IMPORTANCE Postmenopausal vaginal symptoms are common and frequently detrimental to a woman's quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven.OBJECTIVE To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause. DESIGN, SETTING, AND PARTICIPANTSA double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized.INTERVENTIONS Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. MAIN OUTCOMES AND MEASURESThe co-primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status). RESULTSOf 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: -17.2 vs -26.6; difference, 9.4 [95% CI, -28.6 to 47.5]; VAS score for the most severe symptom: -24.5 vs -20.4; difference -4.1 [95% CI, -32.5 to 24.3]; VSQ score: -3.1 vs -1.6; difference, -1.5 [95% CI, -5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, -3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, -0.4 [95% CI, -4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group.CONCLUSIONS AND RELEVANCE Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months.
This review has been registered at PROSPERO: Registration number #CRD42013003829.
Background and Objective:Ambulatory total laparoscopic hysterectomy (TLH) could lead to significant cost savings, but some fear the effects of what could be premature postsurgical discharge. We sought to estimate the feasibility and safety of TLH as an outpatient procedure for benign gynecologic conditions.Methods:We report a prospective, consecutive case series of 128 outpatient TLHs performed for benign gynecologic conditions in a tertiary care center.Results:Of the 295 women scheduled for a TLH, 151 (51%) were attempted as an outpatient procedure. A total of 128 women (85%) were actually discharged home the day of their surgery. The most common reasons for admission the same day were urinary retention (19%) and nausea (15%). Indications for hysterectomy were mainly leiomyomas (62%), menorrhagia (24%), and pelvic pain (9%). Endometriosis and adhesions were found in 23% and 25% of the cases, respectively. Mean estimated blood loss was 56 mL and mean uterus weight was 215 g, with the heaviest uterus weighing 841 g. Unplanned consultation and readmission were infrequent, occurring in 3.1% and 0.8% of cases, respectively, in the first 72 hours. At 3 months, unplanned consultation, complication, and readmission had occurred in a similar proportion of inpatient and outpatient TLHs (17.2%, 12.5%, and 4.7% versus 18.1%, 12.7%, and 5.4%, respectively). In a logistic regression model, uterus weight, presence of adhesions or endometriosis, and duration of the operation were not associated with adverse outcomes.Conclusion:Same-day discharge is a feasible and safe option for carefully selected patients who undergo an uncomplicated TLH, even in the presence of leiomyomas, severe adhesions, or endometriosis.
This systematic review examined energy-based treatments of the vagina for postmenopausal vaginal symptoms. Data Sources: We performed a systematic review from April 2017 (the end date of our previous review) to April 2020, searching Medline, Embase, and Scopus. Methods of Study Selection: The inclusion criteria were all randomized studies, prospective studies with >10 cases, and retrospective studies with >20 cases published in English or French that assessed change in postmenopausal vaginal symptoms and/or sexual function in women after energy-based vaginal treatments. Meta-analyses were performed on randomized data. Tabulation, Integration, and Results: Of the 989 results retrieved, 3 randomized studies, 16 prospective studies, and 7 retrospective studies were included in the review, representing data from 2678 participants. Pooled data from 3 randomized controlled trials show no difference between vaginal laser and topical hormonal treatments for change in vaginal symptoms (−0.14, 95% confidence interval −1.07 to 0.80) or sexual function scores (2.22, 95% confidence interval −0.56 to 5.00). Furthermore, no difference among vaginal laser, topical hormone, and lubricant was demonstrated in sexual function (p = .577). As in our previous review, non-randomized data support energy-based treatments in improving vaginal symptoms, sexual function, and clinician-reported outcomes. No severe adverse events were reported in the included studies. Significant heterogeneity of data arising from differing measures and reported outcomes continues to be an issue, with data remaining low quality, with high risk of bias, and no double-blind or placebo-controlled randomized trials yet reported, although 1 has now completed recruitment. Conclusion: There are 3 randomized trials comparing energy-based systems with hormonal treatment, with no clinical difference in these 2 approaches. Although prospective data continue to show promising outcomes, without strong evidence from well-powered, double-blind placebo-controlled trials to determine the efficacy of treatment compared with placebo, the use of energy-based treatments should continue to be undertaken in research studies only, with high-quality studies essentially free from bias (International Prospective Register of Systematic Review registration number: 178346).
Background:The optimal intraperitoneal pressure during laparoscopy is not known. Recent literature found benefits of using lower pressures, but the safety of doing abdominal surgery with low peritoneal pressures needs to be assessed. This systematic review compares low with standard pneumoperitoneum during gynecologic laparoscopy.Database:We searched Medline, Embase, and the Cochrane Library for randomized controlled trials comparing intraperitoneal pressures during gynecologic laparoscopy. Two authors reviewed references and extracted data from included trials. Risk ratios, mean differences, and standard mean differences were calculated and pooled using RevMan5. Of 2251 studies identified, three were included in the systematic review, for a total of 238 patients. We found a statistically significant but modest diminution in postoperative pain of 0.38 standardized unit based on an original 10-point scale (95% confidence interval [CI], –0.67 to –0.08) during the immediate postoperative period when using low intraperitoneal pressure of 8 mm Hg compared with ≥12 mm Hg and of 0.50 (95% CI, –0.80 to –0.21) 24 hours after the surgery. Lower pressures were associated with worse visualization of the surgical field (risk ratio, 10.31; 95% CI, 1.29–82.38). We found no difference between groups over blood loss, duration of surgery, hospital length of stay, or the need for increased pressure.Conclusion:Low intraperitoneal pressures during gynecologic laparoscopy cannot be recommended on the behalf of this review because improvement in pain scores is minimal and visualization of the surgical field is affected. The safety of this intervention as well as cost-effectiveness considerations need to be further studied.
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