ArticleCureus2024
Long-Term Outcomes of Restorelle® Direct Fix Anterior Mesh in the Treatment of Pelvic Organ Prolapse.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
- Development and Simulation-Based Validation of Biodegradable 3D-Printed Cog Threads for Pelvic Organ Prolapse Repair.Materials (Basel, Switzerland) · 2025Article
- Failure to Adjust Mesh Length Beneath the Bladder Is an Independent Factor of Postoperative Urinary Incontinence After Transvaginal Mesh Surgery.International neurourology journal · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective The objective of this study was to evaluate the efficacy and long-term outcomes of the use of Restorelle® Direct Fix (Coloplast, Humlebæk, Denmark) anterior mesh for transvaginal surgical management of anterior compartment prolapse. Methods A retrospective case series review was conducted for 123 patients who underwent surgery for Baden-Walker Grade three and four anterior compartment prolapse with the Restorelle Direct Fix anterior mesh between July 1, 2017 and September 30, 2018 in a single center. Follow-up was conducted at one, six, 12, 24, and 36 months after treatment. A standardized questionnaire and pelvic examination were conducted at each visit to assess operative complications and subjective and objective cure rates. Results Sixty patients were included in the analysis with a three-year follow-up rate of 70.0%. At three years post-operatively, subjective and objective cure rates were 97.7% and 95.3% respectively. Seven (11.7%) patients complained of de novo stress urinary incontinence, four (6.7%) complained of de novo urge urinary incontinence and one (1.7%) complained of symptomatic recurrence. Significantly, six (10.0%) patients had transvaginal mesh exposure over the three-year follow-up, mostly presenting within the first year. One (2.4%) patient developed new asymptomatic mesh erosion at the 36-month visit and one patient required mesh loosening one month post-surgery. Conclusions Management of anterior compartment prolapse with transvaginal surgery using the Restorelle® Direct Fix anterior mesh was associated with good subjective and objective cure rates. However, significant rates of post-operative mesh exposure were noted within three years post-surgery, which hinders the recommendation of this device for augmentation of repair for anterior compartment prolapse.
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