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Specially Covered Intermittent Catheters for Preventing UTI

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Different coatings have been applied to catheters to minimize various complications associated with catheterization and neurogenic bladder and Table 25 outlines studies investigating the effect of hydrophilic catheters on UTI prevention.

Table 24 Intermittent Catheterization using Specially Coated Catheters for Preventing UTI

Author Year

Country
Research Design
Score
Total Sample Size

MethodsOutcome
Cardenas et al. 2011

USA

RCT

PEDro=5

N=224

Population: Treatment group: mean age: 37.2 yr; males=177, females=47, ASIA scale A=62%, B=18%, C=11%, D=11%; time post-injury=32 d.

Control: mean age: 35.1 yr; male=82%, female=18%; ASIA scale: A=68%, B=10% C=19%; D=3%; time post-injury=29 d.

Intervention: Intermittent catheterization with hydrophilic coated catheter

Outcome Measures: Symptoms of urinary tract infection (UTI), treatment of antibiotics to prevent UTI, urolithiasis.

1.     The time of first symptomatic UTI is significantly delayed in the treatment group (p=0.038). The decrease in daily risk of developing first UTI in the treatment group is 33%.

2.     The incidence of UTI in treatment was reduced by 21% of treatment group. There is a significant difference presence of microhematuria (p<0.0001) between the two groups.

3.     Overall there is a significant higher satisfaction rate reported by caregivers and participants in the treatment group (p=0.007). However, nurses reported no significant differences in overall satisfaction of the 2 catheters group

Cardenas & Hoffman 2009

USA

RCT

PEDro=5

N=56

Population: Treatment Group: Mean age: 42.3 yr; Gender: males=17, females=5; Level of injury: Tetraplegia=5, Paraplegia=17; Severity of Injury: AIS C4-C8 A=2, C4-C8 B-D=3, T6-L5: grade A=13, T6-L5: grade B-D=4; Control Group: Mean age: 40.1 yr; Gender: males=12, females=11; Level of injury: Tetraplegia=12, Paraplegia=11; Severity of injury: AIS C4-C8: grade A=8, C4-C8: grade B-D=4, T6-L5: grade A=5, T6-L5: grade B-D=6

Intervention: Individuals were randomly assigned to either the hydrophilic catheter or the noncoated catheter control group. Urine from these individuals was collected once a mo for first 3 mo and then at 6, 9 and 12 mo mark.

Outcome Measures: Urinary tract infection (UTI).

1.     At least 1 symptomatic UTI was seen over the course of 1 yr for 12 individuals in the hydrophilic catheter group and 14 of the control group.

2.   The hydrophilic catheter group had a mean of 1.18 UTIs, while the control group had 1.

3.   No significant difference was seen between the two groups in the number of symptomatic UTIs and type of symptoms.

4.   There was a significant number of symptomatic UTIs treated in the group using hydrophilic catheters (p=0.02).

5.   Females were more likely to develop UTIs regardless of catheter type.

De Ridder et al. 2005

Spain

RCT

PEDro=5

N=123

Population: SCI using hydrophilic versus polyvinyl chloride catheter (PVC): Mean age: 37.5 yr versus 36.7 yr; Severity of injury: AIS A-D.

Intervention: “SpeediCath®” hydrophilic catheters versus conventional uncoated PVC catheter for intermittent catheterization (IC).

Outcome Measures: Occurrence of symptomatic urinary tract infections (UTIs), hematuria, strictures, convenience of use, satisfaction with catheter, dropout rate. Data collected over a 12 mo period.

1.   Lower incidence of UTIs of those using SpeediCath hydrophilic versus PVC (p=0.02).

2.   No difference in number of bleeding episodes or occurrence of hematuria, leukocyturia and bacteriuria between 2 catheters.

3.   More individuals expressed greater satisfaction with various aspects of the hydrophilic catheter, although these differences were not significant.

4.   54% dropout rate (slightly more so in hydrophilic group) partially due to the fact that many subjects no longer needed to catheterize when bladder function was retained within the 1 yr period.

