Efficacy and safety of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause: A randomized double-blind placebo-controlled trial
•Urinary tract infections are very prevalent among postmenopausal women.•53% of women aged 55 reported a recurrence within a year in primary care.•Overuse of antibiotics increases antimicrobial resistance, threatening public health.•0.005% estriol gel lowers urinary infection rates in postmenopausal...
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creator | Muiños Fernández, Nuno Martínez Salamanca, Juan Ignacio Pardo González de Quevedo, José Ignacio Diz Morales, M. Pilar Palomo Alameda, Lourdes Duce Tello, Susana González Béjar, Milagros Rabanal Carrera, Alejandra Rosado Martín, Javier Noguera Vera, Laura Doyle Sanchez, Ana Rodríguez Mariblanca, Amelia García Aguilar, Eva |
description | •Urinary tract infections are very prevalent among postmenopausal women.•53% of women aged 55 reported a recurrence within a year in primary care.•Overuse of antibiotics increases antimicrobial resistance, threatening public health.•0.005% estriol gel lowers urinary infection rates in postmenopausal women.•Ultra-low-dose estriol vaginal gel could be an alternative form of antibiotic prophylaxis.
This study evaluated the efficacy of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause.
Randomized, double-blind, placebo-controlled, multicenter clinical trial conducted across 28 Spanish sites involving specialists in gynecology, urology, and primary care. A total of 108 postmenopausal women were randomly assigned in a 1:1 ratio to receive 1 g of vaginal gel with 50 micrograms of estriol or an identical moisturizing vaginal gel without estriol.
The primary outcome was the number of episodes of urinary tract infection by the end of the 24-week treatment. Secondary measures encompassed percentage of patients without recurrence, time to first recurrence, use of antibiotic treatment, vaginal pH, safety, and tolerability, among others.
The incidence rate of urinary tract infections (new cases per 100 women-year) was 26 % lower in the group that received estriol vs. the group that received placebo (32.34 vs. 43.76 (RR = 0.74) p |
doi_str_mv | 10.1016/j.maturitas.2024.108128 |
format | Article |
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This study evaluated the efficacy of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause.
Randomized, double-blind, placebo-controlled, multicenter clinical trial conducted across 28 Spanish sites involving specialists in gynecology, urology, and primary care. A total of 108 postmenopausal women were randomly assigned in a 1:1 ratio to receive 1 g of vaginal gel with 50 micrograms of estriol or an identical moisturizing vaginal gel without estriol.
The primary outcome was the number of episodes of urinary tract infection by the end of the 24-week treatment. Secondary measures encompassed percentage of patients without recurrence, time to first recurrence, use of antibiotic treatment, vaginal pH, safety, and tolerability, among others.
The incidence rate of urinary tract infections (new cases per 100 women-year) was 26 % lower in the group that received estriol vs. the group that received placebo (32.34 vs. 43.76 (RR = 0.74) p < 0.001). The frequency of urinary tract infections fell during treatment in all patients in the estriol group. Favorable pH changes from baseline were observed in the estriol arm at all follow-up visits.
Ultra-low-dose 0.005 % estriol vaginal gel is safe and effective in preventing recurrent urinary tract infections in postmenopausal women with genitourinary syndrome of menopause, reducing the incidence and potentially decreasing the susceptibility to urogenital infections by improving vaginal pH.
