Colposuspension or tension free vaginal tape with anterior repair for urinary incontinence and prolapse: a pilot study

ISRCTN	ISRCTN34759911
DOI	https://doi.org/10.1186/ISRCTN34759911
Protocol serial number	UHL 9967
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Medical Research Council (MRC) (UK) (grant ref: 73379)

Submission date: 27/03/2006
Registration date: 17/05/2006
Last edited: 07/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Douglas Tincello
Scientific

Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester Royal Infirmary
P.O. Box 65
Leicester
LE2 7LX
United Kingdom

Phone	+44 (0)116 252 5813
Email	dgt4@le.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised patient preference trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CARPET 1
Study objectives	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(s)	Approved by Leicestershire, Rutland and Northamptonshire Ethics Committee Two, 29/11/2005, reference number: 05/Q2502 91
Health condition(s) or problem(s) studied	Urodynamic stress incontinence/ vaginal prolapse (anterior)
Intervention	1. Colposuspension 2. Suburethal tension free vaginal tape with anterior vaginal repair
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	31
Key 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)
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	30/09/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Robert Kilpatrick Clinical Sciences Building (RKCSB)

Leicester
LE2 7LX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009		Yes	No