European Journal of Obstetrics & Gynecology and Reproductive Biology
Full length articleEvaluation of single-incision apical vaginal suspension for treatment of pelvic organ prolapse
Introduction
Female pelvic organ prolapse (POP) is the herniation of pelvic organs (i.e. bladder, uterus, bowel or rectum) into the vaginal orifice due to loss of fibromuscular support. Symptomatic POP impairs women’s quality of life by causing symptoms such as irritation, bulge discomfort, urinary problems, defaecation symptoms or even sexual complaints. Indeed, POP is a major morbidity affecting up to 50 % of parous women aged >50 years [1]. According to a previous report, the lifetime risk for women of needing to undergo surgery for repair of POP is 11–19 % [2]. The population of aging women is increasing rapidly in developed countries, and surgical repair of symptomatic POP is a viable option. Women with POP who undergo traditional native tissue repair have high recurrence rates of 6–29 % due to less durability [[3], [4], [5]].
Since 1950, meshes have been used in the treatment of abdominal hernias by surgeons [6]. Subsequently, transvaginal meshes have been developed and implemented for treatment of POP due to their characteristically high success rate of anatomical reconstruction while being minimally invasive procedures. The second generation of meshes, such as Perigee/Apogee (American Medical Systems, Inc., Minnetonka, MN, USA) and Prolift (Ethicon, Inc., Piscataway, NJ, USA), attained high success rates for prolapse reconstruction [7]. However, complications have been noted with issues such as mesh extrusion, dyspareunia, organ perforation and urinary problems. The US Food and Drug Administration (FDA) has warned against the use of surgical mesh for POP repair since 2008, listing the complications stated above [8].
The company has been devoted to evolution of its commercial mesh material to reduce associated complications and to attain excellent success rates. The use of single-incision transvaginal mesh with sacrospinous ligament fixation has been popular for the treatment of POP. In comparison with previous transvaginal meshes, which are applied via the transobturator route, the single-incision transvaginal mesh involves apical suspension via the level I compartment. The mesh used in the single-incision procedure is designed to be less dense and stiff than type I polypropylene mesh (Intepro Lite, American Medical Systems, Inc.). This study aimed to follow up the effectiveness and safety of the transvaginal mesh system with apical support. The findings were presented, in part, to a committee of the International Continence Society in 2016 [9].
Section snippets
Materials and methods
This retrospective study was undertaken at a medical centre in Taiwan from September 2011 to December 2014. Two hundred and thirty-nine consecutive women with symptomatic anterior/apical POP stage II or higher (52 patients, 23.6 %) and posterior POP stage II or higher (168 patients, 76.3 %) underwent transvaginal mesh with the Elevate anterior and posterior systems (American Medical Systems, Inc.) [1]. The Elevate system offers use of either the anterior or posterior vaginal wall with apical
Results
Patients’ demographic data are presented in Table 1, and include age, parity, body mass index, menopausal status, smoking history, diabetes mellitus, hypertension, history of hysterectomy and procedure performed. Thirty-three (15 %) women had previously undergone hysterectomy. The Elevate anterior mesh kit was used in 143 patients, the Elevate posterior mesh kit was used in 22 patients, and the Elevate anterior and posterior mesh kits were used in 55 patients. One hundred and eleven patients
Discussion
The Elevate transvaginal mesh system used in this study is dropped off marketing. However, the key procedure of the surgery is similar to methods used by the Calistar system (Promedon, Cordoba, Argentina) and the Uphold light system (Boston Scientific, Natick, MA, USA), using sacrospinous fixation for apical support of a transvaginal mesh system. Referring to De Lancey’s level I, used to describe the level of normal and relaxed anatomic pelvic support, reconstruction can provide preliminary
Conclusion
The apical suspension system provides excellent pelvic anatomy reconstruction with the advantages of sacrospinous fixation and a cure rate of 92.3 %. Surprisingly, a decreased rate of erosion (2.7 %) was noted, which may be attributed to the higher quality of the mesh material used. However, the occurrence of de-novo SUI seems to be higher compared with the results using other mesh kits. Therefore, clinicians should pay more attention to history taking for SUI and prolapse reduction tests. An
Funding
This work was supported by MOHW106-TDU-B-212-113006, Taiwan, MOHW107-TDU-B-212-123006, Taiwan.
Declaration of Competing Interest
None declared.
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