Evidence map›Paper›PMID 25295130›Full record

ArticleCanadian Urological Association journal = Journal de l'Association des urologues du Canada2014

Morbidity and functional mid-term outcomes using Prolift pelvic floor repair systems.

Sébastien Kozal, Thomas Ripert, Younes Bayoud, Johan Menard, Ioannis Nicolacopoulos, Laurence Bednarzyck, Frederic Staerman, Stéphane Larré

Abstract read
In one paragraph

Article in Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Sébastien KozalDepartment of Urology and Andrology. Robert Debré, University Hospital, Reims, France;
Thomas RipertDepartment of Urology and Andrology. Robert Debré, University Hospital, Reims, France; ; Department of Urology and Andrology, Polyclinic Courlancy, Reims, France;
Younes BayoudDepartment of Urology and Andrology. Robert Debré, University Hospital, Reims, France;
Johan MenardDepartment of Urology and Andrology. Robert Debré, University Hospital, Reims, France;
Ioannis NicolacopoulosDepartment of Urology, Manchester General Hospital, Charleville, France;
Laurence BednarzyckDepartment of Obstetrics and Gynecology, Manchester General Hospital, Charleville, France;
Frederic StaermanDepartment of Urology and Andrology. Robert Debré, University Hospital, Reims, France; ; Departement of Urology and Andrology, Polyclinic Les Bleuets, Reims, France.
Stéphane LarréDepartment of Urology and Andrology. Robert Debré, University Hospital, Reims, France;

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe assess midterm morbidity and functional outcomes using the Prolift (Gynecare/Ethicon, Somerville, NJ) system and identify potential related risk factors. The Prolift mesh system to treat genital prolapse was introduced in 2005. It was withdrawn from the market in early 2013 after rising doubts about safety.

methodsOver a 7-year period, we retrospectively analyzed a cohort of 112 consecutive patients who underwent the Prolift procedure since 2006. Intraoperative and postoperative complications, anatomical and functional outcomes were recorded.

resultsThe median follow-up was 49.5 months (range: 16-85). The mean age was 64.7 ± 10.9 years (range: 40-86). Of the 112 patients, 74 patients had stage 3 (66.1%) and 8 patients had stage 4 (7.14%) vaginal prolapse. Prolift surgery was performed for pro-lapse recurrence for 26 patients (23.2%). Total mesh was used in 32 patients (29%), an isolated anterior mesh in 57 patients (51%) and an isolated posterior mesh in 23 patients (21%). Concomitant surgical procedures were performed for 44 patients (39.3%). Overall, 72% (18/25) of the complications were managed medically. We reported a failure rate of 8% (n = 9) occurring after a median follow-up of 9.5 months (range: 1-45). Among the 64 patients who had preoperative sexual activity (57.1%), de novo dyspareunia occurred in 9 patients (16.07%). We extracted predictive factors concerning failure, complications and sexuality.

conclusionDespite its market withdrawal, the Prolift system was associated with good midterm anatomic outcomes and few severe complications. Long-term follow-up data are still lacking, but surgeons and patients may be reassured.

Identifiers

PMID25295130
PMCPMC4164547

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.