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

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.

Keywords: POP-Q; alloplastic mesh; pelvic organ prolapse; quality of life; sexuality.

Conflict of interest statement

Conflict of Interest/Interessenkonflikt The authors state that they have no conflicts of interest beyond the activities listed below. The activities listed here had and have no effect on the results of the study or the studyʼs publication. Christian Fünfgeld: speakerʼs fees from pfm medical, Serag Wiessner, BARD, AMS, AMI, Astellas, Recordati, Promedon; Mathias Mengel: speakerʼs fees from pfm medical, AMI; Markus Grebe: speakerʼs fees from pfm medical; Dirk Watermann: speakerʼs fees for research from Serag Wiessner, fees from AMS and Johnson & Johnson; Margit Stehle, Brigit Henne, Jan Kaufhold: none./ Die Autoren versichern, dass über die nachfolgend genannten Interessenkonflikte hinaus keine weiteren Konflikte bestehen. Die aufgeführten Tätigkeiten hatten und haben keinen Einfluss auf die Studienergebnisse oder deren Publikation. Christian Fünfgeld: Vortragshonorare von pfm medical, Serag Wiessner, BARD, AMS, AMI, Astellas, Recordati, Promedon; Mathias Mengel: Vortragshonorare von pfm medical, AMI; Markus Grebe: Vortragshonorare von pfm medical; Dirk Watermann: Vortragshonorare für Forschung von Serag Wiessner, Honorare von AMS und Johnson & Johnson; Margit Stehle, Brigit Henne, Jan Kaufhold: keine.

Figures

Fig. 1

Diagram showing six-point fixation of the TiLOOP ® Total 6 mesh implant. The mesh is fixed without tension distally, laterally and apically using a transobturator und ischiorectal approach. Apical fixation was done at the sacrospinal ligament. Source: pfm medical ag.

Fig. 2

Chart showing the patients who participated in the study as defined by the CONSORT 2010 Statement .

Fig. 3

Quality of life before and after implantation of an alloplastic mesh. The bar chart shows the figures for quality of life at 6, 12 and 36 months after implantation compared to patientsʼ quality of life before the implantation, with 100 corresponding to the lowest quality of life. Quality of life was itemized into a number of different areas.

Fig. 4

Improvement in sexual function after 36 months. Evaluation of the questions about the negative impact of prolapse on their personal relationship, the negative impact of prolapse on their sex life and whether the vaginal protrusion made sexual intercourse difficult. Available responses included: “not at all”, “negatively affected” and “no answer possible”. Responses were evaluated before the implantation and 6, 12 and 36 months after implantation.

Fig. 5

Pelvic organ prolapse preoperatively and after 36 months. The bar chart shows the percentage of patients with grade 0, I, II, III or IV pelvic organ prolapse preoperatively and 36 months after implantation.

Abb. 1

Schaubild zur Sechs-Punkt-Fixation des TiLOOP ® Total 6-Netzimplantats. Das Netz wird durch einen transobturatorischen und ischiorectalen Zugang spannungsfrei distal, lateral und apikal fixiert. Die apikale Fixierung erfolgt an den Ligamenta sacrospinalia.

Abb. 2

Schaubild der Studienteilnehmer nach dem CONSORT Statement, 2010 .

Abb. 3

Lebensqualität vor und nach Implantation eines alloplastischen Netzes. Angegeben ist der Wert der Einschränkung der Lebensqualität 6, 12 und 36 Monate nach der Implantation im Vergleich zur Einschränkung vor der Implantation, wobei 100 der maximalen Einschränkung entspricht. Die Erfassung der Lebensqualität erfolgt aufgegliedert in verschiedene Bereiche.

Abb. 4

Verbesserung der sexuellen Funktionalität nach 36 Monaten. Auswertung der Fragen zur Beeinträchtigung der Beziehung zum Partner durch die Senkung, Beeinträchtigung des Sexuallebens durch die Senkung und ob die Scheidenwölbung beim Geschlechtsverkehrt stört. Als Antwortmöglichkeiten standen zur Verfügung: „gar nicht“, „beeinträchtigt“ und „keine Angabe möglich“. Die Auswertung erfolgte vor der Implantation, sowie sechs, zwölf und 36 Monate nach der Implantation.

Abb. 5

Descensus genitalis präoperativ und nach 36 Monaten. Dargestellt ist die Anzahl von Patientinnen mit einem Descensus genitalis Grad 0, I, II, III oder IV jeweils präoperativ und 36 Monate nach der Implantation.