Bladder Management

Comparison of Intermittent Catheterization Catheter Types

Table 13. Comparison of Intermittent Catheterization Catheter Types

Author Year Country Research Design Score Total Sample Size	Methods	Outcome
Bermingham et al. 2013 UK Systematic Review AMSTAR=8 N=8 studies	Population: Vapnek et al. 2003 (n=62): Mean age: 40 yr; Gender: males=62, females=0. Cardenas et al. 2009 (n=56): Mean ag=41 yr; Gender: males=29, females=27. De Ridder et al. 2005 (n=123): Mean age: 37 yr; Gender: males=123, females=0. Sutherland et al. 1996 (n=33): Mean age: 12 yr; Gender: males=33, females=0. Pachler et al. 1999 (n=43): Mean age: 71 yr; Gender: males=43, females=0. Giannantoni et al. 2001 (n=18): Mean age: 38 yr; Gender: males=16, females=2. King et al. 1992 (n=46): Mean age: 29 yr; Gender: males=40, females=6. Duffy et al. 1995 (n=80): Mean age: 72 yr; Gender: males=80, females=0. Treatment: A cost effective analysis using a probabilistic Markov model to compare lifetime costs and quality adjusted life years (QALYs) for gel reservoir catheters and clean non-coated self-catheters. Relevant articles were retrieved through a literature search from Medline, Embase, Cochrane, and Cinahl from 2002 to April 2011. Outcome Measures: Symptomatic urinary tract infection (UTI), cost effectiveness.	1. Individuals using gel reservoir and hydrophilic catheters were significantly less likely to report one or more UTIs compared with sterile non-coated catheters (p=0.04). 2. When measured as monthly UTIs (p=0.84) or UTIs per yr (p=0.60), there was no significant difference between hydrophilic and sterile non-coated catheters. 3. There was little difference in the incidence of one or more UTIs for people using clean versus sterile non-coated catheters (p=0.86). 4. Gel reservoir catheters are not cost-effective compared to clean non-coated self-catheters.
Chartier-Kastler et al. 2013 France RCT crossover PEDro=8 N=103	Population: SCI: Mean age: 53.8 yr (range 22.6-87.5 yr); Etiology of injury: traumatic SCI=53), spinal tumor=4, spina bifida=3, MS=19, other=39; Time post-injury: 13.3 yr (range 0.9-47 yr); Severity of injury: complete paraplegia=33, incomplete paraplegia=38, complete tetraplegia=3, and incomplete tetraplegia=9, unsure=33. Intervention: Effectiveness of a compact catheter versus a standard catheter evaluated in a 2 wk crossover trial. Outcome Measures: Intermittent self-catheterization questionnaire (quality of life); Visual Analogue Scale (VAS)	1. Intermittent catheterization questionnaire score increased significantly with compact catheter use (p<0.001). There was a mean difference of 17±1.8 points between the compact and standard intermittent catheters. 2. The compact catheter was preferred over a standard catheter by 67/106 (63%) individuals (p=0.007). 3. Mean VAS satisfaction score was significantly different in favour of the compact catheter (p=0.037).
Costa et al. 2013 United States RCT crossover PEDro=7 N=81	Population: Male SCI individuals: Mean Age: 38.4 yr; Reason for intermittent catheterization: SCI (n=79), Other (n=2) Intervention: Subjects were randomized into groups for use of Apogee hydrophilic catheters in one of two lengths: 1) 30 cm-test size, or 2) 40 cm-control size. Subjects then crossed over to other arm. Outcome Measures: Ease of use, and catheter preference.	1. Subjects preferred the control catheter (91.4%) to the test catheter (8.6%). 2. Preference for the control catheter was due to complete bladder emptying (70%), satisfactory length (74%), ease of draining into a receptacle (58%) with portable urine being the most utilized (37%), followed by toilet (35%).
Denys et al. 2012 France RCT crossover PEDro=7 N=97	Population: SCI: Median age: 46 yr (range 19-64 yr); Median duration of intermittent catheterization: 11 yr (range 0.33-52 yr); Injury etiology: SCI=57.7%, multiple sclerosis=25.8%, spina bifida=4.1%, other=12.4%. Intervention: Subjects were randomized into two groups to use either 1) a “no-touch’ VaPro hydrophilic catheter, or 2) a standard convention catheter, for intermittent catheterization over 15 days. Subjects were then crossed to the other arm. Outcome Measures: Questionnaire evaluating individuals’ experiences before the start of the trial and after each 15 d period of catheter use.	1. More than 50% of individuals would recommend the VaPro Catheter. 2. More than 75% of individuals felt confident and more secure with the new catheter.3. More men than women preferred the VaPro catheter (p=0.030).
Chartier-Kastler et al. 2011 France RCT crossover PEDro=8 N=36	Population: Male SCI individuals: Median age: 43.2 yr (range 20-70 yr); Median time using catheters: 39 mo. (range 1-219 mo); Median number of catheters used per day: 6. (range 4-10 d); Etiology of injury: traumatic=24, non-traumatic=12; severity of injury: complete tetraplegia=3, incomplete tetraplegia=6, complete paraplegia=4, incomplete paraplegia=22, unknown=1; AIS score: A=7,19.4%, B=5,13.9%, C=8, 22.2%, D=16, 45.5%. Intervention: Participants were randomized to either a standard coated catheter or a single-use compact coated catheter and switched at crossover. Outcome Measures: Visual Analogue Scale (VAS) for discomfort, ease of use, discretion, degree of pain, stinging or resistance.	1. The compact catheter did not have more discomfort than the standard-length catheter, however there were significant differences between participants from different countries in comfort levels (p=0.0315). 2. Significant difference in favour of the compact catheter for discretion, carrying and disposal (p<0.0001). 3. The standard catheter had significantly higher mean degrees of resistance than the compact catheter (p=0.0273). 4. No difference was observed between the catheters with pain and stinging (p=0.6831)
