Five-year Follow-up of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods-A Noninferiority Randomised Controlled Trial of Urodynamics.

Abstract

Background and objective: Lower urinary tract symptoms (LUTS) are a key indication for surgery in older men. The Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) study evaluated the diagnostic pathway for men considering surgery to treat LUTS and reported the outcomes at 18 mo. This long-term follow-up study reports the symptoms and rates of prostate surgery at 5 yr.

Methods: UPSTREAM participants who had consented to long-term follow-up received postal questionnaires at 5 yr after randomisation (October 2019-December 2021). The primary outcome was the patient-reported International Prostate Symptom Score (IPSS, scale 0-35). Rates of surgery, derived from the National Health Service (NHS) England routine data, were a key secondary outcome. An intention-to-treat analytic approach was utilised.

Key findings and limitations: At 5 yr, 211/427 (49.4%) participants in the intervention group and 204/393 (51.9%) in the routine care group completed the questionnaires, with routine data obtained for 801/820 (97.7%). The mean IPSS at 5 yr did not differ between randomised groups (adjusted difference 0.41, 95% confidence interval -1.10, 1.93), nor did the rates of surgery (0.96 [0.71, 1.28]). Urinary and sexual symptoms also showed no differences between the randomised groups. The main limitation is the reduced numbers of men in follow-up. In UPSTREAM, men were randomised to routine care diagnostic tests plus invasive urodynamics (intervention) or routine care only for LUTS. Treatment choice was made by the participants, advised by their clinicians.

Conclusions and clinical implications: Five-year follow-up does not support the routine use of invasive urodynamics in reducing LUTS or rates of prostate surgery. Urodynamics should be used selectively in the evaluation of uncomplicated LUTS.