Urinary Tract InfectionsNCT04301934
Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
A study testing Mona Lisa Touch, Conjugated estrogen and Estradiol in people with Urinary Tract Infections, run by Mayo Clinic at 1 site in United States.
Trial summary
Randomized controlled trial to determine clinical and microbiome difference between fractional CO2 Laser and vaginal estrogen in treating patients with recurrent urinary tract infection (UTI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Mona Lisa Touch, Conjugated estrogen and Estradiol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient >18 years old
- Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses >12 months
- Recurrent urinary tract infections as defined by 3 culture positive urine cultures in the last 12 months, or 2 positive urine cultures in the last 6 months.(Positive urine cultures defined by >100K colony forming units of 1 or 2 bacterial species on clean catch sample, or >1000 colony forming units of 1 or 2 bacterial species on sample via straight catheterization).
- Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.
Who cannot join
- Hematuria without appropriate workup
- Pelvic organ prolapse at or beyond the hymen
- Clinically relevant urinary retention
- Pelvic reconstructive surgery within 6 months
- Prior synthetic mesh procedure for pelvic organ prolapse or urinary incontinence
- Clinically relevant nephrolithiasis
Show all 12Show fewer
- History of breast cancer
- Contraindication to topical estrogen therapy
- Anticoagulation therapy
- Prior pelvic or vaginal radiation therapy
- Prior gynecologic malignancy
- Undiagnosed genital bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial to determine clinical and microbiome difference between fractional CO2 Laser and vaginal estrogen in treating patients with recurrent urinary tract infection (UTI).
Read the detailed description
Recurrent urinary tract infection (rUTI) is common in postmenopausal women and can lead to significant bothersome symptoms. This clinical scenario is a difficult and common clinical problem seen by the urologist and urogynecologist with limited options for treatment. Overuse of antibiotics has led to significant resistant microorganisms and can have adverse side effects such as C. Dificile colitis. Current treatments include topical vaginal estrogen and prophylactic antibiotics. Other supplements such as cranberry pills, methenamine and D-mannose have varying levels of evidence and efficacy.
Fractional CO2 LASER vaginal therapy has recently been studied for the treatment of GSM. LASER therapy is currently commercially available and has FDA clearance for use in gynecology. Current evidence shows that with treatment, histologic changes of the vaginal epithelium have shown regeneration to a premenopausal state, along with subjective improvement in GSM symptoms and sexual function. Recent literature has shown improvements in thickening of vaginal epithelium, decreased vaginal pH and improvement in the vaginal microbiome. Based on this, the investigators propose fractional CO2 laser may have a positive impact on women with rUTI.
- The investigators therefore hypothesize that fractional CO2 LASER vaginal therapy is non-inferior to topical vaginal estrogen therapy for the treatment of rUTI.
- Primary Outcome: Improvement in recurrence of culture positive UTI
- The investigators also hypothesize that LASER therapy will improve the urinary and vaginal microbiome, decreasing the uropathogenic presence and increasing Lactobacillus.
- Measurement 1: The number of UTI with UPEC isolated from patients
- Measurement 2: The pH of the vagina as a proxy for presence of Lactobacillus sp.
- Measurement 3: Categorize vaginal and urinary microbial communities
- The investigators hypothesize that LASER therapy will improve symptoms of GSM and be associated with regenerative change in vaginal histology.
- Measurement 1: MESA and DIVA surveys of symptoms
- Measurement 2: Observations of vaginal biopsy between.
Menopausal women will be recruited if subjects have recurrent UTI defined as 3 culture positive UTIs in 1 year or 2 culture positive UTIs in 6 months. Subjects will be randomized to standard of care with topical vaginal estrogen or 3 treatments of fractional CO2 LASER of the vagina. Samples will be collected to show microbiome and histologic changes with treatment.
Samples include:
Vaginal culture Urine culture vaginal biopsy (optional).
Validated questionnaires and clinical recurrence of UTI will also be gathered over 6 months.
- Conditions
- Urinary Tract Infections
- Being tested
- Mona Lisa Touch, Conjugated estrogen, Estradiol
- 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.
Mona Lisa TouchDevice
Fractional CO2 LASER
Conjugated estrogenDrug
Also called Premarin
Current standard treatment for recurrent UTIs in postmenopausal women
EstradiolDrug
Also called Estrace
Current standard treatment for recurrent UTIs in postmenopausal women
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Estrogen Therapy Group | Active comparator | Women randomized to vaginal estrogen therapy will be offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly Receives: Drug: Conjugated estrogen; Drug: Estradiol |
| Laser Therapy Group | Experimental | Women randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart. Receives: Device: Mona Lisa Touch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Urinary Tract Infections (UTI)
Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Jun 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Yi, Mayo Clinic
- Investigators
- Johnny Yi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301934
- Sponsor's protocol ID
- 18-002297
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2020
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Vaginal LASER Therapy for Recurrent Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT04301934
- Acronym / sponsor ID
- 18-002297
- Conditions
- Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial to determine clinical and microbiome difference between fractional CO2 Laser and vaginal estrogen in treating patients with recurrent urinary tract infection (UTI).
