|Bermingham et al. 2013|
|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|
|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|
|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|
|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|
|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|
|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|
|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/d.
|Biering-Sorensen et al. 2007|
|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.
|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|
|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|
|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
|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|
|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|
|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|
|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|
|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|
|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.