Abstract
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.
Similar content being viewed by others
References
Baessler K, Maher CF (2006) Mesh augmentation during pelvic-floor reconstructive surgery: risks and benefits. Curr Opin Obstet Gynecol 18:560–566
Walters MD (2003) The use and misuse of prosthetic materials in reconstructive pelvic surgery: does the evidence support our surgical practice? Int Urogynecol J 14:365–366
Nygaard I (2007) Marketed vaginal mesh kits: rampant experimentation or improved quality of care? Thoughts following the 2006 AUGS meeting by AUGS president Ingrid Nygaard, M.D. Int Urogynecol J 18:483–4
Dwyer PL, O'Reilly BA (2004) Transvaginal repair of anterior and posterior compartment prolapse with Atrium polypropylene mesh. BJOG 111:831–836
Achtari C, Hiscock R, O'Reilly BA, Schierlitz L, Dwyer PL (2005) Risk factors for mesh erosion after transvaginal surgery using polypropylene (Atrium) or composite polypropylene/polyglactin 910 (Vypro II) mesh. Int Urogynecol J 16:389–394
Fatton B, Amblard J, Debodinance P, Cosson M, Jacquetin B (2007) Transvaginal repair of genital prolapse: preliminary results of a new tension-free vaginal mesh (Prolift™ technique)—a case series multicentric study. Int Urogynecol J 18:743–752
Parker MC, Phillips RK (1993) Repair of rectocoele using Marlex mesh. Ann R Coll Surg Engl 75:193–194
Watson SJ, Loder PB, Halligan S, Bartram CI, Kamm MA, Phillips RK (1996) Transperineal repair of symptomatic rectocele with Marlex mesh: a clinical, physiological and radiologic assessment of treatment. J Am Coll Surg 183:257–261
Flood CG, Drutz HP, Waja L (1998) Anterior colporrhaphy reinforced with Marlex mesh for the treatment of cystoceles. Int Urogynecol J 9:200–204
Beets GL, Go PM, van Mameren H (1996) Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs. Eur J Surg 162:823–825
Dietz HP, Vancaillie P, Svehla M, Walsh W, Steensma AB, Vancaillie TG (2003) Mechanical properties of urogynecologic implant materials. Int Urogynecol J 14:239–243
Debodinance P, Berrocal J, Clave H, Cosson M, Garbin O, Jacquetin B, Rosenthal C, Salet-Lizee D, Villet R (2004) Changing attitudes on the surgical treatment of urogenital prolapse: birth of the tension-free vaginal mesh [article in French]. J Gynecol Obstet Biol Reprod 33:577–588
de Tayrac R, Picone O, Chauveaud-Lambling A, Fernandez H (2006) A 2-year anatomical and functional assessment of transvaginal rectocele repair using a polypropylene mesh. Int Urogynecol J 17:100–105
Falconer C, Soderberg M, Blomgren B, Ulmsten U (2001) Influence of different sling materials on connective tissue metabolism in stress urinary incontinent women. Int Urogynecol J 12:S19–23
Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR (1996) The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17
Zdichavsky M, Jones JW, Ustuner ET, Ren X, Edelstein J, Maldonado C, Breidenbach W, Gruber SA, Ray M, Barker JH (1999) Scoring of skin rejection in a swine composite tissue allograft model. J Surg Res 85:1–8
Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA (1994) Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res 3:291–306
Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA (1995) Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn 14:131–139
Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C (2003) A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J 14:164–168
Hiltunen R, Nieminen K, Takala T, Heiskanen E, Merikari M, Niemi K, Heinonen PK (2007) Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 110:455–462
Mellgren A, Anzen B, Nilsson BY, Johansson C, Dolk A, Gillgren P, Bremmer S, Holmstrom B (1995) Results of rectocele repair. A prospective study. Dis Colon Rectum 38:7–13
Kenton K, Shott S, Brubaker L (1999) Outcome after rectovaginal fascia reattachment for rectocele repair. Am J Obstet Gynecol 181:1360–1364
Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U (2001) Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J 12(Suppl 2):S5–S8
Altman D, Falconer C (2007) Perioperative morbidity using transvaginal mesh in pelvic organ prolapse repair. Obstet Gynecol 109:303–308
Popovic I, Debodinance P, Cosson M, Boukerrou M (2007) Prosthetic reinforcements: how to manage bladder injuries? Int Urogynecol J 18:1215–1217 DOI 10.1007/s00192-007-0310-3
LaSala CA, Schimpf MO (2007) Occurrence of postoperative hematomas after prolapse repair using a mesh augmentation system. Obstet Gynecol 109:569–572
Kenton KS, Woods MP, Brubaker L (2002) Uncomplicated erosion of polytetrafluoroethylene grafts into the rectum. Am J Obstet Gynecol 187:233–234
Yamada BS, Govier FE, Stefanovic KB, Kobashi KC (2006) Vesicovaginal fistula and mesh erosion after Perigee (transobturator polypropylene mesh anterior repair). Urology 68:1121–1127
Deffieux X, de Tayrac R, Huel C, Bottero J, Gervaise A, Bonnet K, Frydman R, Fernandez H (2007) Vaginal mesh erosion after transvaginal repair of cystocele using Gynemesh or Gynemesh-Soft in 138 women: a comparative study. Int Urogynecol J 18:73–79
Klinge U, Klosterhalfen B, Muller M, Ottinger AP, Schumpelick V (1998) Shrinking of polypropylene mesh in vivo: an experimental study in dogs. Eur J Surg 164:965–969
Altman D, Mellgren A, Blomgren B, Lopez A, Zetterstrom J, Nordenstam J, Falconer C (2004) Clinical and histological safety assessment of rectocele repair using collagen mesh. Acta Obstet Gynecol Scand 83:995–1000
Acknowledgments
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.
Author information
Authors and Affiliations
Consortia
Corresponding author
Additional information
Clinical trial registration available at www.clinicaltrials.gov, identifier NCT00402844.
Rights and permissions
About this article
Cite this article
Altman, D., Väyrynen, T., Engh, M.E. et al. Short-term outcome after transvaginal mesh repair of pelvic organ prolapse. Int Urogynecol J 19, 787–793 (2008). https://doi.org/10.1007/s00192-007-0526-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00192-007-0526-2