Domurath et al. 2011 Germany RCT crossover PEDro=8 N=37	Population: Male SCI individuals: Mean age: 40 yr (range 21-66 yr); AIS: A =20, B=9, C=3, and D=5; Mean duration of intermittent catheterization: 88.76 mo (range 2-264 mo). Intervention: Evaluate the performance of SpeediCath Compact catheter (30-cm) versus control catheter in a crossover trial. Outcome Measures: Residual Urine (RU) Volume; subject evaluation of their experience, sensation, disposal, bleeding and discomfort with the test and control catheters, final catheter preference.	1. The two catheters did not differ in bladder emptying performance, and the test catheter was no less inferior by RU volume to the control catheter.
Sarica et al. 2010 Turkey RCT PEDro=5 N=25	Population: Mean age: 37.04 yr; Males=18+yr, injury<6 mo, Severity of Injury: ASIA scale-A=8, B=6, C=7, D=4; Level of injury: paraplegia=21, tetraplegia=4 Intervention: Subjects were randomized into one of three groups for the use of 1) hydrophilic catheters, 2) gel-lubricated standard catheters, or 3) standard polyvinyl chloride catheters (PVC) for intermittent catheterization (IC). Outcome Measures: Incidence of urinary tract infections (UTIs), presence of microhematuria, adverse events.	1. No significant differences in the frequency of UTI among types of catheter were reported (p<0.05). 2. The gel lubricated and the hydrophilic catheter received higher individual satisfaction vs. PVC (p<0.05). 3. The gel lubricated catheter found to be superior to hydrophilic and PVC catheters in terms of urethral microtrauma, pyuria and satisfaction. 4. Cost of intermittent catheterization was higher compared to PVC catheters.
Biering-Sorensen et al. 2007 Denmark RCT crossover PEDro=6 N=24	Population: Female SCI individuals: Mean age: 44 yr (range 19-64 yr); Severity of injury: paraplegia=20, tetraplegia=4; Mean duration of intermittent catheterization (IC) use: 8.3 yr (range 4 mo to 23 yr); Mean number of catheterizations per day: 5.5 (range 2-9). Intervention: Participants were randomized to one of two catheters 1) SpeediCath Compact or 2) reference catheter. Subjects then switched to the other arm. Outcome Measures: Residual urine (RU) volume, length and handling of the SpeediCath Compact catheter.	1. There was no difference between the catheters in RU volume. 2. 23/24 (95.83%) found handling the SpeediCath compact catheter easy and their satisfaction was either satisfactory or very satisfactory.
De Ridder et al. 2005 Spain RCT PEDro=5 N=123	Population: SCI individuals using hydrophilic versus peripheral venous catheter (PVC): Mean Age: 37 yr; Gender: males=123, females=0; Severity of injury: AIS: A-D. Intervention: SpeediCath® hydrophilic catheter versus conventional uncoated PVC catheter for intermittent catheterization (IC) over 12 mo. Outcome Measures: Occurrence of symptomatic urinary tract infection (UTIs), hematuria, strictures, convenience of use/satisfaction with catheter at 6 and 12 mo.	1. Lower incidence of UTIs in 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 groups. No significant difference in satisfaction. 3. 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 regained within the 1 yr period.
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: Subjects were randomized into two groups to use either 1) Instacath® non-hydrophilic pre-lubricated catheter or 2) conventional uncoated Nelaton polyvinyl chloride catheters (PVC) for intermittent catheterization (IC). Subjects then crossed over to the other arm. Outcome Measures: Symptomatic UTI and asymptomatic bacteriuria, incidence of urethral complications (bleeding and urethral cell counts), visual analog scale of individual satisfaction.	1. Lower incidence of UTIs (p=0.03) and asymptomatic bacteriuria (p=0.0244) of those using pre-lubricated catheters versus PVC. 2. Fewer epithelial cells found on pre-lubricated catheter versus conventional (p=0.01), reported to be indicative of a 2-fold reduction of 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 and lower tract abnormalities with either catheter.
Waller et al. 1997 Sweden RCT PEDro=7 N=14	Population: SCI treated at SCI Unit: Mean age: 30 yr; Level of injury: paraplegia=5, tetraplegia=8; Severity of injury: complete=8, incomplete=6; Time post-injury=5 d-5 mo. Intervention: Individuals were randomized to 1) Lo-Fric® hydrophilic catheters or 2) EasiCath® hydrophilic catheters for intermittent catheterization (IC) for 10 days; individuals then crossed-over to the other arm. Outcome Measures: Friction force on removal, number of times catheter ”stuck”, urinary tract infection (UTIs), osmolality.	1. Lo-Fric® catheter had significantly reduced friction (55%) as compared to Easicath® (p<0.001). 2. Nurses reported fewer times catheters had “stickings” with Lo-Fric® catheter as compared to Easicath® (3 versus 42). 3. There was no significant difference in the incidence of UTIs with either catheter (2 versus 3). 4. Mean catheterization time was similar for both catheters. 5. Lo-Fric® catheter had >10x higher osmolality as compared to Easicath®. 6. Lower friction, higher osmolality may reduce adhesion and urethral damage.
