A Multicenter Prospective Study of Posterior Transvaginal Mesh Compared to Native Tissue Repair for Pelvic Organ Prolapse: 36 Month Outcomes
Bibliographic record
Abstract
STUDY OBJECTIVE: This multicenter, prospective cohort study aimed to evaluate the efficacy and safety of Restorelle® DirectFix transvaginal mesh compared to native tissue repair (NTR) in pelvic organ prolapse (POP). This manuscript reports on the 12- and 36-months follow-up data in the posterior and apical compartment cohort of this study. DESIGN: Participants, stratified into mesh (163 women) and NTR (76 women) groups, were seen at 2, 6, 12, 18, 24, and 36 months postsurgery. SETTING: The study was conducted at 38 hospitals in the United States, Canada, the Netherlands, Belgium, France, and Australia. PATIENTS: A total of 239 women were enrolled in the posterior arm of this FDA-mandated Restorelle DirectFix 522 study postmarket surveillance study between September 2014 and August 2018. INTERVENTIONS: Restorelle® DirectFix transvaginal mesh compared to native tissue repair (NTR) MEASUREMENTS: The primary efficacy endpoint was prolapse recurrence in the target compartment at 12 months, with secondary outcomes assessing prolapse recurrence at 36 months, serious adverse events, quality of life improvements, and surgical satisfaction based on various validated instruments. MAIN RESULTS: At 12 months, and despite notable differences in baseline characteristics with a poorer prognostic population in the posterior mesh-arm, the prolapse recurrence rate was 11.7% in the posterior mesh-arm and 13.2% in the NTR-arm, increasing to 18% and 27% at 36 months, respectively. Quality of life scores showed significant improvement in both groups, with similar levels of surgical satisfaction. Serious adverse events were low and comparable between the groups. Mesh exposure occurred in 3.5% of the mesh group without any serious complications. CONCLUSION: Restorelle® DirectFix Posterior mesh demonstrated comparable efficacy and safety to NTR for treating posterior and apical compartment prolapse over a 36-month period. Clinical Trial Identification Number: NCT02162615. https://clinicaltrials.gov/study/NCT02162615. Registration date June 11, 2014.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".