Hypothesis / aims of study
Worldwide synthetic mid urethral slings are the most frequently performed surgical procedure for the treatment of primary (no previous surgery) Stress Urinary Incontinence (SUI) and recurrent (1 or more previous failed surgeries) SUI. In the UK an increasing awareness of mesh sling related complications such as vaginal exposure, extrusion into the urinary tract, chronic pain, and sexual dysfunction led to a high vigilance pause (HVP) in 2018 pending a formal review by Baroness Cumberlege (1) and new NICE guidance on the management of urinary incontinence in women and of mesh sling related complications. Following the HVP, intraurethral bulking agents, in particular intraurethral Bulkamid™, became the most commonly performed surgical treatment for SUI.
With the increased scrutiny on mesh associated procedures, there has been an increase in interest in autologous slings. The techniques utilised in each of the Rectus Fascial Sling (RFS) procedures were standardised and performed by several surgeons of the region’s hospital. We have assessed medium to long term outcomes following RFS in women with SUI and stress predominant MUI to determine effectiveness of RFS.
Study design, materials and methods
We conducted a retrospective analysis of a prospectively acquired database of 57 consecutive women having an autologous RFS to treat primary or recurrent SUI between 1st September 2007 and 28th February 2018. Data was collected on patient demographics, pre-operative urodynamic findings, long term complications, and subjective outcome. Subjective outcome was assessed using a 5-Point Patient Global Impressions of Improvement (PGII) score and change in daily incontinence pad usage. Long term complications assessed included: new onset need to intermittent self-catheterisation (ISC) post RFS, new onset recurrent urinary tract infections (rec UTIs) and new onset frequency/urgency (F/U). Outcomes between patients with pure SUI as an indication for RFS were compared with those with sMUI. Outcomes of women having RFS for primary SUI/sMUI with also compared with those of women having RFS for recurrent SUI/sMUI. Inclusion criteria were all women over the age of 18 years old who had an autologous rectus fascial sling operation to treat primary or recurrent SUI or sMUI between the dates detailed and a minimum of 12 months follow up. Exclusion criteria were patients who had not received an autologous rectus fascial sling and instead received alternative treatment for their UI.
Statistical analysis was by Students T-test for parametrically distributed variable, Mann-Whitney U test for non-parametrically distributed variables and Fishers Exact test for comparison of post-operative complication rates between subgroups. Statistical significance was determined as P < 0.05.
Results
A total of 57 patients met the defined inclusion criteria. Their median age was 54 years (range 22-76). There were 39 (68%) patients with SUI and 18 (32%) with sMUI, the women with recurrent SUI had had a mean of 1.6 (range 1 - 4) previous operations for their SUI/sMUI, the commonest of which was tension-free vaginal tape (TVT) (N = 24). Other previous operations for SUI/sMUI included colposuspension (N = 22), Transobturator tape (TOT) (N = 6), intraurethral bulking (N = 6) and RFS (N = 5).
PGII success was noted in 51 (89%) and was a median of 1 (mean 1.36) 12 months post-surgery. Interestingly 39 (68%) of the women had their RFS for recurrent SUI/sMUI whilst 18 (32%) had their RFS for primary SUI/sMUI. PGII outcomes at 12 months for the subgroups are detailed in Table 1. PGII was a median of 1 at 12 months post RFS – indicating that patients were very much improved symptomatically. There was no significant difference in PGIIs at 12 months between patients with SUI and sMUI (P = 0.79) or between patients having RFS for primary or recurrent SUI.
Pads data collected from patients in 48 (84%) of the women. Mean daily pad usage significantly reduced from 5 pads PPD pre-operatively to 1.65 post operatively (P = 0.0000055) – the results for all groups are detailed in Table 2.
ISC was required in 8 (14.04%), rec UTIs developed in 3 (5.26%) and new onset bothersome F/U developed in 11 (19.3%). There was no significant difference in the rate of ISC and recurrent UTI whilst development of new onset bothersome frequency/urgency was significantly greater in women with sMUI.
Interpretation of results
RFS improved or very much improved SUI in 89% of women with primary or recurrent SUI/sMUI with a mean PGII of 1.2 12 months post-surgery. This is irrespective of whether the patients had primary or recurrent SUI/sMUI – this is in line with the literature describing an 85% - 92% overall patient satisfaction.
Of the 57 women in the study, 68% had recurrent SUI/sMUI with a mean of 1.6 previous failed SUI/sMUI surgeries. At 12 months post RFS, median PGII for all 57 patients was 1 (mean 1.35). Although, there were some differences in the results between SUI and sMUI (with SUI having a slightly higher mean PGII of 1.2 compared to 1.125 seen in sMUI) and similarly in primary SUI/sMUI and recurrent SUI/sMUI (a 1.4 mean PGII seen in recurrent SUI/sMUI compared to 1.2 seen in primary SUI/sMUI), these differences did not attain statistical significance.
There have been several studies comparing outcomes in women with recurrent SUI as compared to primary SUI – one such study demonstrated an 86% success rate for primary SUI contrasting with a 79% success rate for recurrent SUI (2). This difference was concluded as being statistically insignificant at P = 0.05, reinforcing our findings.
Following a review of the literature on the outcomes between SUI and sMUI, we came across a study that concluded that there was a nonsignificant difference between the cure/improved rate between SUI (97%, N = 44) and sMUI (93%, N = 47) (P = 0.33) (3). This supports our findings of no statistical significance between the outcomes observed in SUI and sMUI.