title: A prospective, randomized, crossover, multicenter study comparing quality of life using compact versus standard catheters for intermittent self-catheterization.
abstract: OBJECTIVE
  Intermittent catheterization is the recommended standard treatment for neurogenic bladder dysfunction. However, standard intermittent catheters can be unwieldy, difficult to use and carry discreetly. This can influence patient ability to perform catheterization efficiently, discreetly and privately, therefore, affecting patient quality of life. We evaluated whether the discreet design of the compact catheter would improve quality of life in intermittent catheterization users compared with standard catheters.
  
  
  METHODS
  We performed a nonblinded, randomized, multicenter, 2-way crossover study with 2 treatment periods of 6 weeks ± 3 days. A total of 125 patients with neurogenic bladder dysfunction were included in the study from 17 study sites, including 7 in France, 3 each in Germany, Denmark and Sweden, and 1 in Norway. Quality of life was evaluated by the intermittent self-catheterization questionnaire. The difference in questionnaire scores between the compact catheter and standard hydrophilic coated catheters was analyzed using a mixed linear normal model.
  
  
  RESULTS
  The intermittent catheterization questionnaire score increased significantly due to compact catheter use. We noted an estimated mean difference of 17.0 between the compact and standard intermittent catheters (p <0.001), corresponding to a 28% increase. The primary study results were further supported by the positive results of the secondary objective of preference, that is 63% of patients preferred the compact catheter.
  
  
  CONCLUSIONS
  The discreet design of the compact catheter significantly improved patient quality of life related to intermittent self-catheterization.
authors.affiliation: Urology Clinic, Hôpital Raymond Poincaré, Garches, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chartier-Kastler
authors.forename: Gérard
authors.initials: G
authors.lastname: Amarenco
authors.forename: Lena
authors.initials: L
authors.lastname: Lindbo
authors.forename: Irina
authors.initials: I
authors.lastname: Soljanik
authors.forename: Heidi Lunde
authors.initials: HL
authors.lastname: Andersen
authors.forename: Per
authors.initials: P
authors.lastname: Bagi
authors.forename: Kristine
authors.initials: K
authors.lastname: Gjødsbøl
authors.forename: Burkhard
authors.initials: B
authors.lastname: Domurath
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057785:Catheters; D018592:Cross-Over Studies; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012648:Self Care / Q000379:methods*; D001750:Urinary Bladder, Neurogenic / Q000503:physiopathology / Q000628:therapy*; D014546:Urinary Catheterization / Q000295:instrumentation / Q000379:methods*; D055815:Young Adult
keywords: AE; ISC; ISC questionnaire; ISC-Q; ITT; VAS; adverse event; catheters; intent to treat; intermittent self-catheterization; intermittent urethral catheterization; quality of life; questionnaires; urethra; visual analog scale