Background:

Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery.

Objectives:

The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome.

Design:

This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research.

Setting:

Urology departments of 26 NHS hospitals in England.

Participants:

Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised.

Interventions:

Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm).

Main outcome measures:

The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness.

Results:

A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (–0.33, 95% CI –1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43–44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS.

Limitations:

The trial met its predefined recruitment target, but surgery rates were lower than anticipated.

Conclusions:

Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS.

Future work:

Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy.

Trial registration:

Current Controlled Trials ISRCTN56164274.

Funding:

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 12/140/01. The contractual start date was in April 2014. The draft report began editorial review in November 2018 and was accepted for publication in February 2019. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Outside this work, Paul Abrams reports grants and personal fees for being a consultant and speaker for Astellas Pharma Inc. (Tokyo, Japan), and personal fees for being a consultant for Ipsen (Paris, France) and a speaker for Pfizer Inc. (New York City, NY, USA) and Sun Pharmaceutical Industries Ltd (Mumbai, India). He also reports personal fees from Pierre Fabre S.A. (Paris, France) and Coloplast Ltd (Peterborough, UK). Christopher Chapple reports being an author for Allergan plc (Dublin, Ireland) and Astellas Pharma; being an investigator for scientific studies/trials with Astellas Pharma and Ipsen; being a patent holder with Symimetics; receiving personal fees as a consultant/advisor for Astellas Pharma, Bayer Schering Pharma GmbH (Berlin, Germany), Ferring Pharmaceuticals (Saint-Prex, Switzerland), Galvani Bioelectronics (GlaxoSmithKline; Stevenage, UK), Pierre Fabre, Symimetics, TARIS Biomedical Inc. (Lexington, MA, USA), and Urovant Sciences (Irvine, CA, USA); and receiving personal fees as a meeting participant/speaker for Astellas Pharma and Pfizer. J Athene Lane was a member of the Clinical Trials Unit funded by the National Institute for Health Research during the conduct of this trial. Marcus J Drake reports being on associated advisory boards and has received grants, personal fees and non-financial support from Allergan, Astellas Pharma and Ferring Pharmaceuticals. He has also received personal fees from Pfizer.