Vaginal LaxityROSENCT04227392
Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
A study testing vaginal radiofrequency in people with Vaginal Laxity, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Laxity
- What is being tested?
- vaginal radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2018to 31 May 2019
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vaginal laxity score >= 3
- negative pregnancy test within 2 months
Who cannot join
- genital anomaly
- pelvic prolapse stage >= stage 3
- active genital infection
- vulvar pain or deformity
- disease related to sexual behavior
- current, chronic NSAIDs intake
Show all 11Show fewer
- fever
- any acute illness
- cognitive disorder
- pacemaker insertion
- metal implants
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyenggi DO, 463707
About this study
To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.
- Conditions
- Vaginal Laxity
- Being tested
- vaginal radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal radiofrequencyDevice
2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | women who undergo radiofrequency therapy Receives: Device: vaginal radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of vaginal laxity score from baseline
subjective vaginal laxity
Measured: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
Secondary outcomes (3)
change of FSFI score from baseline
female sexual function index, higher is better
Measured: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
change of FSDS score from baseline
female sexual distress scale, lower is better
Measured: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
change of vaginal pressure from baseline
vaginal pressure measured with manometer
Measured: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jul 2018
- Primary completion15 Jan 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal LaxityStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227392
- Sponsor's protocol ID
- E-1801-444-001
- Acronym
- ROSE
- Status last verified
- Dec 2019
- First submitted
- 1 Jan 2020
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vaginal Radiofrequency Therapy on Vaginal Laxity : Pilot Trial
- ClinicalTrials.gov ID
- NCT04227392
- Acronym / sponsor ID
- ROSE / E-1801-444-001
- Conditions
- Vaginal Laxity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 13 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.
To examine the efficacy and safety of radiofrequency therapy on vaginal laxity, The investigators enrolled 30 women with vaginal laxity. Radiofrequency therapy was consisted of 2 sessions with 3 week interval. A session included 20 minutes radiofrequency therapy on vaginal mucosa. Vaginal laxity score, female sexual function index (FSFI), female sexual distress scale (FSDS), vaginal pressure, adverse events were examined. Follow up period is 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: vaginal radiofrequencywomen who undergo radiofrequency therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- vaginal laxity score >= 3
- negative pregnancy test within 2 months
Key exclusion criteria (11 listed)
- genital anomaly
- pelvic prolapse stage >= stage 3
- active genital infection
- vulvar pain or deformity
- disease related to sexual behavior
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 |
|---|---|---|
| vaginal radiofrequency2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes. | Device | Experimental |
Primary outcome
change of vaginal laxity score from baseline
Time frame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
subjective vaginal laxity
3 secondary outcomes
change of FSFI score from baseline
Time frame: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
change of FSDS score from baseline
Time frame: baseline - 1 month from 2nd therapy session - 3 month from 2nd therapy session
change of vaginal pressure from baseline
Time frame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session
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 13 Jan 2020.
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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 vaginal radiofrequency in people with Vaginal Laxity, run by Seoul National University Hospital at 1 site in South Korea.
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 11 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 13 Jan 2020. 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 South Korea. 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?
change of vaginal laxity score from baseline (time frame: baseline - at 2nd therapy session (3week from baseline) - 1 month from 2nd therapy session - 3 month from 2nd therapy session). 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 13 Jan 2020.