The objective of this study is to report on short-term outcomes after pelvic organ prolapse repair using Prolift® transvaginal mesh. A 3-year multicenter prospective cohort study was performed in 28 centers. Assessment preoperatively and at 2 months postoperatively included the condition-specific pelvic organ prolapse quantification system (POP-Q) and a macroscopic inflammatory scale. Subjective outcome was measured using the urogenital distress inventory (UDI) and the incontinence impact questionnaire (IIQ-7). Surgical characteristics and adverse events during follow-up were registered in a separate protocol. The evaluation is based on the interim safety analysis and includes 2-month evaluations of 123 cases. Pelvic organ perforation occurred in four cases (3.2%), three bladder injuries and one case of rectal perforation. At the 2-month follow-up, there were two cases of mesh exposure, an increase of mild–moderate granuloma formation in the operated areas (P < 0.003) but no cases of serious adverse tissue reactions related to the polypropylene mesh. Postoperative anatomical cure (defined as POP-Q stage 0–1) was 87% after anterior repair, 91% after posterior repair and 88% after total repair. All quality of life aspects measured by the IIQ-7 improved 2 months after surgery. Pelvic heaviness, vaginal bulging, and vaginal protrusion all decreased considerably (P < 0.001). There was also a significant improvement in several lower urinary tract symptoms and a decreased need for manually assisted defecation. This first report from an ongoing multicenter study suggests that transvaginal mesh surgery with the Prolift® system is associated with satisfactory outcomes 2 months after surgery. There were no severe adverse events attributed to the polypropylene mesh.
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This study was made possible through the cooperation and collective efforts of the Nordic transvaginal mesh group, listed in alphabetical order: (Denmark) Susanne Axelsen, Karl Möller Bek, Skejby Hospital, Skejby, Jens Prien Larsen, Nyköbing Hospital, Nyköbing; (Finland) Pentti Kiilholma, Riikka Aaltonen, Turku University Hospital, Turku, Teuvo Takala, Tiina Vaari, Päisät-Hämes Central Hospital Lahti, Tapio Väyrynen, Jorvi Hospital, Espoo, Hans-Anders Unnérus, Helsinski University Central Hospital, Lohja Hospital, Lohja; (Norway) Marie Elström Engh, Akershus University Hospital, Ahus, Anja Holstad, Gjøvik Hospital, Gjøvik, Kolbjörn Kasin, Kongsberg Hospital, Kongsberg, Rolf Kirschner, Rikshospitalet, Oslo, Anne-Grethe Paulsen, Haukeland Hospital, Bergen, Sigurd Kulseng Hansen, Asker & Bærum Hospital, Bærum, Margareta Verelst, Regional Hospital in Tromsø, Tromsø; (Sweden) Daniel Altman, Danderyd Hospital, Stockholm, Bo Anzén, Danderyd Hospital, Stockholm, Lena Clementsson, Kristiansstad Hospital, Kristiansstad, Christian Falconer, Danderyd Hospital, Stockholm, Folke Flam, St. Göran Hospital, Stockholm, Eva Fornell, Linköping University Hospital, Linköping, Jonas Gunnarsson, Sahlgrenska University Hospital, Göteborg, Björn Holm, Örebro University Hospital, Örebro, Kenneth Krohn, Vrinnevi Hospital, Norrköping, Nina Kyrklund, Danderyd Hospital, Stockholm, Gregor Larson, Västerås Hospital, Västerås, P-G Larsson, Skaraborg Hospital Skövde, Skövde, Paula Löwenadler, Ystad Hospital, Ystad, Mazoumeh Rezapour, Uppsala University Hospital, Uppsala, Gunilla Tegerstedt, South Hospital, Stockholm, Vasiliki Tsaknakis, Halmstad Hospital, Halmstad, Jan Zetterström, Danderyd Hospital, Stockholm.
Competing interests and financial disclosure
D.A. has an educational advisory position for Gynecare Scandinavia. C.F. has an advisory board position for Gynecare Scandinavia. None of the researchers in the Nordic transvaginal mesh group own stock or hold stock options in the mesh manufacturing company. The study was instigated by the responsible researchers and entirely funded by university-administered research funds including grants from the Swedish Society of Medicine. Investigator meetings in relation to the study have been sponsored by Gynecare Scandinavia.
Clinical trial registration available at www.clinicaltrials.gov, identifier NCT00402844.
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Altman, D., Väyrynen, T., Engh, M.E. et al. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J 19, 787 (2008). https://doi.org/10.1007/s00192-007-0526-2