Objective
To assess whether CO2 laser treatment is more effective than sham application in relieving the most bothersome symptom (MBS) in women with genitourinary syndrome of menopause (GSM).
Design
Single‐centre, sham‐controlled, double‐blind, randomised trial.
Setting
A tertiary centre in Belgium.
Population
Sixty women with moderate to severe GSM symptoms.
Methods
All participants eventually received three consecutive laser and three consecutive sham applications, either first laser followed by sham, or conversely.
Main outcome measures
The primary outcome was the participant‐reported change in severity of the MBS at 12 weeks. Secondary outcomes included subjective (patient satisfaction, sexual function, urinary function) and objective (pH, Vaginal Health Index Score, in vivo microscopy) measurements assessing the short‐term effect and the longevity of treatment effects at 18 months after start of the therapy. Adverse events were reported at every visit.
Results
The MBS severity score decreased from 2.86 ± 0.35 to 2.17 ± 0.93 (−23.60%; 95% CI −36.10% to −11.10%) in women treated with laser compared with 2.90 ± 0.31 to 2.52 ± 0.78 (−13.20%; 95% CI −22.70% to −3.73%) in those receiving sham applications (p = 0.13). There were no serious adverse events reported up to 18 months.
Conclusions
In women with GSM, the treatment response 12 weeks after laser application was comparable to that of sham applications. There were no obvious differences for secondary outcomes and no serious adverse events were reported.
Purpose
Laparoscopic sacrocolpopexy is the gold standard procedure for the management of vaginal vault prolapse. Studying surgical skills and different approaches to this procedure requires an analysis at the level of each of its individual phases, thus motivating investigation of automated surgical workflow for expediting this research. Phase durations in this procedure are significantly larger and more variable than commonly available benchmarks such as Cholec80, and we assess these differences.
Methodology
We introduce sequence-to-sequence (seq2seq) models for coarse-level phase segmentation in order to deal with highly variable phase durations in Sacrocolpopexy. Multiple architectures (LSTM and transformer), configurations (time-shifted, time-synchronous), and training strategies are tested with this novel framework to explore its flexibility.
Results
We perform 7-fold cross-validation on a dataset with 14 complete videos of sacrocolpopexy. We perform both a frame-based (accuracy, F1-score) and an event-based (Ward metric) evaluation of our algorithms and show that different architectures present a trade-off between higher number of accurate frames (LSTM, Mode average) or more consistent ordering of phase transitions (Transformer). We compare the implementations on the widely used Cholec80 dataset and verify that relative performances are different to those in Sacrocolpopexy.
Conclusions
We show that workflow segmentation of Sacrocolpopexy videos has specific challenges that are different to the widely used benchmark Cholec80 and require dedicated approaches to deal with the significantly larger phase durations. We demonstrate the feasibility of seq2seq models in Sacrocolpopexy, a broad framework that can be further explored with new configurations. We show that an event-based evaluation metric is useful to evaluate workflow segmentation algorithms and provides complementary insight to the more commonly used metrics such as accuracy or F1-score.
Laparoscopic sacrocolpopexy using lightweight compared with heavier-weight polypropylene mesh results in fewer graft-related complications and reinterventions, with similar long-term patient satisfaction.
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