Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06124820
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections
Sponsor:
King's College Hospital NHS Trust
Organization:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
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 9/12 (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 9/12 (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:
False
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?: