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.

Staff

Catherine Brennand
Trial Manager

Andrew Bryant
Research Associate

Denise Howel
Senior Lecturer

Professor Elaine McColl
Director(Newcastle Clinical Trials Unit)

Dr Jing Shen
Senior Research Associate (Health Economics)

Professor Luke Vale
Health Foundation Chair in Health Economics, Deputy Director