Abstract
Introduction and hypothesis
The purpose of the study was to analyze anatomical and functional outcomes after sacrocolpopexy (SCP) for vaginal vault prolapse pelvic organ prolapse quantification (POPQ) II–III by random use of absorbable (Vicryl) and non-absorbable sutures (Ethibond) for vaginal mesh fixation.
Methods
This study was designed as a two-center randomized controlled study (RCT). The primary objective was to evaluate the anatomical outcome. Success was defined when the vaginal apex (point C; POPQ) did not descend more than 50% of the total vaginal length (tvl) during Valsalva. Patients completed a pelvic examination incorporating the POPQ and questionnaires (the German pelvic floor questionnaire and the PISQ-12 questionnaire) at baseline and 6 months postsurgery. Perioperative adverse events (AE) were recorded. Sample size calculations, based on a 10% non-inferiority limit required 100 participants per group, with power = 90%.
Results
In 190 out of 195 women (ETH group n = 96; VIC group n = 94) anatomical success was achieved. The relative risk of anatomical success failure in the VIC group versus the ETH group was 0.69, with a 95% confidence interval 0.12–4.02. The change in the symptom scores did not differ significantly between the ETH and the VIC group. In the ETH group, three suture penetrations into the vagina were observed, and none in the VIC group 6 months postoperatively.
Conclusions
Anatomical success after SCP for vaginal vault prolapse POPQ II–III is not affected by suture type for vaginal monofilament mesh attachment. Moreover, we did not see any differences in functional outcomes between the two groups. Three suture penetrations into the vagina were observed in the ETH group, and none in the VIC group 6 months postoperatively.
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Acknowledgements
The authors would like to thank Sabine Hahn, MD, for data collection and the gynecological examination of the study participants at the follow-up visits; Jacqueline Behrend, study nurse, for supporting the part of the study in Berlin; and Friederike Moroff for entering the data into the database.
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The study was not funded.
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Christl Reisenauer: concept and design, analysis and interpretation of data, manuscript draft and revision; Juergen Andress: analysis and interpretation of data, manuscript draft; Birgitt Schoenfisch: concept and design, statistics, analysis and interpretation of data, manuscript revision; Markus Huebner: analysis and interpretation of data, manuscript revision; Sara Yvonne Brucker: concept and design, manuscript revision; Kathrin Beilecke: analysis and interpretation of data, manuscript draft; Andrea Lippkowski: analysis and interpretation of data, manuscript draft; Juliane Marschke: analysis and interpretation of data, manuscript draft; Ralf Tunn: concept and design, analysis and interpretation of data, manuscript revision.
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Christl Reisenauer, Juergen Andress, Birgitt Schoenfisch: no conflicts of interest; Sara Y. Brucker: personal fees from Pfizer; Novartis, Teva, MSD, AstraZeneca, Storz, and Roche; Markus Huebner: consultant for Promedon GmbH; Andrea Lippkowski: grant from Promedon, support for German Pelvic Floor Center Berlin, personal fee from Coloplast; Kathrin Beilecke: grant from Promedon, support for the German Pelvic Floor Center Berlin; Juliane Marschke: grant from Promedon, support for the German Pelvic Floor Center Berlin; Ralf Tunn: grant from Promedon, support for the German Pelvic Floor Center Berlin.
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Reisenauer, C., Andress, J., Schoenfisch, B. et al. Absorbable versus non-absorbable sutures for vaginal mesh attachment during sacrocolpopexy: a randomized controlled trial. Int Urogynecol J 33, 411–419 (2022). https://doi.org/10.1007/s00192-021-04853-4
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DOI: https://doi.org/10.1007/s00192-021-04853-4