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A clinical trial comparing surgical approaches in the care of bulbar urethral stricture

Contact email: robert.pickard@ncl.ac.uk

Background and study aims

About 60,000 younger men aged less than 65 years in the UK suffer from urethral stricture, a narrowing of the urinary channel just beyond the bladder (bulbar urethra). The stricture causes trouble passing urine which is embarrassing for men and often leads to urine infection requiring time off work and visits to their doctor  This research looks at two surgery options for urethral stricture to see how they compare.

Who can participate?

We plan to recruit at least 500 men who have a recurrent bulbar urethral stricture. They must be aged 16 or over, had at least one previous intervention for stricture and be prepared and able to have either an open urethroplasty or an optical urethotomy.

What does the study involve?

We plan a randomised controlled trial carried out in up to 50 UK NHS hospitals. Apart from random allocation of treatment, care received by participants will follow routine clinical practice in each hospital. We will monitor all the participants for 2 years following their treatment, measuring change in symptoms, general well-being, urinary flow rate and rate of recurrence of the stricture. We will record any problems men encounter linked to the operation such as infections and needing time off work, and collect information on the costs.

What are the possible benefits and risks of participating?

Potential participants will need to understand the uncertainty as to which treatment is best and accept allocation to one or other treatment by computer. We will better understand patient views by interviewing up to 20 potential participants in the early part of the study to find out how they weigh up the pros and cons of each treatment and decide which is best for them. This will help identify factors that influence men in making a choice between the treatments.  Those randomised to urethroplasty will potentially benefit from more effective treatment and both groups will have their disease more closely monitored than is usual. The trial results will help shape presentation of treatment options to future men with stricture.

Where is the study run from?

The trial is managed by the Newcastle Clinical Trials Unit based at Newcastle University, Newcastle upon Tyne, UK. Website: http://www.opentrial.co.uk

When is the study starting and how long is it expected to run for?

The trial started on 1st November 2012 and is planned to end on 28th February 2017. Participant recruitment is scheduled to start on 1st February 2013 and end on 31st January 2015.

Who is funding the study?

The trial is funded by the UK Government through its National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme; Clinical Evaluation and Trials Board.

Who is the main contact?

Robert Pickard

Professor of Urology

Newcastle University

Newcastle upon Tyne, UK

Institute of Cellular Medicine, 3rd Floor William Leech Building, The Medical School, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.

E mail: robert.pickard@newcastle.ac.uk

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