Vaginal AtrophyNCT04492176
A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair
A study testing CO2 fractional laser（ACUPULSE,Lumenis） in people with Vaginal Atrophy, run by Xijing Hospital at 1 site in China.
Trial summary
1. Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Atrophy
- What is being tested?
- CO2 fractional laser（ACUPULSE,Lumenis）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Oct 2020
- 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 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married women aged 25-75 with improvement needs;
- Agree to participate in the experiment and sign the informed consent.
- Female sexual dysfunction patients;
- No other external treatment was performed before treatment at the lesion site.
- VTI instrument was used for intravaginal pressure test to assess urinary incontinence and vaginal senility caused by chronic muscle dysfunction
Who cannot join
- Pregnant or lactating women;
- suffering from severe mental disorders, psychological disorders, personality disorders and major organ dysfunction;
- Patients with severe hematological diseases, Sjogren's syndrome, systemic and therapeutic site infections;
- Patients who took high doses of anticoagulants or hormones within one month;
- Laser allergy history, photosensitive reactor;
- Women with acute vaginitis or cervicitis;
Show all 11Show fewer
- Pap smear positive patients;
- Female HIV (HIV), HPV (papillary virus), HSV (herpes simplex virus) positive patients;
- Use of antifungal drugs, vaginal administration, vaginal irrigation and female sprays in the past 30 days
- The condition of the visual field of laser surgery affected by ulceration and infection of the skin lesion
- Those who have undergone vaginal tightening surgery with other substances or means
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair: A Non-randomized, Open, Inter-group and Self-controlled Trial Before and After Treatment
- Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. Laser therapy with small trauma and short repair time has attracted much attention.
- CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.
- It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells.
Read the detailed description
- Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. It should be noted that patients with vaginal constriction need anti-scar training for a long time after operation to prevent the effect of vaginal entrance narrowing and vaginal wall scar formation on the quality of life of patients during the repair period. Therefore, laser therapy with small trauma and short repair time has attracted much attention.
- CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal Internal environment and bacterial flora, and then reduce the probability of gynecological infection.
- It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells. Our center has also passed the clinical observation ethical review of CO2 lattice laser to improve female vaginal relaxation in 2016, and completed the clinical trial at the end of 2017. The data further confirm that CO2 lattice laser can improve vaginal relaxation and is significantly effective for stress urinary incontinence.
- Conditions
- Vaginal Atrophy
- Being tested
- CO2 fractional laser（ACUPULSE,Lumenis）
- Keywords
- Vaginal atrophy, Vaginal relaxation, stress urinary incontinence, CO2 fractional laser
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 fractional laser（ACUPULSE,Lumenis）Device
gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times
| Study group | Role | What they receive |
|---|---|---|
| CO2 fractional laser（ACUPULSE,Lumenis） | Experimental | gradually withdrawn from inside to outside of vaginal. with CO2 fractional laser therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%，ACUPULSE,Lumenis) ,once a month for a total of 3 times .CO2 fractional laser stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection. Receives: Device: CO2 fractional laser（ACUPULSE,Lumenis） |
| before treatment | No intervention | the patient did not receive laser treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
female sexual function FSFI score（Female Sexual Function Index ）
Questionnaire content involving sexual activity, intercourse, sexual stimulation, sexual desire or sexual interest, sexual excitement or sexual arousal, evaluation of female sexual function, questionnaire score ≤ 26.55 is considered female sexual dysfunction
Measured: Changes from preoperative to 1 year after initial treatment
urinary incontinence questionnaire short form assessment
Evaluate urinary incontinence questionnaire short form assessment
Measured: Changes from preoperative to 1 year after initial treatment
VHIS score in vaginal environment
Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness
Measured: Changes from preoperative to 1 year after initial treatment
vaginal pressure VTI data detection
Evaluate vaginal pressure by VTI data detection
Measured: Changes from preoperative to 1 year after initial treatment
pelvic floor magnetic resonance MRI plain
Measure tissue structures in the pelvis
Measured: Changes from preoperative to 1 year after initial treatment
scantransvaginal ultrasound
Measure the structures of the vagina
Measured: Changes from preoperative to 1 year after initial treatment
histopathological biopsy
5 cases were randomly selected for histopathological biopsy
Measured: Changes before and 1month after treatment
Secondary outcomes (2)
patient satisfaction assessment
Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied
Measured: Changes from preoperative to 1 year after initial treatment
VAS Pain Assessment(Immediately after Treatment)
VAS pain scoring criteria (0-10 points): 0 points: no pain; less than 3 points: mild pain, can tolerate; 4 points 1-6 points: patients with pain and affect sleep, can still tolerate; 7 points-10 points : The patient has increasing pain, and the pain is intolerable
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Aug 2019
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, MD, Xijing Hospital
- Investigators
- Gang Wang, Principal investigator, Dermatology Derpartment of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492176
- Sponsor's protocol ID
- XijingH-PF-20190718
- Status last verified
- Apr 2021
- First submitted
- 4 Aug 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair: A Non-randomized, Open, Inter-group and Self-controlled Trial Before and After Treatment
- ClinicalTrials.gov ID
- NCT04492176
- Acronym / sponsor ID
- XijingH-PF-20190718
- Conditions
- Vaginal Atrophy
- Keywords
- Vaginal atrophy, Vaginal relaxation, stress urinary incontinence, CO2 fractional laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 30 Jul 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.
- Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. Laser therapy with small trauma and short repair time has attracted much attention.
- CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection.
- It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells.
Detailed description
- Vaginal atrophy is the most common indication in the treatment of vaginal rejuvenation. Its main manifestation is vaginal relaxation syndrome, which may be the early symptom of female pelvic floor dysfunction. It is a common gynecological physiological change in women. Its clinical manifestations include vaginal wall relaxation, decreased elasticity, poor dryness sensitivity, internal environment disorder, and so on. Vaginal exhaust, often combined with urinary incontinence, pelvic organ prolapse, chronic pelvic discomfort and other symptoms, seriously affecting patients'health and quality of sexual life. At present, there are many treatments for vaginal relaxation,vaginal constriction and laser therapy are the most effective and widely accepted treatments. It should be noted that patients with vaginal constriction need anti-scar training for a long time after operation to prevent the effect of vaginal entrance narrowing and vaginal wall scar formation on the quality of life of patients during the repair period. Therefore, laser therapy with small trauma and short repair time has attracted much attention.
- CO2 fractional laser (Acupulse) stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal Internal environment and bacterial flora, and then reduce the probability of gynecological infection.
- It has been reported that CO2 lattice laser can stimulate collagen synthesis and rearrangement. It has also been reported that CO2 lattice laser may have important clinical significance in improving the morphology and function of vaginal epithelial cells. Our center has also passed the clinical observation ethical review of CO2 lattice laser to improve female vaginal relaxation in 2016, and completed the clinical trial at the end of 2017. The data further confirm that CO2 lattice laser can improve vaginal relaxation and is significantly effective for stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 fractional laser（ACUPULSE,Lumenis） | Experimental | Device: CO2 fractional laser（ACUPULSE,Lumenis）gradually withdrawn from inside to outside of vaginal. with CO2 fractional laser therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%，ACUPULSE,Lumenis) ,once a month for a total of 3 times .CO2 fractional laser stimulates fibroblasts to synthesize and secrete collagen fibers, elastic fibers, reticular fibers and organic matrix through dot exfoliation and thermal stimulation, thus thickening the vaginal wall and achieving long-term vaginal tightening effect. The heat effect of CO2 laser can stimulate vasodilation, increase blood flow, increase cell oxidation and nutrients, increase mitochondrial ATP release, activate cell function, enhance vaginal mucosal secretion, enhance secretion, normalize vaginal PH and bacterial flora, and then reduce the probability of gynecological infection. |
| before treatment | No intervention | –the patient did not receive laser treatment |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Married women aged 25-75 with improvement needs;
- Agree to participate in the experiment and sign the informed consent.
- Female sexual dysfunction patients;
- No other external treatment was performed before treatment at the lesion site.
- VTI instrument was used for intravaginal pressure test to assess urinary incontinence and vaginal senility caused by chronic muscle dysfunction
Key exclusion criteria (11 listed)
- Pregnant or lactating women;
- suffering from severe mental disorders, psychological disorders, personality disorders and major organ dysfunction;
- Patients with severe hematological diseases, Sjogren's syndrome, systemic and therapeutic site infections;
- Patients who took high doses of anticoagulants or hormones within one month;
- Laser allergy history, photosensitive reactor;
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 fractional laser（ACUPULSE,Lumenis）gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times | Device | CO2 fractional laser（ACUPULSE,Lumenis） |
Primary outcome
female sexual function FSFI score（Female Sexual Function Index ）
Time frame: Changes from preoperative to 1 year after initial treatment
Questionnaire content involving sexual activity, intercourse, sexual stimulation, sexual desire or sexual interest, sexual excitement or sexual arousal, evaluation of female sexual function, questionnaire score ≤ 26.55 is considered female sexual dysfunction
urinary incontinence questionnaire short form assessment
Time frame: Changes from preoperative to 1 year after initial treatment
Evaluate urinary incontinence questionnaire short form assessment
VHIS score in vaginal environment
Time frame: Changes from preoperative to 1 year after initial treatment
Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness
vaginal pressure VTI data detection
Time frame: Changes from preoperative to 1 year after initial treatment
Evaluate vaginal pressure by VTI data detection
pelvic floor magnetic resonance MRI plain
Time frame: Changes from preoperative to 1 year after initial treatment
Measure tissue structures in the pelvis
scantransvaginal ultrasound
Time frame: Changes from preoperative to 1 year after initial treatment
Measure the structures of the vagina
histopathological biopsy
Time frame: Changes before and 1month after treatment
5 cases were randomly selected for histopathological biopsy
2 secondary outcomes
patient satisfaction assessment
Time frame: Changes from preoperative to 1 year after initial treatment
VAS Pain Assessment(Immediately after Treatment)
Time frame: 3 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 3 May 2021.
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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.
Gang Wang principal investigator
Dermatology Derpartment of Xijing Hospital
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 fractional laser（ACUPULSE,Lumenis） in people with Vaginal Atrophy, run by Xijing Hospital at 1 site in China.
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 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 3 May 2021. 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 China. 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?
female sexual function FSFI score（Female Sexual Function Index ） (time frame: Changes from preoperative to 1 year after initial treatment). The study lists 7 primary outcomes in all. 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 3 May 2021.