Objective:
The aim of the study was to compare 6-month efficacy and safety for treatment of vaginal dryness/genitourinary syndrome of menopause in women undergoing fractionated CO2 vaginal laser therapy to women using estrogen vaginal cream.
Methods:
This multicenter, randomized trial compared fractionated CO2 laser to estrogen cream at 6 institutions. We included menopausal women with significant vaginal atrophy symptoms and we excluded women with prolapse below stage 2, recent pelvic surgery, prior mesh surgery, active genital infection, history of estrogen sensitive malignancy, and other autoimmune conditions. The primary outcome was the visual analog scale vaginal dryness score. Secondary outcomes included evaluation of vaginal atrophy, quality of life symptoms, assessment of sexual function, and urinary symptoms. Adverse events (AEs) and patient global impression of improvement (PGI-I) and satisfaction were also assessed.
Results:
Sixty-nine women were enrolled in this trial before enrollment was closed due to the Federal Drug Administration requiring the sponsor to obtain and maintain an Investigational Device Exemption. Of the 69 participants enrolled, 62 completed the 6-month protocol; 30 women were randomized to the laser and 32 to estrogen cream from June 2016 to September 2017. Demographics did not differ between groups except the laser group was less parous (0 [range 0-4] vs 2 [0-6], P = 0.04). On patient global impression, 85.8% of laser participants rated their improvement as “better or much better” and 78.5% reported being either “satisfied or very satisfied” compared to 70% and 73.3% in the estrogen group; this was not statistically different between groups. On linear regression, mean difference in female sexual function index scores was no longer statistically significant; and, vaginal maturation index scores remained higher in the estrogen group (adj P value 0.02); although, baseline and 6-month follow-up vaginal maturation index data were only available for 34 participants (16 laser, 18 estrogen).
Conclusions:
At 6 months, fractionated CO2 vaginal laser and vaginal estrogen treatment resulted in similar improvement in genitourinary syndrome of menopause symptoms as well as urinary and sexual function. Overall, 70% to 80% of participants were satisfied or very satisfied with either treatment and there were no serious adverse events.
Video Summary:
http://links.lww.com/MENO/A470.
A home-based pulmonary rehabilitation program for patients with very severe COPD under long-term oxygen treatment is safe and useful, as it achieves an improvement in exercise tolerance, reduces dyspnea after effort, and improves quality of life without causing any complication arising from the performance of the exercises.
Objectives
This study aimed to compare the incidence of adverse events and postoperative health care resource utilization, as well as to determine satisfaction in patients after a same-day discharge (SDD) protocol compared with routine care (discharge ≥postoperative day 1).
Methods
This is a prospective cohort study of SDD after minimally invasive sacrocolpopexy. Eligibility criteria included age younger than 80 years, American Society of Anesthesiologists grade I/II, caretaker for ≥24 hours postoperatively, and surgical start before 1 pm. Perioperative data were obtained through the medical record and direct patient inquiry. A satisfaction survey was administered at the postoperative visit. A historical control group was used to compare outcomes.
Results
Forty-seven women met the eligibility criteria. Mean age was 62 (±9) years. Most were White (95.7%), were overweight (body mass index, 27.7 ± 5.5 kg/m2), and had stage 3 prolapse (63.8%). Same-day discharge was achieved for 37 patients (78.7%). Patient characteristics of the SDD cohort were similar to the routine-care cohort, with the exception of previous hysterectomy (57.5% vs 100.0%, P < 0.001) and the American Society of Anesthesiologists score (2 [1–2] vs 2 [1–3], P = 0.002). There were significantly fewer postoperative telephone calls in the SDD cohort but no other differences in health care resource utilization. Adverse events did not differ between groups. The SDD cohort reported high satisfaction and would recommend SDD to family or friends independent of whether or not SDD was achieved (91.9% vs 80.0%, P = 0.29).
Conclusions
Nearly 80% of women undergoing minimally invasive sacrocolpopexy on an SDD protocol went home as planned. Compared with routine care, there was no increase in adverse events or postoperative health care resource utilization. Patient satisfaction in the SDD cohort was high.
Clinical Trial Registration
Same-day discharge after minimally invasive sacrocolpopexy, https://clinicaltrials.gov/ct2/show/NCT03730103?term=same+day+discharge&cntry=US&state=US%3AOH&city=Cleveland&draw=2&rank=1; NCT03730103.
Complications after vaginoplasty surgery for the transgender woman exist. These adverse outcomes can be minor and easily treatable, whereas others are considered major events and require ongoing care. Adverse outcomes can be immediate or remote after surgery and include bleeding, hematoma, infection, delayed wound healing, neovaginal stenosis, visceral injury, and fistula. Patients may also experience pelvic floor disorders after surgery. Providers performing these surgeries and those providers caring for postoperative patients should be aware of the incidence of these complications and the treatment options that exist to manage them.
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