3 Year outcome after treatment of uterovaginal prolapse with a 6-point fixation mesh.

INTRODUCTION: The aim of this study was to describe the intermediate outcome of a single-incision 6-point fixation transvaginal mesh for the treatment of primary and recurrent pelvic organ prolapse (POP). STUDY DESIGN: This was a prospective cohort study including consecutive patients undergoing POP repair with the InGYNious anterior transvaginal mesh. Inclusion criteria were women with symptomatic stage II POP or higher. Exclusion criteria were the unwillingness or inability to give written informed consent, malignant diseases, neuro-muscular disorders, chronic pain syndrome or previous radiation in the pelvis. Every study participant completed a structured questionnaire, a urogynecological examination according to the IUGA-ICS POP-Q staging system and the validated P-QoL questionnaire before the operation and three years postoperatively. RESULTS: 254 patients were included into the study, 179 were available for the three-year follow-up (70 %). Sixteen patients (8.2 %) had undergone reoperation for recurrent or de novo prolapse (12/16 patients underwent reoperation in the posterior compartment) and were excluded from the objective outcome analysis. In the final study group, all POP-Q measurements, urge urinary incontinence and voiding dysfunction were significantly improved. The de novo SUI rate was 27/ 120 (23 %) in women without reoperation for SUI and/ or POP and without primary SUI. No serious adverse events occurred. Four (1.5 %) patients had mesh exposure at the one-year follow-up and been treated with local oestrogen. At three-year follow-up, no new mesh exposure was seen. De novo dyspareunia rate was low (n = 5 (3 %)). CONCLUSIONS: In this study, the objective outcome three years after anterior POP repair with the InGYNious transvaginal mesh was good. The reoperation rate both for mesh related problems or prolapse were rare.

Significant Improvement in Quality of Life, Positive Effect on Sexuality, Lasting Reconstructive Result and Low Rate of Complications Following Cystocele Correction Using a Lightweight, Large-Pore, Titanised Polypropylene Mesh: Final Results of a National, Multicentre Observational Study.

Introduction Patients who suffer from pelvic organ prolapse can experience severe limitations in their quality of life. To improve the quality of life of women affected and achieve a stable reconstruction, surgical therapy is often indispensable. In conventional prolapse surgery, the rate of recurrence is high. For this reason, alloplastic mesh has been implanted increasingly in recent years to reconstruct the anatomy of the pelvic floor organs. Even if the anatomical result can be significantly improved as a result, the mesh-induced complications have been the subject of controversial discussion. In this national, multicentre study, the quality of life, anatomical result as well as the rate of complications following the implantation of an alloplastic mesh for the correction of a cystocele were investigated. Method Fifty-four patients with symptomatic ≥ grade II were included in this prospective, national, multicentre study. The study participants were implanted with a titanised polypropylene mesh (TiLOOP ® PRO A, pfm medical ag). The follow-up observation period was 12 months. Primary as well as repeat procedures were taken into account. The anatomic result of the pelvic floor reconstruction was quantified using the POP-Q system. Data on quality of life and sexuality were collected using validated questionnaires. All complications which occurred were documented and evaluated by an independent committee. Results On average, the patients were in line with the census. An improvement in quality of life was able to be determined during the study in all domains investigated (p < 0.001, Wilcoxon test). Minus incorrect entries and incorrect reports, a total of 19 reports of adverse events in 15 patients were evaluated by the end of the study. The rate of recurrence in the anterior compartment was 4.3%. Conclusion In the reconstruction of the anatomical position of the pelvic floor organs given the presence of a symptomatic cystocele, the implantation of a third-generation alloplastic mesh achieves very good results. Affected patients benefit from the anatomical stability as well as a significant improvement in quality of life, whereby the risks are justifiable.

1-year outcome after treatment of uterovaginal prolapse with a 6-point fixation mesh.