Study registration N°: 2018-001481-42. Date of registration: 09-04-2018.</description><identifier>ISSN: 0378-5122</identifier><identifier>ISSN: 1873-4111</identifier><identifier>EISSN: 1873-4111</identifier><identifier>DOI: 10.1016/j.maturitas.2024.108128</identifier><identifier>PMID: 39388913</identifier><language>eng</language><publisher>Ireland: Elsevier B.V</publisher><subject>Administration, Intravaginal ; Aged ; Double-Blind Method ; Estriol ; Estriol - administration & dosage ; Female ; Female Urogenital Diseases - drug therapy ; Female Urogenital Diseases - prevention & control ; Genitourinary syndrome of menopause ; Humans ; Middle Aged ; Postmenopausal ; Postmenopause ; Recurrent urinary tract infection ; Syndrome ; Urinary Tract Infections - prevention & control ; Vagina - microbiology ; Vaginal Creams, Foams, and Jellies - administration & dosage ; Vulvovaginal atrophy</subject><ispartof>Maturitas, 2024-12, Vol.190, p.108128, Article 108128</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c247t-7c828cc85b1162039bf9c0b4feefbeb2629603e1bde494730fa14af74eaf28183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.maturitas.2024.108128$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39388913$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Muiños Fernández, Nuno</creatorcontrib><creatorcontrib>Martínez Salamanca, Juan Ignacio</creatorcontrib><creatorcontrib>Pardo González de Quevedo, José Ignacio</creatorcontrib><creatorcontrib>Diz Morales, M. Pilar</creatorcontrib><creatorcontrib>Palomo Alameda, Lourdes</creatorcontrib><creatorcontrib>Duce Tello, Susana</creatorcontrib><creatorcontrib>González Béjar, Milagros</creatorcontrib><creatorcontrib>Rabanal Carrera, Alejandra</creatorcontrib><creatorcontrib>Rosado Martín, Javier</creatorcontrib><creatorcontrib>Noguera Vera, Laura</creatorcontrib><creatorcontrib>Doyle Sanchez, Ana</creatorcontrib><creatorcontrib>Rodríguez Mariblanca, Amelia</creatorcontrib><creatorcontrib>García Aguilar, Eva</creatorcontrib><title>Efficacy and safety of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause: A randomized double-blind placebo-controlled trial</title><title>Maturitas</title><addtitle>Maturitas</addtitle><description>•Urinary tract infections are very prevalent among postmenopausal women.•53% of women aged 55 reported a recurrence within a year in primary care.•Overuse of antibiotics increases antimicrobial resistance, threatening public health.•0.005% estriol gel lowers urinary infection rates in postmenopausal women.•Ultra-low-dose estriol vaginal gel could be an alternative form of antibiotic prophylaxis.
This study evaluated the efficacy of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause.
Randomized, double-blind, placebo-controlled, multicenter clinical trial conducted across 28 Spanish sites involving specialists in gynecology, urology, and primary care. A total of 108 postmenopausal women were randomly assigned in a 1:1 ratio to receive 1 g of vaginal gel with 50 micrograms of estriol or an identical moisturizing vaginal gel without estriol.
The primary outcome was the number of episodes of urinary tract infection by the end of the 24-week treatment. Secondary measures encompassed percentage of patients without recurrence, time to first recurrence, use of antibiotic treatment, vaginal pH, safety, and tolerability, among others.
The incidence rate of urinary tract infections (new cases per 100 women-year) was 26 % lower in the group that received estriol vs. the group that received placebo (32.34 vs. 43.76 (RR = 0.74) p < 0.001). The frequency of urinary tract infections fell during treatment in all patients in the estriol group. Favorable pH changes from baseline were observed in the estriol arm at all follow-up visits.
Ultra-low-dose 0.005 % estriol vaginal gel is safe and effective in preventing recurrent urinary tract infections in postmenopausal women with genitourinary syndrome of menopause, reducing the incidence and potentially decreasing the susceptibility to urogenital infections by improving vaginal pH.