Bjerklund Johansen et al. 2007 Sweden Pre-Post N=378	Population: Mean age: 43.5 yr; Gender: male=283, 75%, female=95, 25%; Injury etiology: SCI=65.6%, spina bifida=2.3%, MS=9.6%, other=22.5%; Mean duration of intermittent catheter (IC) use: 4.6 yr; frequency of IC use: 3/day=13.6%, 5/day=14%, 6/day=15.6%, 7/day=19.3%. Intervention: Administration of a novel hydrophilic catheter device (LoFric Primo®) for a 2-wk trial. Outcome Measures: Visual Analogue Scale scores (insertion, withdrawal, handling, time spent, perception of clean intermittent catheterisation	1. 55.2% of individuals were happy and wished to continue using the novel catheter; of these, 74% of individuals previously used standard polyvinyl chloride catheters (PVC) and 26% of those were using pre-lubricated PVC (p=0.04). 2. VAS results indicated individuals in general found the novel product more troublesome with handling and general satisfaction(p=0.0001). However, for insertion, withdrawal, time spent, and general perception of IC no statistically significant difference was discovered. As well, abilities to comply with activities of daily life was not decreased by the novel catheter (p=0.0001).
Kovindha et al. 2004 Austria Pre-Post N=28	Population: Mean age: 38.5 yr; Gender: males=28, females=0; Level of injury: paraplegia=23, tetraplegia=4, neurogenic bladder=1; Severity of injury: AIS: A or B=20, C or D=8; Mean duration of clean intermittent catheterization (IC) use=4.8 yr. Mean duration of use of each catheter 35 mo. Intervention: Reusable silicone catheters. Outcome Measures: Urinary management, urethral abnormality, catheter stiffness, complications.	1. Urinary management method was not significantly related to UTI. 2. Increased frequency of clean IC was significantly related to decreased urethral abnormality (p<0.05). 3. Reused catheters had increased stiffness of 20%. 4. Complications included urethral bleeding (n=3), urethra pus (n=5), epididymitis (n=5), passing stones (n=4), foul smelly urine (n=18), fever and cloudy urine (n=10); 6/10 individuals had 2-3 episodes/yr 5. Ultrasound found mild hydronephrosis (n=2), mild pelvocalyceal dilation (n=1), focal thinning of parenchyma (n=1), and multiple bladder calculi (n=1).
Wyndaele et al. 2000 Belgium Pre-Post N=39	Population: Male SCI individuals: Mean age: 45 yr (range 19-74 yr); Etiology of bladder dysfunction: SCI=21, neurological disease=12, other=6; Mean neurological bladder dysfunction duration: 7.8 yr (range 1-23). Intervention: Subjects who normally used conventional catheters for intermittent catheterization (IC) changed to hydrophilic low-friction Urocath-Gel catheter. Outcome Measures: Time to catheterize, satisfaction, urodynamic parameters.	1. Time needed for clean IC was not different with both techniques. Difficult introduction or difficult retreat of the catheter were not different in frequency. 2. Impossibility to introduce the catheter was less frequent. Urethritis and urethral bleeding were less frequent than during the use of conventional catheters. Satisfaction was better with the low friction catheters. 3. Negative satisfaction was mainly related to the availability and the use of water to lubricate the catheter, difficulty of manipulation and fear for cost.
Spinu et al. 2012 Romania Case Series N=50	Population: Neurogenic bladder dysfunction individuals=50: Hydrophilic catheter use=35; Mean age: 43.85 yr (range 19-63 yr); Gender: male=31, female=4. Non-hydrophilic catheter use=15: Mean age: 45.46 yr (range 22-62 yr); Gender: male=13, female=2. Intervention: Evaluation of individuals using either hydrophilic or non-hydrophilic catheters for intermittent catheterization (IC). Outcome measures: Inflammatory response; bleeding episodes, urinary tract infection (UTI) activations, satisfaction level.	1. Compared to those using non-hydrophilic catheters, those using hydrophilic catheters presented with a significantly lower number of inflammatory episodes at scrotal level (p=0.0001), a significantly lower number of post/intra/inter catheterization bleeding episodes (p=0.0001), and expressed a significantly higher satisfaction level (p<0.0001).
Waller et al. 1995 Sweden Case Series N=30	Population: SCI: Median age: 37 yr (range 24-61 yr); median clean intermittent catheterization use: 7 yr (range 5-9 yr); Gender: male=26, female=4. Intervention: Retrospective chart review of individuals using disposable hydrophilic low friction catheters for intermittent catheterization (IC). Outcome Measures: Urodynamic parameters.	1. No hydronephrosis, pyelonephritis or renal scarring in any of the individuals. 2. Among 3 individuals who had decreased their IC regimen, signs of upper tract dilation developed but the excretory urogram returned to normal after correction of the regimen. 3. Of 30 individuals, 12 (40%) maintained sterile urine; 4 of the remaining 18 with bacteriuria had episodes of urinary sepsis and chronic infections. 4. Two individuals had epididymitis. 5. In one individual, two dilation attempts had failed, but the individual could perform IC regimen. 6. One individual with Crohn’s disease had advanced urethral changes in the acute phase but could perform IC with a small catheter. 7. One individual has had recurrent modifications of the urethral wall but no development of a false passage.

