Retropubic Tape versus Transobturator Tape: 10 year follow up study
Research type
Research Study
Full title
Low Tension Vaginal Tape (TVT) versus a Transobturator Foramen procedure (MONARC) for surgical treatment of Urodynamic Stress Urinary Incontinence: a ten-year follow-up study.
IRAS ID
223334
Contact name
Robert Freeman
Contact email
Sponsor organisation
Plymouth Hospital R & D
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Background: Mid-urethral slings using polypropylene tape are the recommended surgical procedures for stress urinary incontinence (SUI) when conservative methods have failed. This was first introduced as the retropubic tension free vaginal tape (TVT), with good outcomes. In an attempt to decrease the incidence of bladder injuries, the transobtruator tape procedure (TOT) was developed. Comparison of these two procedures in the MONARC trial (Freeman et al 2011), demonstrated similar success rates and patient satisfaction at one year follow up. However long-term outcome data on the safety and efficacy of these two procedures are lacking. A Cochrane review, the European enquiry (SCENIHR), the Scottish Independent review and NICE, have all highlighted the lack of long-term data to capture late complications as a limitation.
Objectives: We aim to address this limitation by evaluating the outcomes for patients from the MONARC trial. The primary outcome will be as for the original study i.e. cure of SUI at 10 years. However particular emphasis will be placed on secondary objectives including change in quality of life, de novo symptoms, e.g. overactive bladder, recurrent urinary tract infections, urinary retention, and long-term complications.
Methodology: The ICIQ-FLUTS Questionnaire will be sent to each participant to complete and return in a stamped address envelope. In order to overcome recollection bias, participants’ hospital records will be reviewed. Complications will be reported as per the IUGA/ICS classification, which provides data on type, time since surgery and severity. Initial data collection will span 3 months, with 6 months allocated for hospital record review and a further 3 months for data analysis.
This multicentre follow up study should provide more information on the long-term efficacy and safety of transobtruator and retropubic tapes as requested by Cochrane, NICE, SCENIHR and the Scottish Enquiry.REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
17/SW/0110
Date of REC Opinion
5 Jul 2017
REC opinion
Further Information Favourable Opinion