Vapnek et al. 2003

USA

RCT

PEDro=6

Ninitial=62; Nfinal=49

Population: Complete Available Data: Male SCI individuals: Hydrophilic Catheter Group: Mean age: 39.8 yr; Level of injury: paraplegia=25, tetraplegia=4; Polyvinyl chloride catheter (PVC) group: Mean age: 39.6 yr; Level of injury: paraplegia=26, tetraplegia=1.

Intervention: SCI individuals were randomly placed in either the hydrophilic coated plastic LoFric catheters or standard polyvinyl chloride catheter (PVC) group.

Outcome Measures: Urinary tract infections (UTIs), degree of microscopic hematuria and pyuria, incidence of adverse events were all assessed at baseline and every 3 mo for 1 yr.

 

 

Urinary tract infections:

1.     Baseline: – mean incidence of monthly UTI’s was higher for the hydrophilic catheter (HC) group than for the PVC/control group (0.45±0.62 and 0.20±0.26 per individual respectively (p>0.3))

2.     Study Conclusion: – still no significant difference between HC and PVC group for mean # of UTI’s/mo (0.13±0.18 and 0.14±0.21 per individual resp. (p>0.3))

3.     ↓ in UTI rate per mo was significantly higher for HC group than for PVC group (0.44 to 0.14 or -0.3 versus 0.20 to 0.14 or -0.06 per individual), and was statistically significant in the HC group (p=0.012 versus 0.24)

Microscopic Hematuria:

1.     Baseline: – dipstick analysis showed some degree of hematuria in 8 of the 30 individuals from the HC group and 11 of the 31 from the PVC group (no statistically significance difference)

2.     During study – HC group showed a significantly ↓ incidence of microhematuria (p=0.027) (mean code per urinalysis for HC versus PVC (0.31±0.46 and 0.65±0.69 respectively)

Microscopic Pyuria:

1.     Baseline: – number of individuals were similar from both groups (HC – 19 of 30 versus PVC – 22 of 31 respectively.)

2.     Follow-up – no differences

Adverse Events:

1.     HC group – 1 gross hematuria, 1 epididymitis, 1 infected penile prosthesis requiring hospitalization and surgical removal (neurogenic bladder, unrelated to intermittent catheterization).

2.     PVC group – 1 gross hematuria, 1 epididymitis, 1 bladder stone surgically removed (neurogenic bladder, unrelated to intermittent catheterization).

Giannantoni et al. 2001 Italy

RCT

PEDro=9

N=18

Population: SCI: Mean age: 38.2 yr; Level of injury: C5-Cauda Equina; Severity of injury: AIS A-D; Time post-injury=18-60 d.

Intervention: Comparison of “Instacath®” pre-lubricated nonhydrophilic catheter versus conventional uncoated polyvinyl chloride (PVC) Nelaton catheter for intermittent catheterization (IC) (crossover design).

Outcome Measures: Symptomatic urinary tract infection (UTI) incidence of urethral complications (ultrasound, Cystourethrography (CUG)), urinalysis, visual analog scale of individual satisfaction. Collected at the start and end of 7 wk study period.

1.   Lower incidence of UTIs (p=0.03) and asymptomatic bacteriuria (p=0.0244) of those using pre-lubricated catheters versus PVC.

2.   More epithelial cells found on conventional versus pre-lubricated catheter (p=0.01) indicative of possible microtrauma.

3.   2 people had urethral bleeding with conventional catheter, 0 with pre-lubricated.

4.   Pre-lubricated catheters had significantly higher satisfaction scores for 4 of 5 items on the scale.

5.   3 subjects requiring assistance with the conventional catheter became independent with the pre-lubricated catheter (order effect unreported)