Study registration N°: 2018-001481-42. Date of registration: 09-04-2018.</description><subject>Administration, Intravaginal</subject><subject>Aged</subject><subject>Double-Blind Method</subject><subject>Estriol</subject><subject>Estriol - administration & dosage</subject><subject>Female</subject><subject>Female Urogenital Diseases - drug therapy</subject><subject>Female Urogenital Diseases - prevention & control</subject><subject>Genitourinary syndrome of menopause</subject><subject>Humans</subject><subject>Middle Aged</subject><subject>Postmenopausal</subject><subject>Postmenopause</subject><subject>Recurrent urinary tract infection</subject><subject>Syndrome</subject><subject>Urinary Tract Infections - prevention & control</subject><subject>Vagina - microbiology</subject><subject>Vaginal Creams, Foams, and Jellies - administration & dosage</subject><subject>Vulvovaginal atrophy</subject><issn>0378-5122</issn><issn>1873-4111</issn><issn>1873-4111</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkU1uFDEQhVsIRIbAFcAbJDY9-Kdn2s0uisKPFIkNrC23u5x45LYb2z2jyWk4C6fhGFRrMtmysuz63qsqv6p6x-iaUbb9uFuPuszJFZ3XnPIGXyXj8lm1YrIVdcMYe16tqGhlvWGcX1Svct5RSjdUNC-rC9EJKTsmVtXfG2ud0eZIdBhI1hbKkUSLNzL7knTt46EeYgZC1yj_8_s9gVySi57s9Z0L2pM78MQFUu6BTAn2EIqLYfHA-YJOR4I2piBiwSylvNBTzGWEECc9Z_Q4RLyQgyv3aBdciWdtPoYhYXHxO_PwiVyRhPPG0T3AQIY49x7q3jtcYfLaQB9rE0NJ0Xus47jav65eWO0zvHk8L6ufn29-XH-tb79_-XZ9dVsb3rSlbo3k0hi56Rnbciq63naG9o0FsD30fMu7LRXA-gGarmkFtZo12rYNaMslk-Ky-nDynVL8NeNfqdFlA97rAHHOSjC2abquoy2i7Qk1KeacwKopuRG3VoyqJWa1U08xqyVmdYoZlW8fm8z9CMOT7pwrAlcnAHDVvYOksnEQDAwuYQpqiO6_Tf4B3QrE2w</recordid><startdate>202412</startdate><enddate>202412</enddate><creator>Muiños Fernández, Nuno</creator><creator>Martínez Salamanca, Juan Ignacio</creator><creator>Pardo González de Quevedo, José Ignacio</creator><creator>Diz Morales, M. 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Pilar ; Palomo Alameda, Lourdes ; Duce Tello, Susana ; González Béjar, Milagros ; Rabanal Carrera, Alejandra ; Rosado Martín, Javier ; Noguera Vera, Laura ; Doyle Sanchez, Ana ; Rodríguez Mariblanca, Amelia ; García Aguilar, Eva</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c247t-7c828cc85b1162039bf9c0b4feefbeb2629603e1bde494730fa14af74eaf28183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Administration, Intravaginal</topic><topic>Aged</topic><topic>Double-Blind Method</topic><topic>Estriol</topic><topic>Estriol - administration & dosage</topic><topic>Female</topic><topic>Female Urogenital Diseases - drug therapy</topic><topic>Female Urogenital Diseases - prevention & control</topic><topic>Genitourinary syndrome of menopause</topic><topic>Humans</topic><topic>Middle Aged</topic><topic>Postmenopausal</topic><topic>Postmenopause</topic><topic>Recurrent urinary tract infection</topic><topic>Syndrome</topic><topic>Urinary Tract Infections - prevention & control</topic><topic>Vagina - microbiology</topic><topic>Vaginal Creams, Foams, and Jellies - administration & dosage</topic><topic>Vulvovaginal atrophy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Muiños Fernández, Nuno</creatorcontrib><creatorcontrib>Martínez Salamanca, Juan Ignacio</creatorcontrib><creatorcontrib>Pardo González de Quevedo, José Ignacio</creatorcontrib><creatorcontrib>Diz Morales, M. Pilar</creatorcontrib><creatorcontrib>Palomo Alameda, Lourdes</creatorcontrib><creatorcontrib>Duce Tello, Susana</creatorcontrib><creatorcontrib>González Béjar, Milagros</creatorcontrib><creatorcontrib>Rabanal Carrera, Alejandra</creatorcontrib><creatorcontrib>Rosado Martín, Javier</creatorcontrib><creatorcontrib>Noguera Vera, Laura</creatorcontrib><creatorcontrib>Doyle Sanchez, Ana</creatorcontrib><creatorcontrib>Rodríguez Mariblanca, Amelia</creatorcontrib><creatorcontrib>García