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

Abstract

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.

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

Conflict of interest statement

Conflict of Interest/Interessenkonflikt The authors confirm that there are no further conflicts beyond the conflicts of interest listed below. The activities listed did not have and do not have any influence on the study results or their publication. Tina Cadenbach-Blome: Honoraria, consulting – pfm medical, Coloplast, DynaMesh; Markus Grebe: Honoraria – pfm medical; Mathias Mengel: Honoraria – pfm medical, AMI; Dr. Friedrich Pauli: Consulting – pfm medical; Christian Fünfgeld: Honoraria – pfm medical, Serag Wiessner, AMS, AMI, Astellas, Recordati, Promedon./ 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. Tina Cadenbach-Blome: Vortragshonorare, Beratertätigkeit – pfm medical, Coloplast, DynaMesh; Markus Grebe: Vortragshonorare – pfm medical; Mathias Mengel: Vortragshonorare – pfm medical, AMI; Dr. Friedrich Pauli: Beratertätigkeit – pfm medical; Christian Fünfgeld: Vortragshonorare – pfm medical, Serag Wiessner, AMS, AMI, Astellas, Recordati, Promedon.

Figures

Fig. 1

Fixation points of the mesh (blue markings). Figure from: Wedel T, Pauli F. Anatomische und chirurgische Grundlagen zur Netzrekonstruktion des Beckenbodens. Stuttgart: Thieme; 2010 , the blue marks of the fixation points were added.

Fig. 2

Diagram of study participants according to the CONSORT statement, 2010.

Fig. 3

Quality of life before and after implantation of an alloplastic mesh. The value of the limitation in quality of life 6 and 12 months after the implantation in comparison to the limitation prior to the implantation is indicated, where 100 corresponds to the maximum limitation. The documentation of the quality of life is broken down into various areas.

Fig. 4

Improvement in sexual function after twelve months. Assessment of the questions on the negative effects in the relationship with the partner due to the prolapse, negative effects on sex life due to the prolapse, and whether the vaginal bulging is a disruption during sexual intercourse. Possible responses included: “Not at all”, “Impaired” and “No information possible”. The assessment was performed prior to the implantation as well as 6 and 12 months after the implantation.

Fig. 5

Anatomical result prior to the implantation as well as 6 and 12 months postoperatively (scale according to ICS classification).

Abb. 1

Fixationspunkte des Netzes (blaue Markierungen). Abb. aus: Wedel T, Pauli F. Anatomische und chirurgische Grundlagen zur Netzrekonstruktion des Beckenbodens. Stuttgart: Thieme; 2010 , eingefügt wurden die blauen Markierungen der Fixationspunkte.

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 und 12 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 12 Monaten. Auswertung der Fragen zur Beeinträchtigung der Beziehung zum Partner durch die Senkung, Beeinträchtigung des Sexuallebens durch die Senkung und ob die Scheidenwölbung beim Geschlechtsverkehr stört. Als Antwortmöglichkeiten standen zur Verfügung: „gar nicht“, „beeinträchtigt“ und „keine Angabe möglich“. Die Auswertung erfolgte vor der Implantation sowie 6 und 12 Monate nach der Implantation.

Abb. 5

Anatomisches Resultat vor der Implantation sowie 6 und 12 Monate postoperativ (Gradeinteilung gem. ICS-Klassifikation).