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ISRCTN
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ISRCTN34759911
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ClinicalTrials.gov identifier
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Public title
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Colposuspension or tension free vaginal tape with anterior repair for urinary incontinence and prolapse: a pilot study
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Scientific title
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Acronym
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CARPET 1
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Serial number at source
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UHL 9967
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Study hypothesis
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Retropubic colposuspension is more effective than a Tension free Vaginal Tape (TVT) insertion with anterior vaginal repair for the treatment of urodynamic stress incontinence and anterior vaginal prolapse.
Please note that, as of 08/09/2008, the anticipated end date of this trial has been updated from 30/04/2008 to 25/04/2008.
Please note that, as of 16/01/2009, the anticipated end date has been updated from 25/04/2008 to 30/09/2007 (end of recruitment). The last patient completed follow up in November 2007.
As of 19/01/2009, the target number of participants was amended from 150 (estimate) to 31 (actual number recruited). Please note that identification of the number of eligible and willing patients was one of the aims of this pilot trial.
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Lay summary
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Ethics approval
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Approved by Leicestershire, Rutland and Northamptonshire Ethics Committee Two, 29/11/2005, reference number: 05/Q2502 91
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Study design
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Randomised patient preference trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Urodynamic stress incontinence/ vaginal prolapse (anterior)
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Participants - inclusion criteria
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Women with urodynamic stress incontinence (USI) and anterior vaginal prolapse of stage II or more assessed by Pelvic Organ Prolapse Quantification score (POP-Q)
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Participants - exclusion criteria
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1. Detrusor overactivity (DOA) on urodynamics
2. Previous incontinence or prolapse surgery
3. Apical or posterior vaginal prolapse of stage II or more on POP-Q
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Anticipated start date
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01/05/2006
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Anticipated end date
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30/09/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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31
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Interventions
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1. Colposuspension
2. Suburethal tension free vaginal tape with anterior vaginal repair
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Primary outcome measure(s)
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1. Eligible patient numbers, by centre
2. Proportion of patients consenting to randomisation
3. Reasons for non-randomisation
4. Improvement in disease specific quality of life score at 6 weeks and 12 months
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Secondary outcome measure(s)
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1. Change in POP-Q score at 6 weeks and 12 months
2. Change in 24 hour pad test at 6 weeks and 12 months
3. Change in diary completed leakage episodes at 6 weeks and 12 months
4. Change in incidence of USI on urodynamics at follow up
5. Incidence of DOA on urodynamics at follow up at 12 months
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Sources of funding
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Medical Research Council (MRC) (UK) (grant ref: 73379)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19781044
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Contact name
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Dr
Douglas
Tincello
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Address
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Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester Royal Infirmary
P.O. Box 65
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City/town
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Leicester
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Zip/Postcode
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LE2 7LX
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Country
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United Kingdom
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Tel
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+44 (0)116 252 5813
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Fax
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+44 (0)116 252 5846
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Email
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dgt4@le.ac.uk
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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Research Office
Leicester General Hospital
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Tel
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+44 (0)116 258 4109
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Email
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nicola.turner@uhl-tr.nhs.uk
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Date applied
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27/03/2006
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Last edited
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07/10/2009
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Date ISRCTN assigned
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17/05/2006
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