Trial reportInternational urogynecology journal2013
Computer modeling informs study design: vaginal estrogen to prevent mesh erosion after different routes of prolapse surgery.
Trial report in International urogynecology journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 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
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Vaginal estrogen use in postmenopausal women with pelvic floor disorders: systematic review and practice guidelines.International urogynecology journal · 2015Guideline
- Multicenter, randomized trial comparing native vaginal tissue repair and synthetic mesh repair for genital prolapse surgical treatment.International urogynecology journal · 2015Trial
- Medium- to long-term outcomes of vaginally assisted laparoscopic sacrocolpopexy in the treatment of stage III-IV pelvic organ prolapse.BMC women's health · 2022Article
- A late complication of transobturator tape procedure: vaginocutaneous fistula formation with vaginal mesh erosion.International urogynecology journal · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction and hypothesisMany clinicians use perioperative vaginal estrogen therapy (estradiol, E(2)) to diminish the risk of mesh erosion after prolapse surgery, though supporting evidence is limited. We assessed the feasibility of a factorial randomized trial comparing mesh erosion rates after vaginal mesh prolapse surgery (VM) versus minimally invasive sacral colpopexy (MISC), with or without adjunct vaginal estrogen therapy.
methodsA Markov state transition model simulated the probability of 2-year outcomes of visceral injury, mesh erosion, and reoperation after four possible prolapse therapies: VM or MISC, each with or without estrogen therapy (E(2)). We used pooled estimates from a systematic review to generate probability distributions for the following outcomes after each procedure: visceral injury, postoperative mesh erosion, and reoperation for either recurrent prolapse or mesh erosion. Assuming different assumptions for E(2) efficacies (50 and 75 % reduction in erosion rates), Monte Carlo simulations estimated outcomes rates, which were then used to generate sample size estimates for a four-arm factorial trial.
resultsWhile E(2) reduced the risk of mesh erosion for both VM and MISC, absolute reduction was small. Assuming 75 % efficacy, E(2) decreased the risk of mesh erosion for VM from 7.8 to 2.0 % and for MISC from 2.0 to 0.5 %. Total sample sizes ranged from 448 to 1,620, depending on power and E(2) efficacy.
conclusionsThe required sample size for a trial to determine which therapy results in the lowest erosion rates would be prohibitively large. Because this remains an important clinical issue, further study design strategies could include composite outcomes, cost-effectiveness, or value of information analysis.
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