Newcastle Clinical Trials Unit



A non-inferiority randomised controlled trial to compare mixed (multi/single-use) catheter management with single-use catheter management by intermittent catheter users over 12 months.

  • Study stage: Recruiting
  • Sponsor: University of Southampton
  • Funder: National Institute for Health Research (NIHR) Programme Grant for Applied Research programme (PGfAR)
  • Therapeutic area: Renal and Urogenital
  • Type of study: CE Marked Device

Aim: To determine if a strategy of intermittent urinary catheter mixed use is no worse than a strategy of intermittent urinary catheter single (sterile) use only, in terms of incidence of microbiologically-confirmed symptomatic and help-seeking UTI over 12 months (post two week learning period) using a randomised controlled trial design.

Primary Outcome:

At least one episode over the 12 month follow-up period of Microbiologically Confirmed Symptomatic Urinary Tract Infection with Help-seeking behaviour (MC SH- UTI ) defined as:

  • Presence of at least one sign or symptom (S; new or worsening; listed on the trial symptom set or other symptoms reported by the participant)


  • Help-seeking behaviour (i.e. participant seeks help and/or treatment from GP/researcher or other HCP or implements own self-help strategy e.g. increase fluid intake, self-administration of antibiotics)


  • ⩾103 colony-forming units (cfu)/mL of ⩾1 bacterial species in a single catheter urine specimen during a symptomatic episode before or after starting antibiotic treatment.


  • Population: Adult
  • Design: RCT and Health Economics
  • Setting: Primary and  Secondary Care