Single-incision vaginal approach to treat cystocele and vault prolapse with an anterior wall mesh anchored apically to the sacrospinous ligaments

Moore, Robert D.; Mitchell, G.K.; Miklos, John R.

doi:10.1007/s00192-011-1536-7

Cited by 64 publications

(43 citation statements)

References 18 publications

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“…In over 90 % of women postoperative POP-Q stage 0 or 1 of the vaginal apex was achieved by 1 year after surgery, which is largely comparable with previous studies using other synthetic mesh kits, in which the overall rates of POP-Q stage 0-1 range between 79 and 94 % with Prolift® [8,19], and 92-99 % for Anterior Elevate® [20,21]. These results, however, are not directly comparable with the women in our study, because in the previous studies, all vaginal compartment repairs (anterior, posterior, and combined) were allowed.…”

Section: Discussionsupporting

confidence: 84%

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study

et al. 2016

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Introduction and hypothesis The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System. Methods We carried out a 1-year, multicenter, prospective, single cohort study of 207 women with symptomatic Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 apical pelvic organ prolapse, with or without concomitant anterior vaginal wall prolapse. Safety data were collected using a standardized questionnaire. Anatomical outcome was assessed by the POP-Q and subjective outcomes by the Pelvic Floor Distress Inventory after 2 months and 1 year using a one-way repeated measures analysis of variance. Pain was evaluated using a visual analog scale. Results The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, 2 who had undergone reoperations with complete mesh removal because of pain, and 3 surgical interventions during follow-up because of mesh exposure. POP-Q stage ≤1 after 1 year was 94 % and subjective symptom relief was reported by 91 % of patients (p < 0.001). Pain after 2 months and 1 year was 60 % lower compared with the preoperative mean (p < 0.001). Minor complications occurred in 20 women (9.7 %) and were dominated by lower urinary tract dysfunction. No predisposing risk factors for complications were found. Conclusions The Uphold™ Lite procedure in women with apical pelvic organ prolapse provided satisfactory restoration of vaginal topography and symptom relief. However, serious complication rates were largely comparable with those of other transvaginal mesh kits.

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Section: Discussionsupporting

confidence: 84%

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study

et al. 2016

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“…5 Concomitant surgical procedures were permitted, and were conducted according to the usual practice of the surgeon (Table 1). All patients had postoperative vaginal packing for a minimum of 24 hours to limit early movement of the sacrospinous anchors during recovery.…”

Section: Methodsmentioning

confidence: 99%

“…Our objective cure rates are within the range reported by larger studies. 5,9,14 We had two anatomical failures, and these two patients did not differ in baseline characteristics. One had incorrect placement of both anchors and the other had one improper placement.…”

Section: Strengths and Limitationsmentioning

confidence: 96%

“…In the literature these risks have been associated with trocar-based mesh kits. [4][5][6][7] To address concerns about risks associated with trocar placement, new single-incision mesh devices with novel anchoring techniques have been developed. These new kits can be licensed at present without new evidence of safety or effectiveness, instead relying on evidence based on predicate devices.…”

Section: Introductionmentioning

confidence: 99%

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Anchor placement and subsequent movement in a mesh kit with self‐fixating tips: 6‐month follow‐up of a prospective cohort

Brennand

Bhayana

Tang

et al. 2014

BJOG

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Objective To describe the initial placement of Elevate single-incision mesh kit device tips relative to the sacrospinous ligament, and to measure tip movement over a 6-month period from initial placement. Design Prospective cohort.Setting Tertiary care urogynaecology centre in Calgary, Canada.Population Women electing for surgical management of anterior vaginal wall prolapse.Methods Ten women underwent anterior prolapse repair using the Elevate single-incision mesh kit with a metallic fiducial marker attached to the tips of the surgical device. Women were imaged by magnetic resonance imaging (MRI) within 48 hours of surgery, and again 6 months later to investigate the position of the device tips and change ≥4 mm over the 6-month postoperative period.Main outcome measure(s) Position of self-fixating tips within 48 hours of surgery, and at six months post-operative.Results Anchor insertion was directly into the sacrospinous ligament in 10 of 20 insertion points (50%, 95% CI 27-73%).Movement was most often noted in the cranial-caudal direction: a change in location of ≥4 mm was observed for 8/20 anchors (40%, 95% CI 19-64%). Cranial-caudal movement was observed less frequently among sacrospinous anchors than among anchors inserted into other pelvic structures (1/10 versus 7/10, P = 0.020, difference in proportion À60%, 95% CI À94 to À26%). PFDI-20 scores improved statistically significantly by 6 months (P = 0.008, mean change À62.9%, 95% CI À105.1 to À20.7%), but PFIQ-7 scores did not change statistically significantly over the same time period (P = 0.523, mean change À12.4%, 95% CI À54.5 to 29.8%).Conclusions The novel self-fixating anchoring tips of this single-incision mesh kit do not reliably anchor into the sacrospinous ligament. The tips have been shown to move with time, although not all cases of anchor movement were associated with recurrent prolapse.

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“…Symptomatic POP was defined as any complaint relating to a bothersome vaginal bulge or other prolapse-related symptoms [8], confirmed by physical examination. The mesh kits used were Prolift® (Ethicon, Somerville, MA, USA) [9], Elevate® (American Medical System, Minnetonka, MN, USA) [10], and Surelift® (Neomedic International, Terrassa, Spain) [11], all of which are made of polypropylene and are classified as type 1 according to the Amid classification [12]. Surgical procedures were performed in accordance with previously reported techniques [9-11].…”

Section: Methodsmentioning

confidence: 99%

Pelvic Organ Prolapse Repair with Mesh: Mid-Term Efficacy and Complications

et al. 2018

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Introduction: Our aim was to assess the efficacy and complications of pelvic organ prolapse (POP) correction with transvaginal mesh (TVM). Materials and Methods: We retrospectively assessed patients who had undergone a repair of an apical (primary or recurrent) or recurrent POP using TVM in our department since 2007. Meshes used were Prolift®, Elevate®, and Surelift®. Satisfaction with surgery was assessed on a 0–10 scale. Results: A total of 83 patients were included (33 Prolift®, 36 Elevate®, 14 Surelift®), with a mean age of 67.8 ± 9.7 years. Eighteen (21.6%) patients underwent a recurrent POP correction. Follow-up was 49 ± 34 months. Twelve (14.4%) symptomatic recurrences were identified, 3 of which required further surgery. Satisfaction was 8.7. Four (4.8%) vaginal exposures were detected, 2 of which required partial mesh removal. Three (3.6%) cases of dyspareunia and 1 (1.2%) case of mild pelvic pain were reported, which did not require further treatment. Conclusion: The use of TVM for apical or recurrent POP repair is effective and is associated with a high satisfaction rate while complications are infrequent.

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Single-incision vaginal approach to treat cystocele and vault prolapse with an anterior wall mesh anchored apically to the sacrospinous ligaments

Cited by 64 publications

References 18 publications

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study

Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study

Anchor placement and subsequent movement in a mesh kit with self‐fixating tips: 6‐month follow‐up of a prospective cohort

Pelvic Organ Prolapse Repair with Mesh: Mid-Term Efficacy and Complications

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