Author Year
Country
Research Design
Score
Total Sample Size

Methods

Outcome

Bermingham et al. 2013

Systematic Review

AMSTAR=8

N=8 studies

Population: Vapnek et al. 2003 (n=62): Mean age: 40 yr; Gender: males=62, females=0. Cardenas et al. 2009 (n=56): Mean ag=41 yr; Gender: males=29, females=27. De Ridder et al. 2005 (n=123): Mean age: 37 yr; Gender: males=123, females=0. Sutherland et al. 1996 (n=33): Mean age: 12 yr; Gender: males=33, females=0. Pachler et al. 1999 (n=43): Mean age: 71 yr; Gender: males=43, females=0. Giannantoni et al. 2001 (n=18): Mean age: 38 yr; Gender: males=16, females=2. King et al. 1992 (n=46): Mean age: 29 yr; Gender: males=40, females=6. Duffy et al. 1995 (n=80): Mean age: 72 yr; Gender: males=80, females=0.

Treatment: A cost effective analysis using a probabilistic Markov model to compare lifetime costs and quality adjusted life years (QALYs) for gel reservoir catheters and clean non-coated self-catheters. Relevant articles were retrieved through a literature search from Medline, Embase, Cochrane, and Cinahl from 2002 to April 2011.

Outcome Measures: Symptomatic urinary tract infection (UTI), cost effectiveness.

1. Individuals using gel reservoir and hydrophilic catheters were significantly less likely to report one or more UTIs compared with sterile non-coated catheters (p=0.04).

2. When measured as monthly UTIs (p=0.84) or UTIs per yr (p=0.60), there was no significant difference between hydrophilic and sterile non-coated catheters.

3. There was little difference in the incidence of one or more UTIs for people using clean versus sterile non-coated catheters (p=0.86).

4. Gel reservoir catheters are not cost-effective compared to clean non-coated self-catheters.

Chartier-Kastler et al. 2013

France

RCT crossover

PEDro=8

N=103

Population: SCI: Mean age: 53.8 yr (range 22.6-87.5 yr); Etiology of injury: traumatic SCI=53), spinal tumor=4, spina bifida=3, MS=19, other=39; Time post-injury: 13.3 yr (range 0.9-47 yr); Severity of injury: complete paraplegia=33, incomplete paraplegia=38, complete tetraplegia=3, and incomplete tetraplegia=9, unsure=33.

Intervention: Effectiveness of a compact catheter versus a standard catheter evaluated in a 2 wk crossover trial.

Outcome Measures: Intermittent self-catheterization questionnaire (quality of life); Visual Analogue Scale (VAS)

1. Intermittent catheterization questionnaire score increased significantly with compact catheter use (p<0.001). There was a mean difference of 17±1.8 points between the compact and standard intermittent catheters.

