Lax Vaginal IntroitusNCT04111952
The Effect of Additional Laser Treatments.
A study testing CO2 laser in people with Lax Vaginal Introitus, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Lax Vaginal Introitus
- What is being tested?
- CO2 laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jun 2019to 28 Jan 2023
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously treated with 3 laser treatments.
- Clear PAP test from the last 3 years.
Who cannot join
- Vaginal bleeding of unknown source.
- Vaginal surgery in the past 9 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.
Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.
Read the detailed description
The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.
- Conditions
- Lax Vaginal Introitus
- Being tested
- CO2 laser, Sham laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laserDevice
A single session of CO2 vaginal laser treatment
Sham laserDevice
A single session of sham laser treatment.
| Study group | Role | What they receive |
|---|---|---|
| Additional laser treatment | Experimental | Women receiving a single laser treatment. Receives: Device: CO2 laser |
| Sham laser treatment | Sham comparator | Women receiving sham laser treatment. Receives: Device: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of effect
The duration of symptom improvement.
Measured: From the treatment session up to 6 months post-treatment
Secondary outcomes (3)
Female sexual function index
Changes in the female sexual function index questionnaire score (range 0-35)
Measured: From the treatment session up to 6 months post-treatment
Sexual intercourse
Improvement in the monthly rate of sexual intercourse
Measured: From the treatment session up to 6 months post-treatment
Urinary distress index
Changes in the urinary distress index questionnaire score (range 0-15)
Measured: From the treatment session up to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jun 2019
- Primary completion1 Nov 2021
- Study completion28 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lax Vaginal IntroitusStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111952
- Sponsor's protocol ID
- 0349-19-RMB
- Status last verified
- Apr 2022
- First submitted
- 30 Sep 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of an Additional Vaginal Laser Treatment in Women Previously Treated With Laser for Gynecological Indications.
- ClinicalTrials.gov ID
- NCT04111952
- Acronym / sponsor ID
- 0349-19-RMB
- Conditions
- Lax Vaginal Introitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 28 Jan 2023 (estimated)
- First posted
- 2 Oct 2019 (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.
Women previously treated with vaginal CO2 laser will receive an additional treatment 6 months after cessation of previous laser treatment or a sham laser treatment. The efficacy and safety of the additional treatment will be assessed.
Detailed description
The following study is intended to evaluate the efficacy and safety of an additional laser treatment for women previously treated for gynecological indications with laser treatments. Women will be randomized to one of 2 groups: 1. Study group-additional single laser treatment. 2. Control group-single sham laser treatment. All women will fill out validated questionnaires regarding sexual function, urinary stress incontinence and satisfaction after treatment. All women will be followed for an additional 6 months to evaluate the length of effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Additional laser treatment | Experimental | Device: CO2 laserWomen receiving a single laser treatment. |
| Sham laser treatment | Sham comparator | Device: Sham laserWomen receiving sham laser treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previously treated with 3 laser treatments.
- Clear PAP test from the last 3 years.
Key exclusion criteria (2 listed)
- Vaginal bleeding of unknown source.
- Vaginal surgery in the past 9 months.
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 |
|---|---|---|
| CO2 laserA single session of CO2 vaginal laser treatment | Device | Additional laser treatment |
| Sham laserA single session of sham laser treatment. | Device | Sham laser treatment |
Primary outcome
Length of effect
Time frame: From the treatment session up to 6 months post-treatment
The duration of symptom improvement.
3 secondary outcomes
Female sexual function index
Time frame: From the treatment session up to 6 months post-treatment
Sexual intercourse
Time frame: From the treatment session up to 6 months post-treatment
Urinary distress index
Time frame: From the treatment session up to 6 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 laser in people with Lax Vaginal Introitus, run by Rambam Health Care Campus at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2022. 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 Israel. 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?
Results are not available in the source record.
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?
Length of effect (time frame: From the treatment session up to 6 months post-treatment). 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 20 Apr 2022.