Introduction

1. No. 052 Long term follow up of the outcome of the Monarc midurethral sling for urodynamic stress urinary incontinence CR Dowling, E Fitzgerald, JK Lee, A Polyakov, A Rosamilia Department of Surgery and Department of Obstetrics and Gynaecology, Monash University, Southern Health Introduction Transobturator midurethral slings for stress urinary incontinence (SUI) were described in 20031 with an aim to improve the safety of the approach compared with the retropubic sling, however there is less established long term data on the durability of this method compared with the retropubic sling. Results Demographic data and LUTS at baseline as measured by UDI6 and IIQ7 for the entire cohort and for those who completed 5 years follow up was balanced. There were no major complications of the surgery. Repeat surgery for SUI consisted of 1 pubovaginal sling, 2 TVTs and three bulking agents. Overall, a reoperation rate of 6/241 or 2% was found. All reoperations had occurred by the 2 year follow up. Surgery for complications consisted of excision of 3 vaginal mesh exposures, 2 sling divisions and 1 early sling loosening from 241 surgeries. Patient reported outcomes (Table 1a) demonstrate a reduction in SUI (Q3 UDI6, “Urine leakage related to physical activity, coughing or sneezing”), total IIQ7 score and UUI (Q2 UDI-6, “Urine leakage related to the feeling of urgency”) to five years. Between 6 months and 5 years there was a significant difference found in scores suggesting some deterioration in both SUI and UUI. The IIQ7 did not change during this period. De novo urge was defined as an increase in Q2 UDI6 over time (Table 1b). There was a reduction in proportion of those with UUI at 6 months (from 60% to 9%) with a sustained reduction of this at 5 years. There was however, an increase in de novo UUI from 6 months follow up till 5 years. Graph 1 shows % success, defined as VAS ≥ 70,  over time in total, by surgeon experience, by presence of concomitant procedure and pre operative urgency. There is reducing success over time irrespective of these parameters (p>0.0001). 5 year patient global impression of improvement remained high at 93% (PGII >4). The reduction in overall VAS may reflect an increase in de novo UUI as shown in Table 1b. Aim In 2003 we began a prospective register of cases for this new procedure involving an outside-in TOT approach (Monarc, AMS). 241 women who underwent a TOT tape procedure between May 2003 and September 2005 were entered onto the registry. We now present the follow up data of these cases, to assess the durability of the TOT based system using a subjective analysis based on validated patient questionnaires and patient satisfaction scores. Preop 6 months 5 years Preop 6 months 5 years n =2 4 1 n =1 1 5 n =7 2 Median (IQR) Persistence UUI 101/174 10/115 8/71 SUI, Q3 UDI6 3 (2 , 3 ) 0 (0 , 1 ) * 0 (0 , 2 ) * Proportion Q2 UDI6 >2 60% 9% * 11% # Overall UDI6 9 (5 , 1 1 ) 2 (0 , 4 . 5 ) * 3 . 5 (1 , 8 ) * O ve ra l l I I Q 7 9 (5 , 1 3 ) 0 (0 , 2 ) * 0 (0 , 4 ) # De novo UUI 5/115 16/71 Proportion Q2 UDI6 increase >2 2 (1 , 3 ) 1 (0 , 1 ) * 1 (0 , 2 ) * UUI Q2 UDI6 4% 23%* Table 1a: Patient Reported Outcomes (UDI6, IIQ7) after Monarc at 5 years follow up *: p<0.05 #: p>0.05 Table 1b: Persistence in or De novo UUI after Monarc at 5 years follow up. *: p<0.05 #: p>0.05 Methods All women completed an initial assessment including a standardised pelvic floor proforma, POPQ examination, voiding diary and multichannel subtracted urodynamics, a 24 hour pad weigh test and complete validated questionnaires including the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaires (IIQ7). These were repeated at 6 months; the UDI-6 and IIQ7 were also repeated at 12 months and thereafter annually. The overall subjective satisfaction score (VAS) was obtained at 6 weeks, 6 months, 12 months and annually. These results have been previously reported. At the five year follow up patients were recontacted and asked to complete the UDI-6, IIQ7 and 2 indices of patient satisfaction, including the Patient Global Impression of Improvement (PGI-I) and the VAS. Patients with a urodynamic diagnosis of intrinsic sphincter deficiency (ISD) were excluded on the basis that the group had reported on retropubic versus transobturator tape for the management of ISD and had found a statistically significant increased risk of failure in the ISD group who had a transobturator approach2. Statistical analysis was performed, whereby outcomes were compared with Pearson c2 for categorical data and student t-test or Wilcoxon rank-sum for continuous data as appropriate. Changes in UDI6, IIQ7 were analysed using repeated measures ANOVA or Friedman test as appropriate. Graph 1: %VAS score over time in total and relative to experience, concomitant procedure and pre-operative urgency Conclusions At five year follow up, there was a sustained reduction in subjective SUI cure, with an equivalent sustained improvement in incontinence impact (IIQ7). Despite a reduction in UUI to 9% that persists at this low rate, there is an increase in de novo UUI at 5 years (with overall increase in UDI6) leading to a reduction in overall VAS score. While there are issues with lost to follow up, other authors3 have demonstrated a similar subjective cure rate in those who are lost. In a “last record carried forward model” a higher success rate of 77% would be expected. 1. Delorme E. Transobturator urethral suspension mini invasive procedure in treatment of SUI in females. ProgUrol 2001;11:1306-1313 2. Schierlitz L, et al 3 year follow-up of tension-free vaginal tape compared with transobturator tape in women with SUII and intrinsic sphincter deficiency. ObstetGynecol 2012 Feb;119(2 Pt 1):321-7. 3. Stav K et al Long-term outcomes of patients who failed to attend following midurethral sling surgery – a comparative study and analysis of risk factors for non attendanceAust N Z J ObstetGynaecol. 2010 Apr;50(2):173-8. Poster presentation sponsor