Stress Urinary Incontinence and Pelvic Organ Prolapse
Stress urinary incontinence (incontinence) and pelvic organ prolapse (prolapse) are experienced by many women in Scotland. Incontinence is the leaking of urine when the bladder is under pressure, for example when coughing, sneezing, or during exercise. Prolapse is when one or more of the pelvic organs (bladder, uterus/ womb, or lower bowel) bulges into the vagina causing discomfort.
Various operations can be provided for incontinence and prolapse. Some of the newer types of operations involve the insertion of synthetic mesh. The use of mesh may bring benefits but may also carry higher risks than other, non-mesh, operations. In 2014, the Scottish Government set up the Independent Review of Transvaginal Mesh Implants ('the Review'). The Review was asked to examine the safety and effectiveness of mesh surgery for incontinence and prolapse. Information Services Division was asked to help the Review by examining routine NHS information collected on patients treated for these conditions.
The Review published an interim report in October 2015 that included preliminary results from ISD’s analysis. The final results of ISD’s analysis were published in December 2016 in The Lancet. A summary of differences between the preliminary and final results is provided below:
- The study period has been extended from 1997/98-2013/14 to 1997/98-2015/16.
- Enterocele procedures (OPCS4 code P23.4) are now counted in the posterior (rather than anterior) non-mesh colporrhaphy group.
- Vaginal vault prolapse repair procedures involving transvaginal placement of mesh (OPCS4 code P24.6) are now labelled ‘Vaginal mesh vault repair’ (rather than ‘Infracoccygeal colpopexy’).
- Further incontinence and prolapse surgery occurring after the index procedure are now considered as two separate outcomes (rather than a single composite outcome).
- The secondary outcomes initially examined (for example all readmissions, referrals to pain clinics, and prescriptions for pain relief) added little to the main outcomes (complications and further surgery) so have not been included in the final analyses.
- Analysis errors have been corrected, in particular:
- Previously procedures were excluded if the woman had undergone prior incontinence or prolapse surgery in the five years up to 1997/98. Now they are excluded if the woman had undergone prior incontinence or prolapse surgery in the five years up to the procedure being considered. This means that repeat procedures are now more effectively excluded from the analysis as intended.
- Previously vault prolapse repair procedures were excluded if the woman’s prior surgery had involved any incontinence or prolapse procedure. Now vault procedures are excluded if the woman’s prior surgery involved any incontinence or prolapse procedure except hysterectomy. In addition, previously vault procedures were included regardless of any other incontinence or prolapse procedures done at the same time. Now vault procedures are only included if done as a single procedure or in combination with a standard (non-mesh) anterior and/or posterior colporrhaphy. This means that ‘first, single’ vault repair procedures are now included as intended.
- Previously only a certain subtype of immediate complications (procedure related) was counted in the total number of immediate complications. Now all subtypes (haemorrhage, infection, pain, procedure related) are included as intended. This means that our results now show a higher proportion of women experiencing immediate complications.