Long term follow-up of a multicentre randomised controlled trial comparing TVT, PelvicolTM and autologous fascial slings for the treatment of stress urinary incontinence in women - Abstract

OBJECTIVE: To compare the long-term outcomes of TVT, autologous fascial slings (AFS) and PelvicolTM in the management of female SUI.

SUBJECTS/ METHODS AND MATERIALS: A multicenter randomised controlled trial carried out in 4 UK centers from 2001-2006 involving 201 women requiring primary surgery for SUI. Women were randomly assigned to receive TVT, AFS or PelvicolTM. Primary outcome was surgical success defined as "women reporting being completely 'dry' or 'improved' at the time of follow-up". Secondary outcomes included completely 'dry' rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and Euro-QoL scores.

RESULTS: 162 (80.6%) women were available for follow-up with a median duration of 10-years (6.6-12.6 years). 'Success' rates for TVT, AFS and PelvicolTM were 73%, 75.4% and 58% respectively. Comparing the 12-month and 10-year 'success' rates, deterioration from 93% to 73% (p=< 0.05) in the TVT and 90% to 75.4% (p=< 0.05) in the AFS arm were correspondingly noted. 'Dry' rates were 31.7%, 50.8% and 15.7% respectively. Overall, the 'dry' rates favoured AFS when compared to PelvicolTM (p=< 0.001) and TVT (p=0.036). Re-operation for persistent SUI was 3.2% (n=2) in the TVT arm, 13.1% (n=5) in the PelvicolTM arm while none of the patients in the AFS arm required further intervention.

CONCLUSIONS: Our study indicates there is not enough evidence to suggest a difference in long-term success rates between AFS and TVT. However there is some evidence that dry rates for AFS may be more durable compared to TVT.

Written by:
Khan ZA, Nambiar A, Morley R, Chapple CR, Emery SJ, Lucas MG.   Are you the author?
Uro- gynaecology department, Singleton Hospital, Sketty Lane, Swansea, SA2 8QA.

Reference: BJU Int. 2014 Jun 24. Epub ahead of print.
doi: 10.1111/bju.12851


PubMed Abstract
PMID: 24961647

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