Electroporation therapy improves symptoms of vaginal relaxation

Electropuncture therapy is effective in treating vulvar laxity for up to 12 months, according to a recently published study Journal of Clinical Medicine.

Vaginal prolapse, indicated by a loss of vaginal tone or elasticity, is often caused by childbirth. After childbirth, the vaginal walls may stretch or widen due to weakened pelvic floor muscles. This reduces excitement during sexual activity, causes difficulty in achieving orgasm and leads to loss of self-confidence.

Other risk factors for vaginal laxity include aging and obesity. Treatment options include pelvic floor exercises, vaginal resuscitation devices, and vaginal surgery. The Jet Plasma for Her II study (Compex Ltd., Brno, Czech Republic) was conducted to evaluate the safety and efficacy of electrocautery as a vaginal relaxation treatment.

Electroporation creates small temporary nanopores in cell walls by applying a high-voltage electrical pulse to the cell membrane. This reduces vaginal mucosa and submucosal tissue atrophy and improves tissue cohesion.

The Jet Plasma for Her II study started in November 2019 and includes 91 patients. Participants are healthy women aged 18 years and older with vaginal laxity, with self-reported perceptions defined by the vaginal laxity questionnaire (VLQ).

Participants also had a negative pregnancy test and no malformation within 36 months before treatment. Exclusion criteria included epilepsy, metal implants, skin disease or inflammation in the treated area, pregnancy, collagen vascular disease, vulvar oncological disease, urinary tract infection, and untreated or poorly treated vulvar disease.

Further exclusion criteria included vaginal birth defects, vulvar continuity, vaginal stenosis and strictures, vaginal lasers, previous reconstructive vaginal surgery, vaginal fat or filler injections within 6 months, and a body mass index of 35 or greater.

Self-report questionnaires were completed by participants prior to treatment and at 1-, 3-, 6-, and 12-month follow-up visits. These questionnaires included the VLQ, the Female Sexual Functioning Index (FSFI), the Sexual Satisfaction Questionnaire (SSQ), the Urogenital Distress Inventory Short Forms (UDI-6), and the Incontinence Impact Questionnaire (IIQ-7).

No vaginal laxity was defined with a VLQ score of at least 5. The psychosocial impact of incontinence was assessed 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 an electric current of 2.8 mA with a voltage of 5 kV was used. Each application lasted approximately 7.5 minutes.

91 patients with a mean age of 48.6 years were included in the analysis. A statistically significant difference was found in patients receiving active treatment versus those receiving placebo, with a mean VLQ of 3.98 in patients receiving active treatment and 2.68 in the placebo group.

From the first treatment to the last follow-up a mean improvement of 3.15 to 4.27 was observed in patients who received active treatment. This was an improvement of 1.22, compared to a non-significant improvement of 0.22 seen in the placebo group.

The most significant difference was found between the first treatment and the second control, with the highest VLQ value of 4.57 observed in the second control. In the first treatment, 15.76% of patients receiving active treatment reported no vaginal laxity, compared to 0% of the placebo group. In the second control, 45.7% of patients receiving active treatment reported no vaginal laxity, compared with 0% of the placebo group.

Results from the IIQ-7 and UDI-6 questionnaires correlated improvements in vaginal laxity with improved urinary incontinence symptoms. FSFI scores were also significantly improved in patients who received active treatment compared to the placebo group.

SSQ scores did not differ significantly between the two groups. However, generally significant efficacy was observed in the treatment of atrial relaxation with electroporation therapy.

Report

Fait T, Baltazar T, Bubenickova L, et al. Treatment of vulvar laxity with electrocautery: the Jett Plasma Medical for Her II study. J Clin Med. 2023? 12(19):6234. doi: 10.3390/jcm12196234