Contact information
Type
Scientific
Primary contact
Dr Douglas Tincello
ORCID ID
Contact details
Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester Royal Infirmary
P.O. Box 65
Leicester
LE2 7LX
United Kingdom
+44 (0)116 252 5813
dgt4@le.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UHL 9967
Study information
Scientific title
Acronym
CARPET 1
Study hypothesis
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.
Ethics approval
Approved by Leicestershire, Rutland and Northamptonshire Ethics Committee Two, 29/11/2005, reference number: 05/Q2502 91
Study design
Randomised patient preference trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Urodynamic stress incontinence/ vaginal prolapse (anterior)
Intervention
1. Colposuspension
2. Suburethal tension free vaginal tape with anterior vaginal repair
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/05/2006
Overall trial end date
30/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women with urodynamic stress incontinence (USI) and anterior vaginal prolapse of stage II or more assessed by Pelvic Organ Prolapse Quantification score (POP-Q)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
31
Participant exclusion criteria
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
Recruitment start date
01/05/2006
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester
LE2 7LX
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0)116 258 4109
nicola.turner@uhl-tr.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Medical Research Council (MRC) (UK) (grant ref: 73379)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19781044
Publication citations
-
Results
Tincello DG, Kenyon S, Slack M, Toozs-Hobson P, Mayne C, Jones D, Taylor D, Colposuspension or TVT with anterior repair for urinary incontinence and prolapse: results of and lessons from a pilot randomised patient-preference study (CARPET 1)., BJOG, 2009, 116, 13, 1809-1814, doi: 10.1111/j.1471-0528.2009.02355.x.