2. The compact catheter was preferred over a standard catheter by 67/106 (63%) individuals (p=0.007).

3. Mean VAS satisfaction score was significantly different in favour of the compact catheter (p=0.037).

Costa et al. 2013

United States

RCT crossover

PEDro=7

N=81

Population: Male SCI individuals: Mean Age: 38.4 yr; Reason for intermittent catheterization: SCI (n=79), Other (n=2)

Intervention: Subjects were randomized into groups for use of Apogee hydrophilic catheters in one of two lengths: 1) 30 cm-test size, or 2) 40 cm-control size. Subjects then crossed over to other arm.

Outcome Measures: Ease of use, and catheter preference.

1. Subjects preferred the control catheter (91.4%) to the test catheter (8.6%).

2. Preference for the control catheter was due to complete bladder emptying (70%), satisfactory length (74%), ease of draining into a receptacle (58%) with portable urine being the most utilized (37%), followed by toilet (35%).

Denys et al. 2012

France

RCT crossover

PEDro=7

N=97

Population: SCI: Median age: 46 yr (range 19-64 yr); Median duration of intermittent catheterization: 11 yr (range 0.33-52 yr); Injury etiology: SCI=57.7%, multiple sclerosis=25.8%, spina bifida=4.1%, other=12.4%.

Intervention: Subjects were randomized into two groups to use either 1) a “no-touch’ VaPro hydrophilic catheter, or 2) a standard convention catheter, for intermittent catheterization over 15 days. Subjects were then crossed to the other arm.

Outcome Measures: Questionnaire evaluating individuals’ experiences before the start of the trial and after each 15 d period of catheter use.

1. More than 50% of individuals would recommend the VaPro Catheter.
2. More than 75% of individuals felt confident and more secure with the new catheter.3. More men than women preferred the VaPro catheter (p=0.030).

Chartier-Kastler et al. 2011

France

RCT crossover

PEDro=8

N=36

Population: Male SCI individuals: Median age: 43.2 yr (range 20-70 yr); Median time using catheters: 39 mo. (range 1-219 mo); Median number of catheters used per day: 6. (range 4-10 d); Etiology of injury: traumatic=24, non-traumatic=12; severity of injury: complete tetraplegia=3, incomplete tetraplegia=6, complete paraplegia=4, incomplete paraplegia=22, unknown=1; AIS score: A=7,19.4%, B=5,13.9%, C=8, 22.2%, D=16, 45.5%.

Intervention: Participants were randomized to either a standard coated catheter or a single-use compact coated catheter and switched at crossover.

Outcome Measures: Visual Analogue Scale (VAS) for discomfort, ease of use, discretion, degree of pain, stinging or resistance.

1. The compact catheter did not have more discomfort than the standard-length catheter, however there were significant differences between participants from different countries in comfort levels (p=0.0315).

2. Significant difference in favour of the compact catheter for discretion, carrying and disposal (p<0.0001).

3. The standard catheter had significantly higher mean degrees of resistance than the compact catheter (p=0.0273).

4. No difference was observed between the catheters with pain and stinging (p=0.6831)

Domurath et al. 2011

Germany

RCT crossover

PEDro=8

N=37

Population: Male SCI individuals: Mean age: 40 yr (range 21-66 yr); AIS: A =20, B=9, C=3, and D=5; Mean duration of intermittent catheterization: 88.76 mo (range 2-264 mo).

Intervention: Evaluate the performance of SpeediCath Compact catheter (30-cm) versus control catheter in a crossover trial.

Outcome Measures: Residual Urine (RU) Volume; subject evaluation of their experience, sensation, disposal, bleeding and discomfort with the test and control catheters, final catheter preference.

1. The two catheters did not differ in bladder emptying performance, and the test catheter was no less inferior by RU volume to the control catheter.

Sarica et al. 2010

Turkey

RCT

PEDro=5

N=25

Population: Mean age: 37.04 yr; Males=18+yr, injury<6 mo, Severity of Injury: ASIA scale-A=8, B=6, C=7, D=4; Level of injury: paraplegia=21, tetraplegia=4

Intervention: Subjects were randomized into one of three groups for the use of 1) hydrophilic catheters, 2) gel-lubricated standard catheters, or 3) standard polyvinyl chloride catheters (PVC) for intermittent catheterization (IC).

Outcome Measures: Incidence of urinary tract infections (UTIs), presence of microhematuria, adverse events.

1. No significant differences in the frequency of UTI among types of catheter were reported (p<0.05).

2. The gel lubricated and the hydrophilic catheter received higher individual satisfaction vs. PVC (p<0.05).

3. The gel lubricated catheter found to be superior to hydrophilic and PVC catheters in terms of urethral microtrauma, pyuria and satisfaction.