Aguilar, Eva</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Maturitas</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Muiños Fernández, Nuno</au><au>Martínez Salamanca, Juan Ignacio</au><au>Pardo González de Quevedo, José Ignacio</au><au>Diz Morales, M. Pilar</au><au>Palomo Alameda, Lourdes</au><au>Duce Tello, Susana</au><au>González Béjar, Milagros</au><au>Rabanal Carrera, Alejandra</au><au>Rosado Martín, Javier</au><au>Noguera Vera, Laura</au><au>Doyle Sanchez, Ana</au><au>Rodríguez Mariblanca, Amelia</au><au>García Aguilar, Eva</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause: A randomized double-blind placebo-controlled trial</atitle><jtitle>Maturitas</jtitle><addtitle>Maturitas</addtitle><date>2024-12</date><risdate>2024</risdate><volume>190</volume><spage>108128</spage><pages>108128-</pages><artnum>108128</artnum><issn>0378-5122</issn><issn>1873-4111</issn><eissn>1873-4111</eissn><abstract>•Urinary tract infections are very prevalent among postmenopausal women.•53% of women aged 55 reported a recurrence within a year in primary care.•Overuse of antibiotics increases antimicrobial resistance, threatening public health.•0.005% estriol gel lowers urinary infection rates in postmenopausal women.•Ultra-low-dose estriol vaginal gel could be an alternative form of antibiotic prophylaxis.
This study evaluated the efficacy of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause.
Randomized, double-blind, placebo-controlled, multicenter clinical trial conducted across 28 Spanish sites involving specialists in gynecology, urology, and primary care. A total of 108 postmenopausal women were randomly assigned in a 1:1 ratio to receive 1 g of vaginal gel with 50 micrograms of estriol or an identical moisturizing vaginal gel without estriol.
The primary outcome was the number of episodes of urinary tract infection by the end of the 24-week treatment. Secondary measures encompassed percentage of patients without recurrence, time to first recurrence, use of antibiotic treatment, vaginal pH, safety, and tolerability, among others.
The incidence rate of urinary tract infections (new cases per 100 women-year) was 26 % lower in the group that received estriol vs. the group that received placebo (32.34 vs. 43.76 (RR = 0.74) p < 0.001). The frequency of urinary tract infections fell during treatment in all patients in the estriol group. Favorable pH changes from baseline were observed in the estriol arm at all follow-up visits.
Ultra-low-dose 0.005 % estriol vaginal gel is safe and effective in preventing recurrent urinary tract infections in postmenopausal women with genitourinary syndrome of menopause, reducing the incidence and potentially decreasing the susceptibility to urogenital infections by improving vaginal pH.
Study registration N°: 2018-001481-42. Date of registration: 09-04-2018.</abstract><cop>Ireland</cop><pub>Elsevier B.V</pub><pmid>39388913</pmid><doi>10.1016/j.maturitas.2024.108128</doi><oa>free_for_read</oa></addata></record> |
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subjects | Administration, Intravaginal Aged Double-Blind Method Estriol Estriol - administration & dosage Female Female Urogenital Diseases - drug therapy Female Urogenital Diseases - prevention & control Genitourinary syndrome of menopause Humans Middle Aged Postmenopausal Postmenopause Recurrent urinary tract infection Syndrome Urinary Tract Infections - prevention & control Vagina - microbiology Vaginal Creams, Foams, and Jellies - administration & dosage Vulvovaginal atrophy |
title | Efficacy and safety of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause: A randomized double-blind placebo-controlled trial |
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