Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient-preference study (CARPET 1).
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.
University of Leicester & University Hospitals of Leicester, Leicester, UK. dgt4@le.ac.uk
D G
DG
Tincello
S
S
Kenyon
M
M
Slack
P
P
Toozs-Hobson
C
C
Mayne
D
D
Jones
D
D
Taylor
D005240:Feasibility Studies; D005260:Female; D006801:Humans; D057240:Patient Preference; D018579:Patient Selection; D010865:Pilot Projects; D053825:Suburethral Slings; D001743:Urinary Bladder / Q000601:surgery*; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D014596:Uterine Prolapse / Q000601:surgery*