. J Urol. 2003¹²
“Hydrophilic-coated catheters perform better than uncoated catheters with regard to haematuria…”	Stensballe et al. Eur Urol. 2005¹³
“There was no significant difference in the number of patients experiencing macroscopic bleeding episodes and no overall difference in the occurrence of hematuria, leukocyturia, and bacteriuria.”	DeRidder et al. Eur Urol. 2005¹⁴
“The difference in the presence of microhematuria between the two groups was statistically significant (p=0.0001) in favor of the hydrophilic-coated catheter.”	Cardenas et al. PM R. 2011⁹
“No significant differences were seen in urethral injury, hematuria, or difficulty passing the catheter.”	DeFoor et al. J Pediatr Urol. 2017¹⁵

Urinary Tract Infections (UTIs)

Urinary tract infections (UTIs) are a risk for patients performing intermittent catheterization.³ Because the risk is lower with the use of intermittent catheters than for indwelling catheters in neurogenic lower urinary tract dysfunction, the American Urological Association (AUA) and Society of Urodynamics Female Pelvic Medicine and Urological Reconstruction (SUFU) guidelines recommend intermittent catheterization over indwelling catheters if the patient is able to self-catheterize.¹⁶ On average, a CIC user will experience 0.75 to 2.7 UTIs/year, which is significantly higher than the average population (internal Coloplast studies). Three main reasons for the elevated UTI risk are the introduction of bacteria into urethra, damaging of the epithelial cells (micro trauma) of the urethra, weakening the defensive mechanisms and finally incomplete bladder emptying leading to residual urine allowing growth of leftover bacteria which may cause permanent bacteriuria (Figure 2).³ Long term sequalae of UTI include frequent recurrences, pyelonephritis, urosepsis, renal failure and high-level antibiotic resistance (due to prolonged antibiotic consumption, making UTI a major cause of morbidity in patients with NLUTD.^17,18,19

Figure 2. Graphic From: Kennelly M, Thiruchelvam N, Averbeck MA, Konstatinidis C, Chartier-Kastler E, Trøjgaard P, Vaabengaard R, Krassioukov A, Jakobsen BP. Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections. Adv Urol. 2019 Apr 2;2019:2757862. doi: 10.1155/2019/2757862. PMID: 31065264; PMCID: PMC6466920.

Due to the known impact of UTIs on the healthcare system, catheter features have been developed to decrease the occurrence of this clinical complication. One of these features includes hydrophilic coating. Notably, the importance of hydrophilic catheters has been recently highlighted in the American Urological Association guidelines.¹⁸

Here, we present the individual randomized, controlled studies, which specifically look at the impact of hydrophilic coated CIC on UTIs.

Table 4. Literature associated with urinary tract infections (UTIs)

*Click on the quote for further analysis and the reference for connection to PubMed*
“Use of the hydrophilic coated catheter by patients on intermittent self-catheterization is associated with … a significant decrease in the incidence of UTIs."	Vapnek et al. J Urol. 2003¹²
“… there is a beneficial effect regarding UTI when using hydrophilic-coated catheters.”	DeRidder et al. Eur Urol. 2005¹⁴
“…hydrophilic catheter usage was associated with reduced numbers of treated UTIs as compare with standard non-hydrophilic catheters in person with spinal cord injury who used self-intermittent catheterization…”	Cardenas et al. PM R. 2009²⁰
“The use of hydrophilic-coated catheter for intermittent catheters is associated with a delay in the onset of the first antibiotic-treated symptomatic UTI and with a reduction incidence of symptomatic UTI in patients with acute SCI during the acute inpatient rehabilitation.”	Cardenas et al. PM R. 2011⁹
“[Hydrophilic Catheters] may decrease the risk of UTI in children with [neurogenic bladder].”	DeFoor et al. J Pediatr Urol. 2017¹⁵

