A Confirmatory Study Confirming Performance of a New Intermittent Catheter
Condition: Urinary Retention
MeSH terms: Urinary Retention
Study type: Interventional

Summary: 
      A multi-centre, randomised, controlled crossover design. The total study duration for the
      individual subject was approximately 9 weeks, consisting of four site visits and two 4-week
      test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3,
      catheterisations were performed in a hospital setting for bladder emptying assessment and
      collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a
      home-use test period, followed by visit 3 which terminated the study.
    

Detailed description: 
      This investigation was a multi-centre, randomised, controlled crossover study including 73
      male CIC users.

      The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and
      T2). Visit 0 and 1 were performed on the same day if subjects allowed. Visit 0 included the
      screening-, inclusion-, and randomization phase of subjects and at visit 1 subjects performed
      a self-catheterisation with the device according to their respective randomization scheme.
      This was followed by a dipstick test for haematuria.

      In the two 4-week test periods (T1 and T2, respectively) the subjects catheterised at home
      with the specified catheter according to their randomization scheme. Both 4-week periods
      started with a 2-week run-in period followed by a 2-week period during which a dipstick test
      for haematuria was performed daily. For Visit 2 and 3, a sub-group of subjects was invited
      for a clinical test visit during which subjects were catheterised with the same device
      applied during the preceding home-test period. First a healthcare professional (HCP)-led
      catheterisation was performed followed by a self-catheterisation, and endpoints related to
      bladder emptying (residual urine and number of urinary flow-stop episodes) were measured.
      After each catheterisation, any residual urine left in the bladder was measured with a
      bladder scanner and haematuria was assessed with a dip-stick test. After the
      self-catheterisation process, subjects at clinic visit V2 and V3 completed a questionnaire
      related to discomfort.

      Finally, all subjects completed a perception questionnaire and a HRQoL questionnaire
      associated with the catheter during the last two weeks of the home test period. For subjects
      not part of visits V2 and V3, a nurse assisted with the questionnaires after each home-test
      period during a remote home visit. Thereafter, all subjects were introduced to the second
      device to be tested for the next home-test period.

      After the second home-test period, the study was terminated with a test visit 3 (V3), either
      in the clinic (for the subset group) or a home visit by the nurse (the remaining subjects).
    

Intervention name(s): Investigational device - intermittent catheter with micro-hole zone; Comparator - standard intermittent catheter
Intervention type(s): Device; Device
Intervention description(s): Intermittent male catheter with micro-hole zone for urinary drainage; SpeediCath Flex, VaPro Pocket, VaPro Plus and VaPro Plus Pocket.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention