Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods...

Area of Science:

• Urology
• Clinical Trials
• Medical Diagnostics

Background:

• Men with lower urinary tract symptoms (LUTS) often undergo prostate surgery, which may not address all symptom causes.
• Benign prostatic obstruction (BPO) is a common cause of LUTS, but surgery is ineffective if symptoms stem from other issues.

Purpose of the Study:

• To establish if a care pathway including urodynamics is non-inferior to routine care for men with LUTS regarding symptomatic outcomes.
• To assess if urodynamics can reduce the rate of prostate surgery in men with LUTS.

Main Methods:

• The UPSTREAM trial is a UK-based study randomizing men with LUTS to either urodynamics or routine care.
• Outcomes are measured 18 months post-randomization, with the primary outcome assessed using a non-inferiority margin on the International Prostate Symptom Score (IPSS).
• Key secondary outcomes include surgery rates, adverse events, flow rate, and urinary and sexual symptoms.

Main Results:

• The trial is designed to detect if urodynamics is non-inferior to routine care for symptomatic outcomes.
• A key secondary outcome is an estimated at least 18% lower surgery rate in the urodynamics arm.
• The study will also assess superiority for surgery rates, adverse events, and various urinary and sexual symptom measures.

Conclusions:

• The a priori statistical analysis plan aims to minimize reporting bias by pre-specifying trial objectives.
• Trial results are anticipated following the recruitment end date, providing evidence for LUTS management strategies.
• The findings will inform clinical decision-making regarding the use of urodynamics in the pathway for men with LUTS.