Recurrent Urinary Tract InfectionUTIEXTERMINATENCT06124820
RCT Comparing Intravaginal Laser Therapy to Sham in Post-menopausal Women with Recurrent Urinary Tract Infections
A study testing Deka SmartXide Touch C60 (MonaLisa Touch) in people with Recurrent Urinary Tract Infection and Genitourinary Syndrome of Menopause, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Recurrent Urinary Tract Infection, Genitourinary Syndrome of Menopause
- What is being tested?
- Deka SmartXide Touch C60 (MonaLisa Touch)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2023to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women
- History of recurrent UTI (Defined as women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last six months, or at least one episode of UTI requiring hospitalisation, or if previously prescribed prophylactic antibiotics for UTI, have completed a 3-month washout period without antibiotic prophylaxis)
- Able to give informed consent for participation in the trial
- Able and willing to adhere to a 17-month study period
Who cannot join
- Not willing to abstain from vaginal intercourse for 48 hours following laser-therapy
- Use of vaginal hormonal therapy in the three months before study start
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during physical screening exam (e.g., deficient perineal body)
- Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
- History of lichen sclerosis
- History of radiotherapy for cervical or uterine cancer
Show all 12Show fewer
- A medical condition that may interfere with participants' compliance with the protocol
- Women with correctable urinary tract abnormalities that are considered to be contributory to the occurrence of rUTI
- Women taking Methenamine Hippurate and unable to undergo a three-month washout period
- Undiagnosed genital bleeding
- Women who self-catheterise, or have an indwelling/suprapubic catheter
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Deka SmartXide Touch C60 (MonaLisa Touch), Sham
- Keywords
- UTI, Recurrent Urinary Tract Infection, Genitourinary Syndrome of Menopause, Laser, CO2 Laser, Microbiome
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deka SmartXide Touch C60 (MonaLisa Touch)Device
Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch)
ShamDevice
Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch) will be administered intravaginally over a course of 5 cycles Receives: Device: Deka SmartXide Touch C60 (MonaLisa Touch) |
| Control Arm | Sham comparator | Sham treatment -Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine and compare the incidence of symptomatic antibiotic-treated UTI during the 6-month follow-up period after completion of allocated treatment
Determined from the UTI history diary and cross-referenced with hospital and GP records
Measured: 6 months
Secondary outcomes (17)
UTI history diary
Participants will be given a UTI history diary to complete which will documents all symptomatic and treated UTI, the diary will be cross-referenced with participant history and review of medical history at each follow-up appointment.
Measured: 18 months
Vaginal Health Index Score (VHIS)
- It incorporates a clinical examination of the vagina for pH, elasticity, fluid volume, epithelial integrity, moisture. Vaginal pH will be obtained using a piece of litmus paper placed on the lateral wall of the vagina.
Measured: 18 months
King's Health Questionnaire (KHQ)
21 items about urinary tract symptoms yield scores in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy \& severity of symptoms).
Measured: 18 months
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
A 12 item questionnaire for evaluating female lower urinary tract symptoms
Measured: 18 months
International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
A 14 item questionnaire for evaluating vaginal symptoms, associated sexual matters and impact on quality of life (QoL)
Measured: 18 months
10 cm Visual Analogue Scale for Symptoms (VAS)
Consists of a 10cm line, used to determine intensity of symptoms with two endpoints representing 0 ("no symptoms" and 10 ("symptom at the worse it could be"). Symptoms assessed: vaginal dryness, dyspareunia, itching, burning, dysuria, frequency, urgency, overall symptoms
Measured: 18 months
Urinary Tract Infection Symptom Assessment Questionnaire (UTISA)
14-item questionnaire asking about the severity and bothersome of seven key UTI symptoms.
Measured: 18 months
Female Sexual Function Index Scoring (FSFI)
A 19 item questionnaire designed to measure sexual functioning in women.
