Investigating the Effect of Fractional CO2 Therapy on the Improvement of Vaginal Atrophy Symptoms
Design
In a study of 35 patients with vaginal atrophy and having a condition to study at the Pleivc Clinic of Women referring to Imam Khomeini Hospital, all participants are treated as a group.
Settings and conduct
Patients referred to vaginal atrophy symptoms in Vali-e-Asr Hospital in Pleivc Clinic
And eligible for inclusion in the study after being informed consent.
Signs and severity are collected by the questionnaire form at the beginning of the study.
Three sessions of laser therapy are then performed at a distance of one month
Symptoms are re-evaluated at each session and end. Patients after the completion of three sessions, up to one year of the
Follow up
Participants/Inclusion and exclusion criteria
Criteria for entering the study :
The age of the patient is over 45 years old.
There is no history of surgery in the perineal area.
There is no history of using hormone therapy.
Complaint Disparonya patient with or without symptoms of urinary incontinence.
There is no history of neuropathy or mental illness.
Non-admission criteria :
Age of the patient under 45 years of age.
History of Perineal Surgery.
A history of neuropathy or mental illness.
The history of hermeneutic therapy.
No complaints of dyspareunia or urinary disorders.
Intervention groups
Female patients older than 45 years of age with a complaint of Disparonya and urinary incontinence symptoms referred to Pleivc Clinic of Imam Khomeini Hospital and undergoing laser therapy are three sessions.
Assessment of fractional co2 laser effect in treatment of women with vuluvaginal atrophy in Emam Khomeini hospital
Public title
Assessment of laser effect in treatment of women with vuluvaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
one or more symptoms of VVA (e.g., vaginal discharge, itching, dyspareunia, dryness and urge urinary incontinence).
no menstruation for ≥ 12 months.
not using local or systemic estrogen therapy.
wishing to be sexual active.
Exclusion criteria:
: use of hormone replacement therapy (systemic or local) up to 6 month before entry to the study.
pelvic organ prolapse stage > 2 (according to POP-Q system).
active genital infections.
acute or recurrent urinary tract infection.
use of any vaginal lubricants.
moisturizers or local preparations within 30 days before entry to the study.
psychiatric disorders which could interfere with informed consent.
any chronic disease that could interfere with study compliance.
abnormal uterine bleeding which has no exact diagnosis.
malignancies of urogenital.
Age
From 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Quds St., Poursina St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
123456
Approval date
2017-06-09, 1396/03/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1396.2552
Health conditions studied
1
Description of health condition studied
Atrophy of the vagina
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
The percentage of women who have vaginal dryness.
Timepoint
The time intervals for assessing the vaginal dryness before the start of the laser and then one month two months and three months and one year after the laser is done.
Method of measurement
questionnaire
2
Description
Percentage of women who have urinary incontinence.
Timepoint
The time intervals for assessing the vaginal dryness before the start of the laser and then one month two months and three months and one year after the laser is done.
Method of measurement
questionnaire
Secondary outcomes
1
Description
Dysuria together
Timepoint
The time intervals for assessing the vaginal dryness before the start of the laser and then one month two months and three months and one year after the laser is done.
Method of measurement
questionnaire
2
Description
Vaginal itching accompanied.
Timepoint
The time intervals for assessing the vaginal dryness before the start of the laser and then one month two months and three months and one year after the laser is done.
Method of measurement
questionnaire
3
Description
Vaginal discharge accompanied.
Timepoint
The time intervals for assessing the vaginal dryness before the start of the laser and then one month two months and three months and one year after the laser is done.
Method of measurement
questionnaire.
4
Description
Dyspareunia.
Timepoint
The time intervals for assessing the vaginal dryness before the start of the laser and then one month two months and three months and one year after the laser is done.
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: The intervention group uses fractional carbon dioxide laser, which is used in 3 sessions and 4 weeks apart.