Page 25 - DR.BROCHURE 2019_

Articles Red M. Alinsod, M.D., FACOG, FACS, ACGE 25

Results: In all 15 patients, both vulvar laxity and vaginal laxity improved
significantly after the first treatment and continued to improve after the third
treatment. All felt that their introitus and full length of the vaginal canal were
tightened. One patient did not find improvement until after her second treatment.
All patients noted labia majora fullness and tightness with softer skin and less
sagging and a more appealing vulvovaginal appearance. Menopausal patients
Vulvovaginal Breakthroughs in Non-Surgical Vaginal Rejuvenation noticed increased vaginal moisture and much less vulvar irritation. Six patients
Red M. Alinsod, M.D. who had pre procedure incontinence reported measurable reduction in urgency
January 11, 2015 and urinary leakage with activities. Six patients who had prior difficulties in
achieving orgasms reported an improvement in the ability to become orgasmic
and a quicker time to orgasm. 10 of 15 patients reported more coordinated and
Introduction/Objective: Aging, loss of collagen, and vaginal births can result in stronger muscular contractions when performing Kegel exercises. In all cases
vulvovaginal laxity and dryness both externally and internally. Reduction in the patient reported an increase in the VLQ and SSQ to be at least 3 points (e.g.
sexual satisfaction and self-esteem can occur from unappealing genital
appearance and looseness of both the gaping vaginal opening and internal VLQ from very loose to slightly tight, SSQ from poor to very good). Global
vaginal canal. Pelvic organ prolapse, tissue stretching, and nerve impairment Assessment showed that all patients Strongly Agreed with the statement that
are known impediments of sexual satisfaction. We report on a pilot study to treat they would recommend the procedure to a friend or family member and that they
the entire vulvovaginal tissues (both external labia and vaginal introitus as well as were Strongly Satisfied with the series of treatments. There were no blisters or
the full-length of the vaginal canal) using temperature-controlled radiofrequency burns or complications found during the study. There were no adverse events.
(RF). There were very few temperature spikes causing transient discomfort and all
patients felt the treatments were comfortable and even pleasing. None
Materials and Methods: Prospective non-randomized single-arm study of 15 complained of vaginal discharge or pain after the procedure. There was no
parous and sexually active women ages 21-65 using temperature controlled RF downtime to the procedure and sexual activity was encouraged and unrestricted.
(ThermiRF) applied to the external labia minora and majora, perineum, introitus,
periclitoral areas, and the full-length of the vagina. Participants received a 20-30 Analysis and Conclusions: Improvement of sexual satisfaction occurred across
minute treatment monthly for three months (total of 3 treatments per subject). the board on all patients in this pilot study. A single treatment in all but one
The same doctor performed all 45 treatments. Measuring instruments included patient was enough to provide improvement but the full series of three treatments
the validated FSFI (Female Sexual Function Index), VLQ (Vaginal Laxity resulted in the best results in all 15 participants. The primary endpoint of
Questionnaire), SSQ (Sexual Satisfaction Questionnaire), and GRA (Global vulvovaginal tightening was achieved in all patients. The secondary endpoint of
Response Assessment), SQ (Satisfaction Questionnaire), and Adverse Reporting improved vaginal moisture that reduced atrophic vaginitis symptoms was seen in
Questionnaire. During and after treatment administration, subjects was asked to several premenopausal and menopausal patients. Secondary endpoints of
assess the self-reported pain experience using a 10 scale Adverse Event improved continence and improved ability to achieve orgasms were also noted in
questionnaire, with “0” being no pain and “10” being the worst pain imaginable. selected patients with prior problems. Ongoing analysis of results is being
obtained to determine the duration and reproducibility of RF effects on
The FSFI is a validated and well-known 19-question instrument. The VLQ is a 7- vulvovaginal tissue. FSFI results are being compiled and statistically analyzed.
level scale used to obtain self-reported vaginal laxity/tightness (very loose, A larger multi-site IRB study has been submitted for approval. The potential for a
moderately loose, slightly loose, neither loose nor tight, slightly tight, moderately simple and safe temperature controlled RF device to treat vulvovaginal laxity,
tight, or very tight). Additionally, the SSQ, a 6-level scale, will obtain information atrophic vaginitis, mild to moderate stress incontinence, overactive bladder, and
on subject level of sexual satisfaction from vaginal intercourse. The GRA, a 7- orgasmic dysfunctions may hold great promise and could be transformational.
level scale, will be used to evaluate the response to the question “How are you
now (levels of vaginal laxity/tightness and sexual satisfaction) compared to
before treatment?” Subjects will also be asked to complete a general Satisfaction
Survey, which will have the subject evaluate their overall treatment experience.

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