Newcastle University

Project:

INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?: a pragmatic multicentre pilot study to assess the feasibility of a future randomised controlled trial

From January 2011 to December 2012
Project Leader(s): Chief Investigator: Mr Paul Hilton (Newcastle upon Tyne Hospitals NHS Trust)
Contact: Cath Brennand (trial manager)
Sponsors: NETSCC Health Technology Assessment Programme
Partners: Newcastle upon Tyne Hospitals NHS Foundation Trust, Bladder and Bowel Foundation, University of Leicester, Swansea NHS Trust, Royal Hallamshire Hospital

This is a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of urodynamic investigation prior to surgery for stress urinary incontinence. The study consists of a rehearsal pilot RCT of invasive urodynamic testing versus basic assessment plus non-invasive testing; qualitative interviews with subsets of women agreeing and not agreeing to be randomised in the above RCT; a national survey of clinicians about their access to and views on urodynamics in this situation; and qualitative interviews with a subset of clinicians to illuminate questionnaire responses and to explore how they use investigation in clinical decision-making.

This is a multicentre study with sites in Newcastle, Gateshead, Ashington, Sheffield, Leicester and Swansea.  Sample size is 240 with recruitment due to finish mid 2012.