4. Cost of intermittent catheterization was higher compared to PVC catheters.

Biering-Sorensen et al. 2007

Denmark

RCT crossover

PEDro=6

N=24

Population: Female SCI individuals: Mean age: 44 yr (range 19-64 yr); Severity of injury: paraplegia=20, tetraplegia=4; Mean duration of intermittent catheterization (IC) use: 8.3 yr (range 4 mo to 23 yr); Mean number of catheterizations per day: 5.5 (range 2-9).

Intervention: Participants were randomized to one of two catheters 1) SpeediCath Compact or 2) reference catheter. Subjects then switched to the other arm.

Outcome Measures: Residual urine (RU) volume, length and handling of the SpeediCath Compact catheter.

1. There was no difference between the catheters in RU volume.

2. 23/24 (95.83%) found handling the SpeediCath compact catheter easy and their satisfaction was either satisfactory or very satisfactory.

De Ridder et al. 2005

Spain

RCT

PEDro=5

N=123

Population: SCI individuals using hydrophilic versus peripheral venous catheter (PVC): Mean Age: 37 yr; Gender: males=123, females=0; Severity of injury: AIS: A-D.

Intervention: SpeediCath® hydrophilic catheter versus conventional uncoated PVC catheter for intermittent catheterization (IC) over 12 mo.

Outcome Measures: Occurrence of symptomatic urinary tract infection (UTIs), hematuria, strictures, convenience of use/satisfaction with catheter at 6 and 12 mo.

1. Lower incidence of UTIs in 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 groups. No significant difference in satisfaction.

3. 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 regained within the 1 yr period.

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: Subjects were randomized into two groups to use either 1) Instacath® non-hydrophilic pre-lubricated catheter or 2) conventional uncoated Nelaton polyvinyl chloride catheters (PVC) for intermittent catheterization (IC). Subjects then crossed over to the other arm.

Outcome Measures: Symptomatic UTI and asymptomatic bacteriuria, incidence of urethral complications (bleeding and urethral cell counts), visual analog scale of individual satisfaction.

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

2. Fewer epithelial cells found on pre-lubricated catheter versus conventional (p=0.01), reported to be indicative of a 2-fold reduction of 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 and lower tract abnormalities with either catheter.

Waller et al. 1997

Sweden

RCT

PEDro=7

N=14

Population: SCI treated at SCI Unit: Mean age: 30 yr; Level of injury: paraplegia=5, tetraplegia=8; Severity of injury: complete=8, incomplete=6; Time post-injury=5 d-5 mo.

Intervention: Individuals were randomized to 1) Lo-Fric® hydrophilic catheters or 2) EasiCath® hydrophilic catheters for intermittent catheterization (IC) for 10 days; individuals then crossed-over to the other arm.

Outcome Measures: Friction force on removal, number of times catheter ”stuck”, urinary tract infection (UTIs), osmolality.

1. Lo-Fric® catheter had significantly reduced friction (55%) as compared to Easicath® (p<0.001). 2. Nurses reported fewer times catheters had “stickings” with Lo-Fric® catheter as compared to Easicath® (3 versus 42). 3. There was no significant difference in the incidence of UTIs with either catheter (2 versus 3). 4. Mean catheterization time was similar for both catheters. 5. Lo-Fric® catheter had >10x higher osmolality as compared to Easicath®.

6. Lower friction, higher osmolality may reduce adhesion and urethral damage.

Bjerklund Johansen et al. 2007

Sweden

Pre-Post

N=378

Population: Mean age: 43.5 yr; Gender: male=283, 75%, female=95, 25%; Injury etiology: SCI=65.6%, spina bifida=2.3%, MS=9.6%, other=22.5%; Mean duration of intermittent catheter (IC) use: 4.6 yr; frequency of IC use: 3/day=13.6%, 5/day=14%, 6/day=15.6%, 7/day=19.3%.

Intervention: Administration of a novel hydrophilic catheter device (LoFric Primo®) for a 2-wk trial.

Outcome Measures: Visual Analogue Scale scores (insertion, withdrawal, handling, time spent, perception of clean intermittent catheterisation

1. 55.2% of individuals were happy and wished to continue using the novel catheter; of these, 74% of individuals previously used standard polyvinyl chloride catheters (PVC) and 26% of those were using pre-lubricated PVC (p=0.04).

2. VAS results indicated individuals in general found the novel product more troublesome with handling and general satisfaction(p=0.0001). However, for insertion, withdrawal, time spent, and general perception of IC no statistically significant difference was discovered. As well, abilities to comply with activities of daily life was not decreased by the novel catheter (p=0.0001).

Kovindha et al. 2004

Austria

Pre-Post

N=28

Population: Mean age: 38.5 yr; Gender: males=28, females=0; Level of injury: paraplegia=23, tetraplegia=4, neurogenic bladder=1; Severity of injury: AIS: A or B=20, C or D=8; Mean duration of clean intermittent catheterization (IC) use=4.8 yr. Mean duration of use of each catheter 35 mo.

