Vulvovaginal Atrophy
Conditions
Brief summary
The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).
Detailed description
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.
Interventions
DEVICELaser treatment
The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
Sponsors
The Christ Hospital
Stanford University
El. En. SpA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months * Exhibiting VVA symptoms * Prolapse staged \< II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system * Have not had procedures in the anatomical area through 6 months prior to treatment * Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits
Exclusion criteria
* • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida). * Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system * Any serious disease, or chronic condition, that could interfere with the study compliance * Previously undergone reconstructive pelvic surgery * Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months * A history of thrombophlebitis * A history of acute infections * A history of heart failure * Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment * Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study * Taking medications that are photosensitive * A history of keloid formation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline | Baseline and at follow up visit at 12 months post last treatment | The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laser Treatment Laser Treatment
Laser treatment: The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Laser Treatment | — |
|---|---|---|
| Age, Continuous | 58.6 years STANDARD_DEVIATION 8.8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline
The main outcome of the study is the efficacy of the laser procedure, intended as the amelioration of 50% of the severity of the vaginal dryness at 12 months, compared with baseline. The change in the vaginal dryness symptom has been assessed by means of a visual analogic scale (10 cm VAS).
Time frame: Baseline and at follow up visit at 12 months post last treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laser Treatment | The Main Outcome of the Study is the Efficacy of the Laser Procedure, Intended as the Amelioration of 50% of the Severity of the Vaginal Dryness at 12 Months, Compared With Baseline | 27 Participants |