A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial. (Record no. 4666)

MARC details
000 -LEADER
fixed length control field 04804nam a22006857a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 191014s20202020 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1072-3714
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1097/GME.0000000000001416 [doi]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 31574047
245 ## - TITLE STATEMENT
Title A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial.
251 ## - Source
Source Menopause. 27(1):50-56, 2020 01.
252 ## - Abbreviated Source
Abbreviated source Menopause. 27(1):50-56, 2020 01.
252 ## - Abbreviated Source
Former abbreviated source Menopause. 2019 Sep 30
253 ## - Journal Name
Journal name Menopause (New York, N.Y.)
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2020
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2020
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status aheadofprint
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2019-10-14
268 ## - Previous citation
-- Menopause. 2019 Sep 30
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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.
520 ## - SUMMARY, ETC.
Abstract 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).
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Estrogen Replacement Therapy/mt [Methods]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Estrogens/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Laser Therapy/mt [Methods]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Menopause
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vagina/pa [Pathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vaginal Diseases/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vaginal Diseases/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vulva/pa [Pathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vulvar Diseases/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Vulvar Diseases/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Administration, Intravaginal
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Atrophy/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Atrophy/su [Surgery]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Estrogen Replacement Therapy/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Estrogens/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Laser Therapy/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Lasers, Gas/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Middle Aged
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Patient Satisfaction
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Prospective Studies
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Quality of Life
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Single-Blind Method
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Washington Hospital Center
656 ## - INDEX TERM--OCCUPATION
Department Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive Surgery
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Iglesia, Cheryl B
790 ## - Authors
All authors Ferrando CA, Iglesia CB, Karram MM, Matthews CA, Paraiso MFR, Rardin CR, Sokol ER
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1097/GME.0000000000001416">https://dx.doi.org/10.1097/GME.0000000000001416</a>
Public note https://dx.doi.org/10.1097/GME.0000000000001416
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 10/14/2019   31574047 31574047 10/14/2019 10/14/2019 Journal Article

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