Literature cited

Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean, intermittent self-catheterization in the treatment of urinary tract disease. The Journal of urology. 1972;107(3):458-461.
Wyndaele JJ. Complications of intermittent catheterization: their prevention and treatment. Spinal Cord. 2002;40(10):536-541.
Kennelly M, Thiruchelvam N, Averbeck MA, et al. Adult Neurogenic Lower Urinary Tract Dysfunction and Intermittent Catheterisation in a Community Setting: Risk Factors Model for Urinary Tract Infections. Adv Urol. 2019;2019:2757862.
Newman DK, New PW, Heriseanu R, et al. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020;52(8):1443-1451.
Goetz LL, Droste L, Klausner AP, Newman DK. Catheters Used for Intermittent Catheterization. In: Clinical Application of Urologic Catheters, Devices and Products.2018:47-77.
Newman DK, Willson MM. Review of intermittent catheterization and current best practices. Urologic nursing. 2011;31(1):12-28, 48; quiz 29.
Newman DK. Teaching Tool: Methods and Types of Urinary Catheters Used for Indwelling or Intermittent Catheterization. Urologic Nursing. 2021;41(2).
Herter R, Kazer MW. Best Practices in Urinary Catheter Care. Home Healthcare Now. 2010;28(6):342-349.
Cardenas DD, Moore KN, Dannels-McClure A, et al. Intermittent catheterization with a hydrophilic-coated catheter delays urinary tract infections in acute spinal cord injury: a prospective, randomized, multicenter trial. PM R. 2011;3(5):408-417.
Engberg S, Clapper J, McNichol L, Thompson D, Welch VW, Gray M. Current Evidence Related to Intermittent Catheterization: A Scoping Review. J Wound Ostomy Continence Nurs. 2020;47(2):140-165.
Vapnek JM, Maynard FM, Kim J. A prospective randomized trial of the LoFric hydrophilic coated catheter versus conventional plastic catheter for clean intermittent catheterization. J Urol. 2003;169(3):994-998.
Stensballe J, Looms D, Nielsen PN, Tvede M. Hydrophilic-coated catheters for intermittent catheterisation reduce urethral micro trauma: a prospective, randomised, participant-blinded, crossover study of three different types of catheters. Eur Urol. 2005;48(6):978-983.
De Ridder DJ, Everaert K, Fernandez LG, et al. Intermittent catheterisation with hydrophilic-coated catheters (SpeediCath) reduces the risk of clinical urinary tract infection in spinal cord injured patients: a prospective randomised parallel comparative trial. Eur Urol. 2005;48(6):991-995.
DeFoor W, Reddy P, Reed M, et al. Results of a prospective randomized control trial comparing hydrophilic to uncoated catheters in children with neurogenic bladder. J Pediatr Urol. 2017;13(4):373 e371-373 e375.
Ginsberg DA, Boone TB, Cameron AP, et al. The AUA/SUFU Guideline on Adult Neurogenic Lower Urinary Tract Dysfunction: Treatment and Follow-up. J Urol. 2021;206(5):1106-1113.
Biering-Sorensen F. Urinary tract infection in individuals with spinal cord lesion. Curr Opin Urol. 2002;12(1):45-49.
B. Blok JP, D. Castro-Diaz,, G. del Popolo JG, R. Hamid, G. Karsenty, T.M. Kessler, Guidelines Associates: R. Boissier HE, B. Padilla Fernández TG, L. ‘t Hoen, S. Musco, V. Phé,, Schneider MP. EAU Guidelines on Neuro-urology. European Association of Urology. 2016.
Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269-284.
Cardenas DD, Hoffman JM. Hydrophilic catheters versus noncoated catheters for reducing the incidence of urinary tract infections: a randomized controlled trial. Arch Phys Med Rehabil. 2009;90(10):1668-1671.

The materials and resources presented are intended to be an educational resource and presented for general information purposes only. They are not intended to constitute medical or business advice or in any way replace the independent medical judgment of a trained and licensed physician with respect to any patient needs or circumstances. Please refer to product ‘Instructions for Use’ for intended use and relevant safety information. Considerations, techniques, practice, use, and outcomes may vary based on clinical practice and judgment.

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