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

Abstract

ABSTR AC TIntroduction 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 patientsʼ quality of life/sexuality and the long-term stability of this approach were investigated. MethodIn 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 patientsʼ quality of life improved significantly, and the risks were acceptable. . The most serious effect of pelvic organ prolapse is impairment of bladder and bowel function accompanied by incontinence and voiding disorders [2,3]. General well-being, personal relationships, particularly sexuality [4], and physical and social activities often suffer from the effects of prolapse [5,6]. The incidence of pelvic organ prolapse in women has increased in parallel with the general increase in life expectancy, and the likelihood that women aged 80 years will require surgical intervention (e.g. hysterectomy, pelvic floor reconstruction) is 12.2 % [7]. One in nine women is affected by prolapse [8]. Up to 30 % of patients require a repeat operation for recurrence within 5 years of the original procedure [9][10][11][12]. Surgical correction of prolapse should not just reposition the prolapsed pelvic organs, it should also restore the patientʼs quality of life or at least improve it. As the recurrence rate...

The assessment of quality of life and satisfaction with life of patients before and after surgery of an isolated apical defect using synthetic materials

“…A low complication rate as well as quality of life at a comparable level between patients undergoing the procedure and healthy women were found. Similar conclusions were reached by Fünfgeld C et al [35], who assessed the efficacy of the procedure 12 and 36 months after performing the alloplastic mesh implantation. In their work, the authors focused more on functional assessment and anatomical repair of the defect.…”

Health-related quality of life after pelvic organ prolapse surgery in Ethiopia: A 6 month follow-up study

“…In our study, the average scores for prolapse effects on physical and role activities and personal relationships was quiet high at baseline. A previous study carried out in European women also showed similar scores for the same domains [24,38,39]. Daily life for Ethiopian rural women (e.g.…”

“…The better QoL scores compared to baseline scores were also observed in all the 3 P-QoL components (PC, PSC and PRC) after 6 months. Previous studies in Western countries using P-QoL instrument also con rmed that correction of POP via alloplastic vaginal meshes can signi cantly improve patients' QoL [24,[38][39][40][41][42].…”

“…Assuming a paired difference of 3, the standard deviation of the differences 15 [24], considering α = 0.05, power of 80% and a possible loss of 15% during the follow-up, sample size became 224.…”

Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial

“…Titanium-coated meshes are new products in POP repair, which improved the pelvic floor-related quality of life and sexual function in a prospective multicenter trial [8]. Fünfgeld et al [9] reported a large prospective multicenter study in Germany, with 289 patients who underwent surgery with a titanium-coated polypropylene mesh-kit (TiLOOP® Total 6; pfm medical ag, Germany) and were followed up for a median of 36 months. The recurrence rate for the anterior compartment was 4.5%, and the quality of life improved significantly.…”