ArticleInternational urogynecology journal2014
High risk of complications with a single incision pelvic floor repair kit: results of a retrospective case series.
Article in International urogynecology journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.
- Assessing the use of the IUGA/ICS classification system for prosthesis/graft complications in publications from 2011 to 2015.International urogynecology journal · 2016Pooled it
- Heterogeneity in post-intervention prolapse and urinary outcome reporting: a one-year review of the International Urogynecology Journal.International urogynecology journal · 2015Review
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisThe aim of this study was to retrospectively assess the extent and severity of the post-operative complications associated with the Pinnacle Pelvic Floor Repair Kit.
methodsThis is a descriptive analysis of 23 consecutive women who had a prolapse repair with either an anterior (n = 19) or posterior (n = 4) Pinnacle kit. The clinical records of all these patients were available for analysis. Pre-operative data and intra-operative complications were noted. All post-operative complications and repeat surgical interventions were recorded. In addition to pelvic floor symptoms, we looked specifically for pelvic pain and mesh contraction, exposure, extrusion or erosion. Complications were classified according to the joint IUGA/ICS system.
resultsSeventy percent (n = 16) of our cohort experienced at least one complication. All, except one, were following an anterior Pinnacle. 10 patients (43 %) had a tender vaginal mesh prominence, including a contraction band anteriorly or at the vaginal apex. Six (26 %) complained of associated buttock, groin or vaginal pain, while the tenderness was only detected during vaginal examination in 4 (16 %) patients. Three (13 %) patients required vaginal mesh excision for severe pain and one required a second procedure. Three patients (13 %) had vaginal mesh exposure and 8 (35 %) developed de novo stress incontinence. Two patients (8 %) developed symptomatic recurrent prolapse, one following mesh excision owing to large mesh exposure. Another patient had an anterior compartment prolapse above and below a tender contracted anterior vaginal mesh.
conclusionsThe Pinnacle kit was associated with a high incidence of post-operative complications in this small series.
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