Autologous Fascial Slings for Stress Urinary Incontinence: a 17-year Follow-up of a Randomised Controlled Study.

INTRODUCTION AND HYPOTHESIS: Safety concerns with the use of mesh in vaginal surgery have been ongoing. Autologous fascial slings (AFS) avoid foreign body complications. We compared the long-term (17-year) outcomes of two AFS repair methods-the standard sling and short sling (sling-on-string), and assessed durability and patient satisfaction of these for the treatment of stress urinary incontinence (SUI). METHODS: A total of 107 patients from three urogynaecology units who had participated in a randomised controlled trial assessing standard (n = 52) and short (n = 55) slings were followed up for a median period of 17 years. Primary outcomes were Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores to assess the impact on the quality of life and symptom distress. Logistic quantile regression was employed to compare the two methods. Secondary outcomes included long-term complications and patient satisfaction. RESULTS: Mean scores showed no statistically significant difference between the standard and short slings at the 17-year follow-up relating to IIQ and UDI scores, leakage or urgency (p > 0.05). Improved bladder function was observed at 17 years compared with baseline (standard sling-IIQ scores mean difference [MD] 1.22 [CI: 0.69, 1.74], UDI scores MD 0.83 [CI: 0.70, 0.97]; short sling-IIQ score MD 1.14 [CI: 0.73, 1.54], UDI scores MD 0.54 [CI: 0.40, 0.67]) with age-related deterioration over time. Re-operation rates were low and patient satisfaction rates were high (67.2%) at follow-up. CONCLUSIONS: Autologous fascial slings are an effective and durable option for management of SUI and the short sling procedure can be recommended owing to plausible surgical advantages.

Long-term follow-up of a multicentre randomised controlled trial comparing tension-free vaginal tape, xenograft and autologous fascial slings for the treatment of stress urinary incontinence in women.

OBJECTIVE: To compare the long-term outcomes of a tension-free vaginal tape (TVT; Gynecare™, Somerville, NJ, USA), autologous fascial sling (AFS) and xenograft sling (porcine dermis, Pelvicol™; Bard, Murray Hill, NJ, USA) in the management of female stress urinary incontinence (SUI). PATIENTS AND METHODS: A multicentre randomised controlled trial carried out in four UK centres from 2001 to 2006 involving 201 women requiring primary surgery for SUI. The women were randomly assigned to receive TVT, AFS or Pelvicol. The primary outcome was surgical success defined as 'women reporting being completely 'dry' or 'improved' at the time of follow-up'. The secondary outcomes included 'completely dry' rates, changes in the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL EQ-5D questionnaire scores. RESULTS: In all, 162 (80.6%) women were available for follow-up with a median (range) duration of 10 (6.6-12.6) years. 'Success' rates for TVT, AFS and Pelvicol were 73%, 75.4% and 58%, respectively. Comparing the 1- and 10-year 'success' rates, there was deterioration from 93% to 73% (P < 0.05) in the TVT arm and 90% to 75.4% (P < 0.05) in the AFS arm; 'dry' rates were 31.7%, 50.8% and 15.7%, respectively. Overall, the 'dry' rates favoured AFS when compared with Pelvicol (P < 0.001) and TVT (P = 0.036). The re-operation rate for persistent SUI was 3.2% (two patients) in the TVT arm, 13.1% (five) in the Pelvicol 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 than TVT.

Outcomes and complications of trans-vaginal mesh repair using the Prolift™ kit for pelvic organ prolapse at 4 years median follow-up in a tertiary referral centre.

PURPOSE: To evaluate the anatomical, functional and post-operative outcomes of polypropylene mesh (Prolift™) in the surgical management of pelvic organ prolapse (POP). METHODS: A single-centre observational study of 106 successive patients, who underwent Prolift™ mesh repair (POP ≥ 2) with a median follow-up of 4 years, was performed. Outcomes of interest measured included patient demographics, intra and post-operative complications, concomitant procedures for POP or urinary incontinence. Using the Baden-Walker classification, grade ≥2 prolapses in the operated compartment were deemed as surgical failure. Validated questionnaires including ICIQ-VS and ICIQ-UI were used to assess functional outcome. RESULTS: Of the 106 patients, 56 had an anterior, 36 a posterior and 14 a total Prolift™. 101 patients were available for follow-up (median 4 years). 82 women underwent a clinical follow-up whilst 19 underwent a telephonic follow-up. Peri-operative bladder injury was noted in 2 (1.9 %) cases. Six (5.6 %) patients developed mesh exposure post-operatively. Re-operation rates for recurrent prolapse in the operated compartment were 2.8 % (n = 3). At follow-up, prolapse recurrence in the operated compartment was noted in another 7.3 % (n = 6) patients. Combining re-operations for POP and recurrences noted during follow-up, the revised failure rate was 10.1 % (n = 9). De novo prolapse in the non-operated compartment occurred in 19.5 % (n = 16) women. CONCLUSION: Our study demonstrates that Prolift™ vaginal mesh surgery offers anatomical cure rates of 89.9 %. A higher rate of de novo recurrence in the non-operated compartment was noted suggesting that surgical correction in one compartment may exacerbate recurrence in other compartments.