INTRODUCTION: The aim of this study was to describe the safety and anatomical results of a surgical approach with a single-incision 6-point fixation vaginal mesh for the treatment of pelvic organ prolapse at perioperatively and at 1-year follow-up. MATERIALS AND METHODS: This was a prospective observational study of patients who underwent operation receiving an InGYNious anterior transvaginal mesh. All patients with symptomatic stage II prolapse or higher were included in the study. Exclusion criteria were the unwillingness or inability to give written informed consent, neuromuscular disorders, malignant diseases, previous radiation in the pelvis, or chronic pain syndrome. Every patient completed a structured questionnaire and a full physical examination according to the IUGA-ICS POP-Q staging system before the operation and at 1-year follow-up. RESULTS: Two hundred fifty-four patients (91%) were included in the study. The intraoperative complication rate was 7% with hemorrhage being the most common complication. Six patients (2.4%) had undergone reoperation for prolapse (four out of the six patients had reoperation in the posterior compartment) and were excluded from the objective outcome analysis. In the remaining 248 patients all POP-Q measurements were significantly improved in the anterior and apical compartments. Similarly, urge urinary incontinence and voiding dysfunction improved significantly. CONCLUSIONS: In this series, the objective outcome one year after the InGYNious mesh was good with low numbers of mesh-related problems or reoperation for prolapse.

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months.

INTRODUCTION: Pelvic organ prolapse can significantly reduce quality of life of affected women, with many cases requiring corrective surgery. The rate of recurrence is relatively high after conventional prolapse surgery. In recent years, alloplastic meshes have increasingly been implanted to stabilize the pelvic floor, which has led to considerable improvement of anatomical results. But the potential for mesh-induced risks has led to a controversial discussion on the use of surgical meshes in urogynecology. The impact of cystocele correction and implantation of an alloplastic mesh on patients' quality of life/sexuality and the long-term stability of this approach were investigated. METHOD: In a large prospective multicenter study, 289 patients with symptomatic cystocele underwent surgery with implantation of a titanized polypropylene mesh (TiLOOP ® Total 6, pfm medical ag) and followed up for 36 months. Both primary procedures and procedures for recurrence were included in the study. Anatomical outcomes were quantified using the POP-Q system. Quality of life including sexuality were assessed using the German version of the validated P-QoL questionnaire. All adverse events were assessed by an independent clinical event committee. RESULTS: Mean patient age was 67 ± 8 years. Quality of life improved significantly over the course of the study in all investigated areas, including sexuality and personal relationships (p < 0.001, Wilcoxon test). The number of adverse events which occurred in the period between 12 and 36 months after surgery was low, with just 22 events reported. The recurrence rate for the anterior compartment was 4.5%. Previous or concomitant hysterectomy increased the risk of recurrence in the posterior compartment 2.8-fold and increased the risk of erosion 2.25-fold. CONCLUSION: Cystocele correction using a 2nd generation alloplastic mesh achieved good anatomical and functional results in cases requiring stabilization of the pelvic floor and in patients with recurrence. The rate of recurrence was low, the patients' quality of life improved significantly, and the risks were acceptable.

Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial.

PURPOSE: Pelvic organ prolapse (POP) impairs quality of life (QoL) due to vaginal bulge symptoms and changes in bladder/bowel and sexual function. The effect of alloplastic meshes on QoL is still being discussed. The purpose of this study was to prospectively evaluate the effect of mesh implantation on QoL and sexual function over 1 year. METHODS: 289 women with cystocele > stage I were included in this prospective multicenter study, with nine hospitals participating (ClinicalTrials.gov NCT01084889). Mesh exposures rates and pelvic floor-related QoL using the validated German version of the p-QoL questionnaire were evaluated as the primary endpoints. Based on a single-sided binominal test with α = 0.05 and a power of 0.80, a sample size of 225 for the mesh exposures was calculated. The mesh used was a 6-arm mesh with titanium coating (TILOOP(®) Total 6, sponsor pfm medical ag, Germany). Preoperative data were compared to 6 and 12 months postoperative data, using Wilcoxon test. RESULTS: The mean age of the patients was 67 years (min 43, max 87). All domains of QoL improved significantly compared after surgery: mean prolapse score dropped from 73.7 to 19.4 after 6 and 16.2 after 12 months (p < 0.001). Sexual function also improved significantly. The rate of dyspareunia was lower at follow-up. CONCLUSIONS: In this prospective trial, a significant positive effect of mesh implantation on pelvic floor-related QoL was observed. These findings remained stable 1 year after surgery with further improvement. This trial adds further data to the ongoing discussion on the role and risk of meshes in POP surgery.