doi:10.1111/1471-0528.16899
Congratulations to the authors on publishing a robust long term follow
up of a randomised controlled trial on the use of mesh tapes for the
treatment of stress urinary incontinence in women.
With regard to safety, the authors report the risk of moderate to severe
pain as 14% (17/121) and describe it as ‘uncommon’ . Such
description does not appear in line with the 2015 Guidance on Obtaining
Consent from the Royal College of Obstetricians & Gynaecologists (1).
According to the Guidance, a 14% risk is ‘very common ’ and
carries the colloquial equivalent of ‘one in a family ’.
The risk of all-severity chronic pain was not directly mentioned in the
paper, but it appears to be 17.5%. If this figure is correct, the team
looking after the NHS Patient Information Leaflet (2) on mesh tape
surgery would consider updating the risk of chronic pain. Currently, it
is ‘common’ after transobturator tape and ‘uncommon ’ after
the retropubic tape. The authors’ conclusion on the importance of
careful counselling could not be overemphasised.
A key finding of the long-term study is the loss of the recognised and
significant short-term difference in chronic pain between the two mesh
procedures. Most shorter-term trials, and subsequently their systematic
reviews (3), had consistently favoured the retropubic procedure over its
transobturator variant when chronic pain is considered.
In addition, many shorter-term trials(3) reported higher risk of voiding
dysfunction with the retropubic tape, giving surgeons the impression of
it being more obstructive than the transobturator variant. How would the
authors explain the loss of such significant differences in their
long-term study and also the more bothersome OAB symptoms in the
transobturator group?
With regard to efficacy, the difference in the primary outcome (Patient
Global Impression of Improvement, PGI-I) was not significant, suggesting
a similar overall effectiveness of the two procedures at 12 years. Usingcure as a study outcome, however, led to the conclusion of
superiority of the retropubic procedure. Most relevant qualitative
studies had confirmed that improving, rather than curing, incontinence
may be adequate for many women(4). Therefore, the authors’ application
of a slightly different outcome that carries a strict definition of cure
may have unnecessarily disadvantaged the transobturator variant.
Finally, the authors appear to confidently extrapolate the mostly
favourable results from the patient-reported PGI-I scores to indicate
satisfaction. As a marker for clinical improvement, the PGI-I scores may
or may not directly correlate with overall satisfaction with the
surgical procedure, which is a wider concept that extends to safety
matters amongst others.
Offiah & Freeman study is indeed a landmark that is expected to change
Clinical Guidelines and to influence the national discourse on
continence mesh surgery in the UK and beyond.