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This article is intended for gynecologists, pelvic surgeons, and other specialists who care for women with pelvic organ prolapse.
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CME Released: 12/26/2008
Valid for credit through: 12/26/2009, 11:59 PM EST
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December 26, 2008 — Trocar-guided transvaginal mesh surgery for pelvic organ prolapse results in good clinical outcomes at 1 year, according to the results of a prospective, multicenter cohort study reported in the January 1, 2009, issue of Obstetrics & Gynecology.
"Due to the lack of clinical safety and efficacy data, the adoption of polypropylene mesh for pelvic organ prolapse surgery remains a source of controversy," write Caroline Elmér, MD, from the Karolinska Institutet Danderyd Hospital in Stockholm, Sweden, and colleagues from the Nordic Transvaginal Mesh Group. "It has been suggested that in order for biomaterials to provide the intended pelvic floor support, they need to be 'anchored' outside the afflicted tissues. This has given rise to trocar-guided transvaginal surgical techniques using a transobturator or transgluteal approach, passing the mesh fixation arms through the arcus tendineus fascia pelvis or the sacrospinous ligaments."
The goal of this study, which was conducted in 26 clinics, was to evaluate clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh. Prolapse was graded with use of the pelvic organ prolapse quantification system (POP-Q), and symptoms were evaluated with use of the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) at baseline, 2 months, and 1 year after surgery. Anatomic cure was defined as postoperative POP-Q stage 0 to 1.
Of 261 patients included in the study, 232 (89%) attended the 1-year follow-up. Mean age at surgery was 66.3 ± 9.4 years. Anatomic cure 1 year after surgery occurred in 96 (79%) of 121 women after anterior repair with mesh (P < .001), and in 56 (82%) of 68 women after posterior repair with mesh (P <.001). In women undergoing combined anterior and posterior mesh repair, cure occurred in 51 (81%) of 63 for the anterior compartment and 54 (86%) of 63 for the posterior compartment (P < .001 for both).
Nine (3.4%) of 252 patients had bladder and rectal perforations, and 26 (11%) of 232 patients developed vaginal erosions, most of which were mild to moderate. Seven women (2.8%) required surgical intervention because of mesh exposure.
All domains of the IIQ-7 showed significant quality-of-life improvements. Although UDI-6 scores improved significantly, symptoms specific for stress urinary incontinence were not reduced.
"Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery," the study authors write.
Limitations of this study include some degree of classification bias caused by not having access to an independent examiner for the postoperative POP-Q examinations at all study sites, wide inclusion criteria potentially introducing some selection bias, and lack of an independent control group.
"The uniform surgical technique, the condition-specific outcome measures, the multicenter setting, and the prospective data collection are some of the methodologic merits of our study," the study authors conclude. "Randomized controlled trials are now needed to clarify how the risks and benefits associated with the use of synthetic mesh kits in prolapse surgery relate to patient satisfaction when compared with traditional prolapse repair."
The Swedish Society of Medicine and the regional agreement on medical training and clinical research between Stockholm county council and Karolinska Institutet supported this study. Gynecare Scandinavia sponsored investigator meetings related to the study and used 2 of the study authors as advisors.
Obstet Gynecol. 2009;113:117-126.
Traditional surgery for pelvic organ prolapse often results in unsatisfactory surgical outcomes. Therefore, the use of synthetic and biologic implants in pelvic reconstructive surgery has increased, reflecting the successful use of biomaterials in surgery for stress urinary incontinence.
Compared with other synthetic biomaterials, polypropylene mesh has several advantages, and it has therefore become the most commonly marketed biomaterial also for use in pelvic organ prolapse surgery. However, the use of polypropylene mesh for pelvic organ prolapse surgery remains controversial because of the lack of clinical safety and efficacy data. With trocar-guided mesh kits, perioperative morbidity and short-term clinical outcomes appear promising, but many important long-term outcomes have not been studied until now.
