Condition category
Urological and Genital Diseases
Date applied
27/03/2006
Date assigned
17/05/2006
Last edited
07/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19781044

Publication citations

  1. 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.

Additional files

Editorial Notes