Evaluation of a new PVC-free catheter material for intermittent catheterization: A prospective, randomized, crossover study

Figures & data

Table I. Diagnosis and current catheter use.

Reported reason(s) ^a for catheterization	n = 148
Spinal cord injury	2
Enlarged prostate/prostate hyperplasia	19
Residual urine	89
Other	38
Bladder dysfunction	12
Urine retention	11
Prostate cancer	6
Multiple sclerosis	3
Type 2 diabetes	1
Intravesical obstruction	1
Rectum cancer	1
Slipped disk	1
Fever	1
Urinary infection	1
Current catheter use ^b	n = 105	(%)
Speedicath	6	(6)
EasiCath	37	(35)
LoFric PVC Free	44	(42)
LoFric PVC	18	(17)
Retained hand function	97	(92)

^a More than one reason could be given per subject; therefore, the total n for reason(s) for catheterization is 148 instead of 105. ^b Current catheter use was assessed at study inclusion. All subjects verified experience of LoFric catheter use during the last year.

Table II. Reported discomfort per catheter type.

Discomfort	Current catheter (n = 105)	PVC-free (n = 104)	PVC (n = 104)
Discomfort	13 (12)	15 (14)	29 (28)
Pain^a	12 (11)	14 (13)	23 (22)
Burning sensation^a	13 (12)	13 (13)	24 (23)
Bleeding^a	5 (5)	4 (4)	10 (10)
Other discomfort	0 (0)	4 (4)	6 (6)

Data are shown as n (%).

^a At insertion, during catheterization, at withdrawal or after catheterization.

Table III. Reported perception of general catheter properties per catheter type.

Patients agreed or agreed entirely that the catheter provided …	Current catheter (n = 105)	PVC-free^b (n = 104)	PVC^b (n = 104)
… easy handling before insertion^a	102 (98)	97 (93)	74 (71)
… easy insertion	99 (94)	86 (83)	64 (62)
… complete emptying	103 (98)	92 (88)	81 (78)
… easy withdrawal^a	99 (96)	94 (90)	79 (77)

Data are shown as n (%).

^a n = 103 for the current catheter and for PVC. ^b p values (Wilcoxon signed rank test, exact significance, two-tailed) for comparison between PVC-free and PVC: before insertion p < 0.0001, at insertion p = 0.0004, complete emptying p = 0.0174 and at withdrawal p = 0.0005.

Table IV. Number of reported adverse events.

	Causality relation
Adverse event	Unrelated	Possibly related	Related	Total
Allergy, itching	1	–	–	1
Bleeding	2	–	10	12
Burning sensation	–	7	25	32
Cold	2	–	–	2
Cytostatica treatment^a	1	–	–	1
Feeling of incomplete bladder emptying	–	–	1	1
Suspected gout	1	–	–	1
Haematuria	–	1	–	1
Pain	–	4	31	35
Stroke	1	–	–	1
Suspected snakebite	1	–	–	1
Suspected urinary infection	–	1	–	1
Urinary tract infection	1	1	–	2
Total	10	14	67	91

^aPlanned cytostatica treatment caused prolongated hospitalisation