Genitourinary Syndrome of MenopauseNCT06142695
Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
An observational study of Genitourinary Syndrome of Menopause, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular to assess the ultrasound measurement of… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jan 2021to 9 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Menopausal patients that attended our clinic of menopausal disorders and performed Carbon Dioxide Laser therapy for genitourinary syndrome. In order to enroll patients with Genitourinary Syndrome of Menopause, the investigator used the Vaginal Health Index (VHI), Vulvar Health Index (VuHI), and Stress Urinary Incontinence (SUI) scales. * The VHI score assesses vaginal health, with a cutoff of <15 on the index to diagnose patients with atrophy [ranging from "complete atrophy" (0) to "optimal vaginal health" (25)]. * The VuHI score assesses vulvar health, on a scale from normal (0) to severe (3). The overall score ranges from 0 to 24, and its cutoff for diagnosing atrophic vulva is >8 on the index. * Stress Urinary Incontinence (SUI) is characterized by sudden urine loss. Evaluated using the Stamey score, with ratings of no incontinence (0) to severe incontinence (3).
Who may be able to join
- Age <75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months)
- Negative Papanicolaou test (PAP) performed within 12 months before enrolment. and one of the following:
- Presence of vulvovaginal atrophy [vaginal health index (VHI) < 15]
- Initial Urinary Incontinence based on patient history = 1 (according to the "Stamey incontinence score of Stress Urinary Incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence)
- Standardized stress provocation test
Who cannot join
- Age >45 years
- The presence of vaginal lesions (active or in the previous 30 days).
- genitourinary tract infection.
- abnormal uterine bleeding.
- use of hormone replacement therapy up to 6 months before enrolment.
- history of photosensitivity disorder or use of photosensitizing drugs.
- genitals prolapse (grade II - III according to the Pelvic Organ Prolapse Quantification)
- a serious or chronic condition that could interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a new objective tool of assessment.
- Conditions
- Genitourinary Syndrome of Menopause
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the effectiveness of Carbon Dioxide Laser in patients with genitourinary syndrome of menopause in terms of the improvement in a specific vaginal ultrasonographic parameters
To evaluate the primary outcome, we examined the following vaginal ultrasonographic parameters (by transvaginal probe), both before and after 3 vaginal Carbon Dioxide Laser applications:
- Thickness of the anterior vaginal walls (VWT) at the level of the introitus of the inferior vaginal third (expressed in millimeters);
- Thickness of the posterior VWT at the level of the introitus of the inferior vaginal third (expressed in millimeters).
Positive outcomes are evidenced if thickness (expressed in millimeters) is increased after treatment in both anterior and posterior vaginal walls.
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 posted21 Nov 2023
- Study start11 Jan 2021
- Primary completion12 Dec 2021
- Study completion9 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VILLA PAOLA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142695
- Sponsor's protocol ID
- 4689
- Status last verified
- Nov 2023
- First submitted
- 18 Jul 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Evaluation of Carbon Dioxide Laser Effects on Patients With Genitourinary Syndrome
- ClinicalTrials.gov ID
- NCT06142695
- Acronym / sponsor ID
- 4689
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 9 Jan 2022 (actual)
- First posted
- 21 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.
The aim of the study was to evaluate the efficacy of vaginal Carbon Dioxide Laser treatment in patients with Genitourinary Syndrome of Menopause on the improvement of Vulvovaginal Atrophy (VVA) and stress urinary incontinence (SUI) by objective parameters and in particular to assess the ultrasound measurement of specific vaginal parameters in order to evaluate a new objective tool of assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Menopausal patients that attended our clinic of menopausal disorders and performed Carbon Dioxide Laser therapy for genitourinary syndrome. In order to enroll patients with Genitourinary Syndrome of Menopause, the investigator used the Vaginal Health Index (VHI), Vulvar Health Index (VuHI), and Stress Urinary Incontinence (SUI) scales. * The VHI score assesses vaginal health, with a cutoff of <15 on the index to diagnose patients with atrophy [ranging from "complete atrophy" (0) to "optimal vaginal health" (25)]. * The VuHI score assesses vulvar health, on a scale from normal (0) to severe (3). The overall score ranges from 0 to 24, and its cutoff for diagnosing atrophic vulva is >8 on the index. * Stress Urinary Incontinence (SUI) is characterized by sudden urine loss. Evaluated using the Stamey score, with ratings of no incontinence (0) to severe incontinence (3).
Key inclusion criteria (5 listed)
- Age <75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months)
- Negative Papanicolaou test (PAP) performed within 12 months before enrolment. and one of the following:
- Presence of vulvovaginal atrophy [vaginal health index (VHI) < 15]
- Initial Urinary Incontinence based on patient history = 1 (according to the "Stamey incontinence score of Stress Urinary Incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence)
- Standardized stress provocation test
Key exclusion criteria (8 listed)
- Age >45 years
- The presence of vaginal lesions (active or in the previous 30 days).
- genitourinary tract infection.
- abnormal uterine bleeding.
- use of hormone replacement therapy up to 6 months before enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluating the effectiveness of Carbon Dioxide Laser in patients with genitourinary syndrome of menopause in terms of the improvement in a specific vaginal ultrasonographic parameters
Time frame: 4 months
To evaluate the primary outcome, we examined the following vaginal ultrasonographic parameters (by transvaginal probe), both before and after 3 vaginal Carbon Dioxide Laser applications: * Thickness of the anterior vaginal walls (VWT) at the level of the introitus of the inferior vaginal third (expressed in millimeters); * Thickness of the posterior VWT at the level of the introitus of the inferior vaginal third (expressed in millimeters). Positive outcomes are evidenced if thickness (expressed in millimeters) is increased after treatment in both anterior and posterior vaginal walls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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?
An observational study of Genitourinary Syndrome of Menopause, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 inclusion and 8 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 21 Nov 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluating the effectiveness of Carbon Dioxide Laser in patients with genitourinary syndrome of menopause in terms of the improvement in a specific vaginal ultrasonographic parameters (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 21 Nov 2023.