INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing
2011

Study Protocol for Investigating Urodynamic Testing in Women with Urinary Incontinence

Sample size: 240 publication Evidence: moderate

Author Information

Author(s): Megan Murdoch, Elaine McColl, Denise Howel, Mark Deverill, Brian S Buckley, Malcolm Lucas, Christopher R Chapple, Douglas G Tincello, Natalie Armstrong, Cath Brennand, Jing Shen, Luke Vale, Paul Hilton

Primary Institution: Newcastle upon Tyne Hospitals NHS Foundation Trust

Hypothesis

Does invasive urodynamic testing alter treatment decisions and outcomes in women with urinary incontinence?

Conclusion

The pilot study aims to assess the feasibility of a larger trial to determine the clinical utility of invasive urodynamic testing.

Supporting Evidence

  • Urinary incontinence affects a significant portion of the population, with estimates ranging from 5% to 69%.
  • Current guidelines suggest that invasive urodynamic testing is not necessary before conservative treatments.
  • Previous studies have shown low recruitment rates in similar trials, highlighting the need for this pilot study.

Takeaway

This study is trying to find out if a specific test helps doctors make better decisions for women with bladder problems before surgery.

Methodology

A mixed methods pragmatic multicentre feasibility pilot study with randomised trials, qualitative interviews, and a national survey.

Potential Biases

Potential bias in clinician willingness to randomise patients based on their beliefs about the utility of invasive testing.

Limitations

The pilot study may not fully represent the larger population due to its limited sample size and specific recruitment criteria.

Participant Demographics

Women with stress urinary incontinence or mixed urinary incontinence, aged 18 and older.

Digital Object Identifier (DOI)

10.1186/1745-6215-12-169

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