Measured: 18 months
Health Service Utilisation Questionnaire (HSU-Q)
An instrument for the standardized and systematic assessment of various aspects of health care utilisation
Measured: 18 months
Treatment satisfaction questionnaire for laser (TSQ-L)
A modified 10-item questionnaire used to determine participant satisfaction with treatment
Measured: 18 months
Vulvoscopic Genital Tissue Appearance Scale (VGTA)
assesses 10 parameters of the appearance of the genital tissue including loss of labia minora/majora, decreased glans clitoris, stenosis of introitus, prominence of the urethral meatus, vestibular pallor, vestibular pallor, vesicular erythema, loss of vaginal rugae, loss of vestibular moisture and loss of prominence of the anterior vaginal wall. A score of 0 to 30 is obtained, the higher the score the worse the vulvoscopic genital tissue appearance
Measured: 18 months
Adverse event recording
Adverse events will be asked at each visit and participant will have contact details to reports any throughout the study period
Measured: 18 months
Dipstick urine analysis
Reagent strips used to detect substances in urine including nitrate, leucocytes, glucose, protein, pH, ketones and blood
Measured: 18 months
Standard urine culture
Routine urinalysis that identify bacteria or yeast causing a urinary tract infection
Measured: 18 months
Expanded Quantitative Urine Culture (EQUC)
- EQUC uses larger urine volume, longer incubation times, multiple growth media and atmospheric conditions and enables species-level identification
Measured: 18 months
16S rRNA rapid Next-generation Gene Sequencing
16S rRNA NGS provide gene-level information for species. It utilises PCR amplification and NGS of essential 16S ribosomal RNA genes. It enables the evaluation of even closely related bacterial species through evolutionary polymorphisms
Measured: 18 months
Shotgun metagenomic sequencing
allows the identification and profiling of microbial species independent of reference sequences.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Oct 2023
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monalisa Touch (SmartXide2 V2LR, DEKA, Florence, Italy)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124820
- Sponsor's protocol ID
- 302037
- Acronym
- UTIEXTERMINATE
- Status last verified
- Mar 2025
- First submitted
- 6 Sep 2022
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be available at request
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06124820
- Acronym / sponsor ID
- UTIEXTERMINATE / 302037
- Keywords
- UTI, Recurrent Urinary Tract Infection, Genitourinary Syndrome of Menopause, Laser, CO2 Laser, Microbiome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monalisa Touch (SmartXide2 V2LR, DEKA, Florence, Italy)
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Deka SmartXide Touch C60 (MonaLisa Touch)Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch) will be administered intravaginally over a course of 5 cycles |
| Control Arm | Sham comparator | Device: ShamSham treatment -Participants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women
- History of recurrent UTI (Defined as women who have suffered at least three episodes of symptomatic UTI within the preceding 12 months or two episodes in the last six months, or at least one episode of UTI requiring hospitalisation, or if previously prescribed prophylactic antibiotics for UTI, have completed a 3-month washout period without antibiotic prophylaxis)
- Able to give informed consent for participation in the trial
- Able and willing to adhere to a 17-month study period
Key exclusion criteria (12 listed)
- Not willing to abstain from vaginal intercourse for 48 hours following laser-therapy
- Use of vaginal hormonal therapy in the three months before study start
- History of a genital fistula, a thin recto-vaginal septum as determined by the investigator or history of a fourth-degree laceration during physical screening exam (e.g., deficient perineal body)
- Active sexually transmitted disease upon vaginal exam (as determined by the investigator) that precludes treatment or any other vaginal infection
- History of lichen sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deka SmartXide Touch C60 (MonaLisa Touch)Intravaginal micro-ablative fractional CO2 laser technology Deka SmartXide Touch C60 (MonaLisa Touch) | Device | Treatment Arm |
| ShamParticipants receiving sham treatment will have the probes advanced in the same manner without the use of a laser energy device. | Device | Control Arm |
Primary outcome
To determine and compare the incidence of symptomatic antibiotic-treated UTI during the 6-month follow-up period after completion of allocated treatment
Time frame: 6 months
Determined from the UTI history diary and cross-referenced with hospital and GP records
17 secondary outcomes
UTI history diary
Time frame: 18 months
Vaginal Health Index Score (VHIS)
Time frame: 18 months
King's Health Questionnaire (KHQ)
Time frame: 18 months
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
Time frame: 18 months
International Consultation on Incontinence Questionnaire - Vaginal Symptoms (ICIQ-VS)
Time frame: 18 months
10 cm Visual Analogue Scale for Symptoms (VAS)
Time frame: 18 months
Urinary Tract Infection Symptom Assessment Questionnaire (UTISA)
Time frame: 18 months
Female Sexual Function Index Scoring (FSFI)
Time frame: 18 months
Health Service Utilisation Questionnaire (HSU-Q)
Time frame: 18 months
Treatment satisfaction questionnaire for laser (TSQ-L)
Time frame: 18 months
Vulvoscopic Genital Tissue Appearance Scale (VGTA)
Time frame: 18 months
Adverse event recording
Time frame: 18 months
Dipstick urine analysis
Time frame: 18 months
Standard urine culture
Time frame: 18 months
Expanded Quantitative Urine Culture (EQUC)
Time frame: 18 months
16S rRNA rapid Next-generation Gene Sequencing
Time frame: 18 months
Shotgun metagenomic sequencing
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: Undecided. Will be available at request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deka SmartXide Touch C60 (MonaLisa Touch) in people with Recurrent Urinary Tract Infection and Genitourinary Syndrome of Menopause, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine and compare the incidence of symptomatic antibiotic-treated UTI during the 6-month follow-up period after completion of allocated treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.