Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse
Daniel Altman, Tapio Väyrynen, Marie Ellström Engh, Susanne Axelsen, Christian Falconer, Nordic Transvaginal Mesh Group, Daniel Altman, Catarina Asplund Isaksson, Kristina Craford, Marion Ek, Caroline Elmér, Lena Enesund, Christian Falconer, Folke Flam, Karin Franzén, Philip Gottlieb, Jonas Gunnarsson, Tanja Gustafson, Björn Holm, Ingela Högerås, Annelie Json-Söderström, Anders Kjaeldgaard, Ulrika Klemets, Kenneth Krohn, Ulla-Beth Kroon, Nina Kyrklund, Gregor Larsson, P-G Larsson, Margareta Linqvist Berglund, Paula Löwenadler, Daniel Murkes, Masoumeh Rezapour, Jesper Sørensen, Fatima Taheri-Johansson, Gunilla Tegerstedt, Vasiliki Tsaknakis, Eva Uustal Fornell, Eva Vejt, Tomas Winberg, Riikka Aaltonen, Pauliina Aukee, Pentti Kiilholma, Pekka Kulju, Tomi Mikkola, Pontus Molander, Raija Räty, Arimo Vallasto, Antti Valpas, Tapio Väyrynen, Susanne Axelsen, Karl Møller Bek, Martin Rudnicki, Marie Elström Engh, Kolbjorn Kasin, Ingeborg Kinne, Rolf Kirschner, Gabriel Kral, Sigurd Kulseng Hansen, Milan Milenkovic, Axel Muehlan, Vladimir Petrovic, Branislav Rosic, Astrid Rygh, Per Solberg, Jostein Tjugum, Daniel Altman, Tapio Väyrynen, Marie Ellström Engh, Susanne Axelsen, Christian Falconer, Nordic Transvaginal Mesh Group, Daniel Altman, Catarina Asplund Isaksson, Kristina Craford, Marion Ek, Caroline Elmér, Lena Enesund, Christian Falconer, Folke Flam, Karin Franzén, Philip Gottlieb, Jonas Gunnarsson, Tanja Gustafson, Björn Holm, Ingela Högerås, Annelie Json-Söderström, Anders Kjaeldgaard, Ulrika Klemets, Kenneth Krohn, Ulla-Beth Kroon, Nina Kyrklund, Gregor Larsson, P-G Larsson, Margareta Linqvist Berglund, Paula Löwenadler, Daniel Murkes, Masoumeh Rezapour, Jesper Sørensen, Fatima Taheri-Johansson, Gunilla Tegerstedt, Vasiliki Tsaknakis, Eva Uustal Fornell, Eva Vejt, Tomas Winberg, Riikka Aaltonen, Pauliina Aukee, Pentti Kiilholma, Pekka Kulju, Tomi Mikkola, Pontus Molander, Raija Räty, Arimo Vallasto, Antti Valpas, Tapio Väyrynen, Susanne Axelsen, Karl Møller Bek, Martin Rudnicki, Marie Elström Engh, Kolbjorn Kasin, Ingeborg Kinne, Rolf Kirschner, Gabriel Kral, Sigurd Kulseng Hansen, Milan Milenkovic, Axel Muehlan, Vladimir Petrovic, Branislav Rosic, Astrid Rygh, Per Solberg, Jostein Tjugum
Abstract
Background: The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy.
Methods: In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery.
Results: Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group.
Conclusions: As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).
Source: PubMed