Quality control of uroflowmetry and urodynamic data from two large multicenter studies of male lower urinary tract symptoms

Abstract

Aim: The International Continence Society (ICS) has standardized quality control and interpretation of uroflowmetry and urodynamics. We evaluated traces from two large studies of male lower urinary tract symptoms (UPSTREAM and UNBLOCS) against ICS standards of urodynamic equipment and practice. Methods: Ten percent of uroflowmetry and urodynamics traces were selected at random from hospital sites. A data capture template was designed from the ICS Fundamentals of Urodynamic Practice checklist. Two pretrained blinded assessors extracted the data, with a third assessor to arbitrate. Departmental records of calibration checks and equipment maintenance were scrutinized. Results: Seven out of twenty-five (28%) departments reported no calibration checks. Four sites (16%) could not provide annual service records. In 32 out of 296 (10.8%) uroflowmetry traces, findings were affected by artifact. One hundred ten urodynamic study traces were reviewed; in 11 records (10%), key pressure traces were incompletely displayed. In 30 (27.2%), reference zero was not set to atmospheric pressure. Resting pressures were outside the expected range for 36 (32.7%). Pressure drift was seen in 18 traces (16.4%). At pressureflow study commencement, permission to void was omitted in 15 (13.6%).Cough testing after voiding was done in 71.2%, but the resulting cough spikes were significantly different in 16.5%. Erroneous diagnosis of bladder outlet obstruction (BOO) was identified in six cases (5.5%).Conclusions: Erroneous diagnosis of BOO is a serious error of interpretation, as it could lead to unnecessary surgery. Other errors of standardization, testing, and interpretation were identified with lower risk of adverse implications. ---This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT

“…Chapter Results S ome of the work reported in this chapter may overlap with content published in dedicated journal papers, which we wish to acknowledge. [27][28][29] Some text has been based on Drake et al 28 Participant flow Figure 3 shows the layout of the trial and the different levels of dropout and analysis. Overall, 67 men withdrew from the trial within 548 days (18 months) of randomisation (seven of whom requested complete data withdrawal), with a median withdrawal time of 8 months (of 60 men with an available date).…”

Good urodynamic practice: Pressure signal quality immediately after catheter insertion for cystometry with a water‐filled pressure transducer system and its relevance for the ICS zero procedure

“…We start and display the digital recording of the urodynamic test before the filling pump is switched on, thus we include the initial zero to atmosphere in the urodynamic graph, in every patient. We also flushed both pressure lines with water at the beginning of the cystometry in every patient, as previously advised 3,4,7 and recently again 8 (see Figures 2 and 3).…”

“…Furthermore, the pressures have been outside the expected range in 30% of the studies. 8 Zeroing is discussed in the earliest ICS-GUP document, 3 which explains: [Citations] Many important aspects of quality and plausibility control, such as typical resting value ranges at different patient position, are based on the proper recording of pressures, and will not apply if pressures are not recorded according to ICS standards. Also, it is only meaningful to subtract one pressure from the other, for example (p ves − p abd = p det ), when both are recorded to the same reference level.…”

Obstruktive Blasenentleerungsstörungen – Bedeutung der Urodynamik

“…UPSTREAM ist eine zweiarmige, multizentrische und randomisierte Studie zur Bestimmung der klinischen und wirtschaftlichen Wirksamkeit der Urodynamik zur Diagnose und Behandlung von obstruktiven Blasenentleerungsstörungen, mit störender Symptomatik der unteren Harnwege, bei Männern, die für eine Operation in Frage kommen. [5], zum anderen wurden die urodynamischen Untersuchungen offensichtlich zu einem beachtlichen Teil nicht entsprechend gängiger Empfehlungen durchgeführt [6]. Es gab keinen klaren Algorithmus zur Empfehlung einer Operation (analog dem "pragmatischem Design").…”