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: Assessment of “Instacath®” nonhydrophilic pre-lubricated catheter vs conventional uncoated PVC Nelaton catheter for IC (crossover design).
Outcome Measures: Symptomatic UTI & asymptomatic bacteriuria, incidence of urethral complications (bleeding and urethral cell counts), visual analog scale of patient satisfaction.

• Lower incidence of UTIs (p=0.03) and asymptomatic bacteriuria (p=0.0244) of those using pre-lubricated catheters vs PVC.
• Fewer epithelial cells found on pre-lubricated catheter vs conventional (p=0.01), reported to be indicative of a 2 – fold reduction of 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.

Waller et al. 1997 Sweden
PEDro=7
RCT
N=14

Population: SCI treated at SCI Unit: Mean age = 30 yrs; Level of injury: paraplegia = 5, tetraplegia = 8; Severity of injury: complete = 8, incomplete =6; Time since injury = 5 days-5 months.
Treatment: 10 day crossover design. “Lo-Fric®” vs “EasiCath®” hydrophilic catheters for IC.
Outcome Measures: Friction force on removal, # of times catheter ”stuck”, UTIs, osmolality.

• Lo-Fric® catheter had significantly reduced friction (55%) as compared to Easicath® (p<0.001).
• Nurses reported fewer # of times catheters had “stickings” with Lo-Fric® catheter as compared to Easicath® (3 vs 42).
• There was no significant difference in the incidence of UTIs with either catheter (2 vs 3).
• Mean catheterization time was similar for both catheters.
• Lo-Fric® catheter had >10x higher osmolality as compared to Easicath®.
• Lower friction, higher osmolality may reduce adhesion and urethral damage.

Polliack et al. 2005
Israel
PEDro=6
RCT
N=24

Population: Study group: Mean age = 42.7 yrs; Gender: males = 9, females = 4; Level of injury: paraplegic = 5, tetraplegia = 8; Control group: Mean age = 53.46 yrs; Gender: males = 6, females = 5; Level of injury: paraplegic = 6, tetraplegic = 5.  AIS A – D.
Treatment: Patients were randomly assigned to 1 of 2 groups: 1) study group was treated with volume dependent intermittent catheterization as measured by a portable ultrasound device (PUD); 2) control group was treated with time dependent intermittent catheterization. F/U period 12 – 30 days. All patients were catheterized by
Outcome Measures: Frequency of catheterization, time to perform, total cost, complications.

• The study group compared to the control group had: 6 fewer catheterizations per day (44% decrease), required 20 minutes less time to perform volume measurements and catheterizations (49% decrease), and  experienced  46% less cost (p<0.001). (cost analysis did not include cost of PUD).

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

Population: SCI patients using hydrophilic vs PVC catheter: Mean Age: 37 yrs; Gender: males = 123; Severity of injury: AIS: A-D.
Treatment:  “SpeediCath®” hydrophilic catheter vs conventional uncoated PVC catheter for IC over 12 months.
Outcome Measures: Occurrence of symptomatic UTIs, hematuria, strictures, convenience of use/satisfaction with catheter at 6 and 12 months.

• Lower incidence of UTIs in those using SpeediCath hydrophilic vs PVC (p=0.02).
• No difference in number of bleeding episodes or occurrence of hematuria, leukocyturia and bacteriuria between  groups. No significant difference in satisfaction.
• 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 year period.

Ku et al. 2006
Korea
Downs & Black score=21
Case series
N=140

Population: Gender: males = 100; Level of injury: complete = 24.3%, incomplete = 75.5%; Time since injury = 17 yrs.
Treatment: Review of urological medical records from January 1987 to December 2003 on patients with SCI. Methods of bladder management included spontaneous voiding, clean intermittent catheterization (CIC), suprapubic or indwelling catheters.  
Outcome Measures: Patients with epididymo-orchitis, variables associated with risk.

• Overall, 27.9% of patients had epididymo-orchitis.
• Epididymo-orchitis was more common for patients on CIC than with indwelling urethral catheterization (p=0.03).
• Rate of urethral stricture: 0% urethral catheterization, 4.3% voiding spontaneously, 18.2% CIC, and 2.8% suprapubic catheter.
• Patients on CIC had a 7 fold higher risk (odds ratio, 6.96; 95% CI, 1.26-38.53, p=0.026).
• CIC was an independent risk factor for epididymoorchitis.

Kovindha et al. 2004
Thailand/Austria
Downs & Black score=18
Case series
N=28

Population: Mean age = 38.5 yrs; Gender: all males; Level of injury: paraplegia = 23, tetraplegia = 4, just neurogenic bladder = 1; Severity of injury: AIS: A or B = 20, C or D = 8; Mean years CIC used = 4.8 yrs. Mean duration of use of each catheter 35 mo (3 years)
Treatment: Data from spinal cord injured men was collected and analysed to investigate the safety of reusing silicone catheter.
Outcome Measures: Urinary management, urethral abnormality, catheter stiffness, complications.