Detailed description
Recurrent urinary tract infection (rUTI) is common in postmenopausal women and can lead to significant bothersome symptoms. This clinical scenario is a difficult and common clinical problem seen by the urologist and urogynecologist with limited options for treatment. Overuse of antibiotics has led to significant resistant microorganisms and can have adverse side effects such as C. Dificile colitis. Current treatments include topical vaginal estrogen and prophylactic antibiotics. Other supplements such as cranberry pills, methenamine and D-mannose have varying levels of evidence and efficacy.
Fractional CO2 LASER vaginal therapy has recently been studied for the treatment of GSM. LASER therapy is currently commercially available and has FDA clearance for use in gynecology. Current evidence shows that with treatment, histologic changes of the vaginal epithelium have shown regeneration to a premenopausal state, along with subjective improvement in GSM symptoms and sexual function. Recent literature has shown improvements in thickening of vaginal epithelium, decreased vaginal pH and improvement in the vaginal microbiome. Based on this, the investigators propose fractional CO2 laser may have a positive impact on women with rUTI.
- The investigators therefore hypothesize that fractional CO2 LASER vaginal therapy is non-inferior to topical vaginal estrogen therapy for the treatment of rUTI.
- Primary Outcome: Improvement in recurrence of culture positive UTI
- The investigators also hypothesize that LASER therapy will improve the urinary and vaginal microbiome, decreasing the uropathogenic presence and increasing Lactobacillus.
- Measurement 1: The number of UTI with UPEC isolated from patients
- Measurement 2: The pH of the vagina as a proxy for presence of Lactobacillus sp.
- Measurement 3: Categorize vaginal and urinary microbial communities
- The investigators hypothesize that LASER therapy will improve symptoms of GSM and be associated with regenerative change in vaginal histology.
- Measurement 1: MESA and DIVA surveys of symptoms
- Measurement 2: Observations of vaginal biopsy between.
Menopausal women will be recruited if subjects have recurrent UTI defined as 3 culture positive UTIs in 1 year or 2 culture positive UTIs in 6 months. Subjects will be randomized to standard of care with topical vaginal estrogen or 3 treatments of fractional CO2 LASER of the vagina. Samples will be collected to show microbiome and histologic changes with treatment.
Samples include:
Vaginal culture Urine culture vaginal biopsy (optional).
Validated questionnaires and clinical recurrence of UTI will also be gathered over 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Estrogen Therapy Group | Active comparator | Drug: Conjugated estrogen, Drug: EstradiolWomen randomized to vaginal estrogen therapy will be offered vaginal cream conjugated estrogen (Premarin) 0.5 gm per vaginal twice weekly or estradiol (Estrace): 1gm per vaginal twice weekly |
| Laser Therapy Group | Experimental | Device: Mona Lisa TouchWomen randomized to the laser therapy group will undergo 3 treatments, 6 weeks apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patient >18 years old
- Postmenopausal status, documented by prior bilateral salpingo-oophorectomy, or absence of menses >12 months
- Recurrent urinary tract infections as defined by 3 culture positive urine cultures in the last 12 months, or 2 positive urine cultures in the last 6 months.(Positive urine cultures defined by >100K colony forming units of 1 or 2 bacterial species on clean catch sample, or >1000 colony forming units of 1 or 2 bacterial species on sample via straight catheterization).
- Patients on vaginal estrogen must undergo a 1 month washout period prior to initiation of the trial.
Key exclusion criteria (12 listed)
- Hematuria without appropriate workup
- Pelvic organ prolapse at or beyond the hymen
- Clinically relevant urinary retention
- Pelvic reconstructive surgery within 6 months
- Prior synthetic mesh procedure for pelvic organ prolapse or urinary incontinence
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 |
|---|---|---|
| Mona Lisa TouchFractional CO2 LASER | Device | Laser Therapy Group |
| Conjugated estrogenAlso: PremarinCurrent standard treatment for recurrent UTIs in postmenopausal women | Drug | Vaginal Estrogen Therapy Group |
| EstradiolAlso: EstraceCurrent standard treatment for recurrent UTIs in postmenopausal women | Drug | Vaginal Estrogen Therapy Group |
Primary outcome
Prevalence of Urinary Tract Infections (UTI)
Time frame: 4 months
Prevalence of urinary tract infections (UTI) described as percentage of subjects with none vs one or more UTI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Johnny Yi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mona Lisa Touch, Conjugated estrogen and Estradiol in people with Urinary Tract Infections, run by Mayo Clinic at 1 site in United States.
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: finished, as of the sponsor's last update on 26 Mar 2024. 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 States. 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. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Urinary Tract Infections (UTI) (time frame: 4 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 26 Mar 2024.