Intervention: Reusable silicone catheters.

Outcome Measures: Urinary management, urethral abnormality, catheter stiffness, complications.

1. Urinary management method was not significantly related to UTI.

2. Increased frequency of clean IC was significantly related to decreased urethral abnormality (p<0.05).

3. Reused catheters had increased stiffness of 20%.

4. Complications included urethral bleeding (n=3), urethra pus (n=5), epididymitis (n=5), passing stones (n=4), foul smelly urine (n=18), fever and cloudy urine (n=10); 6/10 individuals had 2-3 episodes/yr

5. Ultrasound found mild hydronephrosis (n=2), mild pelvocalyceal dilation (n=1), focal thinning of parenchyma (n=1), and multiple bladder calculi (n=1).

Wyndaele et al. 2000

Belgium

Pre-Post

N=39

Population: Male SCI individuals: Mean age: 45 yr (range 19-74 yr); Etiology of bladder dysfunction: SCI=21, neurological disease=12, other=6; Mean neurological bladder dysfunction duration: 7.8 yr (range 1-23).

Intervention: Subjects who normally used conventional catheters for intermittent catheterization (IC) changed to hydrophilic low-friction Urocath-Gel catheter.

Outcome Measures: Time to catheterize, satisfaction, urodynamic parameters.

1. Time needed for clean IC was not different with both techniques. Difficult introduction or difficult retreat of the catheter were not different in frequency.

2. Impossibility to introduce the catheter was less frequent. Urethritis and urethral bleeding were less frequent than during the use of conventional catheters. Satisfaction was better with the low friction catheters.

3. Negative satisfaction was mainly related to the availability and the use of water to lubricate the catheter, difficulty of manipulation and fear for cost.

Spinu et al. 2012

Romania

Case Series

N=50

Population: Neurogenic bladder dysfunction individuals=50: Hydrophilic catheter use=35; Mean age: 43.85 yr (range 19-63 yr); Gender: male=31, female=4. Non-hydrophilic catheter use=15: Mean age: 45.46 yr (range 22-62 yr); Gender: male=13, female=2.

Intervention: Evaluation of individuals using either hydrophilic or non-hydrophilic catheters for intermittent catheterization (IC).

Outcome measures: Inflammatory response; bleeding episodes, urinary tract infection (UTI) activations, satisfaction level.

1. Compared to those using non-hydrophilic catheters, those using hydrophilic catheters presented with a significantly lower number of inflammatory episodes at scrotal level (p=0.0001), a significantly lower number of post/intra/inter catheterization bleeding episodes (p=0.0001), and expressed a significantly higher satisfaction level (p<0.0001).

Waller et al. 1995

Sweden

Case Series

N=30

Population: SCI: Median age: 37 yr (range 24-61 yr); median clean intermittent catheterization use: 7 yr (range 5-9 yr); Gender: male=26, female=4.

Intervention: Retrospective chart review of individuals using disposable hydrophilic low friction catheters for intermittent catheterization (IC).

Outcome Measures: Urodynamic parameters.

1. No hydronephrosis, pyelonephritis or renal scarring in any of the individuals.

2. Among 3 individuals who had decreased their IC regimen, signs of upper tract dilation developed but the excretory urogram returned to normal after correction of the regimen.

3. Of 30 individuals, 12 (40%) maintained sterile urine; 4 of the remaining 18 with bacteriuria had episodes of urinary sepsis and chronic infections.

4. Two individuals had epididymitis.

5. In one individual, two dilation attempts had failed, but the individual could perform IC regimen.

6. One individual with Crohn’s disease had advanced urethral changes in the acute phase but could perform IC with a small catheter.

7. One individual has had recurrent modifications of the urethral wall but no development of a false passage.

Discussion

The traditional catheter used for IC has long been the poly vinyl catheter (PVC) in varying lengths and gauges individualized for each patient. However, recent advances in catheter material, lubricant, and length have led to the development of several new catheter types. Hydrophilic catheters are made of a water-adherent polymer that, when lubricated with water, creates an extremely slippery surface effective for smooth insertion. Frictionless insertion reduces incidence of UTIs, bleeding, and other urinary complications. Other methods to reduce friction include gel-lubricated or pre-coated non-hydrophilic catheters. In total, there have been ten RCTs, and several small non-RCTs, investigating varying types and properties of catheters used for IC.

