| RADIOFREQUENCY | PEER-REVIEW
effective on surface skin of the face and other body regions, RF is even more effective in tissue that is naturally moist and well hydrated, as is the vaginal and ancillary structures. Treatment is non-invasive and there is no downtime. The treatment probe is of a proprietary design
developed with expert physician input. During TTCRF treatment, the probe tip is passed back and forth slowly and with wide sweeps over the desired zone of treatment for 3 to 5 minutes, until the tissue is gradually heated to the therapeutically relevant level to induce tightening of the skin, mucosa, and fascia as well as stimulate neocollagenesis. This also promotes patient comfort and assures that the practitioner does not over-treat. The purpose of the study is to evaluate the safety,
tolerability, and clinical efficacy of TTCRF as well as anecdotally document possible ancillary beneficial effects of treatment, to promote further study.
Patients and methods In this prospective study, 23 subjects (age range 26–58 years, mean 43.6; median vaginal births=2, mean parity 1.7; 5 menopausal, 6 perimenopausal) presented with self- described mild to moderate primary or secondary vulvovaginal laxity. Associated secondary conditions (orgasmic dysfunction, stress incontinence, atrophic vaginitis) were present in most subjects. Those who presented with mild to moderate stress urinary incontinence (n=6) were evaluated by examination showing urethral hyper-mobility, positive Valsalva, and recording incontinence episodes per day along with pad counts. Severe incontinence patients with suspected ISD and positive empty bladder stress tests were excluded. Patients who complained of clinical significant atrophic vulvovaginitis (n=8) were evaluated with symptoms of vaginal and vulvar dryness as well as painful intercourse and discomfort with their clothing. Exclusion criteria included pelvic surgery within 5
years of study commencement, presence of major psychiatric conditions or related need for medication, chronic use of anti-inflammatory agents (including steroids) and immunosuppressants, pregnancy or planned pregnancy within the study period, recent abnormal Papnicolaou test result, presence of vulvar lesions or disease (dermatitis, human papillomavirus, herpes simplex, vulvar dystrophy), or the presence of any condition or circumstance that, in the opinion of the investigating physician, may be unsafe or otherwise interfere with the study. Informed consent was obtained from all subjects prior to commencement of the study. Pre-treatment digital photography was performed at
baseline along with physician evaluation of patients. Treatment was performed in a clinical office setting without anesthesia. During treatment, subjects were placed on a treatment table in the dorsal lithotomy position. A neutral return pad was placed underneath the buttocks of the subject, and a coupling gel was used as a lubricant for treatment with the TTCFR device. Once patients were settled and comfortable they were treated using the TTCRF device (ThermiVa, ThermiAesthetics,
Treatment
was performed in a clinical office setting without anesthesia.
Table 2 Median score and improvement from baseline in vulvovaginal laxity and sexual satisfaction after TTCRF*
BASELINE 10 DAYS SCORE
VLQ† 2 SSQ‡ 3
2 POST TX1 1.5
TX2 (BEFORE TX3 (BEFORE 30 DAYS TREATMENT)
TREATMENT) 5 3 4 1.5
6 4.5 5
2.0 6 5 6 2.5 POST TX3
SCORE IMPROVEMENT SCORE IMPROVEMENT SCORE IMPROVEMENT SCORE IMPROVEMENT 5 4
*Values expressed as median because data were not continuous and not normally distributed; median raw score and median improvement from baseline, thus, may not appear to agree. †Vaginal Laxity Questionnaire [Millheiser 2010] rating vulvovaginal laxity on a seven point scale where 1=very loose and 7=very tight. ‡Sexual Satisfaction Questionnaire [Millheiser 2010] rating sexual satisfaction on a six-point scale where 1=none and 6=excellent.
Inc., Southlake, TX) for approximately 5 minutes per zone (left and right labia majora; and the ventral, dorsal, left and right surfaces of the vaginal wall). The labia majora were treated first; the treatment tip was applied to each labial surface bilaterally from the lowest edge of the mons pubis to the perineal body and laterally to the crural folds. The clinical endpoint was achievement of the target temperature range of 40°C to 45°C for approximately 3–5 minutes per zone (or longer, depending on heat tolerance). This was followed by treatment of the mucosal surface of the vaginal introitus starting at the hymenal ring and advancing to approximately 4 to 9 cm into the cavity for each zone of the vaginal wall (ventral, dorsal, left and right). For each zone the treatment tip is inserted into the vagina with the emitter surface facing the desired direction, and energy is applied with the treatment cannula using an in-and-out motion. The clinical endpoint was achievement of the target temperature in the range of 40°C to 45°C for approximately 3–5 minutes per zone (or longer, depending on heat tolerance); treatment was repeated identically for each of the four vaginal surfaces. Total treatment time was less than 30 minutes. A complete course of therapy consisted of three treatments with the TTCRF device, at an interval of approximately 4–6 weeks. Patients were offered up to three treatments but not required to undergo all three.
Figure 3 (A) Before and (B) after images of nulliparous woman, age 52 years, presenting with severe laxity of the vagina and labia majora resulting in chronic irritation of the left majora, severe atrophic vaginitis, and anorgasmia. Outcome after two treatments with TTCRF included statistically significant improvement in laxity with visible aesthetic improvement and complete resolution of irritation, atrophic vaginitis, and anorgasmia
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