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BJOG. 2009 Dec;116(13):1809-14. doi: 10.1111/j.1471-0528.2009.02355.x. Epub 2009 Sep 14.

Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient-preference study (CARPET 1).

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1
University of Leicester & University Hospitals of Leicester, Leicester, UK. dgt4@le.ac.uk

Abstract

In a multicentre randomised, unblinded patient preference pilot trial to assess the feasibility of a definitive randomised trial comparing colposuspension with tension-free vaginal tape (TVT) plus anterior repair in women with incontinence and prolapse, we found that 31 of 56 eligible women agreed to participate (55%). Recruitment was more successful face to face (87%) than by letter (16%). Only four of our women agreed to be randomised, 21 (68%) chose anterior repair+TVT and six (19%) chose colposuspension. This study demonstrates the importance of pilot work for complex trials to identify issues likely to adversely affect recruitment.

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