Evaluation of single-incision apical vaginal suspension for treatment of pelvic organ prolapse

Abstract

Objective

To present a comprehensive evaluation of anterior/apical and/or posterior prolapse repair systems with a focus on safety and surgical efficacy.

Methods

Two hundred and twenty women with pelvic organ prolapse (POP) stage II–IV were referred for single-incision transvaginal mesh procedures in a single institution. Pre- and postoperative assessments included pelvic examination, urodynamic studies, and personal interviews about patients’ quality of life and urinary symptoms.

Results

The anatomical success rate was 92.3 % (203/220), regardless of primary or de-novo POP, at 12–38 month follow-up. The POP quantification parameters, except total vaginal length, improved significantly after surgery (p < 0.05). Complications included bladder injury (one case), mesh exposure (six cases) and urinary retention that required intermittent catheterization (five cases). There were no cases of bowel injury during surgery. The results indicated that 29 % of patients had de-novo stress urinary incontinence and 7.7 % of patients had de-novo POP after surgery.

Conclusion

The apical vaginal suspension system is a safe and effective procedure, creating good anatomical restoration and significant improvement in quality of life. However, the rate of de-novo POP in the anterior compartment of the vagina (31.8 %) seems high after treatment with apical and posterior prolapse repair systems.

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].