Several studies and one systematic review (Bermingham et al. 2013) have aimed to determine whether there is a superior catheter type for IC. In a small RCT, Sarica et al. (2010) found that gel-lubricated non-hydrophilic catheters were superior to hydrophilic and PVC catheters in terms of reduced urethral microtrauma and pyuria, and increased patient satisfaction, despite higher cost. However, there was no significant difference rate of UTIs between groups. Giannantoni et al. (2001) also examined pre-lubricated non-hydrophilic catheters versus conventional PVC catheters and demonstrated a reduction in the incidence of UTIs and the presence of asymptomatic bacteriuria. Of note, there were three subjects initially requiring assistance with a conventional catheter transitioning to independence with a pre-lubricated catheter. However, the order of catheter use by type was not reported. In terms of general satisfaction, subjects rated the pre-lubricated catheter significantly higher than the conventional catheter with respect to comfort, ease of insertion, extraction, and handling. De Ridder et al. (2005) compared hydrophilic catheters to non-coated PVC catheters and found reduced incidence of UTIs in favour of the hydrophilic catheter. Although this multi-centre investigation employed a RCT design (N=123) results should be cautiously interpreted given a 54% drop-out rate.

An additional investigation examined the effect of osmolality on two different hydrophilic catheters. Waller et al. (1997) demonstrated reduced friction with the high-osmality catheter versus the other, a finding corroborated by nursing reports of fewer catheter “stickings”. These differences did not translate into clinically significant results for differences in the incidence of UTIs with either hydrophilic catheter type.

To reduce risk of infection, a new “no touch” ValPro® catheter has been developed and being trialled for use. Denys et al. (2012) performed a crossover RCT whereby patients trialled the ValPro® catheter and a standard catheter. The authors reported that the majority of patients were confident and secure with catheter (>75%) and would recommend it (>50%). It is important to note that bacteremia analyses were not conducted.

To improve QoL and user satisfaction, discrete compact size catheters continue to be developed. Chartier-Kastler et al. (2011) examined the effectiveness of compact catheters compared to standard catheters in a small crossover RCT. The authors reported that patients were more satisfied with the compact versus standard catheters as the former were more discrete when carrying and disposing; further, the standard catheter had greater resistance on insertion. The findings were echoed in a recent, large crossover RCT by Chartier-Kasler et al. (2013) and a small crossover RCT by Biering-Sorensen et al. (2007) where greater satisfaction was reported with use of the compact versus standard catheters.

While catheter length generally reflects the anatomy of the user, some compact catheters are shorter in length (30 cm) than standard catheters (40 cm). A comparison of the two catheters in terms of residual IC urine volume has demonstrated no significant difference in two crossover RCTs (Domurath et al. 2011; Biering-Sorensen et al. 2007). While a third crossover RCT by Costa et al. (2013) found that subjects reported greater satisfaction with standard catheters versus compact catheters for bladder emptying, only descriptive statistics were reported.

A study by Kovindha et al. (2004), provides data on reusable silicone catheters (average of 3 years of usage). The frequency of UTIs reported for the reusable catheter was comparable to that reported for standard disposable catheters (3-7 days of usage), but inferior to frequencies reported for pre-lubricated catheters. Kovindha et al. (2004) stated that the long-term silicone catheter is an economical option for those in developing countries. In developing countries, the high cost of the single use, pre-lubricated catheters is prohibitive outside of exceptional situations.

It should be noted that some assistive devices that may enhance compliance with intermittent catheterization for those with impaired hand function do exist, but are likely not in widespread use. For example, Adler and Kirshblum (2003) reported a series of 9 individuals with C5-C7 SCI, originally unable to perform intermittent catheterization, that were subsequently satisfied and successful with a device to help performance of intermittent catheterization.

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 one RCT: Sarica et al. 2010) that, compared to hydrophilic or conventional poly vinyl catheters, pre-lubricated non-hydrophilic catheters are associated with reduced pyuria and greater patient satisfaction.

There is level 1b evidence (from two RCTs: Giannantoni et al. 2001; Sarica et al. 2010) that, compared to hydrophilic or conventional poly vinyl catheters, pre-lubricated non-hydrophilic catheters are associated with reduced urethral microtrauma.

There is level 1b evidence (from one crossover RCT: Denys et al. 2012) that compared to standard catheters, no-touch catheters may promote greater confidence and security to individuals performing intermittent catheterization post SCI.

There is level 1a evidence (from three crossover RCTs: Chartier-Kastler et al. 2011, 2013; Biering-Sorensen et al. 2007) that, compared to standard catheters, compact catheters may be more discrete for carrying and disposing and therefore provide greater satisfaction to individuals performing intermittent catheterizations post SCI.

There is level 1b evidence (from two cross-over RCTs: Domurath et al. 2011; Biering-Sorecnsen et al. 2007) that compact catheters (30 cm) and standard catheters (40 cm) provide comparable bladder performance with equitable residual urine volume.

Although both pre-lubricated and hydrophilic catheters have been associated with reduced incidence of UTIs as compared to conventional PVC catheters, less urethral microtrauma with their use may only be seen with pre-lubricated catheters.

Compact catheters are more discrete than standard catheters for carrying and disposal but offer comparable performance in bladder emptying and residual urine volumes.

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