6.   No subject had impaired renal function of upper & lower tract abnormalities with either catheter.

Discussion

Another approach used to reduce the incidence of UTI associated with catheterization in patients with neurogenic bladder involves the application of coatings to the catheter (Giannantoni et al. 2001; Vapnek et al. 2003; De Ridder et al. 2005; Cardenas & Hoffman 2009; Cardenas et al. 2011). For example, Giannantoni et al. (2001) employed a double-blind, crossover RCT design (n=18) to examine the difference between a pre-lubricated, nonhydrophilic Instantcath catheter as compared to a conventional polyvinyl chloride (PVC) silicon-coated Nelaton catheter with respect to the occurrence of UTIs and urethral trauma. The subjects were randomized to 1 of 2 groups which tried each catheter for a period of 7 weeks in an A-B, B-A design. Both incidence of UTIs (p=0.3) and presence of asymptomatic bacteriuria (p=0.024) were significantly reduced for the pre-lubricated catheter versus the conventional PVC catheter. Perhaps most interesting, three subjects requiring assistance with the conventional catheter became independent with the pre-lubricated catheter, although it was not reported if these individuals were in the group using the conventional catheter initially or lastly. The existence of an order effect (or not) for any of the measures was not reported. In terms of general satisfaction with use, subjects rated the pre-lubricated catheter significantly higher than the conventional catheter with respect to comfort, ease of inserting and extracting, and handling.

A similar finding of reduced incidence of UTIs (p=0.02) was reported by De Ridder et al. (2005), but in this case the reduction was associated with a hydrophilic catheter as compared to the conventional PVC catheter. This multi-centre investigation also employed a RCT design (N=123) but had several methodological problems that likely constrained the potential utility of the results. Most significant was a high drop-out rate (54%) with slightly more individuals not completing the study from the hydrophilic catheter group. A probable cause for many of these drop-outs was the lengthy treatment period of 1 year during which many individuals were likely to improve bladder function such that intermittent catheterization was no longer required. There were no other significant differences noted between the two groups including the number of bleeding episodes or occurrence of hematuria, leukocyturia and bacteriuria. More individuals expressed greater satisfaction with various aspects of the hydrophilic catheter, although these differences were also not significant. A reduced incidence of hematuria and a significant decrease in UTI incidence was also reported by Vapnek et al. (2003), when hydrophilic versus non-hydrophilic catheter use was compared in a 12 month study of 62 patients (n=49 completed).

Reduced numbers of treated UTIs were reported by Cardenas and Hoffman (2009) with the use of hydrophilic catheters versus standard nonhydrophlic catheters even though no difference was reported between the 2 groups of self-IC SCI patients for number of symptomatic UTIs. Furthermore, lubrication was more beneficial for men since women on self-IC were more likely to develop UTIs regardless of catheter type. Although this study may have been underpowered, it is important to note that the drop out rate was just under 20% as compared to almost 54% in the DeRidder et al. (2005) study with only 57/123 subjects remaining at the end of year 1. Cardenas and Hoffman (2009) also included women which allowed for potential gender differentiation in the effect of hydrophilic catheter use. Although females accounted for 29% of the participants, a sample size of should invoke caution when interpreting the data.

More recently, Cardenas et al. (2011) showed that time to the first antibiotic-treated symptomatic UTI in acute SCI patients (less than 3 months injured for inclusion) could be delayed by opting for a hydrophilic coated catheter as compared to an uncoated catheter. However effects disappeared when first months after institutional discharge were included in the analysis. Participants and/ or caregivers reported significantly higher satisfaction (P=0.007) with the hydrophilic coated catheter versus the uncoated however no differences were found in a similar evaluation by nursing staff. This is largest RCT to date on this topic.

Conclusion

There is level 1b evidence (from one RCT; Giannantoni et al. 2001) that, compared to conventional poly vinyl chloride catheters, pre-lubricated non-hydrophilic catheters are associated with fewer UTIs and reduced urethral bleeding.

There is level 2 evidence (from one RCT; De Ridder et al. 2005) that, compared to conventional poly vinyl catheters, hydrophilic catheters may be associated with fewer UTIs, but not necessarily urethral bleeding.

There is level 2 evidence (from two RCTs; Cardenas & Hoffman 2009; Cardenas et al. 2011) that use of hydrophilic versus non-hydrophilic catheters are associated with fewer symptomatic UTIs treated with antibiotics even though the number of symptomatic UTIs are similar between groups.

A reduced incidence of UTIs or reduced antibiotic treatment of symptomatic UTIs have been associated with pre-lubricated or hydrophilic catheters as compared to standard non-hydrophilic catheters.