Radiofrequency and Hybrid Fractional Laser for Vaginal Rejuvenation
Maneno muhimu
Kikemikali
Maelezo
Vaginal rejuvenation is a catch-all term of trendy procedures which claim to provide relief of many issues affecting women's health, ranging from postmenopausal vulvovaginal symptoms (i.e. dryness, burning, itching), stress urinary incontinence, sexual dysfunction or discomfort, vaginal laxity, and labial appearance, amongst others2,3. Several companies have emerged with non-invasive or minimally-invasive technologies to alleviate these conditions which operate by radiofrequency delivery (IntraGen by Jeisys), Hybrid Fractional Laser (diVa by Sciton), or fractional CO2 laser (Mona Lisa Touch by Cynosure and Femi Lift by Alma Laser)4.
All of these technologies work theoretically by remodeling extracellular matrix configuration. It is of important note that radiofrequency therapies are typically delivered at 45-55 degrees Celsius in the tissues whereas the laser based products heat up to 60-70 degrees Celsius5. It is believed that "neocollagenesis" may only start if the temperatures are high enough and that such changes in the collagen matrix of the vagina could lead to durable vaginal wall changes. Sciton's diVa is hybrid fractional laser with wavelengths of 2940 nm and 1470 nm for ablation and coagulation, respectively, to treat vaginal tissue6. It is not known whether the changes experienced by patients are due to the reconfiguration of the extracellular matrix (ECM) deep in the vaginal wall or related to the acute swelling and inflammatory processes that occur at the surface of the vagina after these rejuvenation procedures.
The early anecdotal success reported on some user websites might be attributable to surface changes that may not be lasting or to possibly more lasting deeper muscular vaginal wall changes, which may or may not be beneficial. Based on the answer to this first set of questions, we might possibly surmise how such changes will ultimately improve vaginal dryness and/or stress urinary incontinence complaints.
An overriding question and concern is: Assuming these treatments induce collagen changes in the vagina, is it safe to induce such changes? If changes occur, are they long lasting? Can it age the vagina instead of making it "younger"? What are the long-term effects of doing so? Is tissue tightening really scar formation that may be deleterious in the future? The histological, genetic and dynamic changes following vaginal rejuvenation have never been studied.
Tarehe
| Imethibitishwa Mwisho: | 01/31/2020 |
| Iliyowasilishwa Kwanza: | 10/16/2017 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 10/16/2017 |
| Iliyotumwa Kwanza: | 10/22/2017 |
| Sasisho la Mwisho Liliwasilishwa: | 02/02/2020 |
| Sasisho la Mwisho Lilichapishwa: | 02/04/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 06/14/2018 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 05/29/2021 |
| Tarehe ya Kukamilisha Utafiti: | 08/29/2021 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: IntraGen RF
Device: DiVA
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: IntraGen RF Patients will undergo treatment with radiofrequency device, using the device's standard protocol. Patients will have 3 treatments space one month apart. Each treatment will be a total of 20 minutes for internal treatment only. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. | |
| Sham Comparator: IntraGen Sham Patients will undergo all acts of receiving radiofrequency treatment, but no direct energy will be applied. Patients will have 3 sham treatments space one month apart. Each treatment session will be a total of 20 minutes. Prior to sham treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. | |
| Experimental: DiVA Patients randomized into the DiVA treatment group will receive treatment per DiVA protocol. Patients will have a total of 3 treatments, space 1 month apart. Each treatment will last approximately 10 minutes. Prior to treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. | |
| Sham Comparator: DiVA Sham Patients randomized into the DiVA sham group will undergo all acts of receiving DiVA treatment, but not direct energy will be applied. Patients will have a total of 3 treatments, spaced 1 month apart. Each treatment will last approximately 10 minutes. Prior to sham treatment, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken 3 months after final treatment. | |
| Experimental: Dual Treatment Patients previously randomized into the DiVA Sham and IntraGen Sham groups will be placed in the Dual Treatment group. Patients will have a total of 3 dual treatments, spaced 1 month apart. Each treatment will last approximately 20 minutes. Prior to dual treatments, the Zimmern probe will be used to measure vaginal wall elasticity and a 0.33mm biopsy will be taken. At each visit, the Zimmern probe will be used. Biopsies will be taken at follow up visits. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 40 Years Kwa 40 Years |
| Jinsia Inastahiki Kujifunza | Female |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Women should be between 40 and 65 years of age - Women should be post-menopausal - Women should be amenorrheic for at least 12 months - Postmenopausal women presenting with one or more of the following: - Vulvar itching - Vulvar burning or stinging - Vulvar pain - Vulvar irritation - Vulvar dryness - Discharge from subject's vulva or vagina - Odor from subject's vulva or vagina Exclusion Criteria: - Unable to commit to future appointments within one year - Planning on moving away from Dallas within one year - History of other energy-based vaginal therapy within one year - Vaginal hormone replacement therapy must have a one month washout period prior to treatment and discontinued use for duration of study, systemic replacement is not excluded - Prior labiaplasty, or vaginal injections of fat or fillers within 6 months - Prior anti-incontinence surgery in the last 12 months - Urinary incontinence requiring more than 2 pads/day - Clinically significant pelvic organ prolapse (POP) - Urinary tract infection in the past 3 months - Unstable diabetes - Ongoing chemotherapy - Immunodeficiency status (steroid intake, ongoing chemotherapy) - Diffuse pain syndrome or chronic pain requiring daily narcotics - Chronic vaginitis including bacterial vaginosis, HPV, herpes, or other active STI - Recent abnormal Papanicolaou test result - Recent abnormal pelvic exam (i.e. concerning lesions) - Vulvar dermatologic pathology requiring local steroid use - Undiagnosed abnormal genital bleeding - If less than two years postmenopausal, not using a medically approved method of contraception (i.e. oral, transdermal, implanted contraceptives, intrauterine device, diaphragm, condom, etc.) - Pregnancy - History of genital fistula or a thin rectovaginal septum - Uncontrolled psychiatric conditions (well-controlled depression/anxiety is not excluded) - Body Mass Index > 35 - Actively participating in or planning on participating in pelvic floor muscle strengthening exercise - Presence of pacemaker, AICD, or other electrical health maintenance device |
Matokeo
Hatua za Matokeo ya Msingi
1. Vulvovaginal Symptoms Questionnaire [12 months - 18 months]
2. Vaginal Laxity Questionnaire [12 months - 18 months]
Hatua za Matokeo ya Sekondari
1. Zimmern Probe [12 months - 18 month]
2. Urogenital Distress Short Form (UDI-6) [12 months - 18 months]
3. Incontinence Impact Questionnaire Short Form (IIQ-7) [12 months - 18 months]
4. Female Sexual Function Index (FSFI) [12 months - 18 months]
5. Histological changes [12 months - 18 months]
