The Jet Plasma for Her II study began in November 2019 and includes 91 patients. Participants are healthy women aged 18 years and older with vaginal laxity, with self-reported perceptions defined on the vaginal laxity questionnaire (VLQ).
Participants also had a negative pregnancy test and no dysplasia within 36 months before treatment. Exclusion criteria included epilepsy, metal implants, skin diseases or inflammation in the treated area, pregnancy, collagen vascular disease, vulvovaginal oncological disease, urinary tract infection, and untreated or poorly treated vulvovaginal conditions.
Further exclusion criteria included vagina birth defects, synechia of vulva, stenosis and strictures of the vagina, vaginal lasers, prior reconstructive vaginal surgery, vaginal injections of fat or fillers within 6 months, and body mass index of 35 and above.
Self-report questionnaires were completed by participants before treatment and at 1-, 3-, 6-, and 12-month follow-up visits. These questionnaires included the VLQ, the female sexual function index (FSFI), the sexual satisfaction questionnaire (SSQ), the short forms of the urogenital distress inventory (UDI-6), and the incontinence impact questionnaire (IIQ-7).
No vaginal laxity was determined by a VLQ score of at least 5. The psychosocial impact of incontinence was evaluated through the IIQ-7, with a total score ranging from 0 to 100. Sexual function was assessed using the FSFI, and sexual satisfaction through the SSQ. Finally, the UDI-6 is a condensed version of a condition-specific quality of life instrument.
The electroporation treatment was performed 3 times and used an electric current of 2.8 mA with a voltage of 5 kV. Each application lasted approximately 7 and a half minutes.
There were 91 patients aged a median 48.6 years included in the analysis. A statistically significant difference was found in actively treated patients vs those treated with placebo, with an average VLQ value of 3.98 in actively treated patients and 2.68 in the placebo group.
From the first treatment to last follow-upan average improvement from 3.15 to 4.27 was observed in actively treated patients. This was an improvement of 1.22, compared to a nonsignificant improvement of 0.22 observed in the placebo group.
The most significant difference was found between the first treatment and second control, with the highest VLQ value of 4.57 observed in the second control. At the first treatment, 15.76% of patients actively treated reported no vaginal laxity, vs 0% of the placebo group. In the second control, 45.7% of actively treated patients reported no vaginal laxity, vs 0% of the placebo group.
Results from the IIQ-7 and UDI-6 questionnaires associated improvements in vaginal laxity with improved symptoms of urinary incontinence. FSFI scores were also significantly improved in actively treated patients compared to the placebo group.
SSQ scores were not significantly different between both groups. However, overall significant efficacy was observed when treating vaginal laxity withelectroporation therapy.
Reference
Fait T, Baltazár T, Bubenickova L, et al. Treatment of vulvovaginal laxity by electroporation: the Jett Plasma Medical for Her II study. J Clin Med. 2023;12(19):6234. doi:10.3390/jcm12196234