• Urinary management method was not significantly related to clinical UTI.
• Increase frequency of CIC was significantly related to decreased urethral abnormality (p<0.05).
• Reused catheters had increased stiffness of 20%.
• Complications included:
• Urethral bleeding in 3 subjects.
• Pus per urethra in 5 subjects.
• Epididymitis, 5.
• Passing stones, 4
• Foul smelly urine, 18.
• Fever and cloudy urine, 10. 6/10 patients had 2 – 3 episodes/yr
• Cr. Clearance stable. Ultrasound findings:  2 mild hydronephrosis, 1 mild pelvocalyceal dilation, 1 mild focal thinning of parenchyma and 1 multiple bladder calculi.

Perrouin-Verbe et al. 1995
France
Downs & Black score=16
Case series
N=188

Population: Group 1 (SCI patients using CIC from acute period to 8 years, N=159): Mean age = 38 yrs; Gender: males = 113, females = 46; Level of injury: tetraplegia = 50, thoracic = 67, conus medullaris syndrome = 20, cauda equina syndrome = 22; Group 2 (Patients who discontinued CIC after 2 years, N=8): Mean age = 38 yrs; Gender: males = 8; Level of injury: cervical = 1, thoracic = 4, thoracolumbar = 1, lumbosacral = 2; Severity of injury: Frankel grade: A = 6, D = 2; Group 3 (Patients performing CIC for over 5 yrs, N=21): Mean age = 37.3 yrs; Gender: males = 21; Level of injury: cervical = 2, thoracic = 10, thoracolumbar = 6, lumbosacral = 3; Severity of injury: Frankel grade: A = 17, B = 1, C = 2, D = 1; Duration of CIC = 9.5 yrs.
Treatment: Data of SCI patients using CIC was retrospectively reviewed.
Outcome Measures: Infection rate (urinary tract and genital), incontinence, duration of CIC use, complications, procreation while using CIC, patient satisfaction (visual analogue scale).

Group 1:

• 60% of patients had asymptomatic cytobacteriological infection.
• 28% had symptomatic lower urinary tract infection.
• Males had a significantly (p<0.05) higher rate of infection than females:
• 32.7% vs 17.3% had symptomatic lower urinary tract infection.
• Epididymitis occurred in 10%; urethral stricture in 5.3%
• Deterioration of the upper urinary tract was seen in 2% of patients and was correlated with high intravesical pressure.

Group 2:

• Even with use of anticholinergic drugs, 62% of patients were incontinent.
• Mean time before discontinuance of catheterisation was 5.25 yrs.
• Reasons for discontinuance included:
• Persistent incontinence (62% of patients).
• Upper urinary tract deterioration (1 patient).
• Catheterisation difficulty in 4 patients.
• Urethral stricture (1 patient).

Group 3:

• Group comprised of 10 with detrusor areflexia; 11 with DESD (7 used anticholinergic drugs)
• All patients catheterized independently
• Satisfactory level of continence in 89%
• Symptomatic infections less than once every two years in most patients but 2 – 4 x per year in 4 patients.
• Catheterization difficulty was seen in 11 patients, and was sometimes impossible in 5 patients.
• Rate of urethral stricture was 19% and epidydimitis was 28.5%; These rates increased with the number of years of CIC use.

Nanninga et al. 1982
USA
Downs & Black score=15
Case series
N=85

Population: Gender: males = 84%, females = 16%, Level of injury: paraplegia = 66%, tetraplegia = 34%; Severity of injury: complete = 75%, incomplete = 25%.
Treatment:  Patients on intermittent catheterization followed for 11 (6 – 72) mo.
Outcome Measures: Excretory urogram and cystogram at 6 mo intervals. Urine culture. Serum urea and creatinine

• 12 developed reflux, 16 developed ureterectasis or hydroureternephrosis.  11 of these 28 had elevated creatinine.
• 64 (75%) had at least 1 UTI, 1 had bladder calculi.
• Treatment in 15: Increased frequency of catheterization. Avoiding short duration high fluid intakes.  3 had sphincterotomy.  10 were converted to indwelling catheterization.

Jensen et al. 1995 Norway
Downs & Black score=14
Case Series
N=12

Population: Age = 17-72 yrs; Gender: males = 11, females = 1; Severity of injury: complete, incomplete; Time since injury: 3-7mths.
Treatment:  Three separate ultrasonographic measurements of residual urine after Intermittent catheterization
Outcome Measures: Residual urine volume; urinary tract infections.

• 7 patients had 50 - 100 mL residual urine; 2 patients had >100 mL residuals. 
• 9 patients had 1 + UTI during hospital stay.
• No correlation between residual urine volume and UTI incidence r=.19 (mean) & .16 (max) (p=.52 & .63)