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 |
| Secondary identifying numbers | UHL 9967 |
- 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
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 |
|---|---|
| dgt4@le.ac.uk |
Study information
| Study design | Randomised patient preference trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/05/2006 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Robert Kilpatrick Clinical Sciences Building (RKCSB)
Leicester
LE2 7LX
United Kingdom
LE2 7LX
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk | |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
Medical Research Council (MRC) (UK) (grant ref: 73379)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
