Sexual DysfunctionNCT04228679
Erbium Laser for Treatment of Vaginal Looseness and Sexual Dysfunction.
A study testing Erbium laser in people with Sexual Dysfunction, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Erbium laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2020to 31 Mar 2022
- 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 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women.
- Women with vaginal looseness and sexual dysfunction as a primary complaint.
Who cannot join
- Vaginal bleeding of unknown source.
- Repeated vaginal infections.
- Known or suspected cervical pre-malignant neoplasia.
- Previous treatment with vaginal laser or other forms of energy-based treatment modalities.
- Pregnancy.
- Current pelvic inflammatory disease or urinary tract infection.
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- Vaginal surgery during the year preceding study participation.
- Treatment with systemic or vaginal hormone replacement therapy.
- Current pelvic floor physiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Affect of Erbium Laser Treatments on Vaginal Looseness and Sexual Dysfunction in Pre-menopausal Female Individuals.
Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Read the detailed description
Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.
Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Follow up after treatment cessation will be for 12 months post-treatment.
- Conditions
- Sexual Dysfunction
- Being tested
- Erbium laser, Sham Laser
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erbium laserDevice
Erbium laser device
Sham LaserDevice
Sham laser device
| Study group | Role | What they receive |
|---|---|---|
| Erbium laser treatment | Experimental | Women with vaginal looseness and sexual dysfunction treated with real laser. Receives: Device: Erbium laser |
| Sham laser treatment | Sham comparator | Women with vaginal looseness and sexual dysfunction treated with sham laser. Receives: Device: Sham Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female sexual function index.
Female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.
Measured: From recruitment up to 15 months.
Secondary outcomes (4)
Vaginal health index
Vaginal health index score. The total VHI scores range between 5 and 25. A higher score indicates increased vaginal health.
Measured: From recruitment up to 15 months.
Pelvic floor disability index.
Changes in the pelvic floor disability index scores pre- and post-treatment. Minimal score is 0, maximal score is 300. The higher the score, the improved the worse pelvic floor dysfunction is.
Measured: From recruitment up to 15 months.
Vaginal laxity questionnaire.
Changes in the vaginal laxity questionnaire scores pre- and post-treatment. Minimal score is 1, maximal score is 7. The lower the score, the worse vaginal laxity is.
Measured: From recruitment up to 15 months.
Monthly sexual intercourse rate
Average monthly sexual intercourse rates.
Measured: From recruitment up to 15 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Apr 2020
- Primary completion1 Jan 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies 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
- 106 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 healthcare campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228679
- Sponsor's protocol ID
- 0309-19-RMB
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2020
- Last updated
- 17 Jan 2023
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affect of Erbium Laser Treatments on Vaginal Looseness and Sexual Dysfunction in Pre-menopausal Female Individuals.
- ClinicalTrials.gov ID
- NCT04228679
- Acronym / sponsor ID
- 0309-19-RMB
- Conditions
- Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 14 Jan 2020 (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.
Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Detailed description
Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.
Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Follow up after treatment cessation will be for 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erbium laser treatment | Experimental | Device: Erbium laserWomen with vaginal looseness and sexual dysfunction treated with real laser. |
| Sham laser treatment | Sham comparator | Device: Sham LaserWomen with vaginal looseness and sexual dysfunction treated with sham laser. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Premenopausal women.
- Women with vaginal looseness and sexual dysfunction as a primary complaint.
Key exclusion criteria (9 listed)
- Vaginal bleeding of unknown source.
- Repeated vaginal infections.
- Known or suspected cervical pre-malignant neoplasia.
- Previous treatment with vaginal laser or other forms of energy-based treatment modalities.
- Pregnancy.
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 |
|---|---|---|
| Erbium laserErbium laser device | Device | Erbium laser treatment |
| Sham LaserSham laser device | Device | Sham laser treatment |
Primary outcome
Female sexual function index.
Time frame: From recruitment up to 15 months.
Female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is.
4 secondary outcomes
Vaginal health index
Time frame: From recruitment up to 15 months.
Pelvic floor disability index.
Time frame: From recruitment up to 15 months.
Vaginal laxity questionnaire.
Time frame: From recruitment up to 15 months.
Monthly sexual intercourse rate
Time frame: From recruitment up to 15 months.
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 17 Jan 2023.
- 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.
Roy Lauterbach, MD principal investigator
Rambam healthcare 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 Erbium laser in people with Sexual Dysfunction, 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 9 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 17 Jan 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 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?
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?
Female sexual function index. (time frame: From recruitment up to 15 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 17 Jan 2023.