Giannantoni et al. 2001 Italy
PEDro=9
RCT
N=18

Population: SCI: Mean age = 38.2 yrs; Level of injury: C5-Cauda Equina; Severity of injury: AIS A-D; Time since injury = 18-60 days.
Treatment: Comparison of “Instacath®” pre-lubricated nonhydrophilic catheter vs conventional uncoated PVC Nelaton catheter for IC (crossover design).
Outcome Measures: symptomatic UTI, incidence of urethral complications (ultrasound, CUG), urinalysis, visual analog scale of patient satisfaction. Collected at the start and end of 7 week study period.

• Lower incidence of UTIs (p=0.03) and asymptomatic bacteriuria (p=0.0244) of those using pre-lubricated catheters vs PVC.
• More epithelial cells found on conventional vs pre-lubricated catheter (p=0.01) indicative of possible microtrauma.
• 2 people had urethral bleeding with conventional catheter, 0 with pre-lubricated.
• Pre-lubricated catheters had significantly higher satisfaction scores for 4 of 5 items on the scale.
• 3 subjects requiring assistance with the conventional catheter became independent with the pre-lubricated catheter (order effect unreported)
• No subject had impaired renal function of upper & lower tract abnormalities with either catheter.

Vapnek et al. 2003
USA
PEDro=6
RCT
N=62

Population: Male SCI patients: Hydrophilic Catheter Group: Mean age=39.8yrs; Level of injury: paraplegia=25, tetraplegia=4; Polyvinyl Catheter Group: Mean age=39.6yrs; Level of injury: paraplegia=26, tetraplegia=1
Treatment: SCI individuals were randomly placed in either the hydrophilic coated plastic LoFric catheters or standard polyvinyl chloride catheters group.
Outcome Measures: UTI’s, degree of microscopic hematuria and pyuria, incidence of adverse events were all assessed at baseline and every 3 months for 1 year.

• Urinary tract infections:
• Baseline: - mean incidence of monthly UTI’s was higher for the hydrophilic catheter (HC) group than for the polyvinyl catheter (PVC)/control group (0.45 ± 0.62 and 0.20 ± 0.26 per patient resp. (p>0.3))
• Study Conclusion: - still no significant difference between HC and PVC group for mean # of UTI’s/month (0.13 ± 0.18 and 0.14 ± 0.21 per patient resp. (p>0.3))
• ↓ in UTI rate per month was significantly higher for HC group than for PVC group (0.44 to 0.14 or -0.3 vs 0.20 to 0.14 or -0.06 per patient), and was statistically significant in the HC group (p=0.012 vs 0.24)
• Microscopic Hematuria:
• Baseline: - dipstick analysis showed some degree of hematuria in 8 of the 30 (26.7%) patients from the HC group and 11 of the 31 (35.5%) from the PVC group (no statistically significance difference)
• During study - HC group showed a significantly ↓ incidence of microhematuria (p=0.027) (mean code per urinalysis for HC vs PVC (0.31 ± 0.46 and 0.65 ± 0.69 resp)
• Microscopic Pyuria:
• Baseline: - # patients were similar from both groups (HC – 19 of 30 (63.3%) vs PVC – 22 of 31 (71%) resp.)
• Follow-up – no differences
• Adverse Events (possibly treatment related):
• HC group – 1 gross hematuria, 1 epididymitis, 1 infected penile prosthesis requiring hospitalization and surgical removal (neurogenic bladder, unrelated to intermittent catheterization)
• PVC group – 1 gross hematuria, 1 epididymitis, 1 bladder stone surgically removed (neurogenic bladder, unrelated to intermittent catheterization)

De Ridder et al. 2005
Belgium/Spain
PEDro=5
RCT
N=123

Population: SCI using hydrophilic vs PVC catheter: Mean age = 37.5 vs 36.7 yrs; Severity of injury: AIS A-D.
Treatment:  “SpeediCath®” hydrophilic catheters vs conventional uncoated PVC catheter for IC.
Outcome Measures: Occurrence of symptomatic UTIs, hematuria, strictures, convenience of use, satisfaction with catheter. Data collected over a 12 month period.

• Lower incidence of UTIs of those using SpeediCath hydrophilic vs PVC (p=0.02).
• No difference in number of bleeding episodes or occurrence of hematuria, leukocyturia and bacteriuria between 2 catheters.
• More individuals expressed greater satisfaction with various aspects of the hydrophilic catheter, although these differences were not significant.
• 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 year period.

Cardenas & Hoffman 2009
USA
PEDro=5
RCT
N=56

Population: Treatment: Mean age=42.3yrs; 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: Mean age=40.1yrs; 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
Treatment: Individuals were randomly assigned to either the hydrophilic catheter or the noncoated catheter control group. Urine from these individuals was collected once a month for first 3 months and then at 6, 9 and 12 month mark.
Outcome Measures: UTI

• At least 1 symptomatic UTI was seen over the course of 1 year for 54% of individuals in the hydrophilic catheter group and 61% of the control group.
• The hydrophilic catheter group had a mean of 1.18 UTIs, while the control group had 1.
• No significant difference was seen between the two groups in the number of symptomatic UTIs and type of symptoms.
• There was a significant number of symptomatic UTIs treated in the group using hydrophilic catheters (p=.02).
• Females were more likely to develop UTIs regardless of catheter type.