Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124820
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2022-09-06
Brief Title:
RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
A Single-blinded Randomised Controlled Trial Comparing the Use of Intravaginal Laser Therapy to Sham in Post-menopausal Women With Recurrent Urinary Tract Infections rUTI and the Impact on the Vaginal and Urinary Microbiome
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UTIEXTERMINATE
Brief Summary:
Recurrent urinary tract infection rUTI is a common and difficult to treat problem with limited treatment option postmenopausal women are disproportionately affected The genitourinary syndrome of menopause GSM describes the broad spectrum of signs and symptoms caused by the loss of endogenous sex steroids The combined effects of urogenital epithelial tissue thinning and changes to the vaginal and bladder microbiome can predispose to ascending UTIs Recurrent UTIs is a component of GSM
Intravaginal laser therapy has been shown to be safe and effective for the treatment of GSM however the role of laser for treatment of recurrent UTIs is unknown We hypothesis that the incidence of UTI will be reduced as CO2 laser restores vaginal epithelium to a state similar to that of a pre-menopausal woman preventing microtrauma and increases Lactobacillus and normal flora Athanasiou et al 2016 Lactobacillus is considered the bacteria that helps keep the vagina healthy and infection free through its production of lactic acid which lowers vaginal pH this more acidic environment may be protective from uropathogens
We therefore aim to conduct a single-blinded multi-centre randomised controlled trial comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and to determine the impact on the microbiome
Intravaginal laser therapy has been shown to be safe and effective for the treatment of GSM however the role of laser for treatment of recurrent UTIs is unknown We hypothesis that the incidence of UTI will be reduced as CO2 laser restores vaginal epithelium to a state similar to that of a pre-menopausal woman preventing microtrauma and increases Lactobacillus and normal flora Athanasiou et al 2016 Lactobacillus is considered the bacteria that helps keep the vagina healthy and infection free through its production of lactic acid which lowers vaginal pH this more acidic environment may be protective from uropathogens
We therefore aim to conduct a single-blinded multi-centre randomised controlled trial comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and to determine the impact on the microbiome
Detailed Description:
Urinary tract infections UTIs are the most common outpatient infection with a prevalence of 20 in women over 65 compared with 11 in the overall population Chu and Lowder 2018
The genitourinary syndrome of menopause GSM is the accepted term used to describe the broad spectrum of genitourinary tract symptoms and signs caused by the loss of endogenous sex steroids that occurs at the time of and after the menopause Global improvements in healthcare have resulted in an aging population Today women are spending 40 of their lives in the postmenopausal state with 50-70 of postmenopausal women reporting symptomatic GSM The combined effects of urogenital epithelial tissue thinning and changes to the vaginal and bladder microbiome can predispose to ascending UTIs Recurrent UTIs is a component of GSM
Current interventions for recurrent urinary tract infections in women include lifestyle and behavioural advice complimentary therapies and antibiotics These treatment regimens are not always effective or acceptable Intravaginal Laser therapy is an alternative non-hormonal treatment of GSM as it stimulates tissue repair and restores normal vaginal function
Currently intravaginal laser therapy has been shown to be safe and effective for the treatment of GSM as described in a recent network analysis of 29 randomised controlled studies incorporating 8311 patients Li et al 2021 Provisional results using FemTouch fractional CO2 laser appear promising with 912 75 of post-menopausal women UTI free at 12 months follow-up Yang and Foley However there is a scarcity of studies available looking at the impact of this novel technology for the treatment of recurrent UTIs
The investigators aim to conduct a single-blinded randomised controlled trial comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and to determine the impact on the microbiome The investigators hypothesise that this treatment will be effective in reducing the incidence of urinary tract infection as CO2 laser through a process of thermomodulation simulates tissue repair by restoring vaginal epithelium to a state similar to that of a pre-menopausal woman In addition a study assessing the effect of micro-ablative functional CO2 laser reported an increase in Lactobacillus and normal flora Athanasiou et al 2016 Lactobacillus is considered the bacteria that helps keep the vagina healthy and infection free through its production of lactic acid which lowers the vaginal pH this more acidic environment may be protective from uropathogens The role and impact of Laser on other microbial communities is still not fully understood this study aims to expand this knowledge base
Recurrent UTIs is a common and difficult to treat problem with limited treatment options this study endeavors to expand the knowledge pool and provide alternative non-pharmacological options using this novel technology
The genitourinary syndrome of menopause GSM is the accepted term used to describe the broad spectrum of genitourinary tract symptoms and signs caused by the loss of endogenous sex steroids that occurs at the time of and after the menopause Global improvements in healthcare have resulted in an aging population Today women are spending 40 of their lives in the postmenopausal state with 50-70 of postmenopausal women reporting symptomatic GSM The combined effects of urogenital epithelial tissue thinning and changes to the vaginal and bladder microbiome can predispose to ascending UTIs Recurrent UTIs is a component of GSM
Current interventions for recurrent urinary tract infections in women include lifestyle and behavioural advice complimentary therapies and antibiotics These treatment regimens are not always effective or acceptable Intravaginal Laser therapy is an alternative non-hormonal treatment of GSM as it stimulates tissue repair and restores normal vaginal function
Currently intravaginal laser therapy has been shown to be safe and effective for the treatment of GSM as described in a recent network analysis of 29 randomised controlled studies incorporating 8311 patients Li et al 2021 Provisional results using FemTouch fractional CO2 laser appear promising with 912 75 of post-menopausal women UTI free at 12 months follow-up Yang and Foley However there is a scarcity of studies available looking at the impact of this novel technology for the treatment of recurrent UTIs
The investigators aim to conduct a single-blinded randomised controlled trial comparing the use of intravaginal CO2 laser therapy to sham in post-menopausal women with rUTIs and to determine the impact on the microbiome The investigators hypothesise that this treatment will be effective in reducing the incidence of urinary tract infection as CO2 laser through a process of thermomodulation simulates tissue repair by restoring vaginal epithelium to a state similar to that of a pre-menopausal woman In addition a study assessing the effect of micro-ablative functional CO2 laser reported an increase in Lactobacillus and normal flora Athanasiou et al 2016 Lactobacillus is considered the bacteria that helps keep the vagina healthy and infection free through its production of lactic acid which lowers the vaginal pH this more acidic environment may be protective from uropathogens The role and impact of Laser on other microbial communities is still not fully understood this study aims to expand this knowledge base
Recurrent UTIs is a common and difficult to treat problem with limited treatment options this study endeavors to expand the knowledge pool and provide alternative non-pharmacological options using this novel technology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None