Abstract
Objective : Concerns exist regarding the risks of mid-urethral
slings (MUS) for stress urinary incontinence (SUI), particularly the
lack of long-term data. We compare patient reported outcomes of a
multicentre randomised controlled trial of retropubic
(TVT-GYNECARETM) versus transobturator
(TOT-MONARCTM) tape surgery at 12 years.
Design and setting : A multicentre study was performed in 11
tertiary referral centres.
Population: The 180 participants from the original trial.
Methods: Postal questionnaire survey of Patient Reported
Outcome Measures using the International Consultation on Incontinence
Questionnaire, Patient Global Impression of Improvement questionnaire
(PGI-I) and a Numeric rating scale pain questionnaire.
Main outcome measures: comparison of the efficacy and
complications between the TVT and TOT procedures in the long term.
Results : 110/180 responses were received: 55 TVT and 55 TOT
participants. Mean follow up: 12.8 years, STD +/- 0.29 years. TVT was
significantly superior to TOT in terms of cure ie no SUI: 41.8% TVT
versus 21.8% TOT (p=0.04). Urgency urinary incontinence (UUI) was the
most bothersome urinary symptom: 14.5% TVT and TOT respondents reported
UUI most or all the time. Severe groin or vaginal pain was reported in
4.8% TVT and 1.7% TOT participants. 80% TVT and 77% TOT participants
reported their symptoms as improved on the PGI-I.
Conclusions: TVT is superior to TOT for SUI cure. Efficacy and
patient satisfaction are reduced by 12 years. Severe vaginal or groin
pain is uncommon. Careful patient counselling of long-term outcomes is
required. The MUS appears to be an effective treatment for the majority
of women with SUI.
Funding: The United Kingdom Continence Society grant.
Keywords : complications, long-term patient reported outcomes,
retropubic mid-urethral sling, stress urinary incontinence,
transobturator mid-urethral sling.
Tweetable abstract: The retropubic tape has superior efficacy
to the transobturator tape. Complications are comparable and uncommon.