Treatment of Vulvovaginal Laxity by Electroporation: The Jett
Plasma Medical for Her II Study

J 2023

Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study

FAIT, Tomas, Tivadar BALTAZAR, Leona BUBENÍČKOVÁ, Jan KESTRANEK, Martin STEPAN et. al.

Basic information

Original name

Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study

Authors

FAIT, Tomas (203 Czech Republic), Tivadar BALTAZAR (203 Czech Republic), Leona BUBENÍČKOVÁ (203 Czech Republic, belonging to the institution), Jan KESTRANEK (203 Czech Republic), Martin STEPAN (203 Czech Republic), Miroslav MULLER (203 Czech Republic) and Pavel TURCAN (203 Czech Republic, guarantor)

Edition

Journal of Clinical Medicine, Basel, MDPI, 2023, 2077-0383

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30214 Obstetrics and gynaecology

Country of publisher

Switzerland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 3.900 in 2022

RIV identification code

RIV/00216224:14110/23:00133376

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.3390/jcm12196234

UT WoS

001085248800001

Keywords in English

vaginal laxity; vulvovaginal laxity; nonsurgical vaginal tightening; incontinence; sexual function; urogenital distress; electroporation therapy

Abstract

V originále

Introduction: Vaginal laxity is a widespread and undertreated medical condition associated especially with vaginal parity. Aim: To evaluate the efficacy and safety of electroporation therapy treatment of vulvovaginal laxity by the Jett Plasma for Her II device. Methods: The Jett Plasma for Her II Study is a multicentric, prospective, randomized, single-blinded, and controlled study. Women presenting with vaginal laxity were randomized to receive electroporation therapy delivered to the vaginal tissue (active-82 patients) vs. therapy with zero intensity (placebo-9 patients). Results: A total of 91 subjects whose average age was 48.69 +/- 10.89 were included. Due to the results of a one-way analysis of variance, it may be concluded that in the case of the vaginal laxity questionnaire (VLQ), there is a statistically significant difference between actively treated patients and the placebo group (F-1,F-574 = 46.91; p < 0.001). In the case of the female sexual function index (FSFI), a one-way ANOVA test also showed a statistically significant difference between the actively treated patients and the placebo group (F-1,F-278 = 7.97; p = 0.005). In the case of the incontinence impact questionnaire-7 (IIQ-7), a one-way ANOVA test showed a statistically significant difference between the actively treated patients and the placebo group (F-1,F-384 = 15.51; p < 0.001). It confirms that improvement of vaginal laxity is conjoined with benefits in symptoms of urinary incontinence. Biopsy performed after the end of the treatment shows an increase in the vaginal mucosa thickness by an average of 100.04% in the active group. The treatment was well tolerated with no adverse events. No topical anesthetics were required. Conclusions: Treatments of vulvovaginal laxity by electroporation therapy achieved significant and sustainable 12-month effectiveness. Responses to the questionnaires also suggest subjective improvement in self-reported sexual function, incontinence, sexual satisfaction, and urogenital distress.

Citovat

FAIT, Tomas, Tivadar BALTAZAR, Leona BUBENÍČKOVÁ, Jan KESTRANEK, Martin STEPAN, Miroslav MULLER and Pavel TURCAN. Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study. Journal of Clinical Medicine. Basel: MDPI, 2023, vol. 12, No 19, p. 1-12. ISSN 2077-0383. Available from: https://dx.doi.org/10.3390/jcm12196234.

@article{2368570,
   author = {Fait, Tomas and Baltazar, Tivadar and Bubeníčková, Leona and Kestranek, Jan and Stepan, Martin and Muller, Miroslav and Turcan, Pavel},
   article_location = {Basel},
   article_number = {19},
   doi = {http://dx.doi.org/10.3390/jcm12196234},
   keywords = {vaginal laxity; vulvovaginal laxity; nonsurgical vaginal tightening; incontinence; sexual function; urogenital distress; electroporation therapy},
   language = {eng},
   issn = {2077-0383},
   journal = {Journal of Clinical Medicine},
   title = {Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study},
   url = {https://www.mdpi.com/2077-0383/12/19/6234},
   volume = {12},
   year = {2023}
}

TY  - JOUR
ID  - 2368570
AU  - Fait, Tomas - Baltazar, Tivadar - Bubeníčková, Leona - Kestranek, Jan - Stepan, Martin - Muller, Miroslav - Turcan, Pavel
PY  - 2023
TI  - Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study
JF  - Journal of Clinical Medicine
VL  - 12
IS  - 19
SP  - 1-12
EP  - 1-12
PB  - MDPI
SN  - 20770383
KW  - vaginal laxity
KW  - vulvovaginal laxity
KW  - nonsurgical vaginal tightening
KW  - incontinence
KW  - sexual function
KW  - urogenital distress
KW  - electroporation therapy
UR  - https://www.mdpi.com/2077-0383/12/19/6234
N2  - Introduction: Vaginal laxity is a widespread and undertreated medical condition associated especially with vaginal parity. Aim: To evaluate the efficacy and safety of electroporation therapy treatment of vulvovaginal laxity by the Jett Plasma for Her II device. Methods: The Jett Plasma for Her II Study is a multicentric, prospective, randomized, single-blinded, and controlled study. Women presenting with vaginal laxity were randomized to receive electroporation therapy delivered to the vaginal tissue (active-82 patients) vs. therapy with zero intensity (placebo-9 patients). Results: A total of 91 subjects whose average age was 48.69 +/- 10.89 were included. Due to the results of a one-way analysis of variance, it may be concluded that in the case of the vaginal laxity questionnaire (VLQ), there is a statistically significant difference between actively treated patients and the placebo group (F-1,F-574 = 46.91; p < 0.001). In the case of the female sexual function index (FSFI), a one-way ANOVA test also showed a statistically significant difference between the actively treated patients and the placebo group (F-1,F-278 = 7.97; p = 0.005). In the case of the incontinence impact questionnaire-7 (IIQ-7), a one-way ANOVA test showed a statistically significant difference between the actively treated patients and the placebo group (F-1,F-384 = 15.51; p < 0.001). It confirms that improvement of vaginal laxity is conjoined with benefits in symptoms of urinary incontinence. Biopsy performed after the end of the treatment shows an increase in the vaginal mucosa thickness by an average of 100.04% in the active group. The treatment was well tolerated with no adverse events. No topical anesthetics were required. Conclusions: Treatments of vulvovaginal laxity by electroporation therapy achieved significant and sustainable 12-month effectiveness. Responses to the questionnaires also suggest subjective improvement in self-reported sexual function, incontinence, sexual satisfaction, and urogenital distress.
ER  -

FAIT, Tomas, Tivadar BALTAZAR, Leona BUBENÍČKOVÁ, Jan KESTRANEK, Martin STEPAN, Miroslav MULLER and Pavel TURCAN. Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study. \textit{Journal of Clinical Medicine}. Basel: MDPI, 2023, vol.~12, No~19, p.~1-12. ISSN~2077-0383. Available from: https://dx.doi.org/10.3390/jcm12196234.

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