Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals

Objective

Prostate surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, surgery is less effective without BOO, or if detrusor underactivity (DU) is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. UPSTREAM (Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods) evaluated whether a care
pathway including UDS would reduce surgery without increasing urinary symptoms.

Design, setting and participants

UPSTREAM is a pragmatic, non-inferiority randomised controlled trial in 26 hospitals in England (ISRCTN56164274) in men with bothersome LUTS where surgery was an option.

Intervention

Participants were randomised (1:1) to routine care (RC) diagnostic tests, or routine care plus urodynamics (UDS).

Outcome measures

The primary outcome was International Prostate Symptom Score (IPSS; patient reported outcome scale from 0 to 35 points) 18-months post-randomisation, with a non-inferiority margin of one point. Urological surgery rates were a key secondary outcome.

Statistical analysis

The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis.

Results and limitations

Between October 2014 and December 2016, 820 men (median age 68 years) were randomised (393 and 427 in RC and UDS arms, respectively). The UDS arm showed noninferiority of mean IPSS scores (UDS 12·6; RC 13.1; adjusted difference at 18 months -0·33 (95% CI -1·47, +0·80)). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) for RC (adjusted OR 1·05; 95% CI 0·77, 1·43). 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms, and 11 unrelated deaths.

Conclusion

In this population, the UDS randomised group was non-inferior to RC for IPSS but did not reduce surgical rates. The study shows that routine use of UDS in evaluation of uncomplicated LUTS has a limited role and should be used selectively.

Patient summary

For men with uncomplicated lower urinary tract symptoms, the symptom improvements after treatment and the number of operations done are similar, whether or not urodynamic tests are
done in addition to routine tests. Accordingly, routine use of UDS has a limited role in this population group.