Newcastle Clinical Trials Unit


A randomised controlled trial of minimally invasive surgical treatments for bladder outlet obstruction due to enlarged prostate in the National Health Service

  • Study stage: Set-up
  • Sponsor: Newcastle upon Tyne Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Renal and Urogenital
  • Type of study: Surgical

Aim: To compare the clinical effectiveness of 3 minimally invasive treatments (MITS) to transurethral resection of prostate (TURP) for treatment of bladder outlet obstruction (BOO) due to enlarged prostate over 12 months

Primary Outcome: Change in international prostate symptom score (IPSS) from baseline to 12 months post-intervention

  • Population: Adult
  • Design: Multi-arm, multi-centre, non-inferiority randomised controlled trial, with 6-month internal pilot
  • Setting: Secondary care
  • Planned Sample Size: 536