Long-term efficacy and complications of a multicentre randomised
controlled trial comparing Retropubic and Transobturator Mid-Urethral
Slings: a prospective observational study.
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-GYNECARE) versus
transobturator (TOT-MONARC) 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/
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.