- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04492176
A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair
April 27, 2021 updated by: Gang Wang, MD, Xijing Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Dermatology Derpartment of Xijing Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
|
No Intervention: before treatment
the patient did not receive laser treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Changes from preoperative to 1 year after initial treatment
|
urinary incontinence questionnaire short form assessment
Time Frame: Changes from preoperative to 1 year after initial treatment
|
Evaluate urinary incontinence questionnaire short form assessment
|
Changes from preoperative to 1 year after initial treatment
|
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
|
Changes from preoperative to 1 year after initial treatment
|
vaginal pressure VTI data detection
Time Frame: Changes from preoperative to 1 year after initial treatment
|
Evaluate vaginal pressure by VTI data detection
|
Changes from preoperative to 1 year after initial treatment
|
pelvic floor magnetic resonance MRI plain
Time Frame: Changes from preoperative to 1 year after initial treatment
|
Measure tissue structures in the pelvis
|
Changes from preoperative to 1 year after initial treatment
|
scantransvaginal ultrasound
Time Frame: Changes from preoperative to 1 year after initial treatment
|
Measure the structures of the vagina
|
Changes from preoperative to 1 year after initial treatment
|
histopathological biopsy
Time Frame: Changes before and 1month after treatment
|
5 cases were randomly selected for histopathological biopsy
|
Changes before and 1month after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient satisfaction assessment
Time Frame: Changes from preoperative to 1 year after initial treatment
|
Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied
|
Changes from preoperative to 1 year after initial treatment
|
VAS Pain Assessment(Immediately after Treatment)
Time Frame: 3 months
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
August 4, 2019
First Submitted That Met QC Criteria
July 26, 2020
First Posted (Actual)
July 30, 2020
Study Record Updates
Last Update Posted (Actual)
May 3, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XijingH-PF-20190718
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaginal Atrophy
-
Petra LarmoTurun Gynekologikeskus Oy; Tekes - The Finnish Funding Agency for Technology...CompletedVaginal Atrophy | Vaginal Dryness | Vulvar Atrophy | Vulvar DrynessFinland
-
BionovoUnknownVaginal Atrophy | Vulvar AtrophyUnited States
-
Rajavithi HospitalTerminatedVaginal Atrophy | Oxytocin Gel | Postmenopausal Women | Vaginal Maturation IndexThailand
-
Sun Pharmaceutical Industries LimitedTerminated
-
Bitop AGCompleted
-
University of Texas Southwestern Medical CenterAmerican Society for Aesthetic Plastic SurgeryCompleted
-
Dr. August Wolff GmbH & Co. KG ArzneimittelproDERM GmbHCompleted
-
National and Kapodistrian University of AthensIRCCS San RaffaeleUnknown
-
Syneron MedicalUnknownVaginal AtrophyUnited States
-
Herbarium Laboratorio Botanico LtdaNot yet recruiting
Clinical Trials on CO2 fractional laser(ACUPULSE,Lumenis)
-
Massachusetts General HospitalActive, not recruitingChronic Radiation DermatitisUnited States
-
Scientific Institute San RaffaeleUnknown
-
Rambam Health Care CampusCompleted
-
Lumenis Be Ltd.Completed
-
Rambam Health Care CampusCompleted
-
Moy-Fincher Medical GroupCompleted
-
Lumenis Be Ltd.Terminated
-
Aarhus University HospitalBispebjerg HospitalUnknownAcne Scars - Mixed Atrophic and HypertrophicDenmark
-
NYU Langone HealthRecruitingLaryngeal DiseasesUnited States
-
Moy-Fincher Medical GroupUnknown