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A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair

Primary Purpose

Vaginal Atrophy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CO2 fractional laser(ACUPULSE,Lumenis)
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Atrophy focused on measuring Vaginal atrophy, Vaginal relaxation, stress urinary incontinence, CO2 fractional laser

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Dermatology Derpartment of Xijing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CO2 fractional laser(ACUPULSE,Lumenis)

before treatment

Arm Description

gradually withdrawn from inside to outside of vaginal.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.

the patient did not receive laser treatment

Outcomes

Primary Outcome Measures

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
urinary incontinence questionnaire short form assessment
Evaluate urinary incontinence questionnaire short form assessment
VHIS score in vaginal environment
Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness
vaginal pressure VTI data detection
Evaluate vaginal pressure by VTI data detection
pelvic floor magnetic resonance MRI plain
Measure tissue structures in the pelvis
scantransvaginal ultrasound
Measure the structures of the vagina
histopathological biopsy
5 cases were randomly selected for histopathological biopsy

Secondary Outcome Measures

patient satisfaction assessment
Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied
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

Full Information

First Posted
August 4, 2019
Last Updated
April 27, 2021
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04492176
Brief Title
A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
Keywords
Vaginal atrophy, Vaginal relaxation, stress urinary incontinence, CO2 fractional laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CO2 fractional laser(ACUPULSE,Lumenis)
Arm Type
Experimental
Arm Description
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.
Arm Title
before treatment
Arm Type
No Intervention
Arm Description
the patient did not receive laser treatment
Intervention Type
Device
Intervention Name(s)
CO2 fractional laser(ACUPULSE,Lumenis)
Intervention Description
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
Primary Outcome Measure Information:
Title
female sexual function FSFI score(Female Sexual Function Index )
Description
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
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
urinary incontinence questionnaire short form assessment
Description
Evaluate urinary incontinence questionnaire short form assessment
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
VHIS score in vaginal environment
Description
Comprehensive evaluation of vaginal status by vulvar status, internal PH value, vaginal elasticity, guided endocrine secretion, and vaginal moistness
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
vaginal pressure VTI data detection
Description
Evaluate vaginal pressure by VTI data detection
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
pelvic floor magnetic resonance MRI plain
Description
Measure tissue structures in the pelvis
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
scantransvaginal ultrasound
Description
Measure the structures of the vagina
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
histopathological biopsy
Description
5 cases were randomly selected for histopathological biopsy
Time Frame
Changes before and 1month after treatment
Secondary Outcome Measure Information:
Title
patient satisfaction assessment
Description
Patient satisfaction: Very satisfied, satisfied, average, dissatisfied, very dissatisfied
Time Frame
Changes from preoperative to 1 year after initial treatment
Title
VAS Pain Assessment(Immediately after Treatment)
Description
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
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang
Organizational Affiliation
Dermatology Derpartment of Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Derpartment of Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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A Clinical Clinical Observation of CO2 Fractional Laser in Female Vaginal Repair

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