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Long-term efficacy and complications of a multicentre randomised controlled trial comparing Retropubic and Transobturator Mid-Urethral Slings: a prospective observational study.
  • Ifeoma Offiah,
  • Robert Freeman
Ifeoma Offiah
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Robert Freeman
Plymouth Hospitals NHS Trust
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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.

Peer review status:ACCEPTED

26 Oct 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
27 Oct 2020Submission Checks Completed
27 Oct 2020Assigned to Editor
09 Nov 2020Reviewer(s) Assigned
26 Nov 2020Review(s) Completed, Editorial Evaluation Pending
15 Dec 2020Editorial Decision: Revise Major
12 Jan 20211st Revision Received
15 Jan 2021Submission Checks Completed
15 Jan 2021Assigned to Editor
22 Jan 2021Reviewer(s) Assigned
03 Feb 2021Review(s) Completed, Editorial Evaluation Pending
02 Mar 2021Editorial Decision: Accept