Hydrophilic-Coated Catheters for Intermittent Catheterisation Reduce Urethral Micro Trauma: A Prospective, Randomised, Participant-Blinded, Crossover Study of Three Different Types of Catheters

Stensballe, Jakob; Looms, Dagnia; Nielsen, Pia N; Tvede, Michael

doi:10.1016/j.eururo.2005.07.009

Cited by 114 publications

(84 citation statements)

References 15 publications

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“…Although it is a subjective measure, it has been used successfully in other clinical trials comparing catheters. 12,14 The non-inferiority demonstrated in this trial is therefore a key clinically relevant result, together with the lack of any additional pain, resistance or stinging. This is important, as other results described here suggest that the compact catheter may have other advantages over the standard catheter.…”

Section: Discussionmentioning

confidence: 99%

Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

Chartier-Kästler

Lauge²,

Ruffion

et al. 2011

Spinal Cord

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Study design: Self-catheterising males aged X18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial. Objectives: When possible, intermittent catheterisation is the preferred method of bladder emptying for neurogenic bladder dysfunction. Hydrophilic-coated catheters have improved safety and ease of use, and a new compact catheter for men has been developed to improve discretion. Methods: Participants self-catheterised at least four times daily for 14 days with a standard or compact catheter. The primary outcome measure was discomfort, using a visual analogue scale. Non-inferiority was defined as a difference in mean discomfort score of o0.9 cm. Other assessments included ease of use, discretion and the degree of pain, stinging or resistance. Results: A total of 36 individuals participated and 30 were included in the intention-to-treat analysis. The mean difference between catheters for participant discomfort was À0.347 cm (95% confidence intervals: À1.493, 0.800). There were significant differences (Pp0.0001) in favour of the compact catheter for disposal and discretion, and inserting, storing, carrying and controlling the catheter. Fewer participants experienced resistance with the compact catheter. Participants were less likely to touch the coated part of the compact catheter. One adverse event was reported for each catheter. Conclusions: The coated compact catheter is at least as acceptable to the user as the standard catheter, with no inferiority observed in the level of discomfort. Secondary endpoints suggest that there are advantages of using the compact catheter, particularly with regard to discretion and ease of use.

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Section: Discussionmentioning

confidence: 99%

Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

Chartier-Kästler

Lauge²,

Ruffion

et al. 2011

Spinal Cord

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“…Previous studies showed that hydrophilic catheters produce less urethral irritation, 3,4 provide better patient satisfaction 3,4 and prevent urinary tract infection (UTI) more efficiently than the uncoated catheters. 2 De Ridder and colleagues found that the number of spinal cord injury patients free of clinical UTI was doubled in the SpeediCath group compared to the plastic (PVC) group over a 1-year period.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have demonstrated its efficacy in comparison with uncoated-catheters. 2,4 Unfortunately, this catheter is more expensive and single use. Only one study was performed in the pediatric population; 5 other studies were performed in adults only.…”

Section: Introductionmentioning

confidence: 99%

“…The polymer absorbs and binds water to the catheter, resulting in a thick, smooth and slippery surface. 4 SpeediCath (Coloplast, Mississauga, ON) is a brand of these catheters, and it also has the advantage of being ready-to-use (no need 09138.indd 150 11/26/10 12:12 PM for water). Previous studies have demonstrated its efficacy in comparison with uncoated-catheters.…”

Section: Introductionmentioning

confidence: 99%

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Hydrophilic-coated catheter appreciation study in a pediatric population

Boucher

Cloutier

Lebel

et al. 2013

CUAJ

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Objective: The objective of the paper was to compare the satisfaction of hydrophilic-coated catheters (HC) (SpeediCath, Coloplast Canada, Mississauga, ON) versus uncoated catheters in a pediatric neurogenic bladder population, in order to identify a target group for HC. The main hypothesis was that our patients, with regard to their limitations, might have difficulties using the HC. Material and methods: A comparative prospective study was initiated in one pediatric rehabilitation centre. Out of the 39 patients who tried the HC during a routine clinic visit, 31 patients/parents accepted to participate in a 1-week trial and to answer a satisfaction questionnaire. Their medical records were reviewed for age, neurological disease, intellectual deficit, impaired dexterity and method of catheterization (Mitrofanoff/urethra). Results: Thirty of the 31 patients answered the satisfaction questionnaire. The median age for the 30 patients was 13.5 years (range 6-20 years). Of these patients, 19 were females (63%), 26 performed self-catheterization (87%), and 6 had Mitrofanoff (20%). Ten children (33%) would be ready to proceed with HC and all 10 children would receive catheterization by the urethra. Of these, 9 were females (90%), 8 used compact-HC (80%) and all were selfsufficient. Patients using compact-HC would continue with this catheter. In the patient comments, males catheterizing per-urethra and patients using a continent stoma requiring long catheters had problems with the excess of lubricant. Conclusion: Most children preferred their usual uncoated catheter and would not change for HC. Female patients catheterizing perurethra with a compact-HC seem to benefit most from this catheter.Can Urol Assoc J 2010;4(6):E150-E154 RésuméObjectif : L'étude visait à comparer le niveau de satisfaction avec les cathéters à enrobage hydrophile (SpeediCath, Coloplast Canada, Mississauga, Ontario) et avec les cathéters sans enrobage chez des enfants avec vessie neurogène, afin de cerner un groupe cible pour le cathéter à enrobage hydrophile. La principale hypothèse de l'étude était que les participants pourraient éprouver des difficultés avec ce dernier, en fonction de leurs limites physiques.

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“…In a prospective randomized controlled trial, patients using hydrophilic catheters experienced less hematuria and withdrawal friction than those using uncoated catheters, but the hydrophilic catheters are associated with higher costs. 2 In Germany, the current price for singleuse hydrophilic catheters is approximately €3 each, with a frequency of 4-5 times a day for a patient aged 40 years at initial diagnosis. This brings the projected lifetime sum (at 80 years) for single-use catheters to around €300,000-approximately 15-fold higher than the total cost for LDDM surgery.…”

Section: Georgios Gakis Milomir Ninkovic and Arnulf Stenzlmentioning

confidence: 99%