Aim of this study was to evaluate the objective and functional outcomes, and the complications of women undergoing anterior vaginal wall reconstruction with tension free vaginal mesh (Restorelle®) implant for recurrent high stage prolapse (3 or 4) at the Pelvic Organ Prolapse Quantification (POP-Q) system.

Women with recurrent anterior vaginal wall prolapse POP-Q stage 3 or 4 requiring surgery were enrolled in this prospective study. Inclusion criteria were: presence of at least two vaginal compartment defects, recurrent POP-Q ≥3. Preoperative assessment included: a detailed history, vaginal inspection with evaluation of prolapse according to POP-Q system, uroflowmetry (UF) with post- void residual volume (PVR) measurement, Female Sexual Function Index (FSFI) questionnaire, a VAS scale to assess the impact of urinary symptoms on Quality of Life (QoL; 0= worse; 10= best). The same evaluations were performed at follow-up scheduled at month 3, 6, 12 and then every year. A polypropylene mesh implant (Restorelle®) was placed in all patients. Objective success was considered as a prolapse grade <1 at point C, while recurrence a prolapse POP-Q stage >1. Complications were accurately recorded.

Thirty- five consecutive patients were eligible for the study, with a mean age ± SD of 67.8 ± 10.2 years and a mean ± SD follow-up of 24.2 ± 4.3 mos. At baseline, stage >3 Aa/ Ap recurrence was detected in 19/35 pts (54,2%), stage >3 C recurrence in 14/35 pts (40 %) and stage >3 Ba/ Bp recurrence in 2/35 pts (5,8 %). Clinical results are showed in the Table. At baseline, all patients presented with bulge symptoms and low VAS scores. At 2 years follow-up, objective cure rate was 94.2% (33/35 patients), and there was a significant improvement in bulge symptoms, voiding dysfunction, dyspareunia, urgency and stress urinary incontinence (SUI). A reduction in PVR was also detected (p<0.00). Mean ± SD VAS score significantly increased from 3.8 ± 0.9 to 7.7 ± 2.6 (p< 0.001). At baseline, all patients presented with female sexual dysfunction (FSD). At 2 years follow-up, 28/35 patients (80%) reported improvements in FSFI Total Score and 7 patients (20%) presented with no FSD (Total FSFI Score: from 18.2 ± 3.5 to 21.7 ± 3.2, p< 0.001). The domains most relevantly improved were desire and satisfaction. No severe complications were observed (2 patients presented with postoperative pelvic haematoma conservatively managed) and none of the patients had mesh exposure/ erosion.

In the current scenario on the use of mesh surgery for POP, the role of synthetic polypropylene mesh implant is highly debated. The high stage recurrent prolapse is a severe urogynaecological challenge, not easy to manage with native tissue surgery and often requiring more invasive surgery with abdominal approach. For these reasons, we used a polypropylene mesh implant (Restorelle®) for these patients. Our results demonstrated a high objective cure rate (94.2%), a significant improvement in urinary symptoms and in quality of life, with a low complication rate.  The relevant improvement of both functional (urinary symptoms and female sexual function) and QoL outcomes may be related to the high objective cure rate and the low complication rate.  The no long- term follow-up and the low sample size have been the limits of this study. Literature data showed that in 80% of the women the mesh exposure occurred in 6-12 months after surgery, but the follow-up of our patients was higher; thus, it is possible to suppose that this complication rate may remain still low also in the further follow-up. Longer term data will be needed to confirm these results.

Tension free vaginal mesh implant (Restorelle®) was safe and effective for the treatment of recurrent high stage (>3) anterior vaginal wall prolapse with an acceptable complication rate. Overall results demonstrated that this procedure is also efficacy in controlling urinary symptoms and in improving the QoL and FSD.