{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T01:26:05Z","timestamp":1788312365244,"version":"build-2803163510"},"reference-count":38,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2023,9,27]],"date-time":"2023-09-27T00:00:00Z","timestamp":1695772800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Educational grant of Compex Ltd., Brno, Czech Republic"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>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\u201482 patients) vs. therapy with zero intensity (placebo\u20149 patients). Results: A total of 91 subjects whose average age was 48.69 \u00b1 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 (F1,574 = 46.91; p &lt; 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 (F1,278 = 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 (F1,384 = 15.51; p &lt; 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.<\/jats:p>","DOI":"10.3390\/jcm12196234","type":"journal-article","created":{"date-parts":[[2023,9,28]],"date-time":"2023-09-28T01:51:14Z","timestamp":1695865874000},"page":"6234","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Treatment of Vulvovaginal Laxity by Electroporation: The Jett Plasma Medical for Her II Study"],"prefix":"10.3390","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2812-9274","authenticated-orcid":false,"given":"Tomas","family":"Fait","sequence":"first","affiliation":[{"name":"Department of Obsterics and Gynaecology, 2nd Faculty of Medicine, Charles University, 150 00 Prague, Czech Republic"},{"name":"Department of Health Care Studies, College of Polytechnics Jihlava, 586 01 Jihlava, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tivadar","family":"Baltaz\u00e1r","sequence":"additional","affiliation":[{"name":"Department of Agrochemistry, Soil Science, Microbiology and Plant Nutrition, Faculty of AgriSciences, Mendel University in Brno, 613 00 Brno, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0536-3147","authenticated-orcid":false,"given":"Leona","family":"Bubenickova","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Masaryk University, 625 00 Brno, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan","family":"Kestranek","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology, Hospital Trutnov, 541 01 Trutnov, Czech Republic"},{"name":"Department of Obsterics and Gynaecology, Medical Faculty in Hradec Kralove, Charles University, 500 05 Hradec Kralove, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Stepan","sequence":"additional","affiliation":[{"name":"Department of Obsterics and Gynaecology, Medical Faculty in Hradec Kralove, Charles University, 500 05 Hradec Kralove, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miroslav","family":"Muller","sequence":"additional","affiliation":[{"name":"Gynedology Pardubice Muller, 530 02 Pardubice, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavel","family":"Turcan","sequence":"additional","affiliation":[{"name":"Mediol Centre\u2014Olomouc, 779 00 Olomouc, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1435","DOI":"10.1007\/s00192-012-1757-4","article-title":"Vaginal laxity: A poorly understood quality of life problem; a survey of physician members of the International Urogynecological Association (IUGA)","volume":"23","author":"Pauls","year":"2012","journal-title":"Int. Urogynecol. J."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1389","DOI":"10.1007\/s00192-014-2331-z","article-title":"Do women notice the impact of childbirth-related levator trauma on pelvic floor and sexual function?","volume":"25","author":"Yusuf","year":"2014","journal-title":"Int. Urogynecol. J."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"429","DOI":"10.1016\/j.cps.2022.06.005","article-title":"Anatomical changes of the vulva due to childbirth and aging","volume":"49","author":"Hustak","year":"2022","journal-title":"Clin. Plast. Surg."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"867","DOI":"10.1111\/1471-0528.12920","article-title":"The association between vaginal childbirth and hiatal dimensions: A retrospective observational study in a tertiary urogynaecological centre","volume":"122","author":"Gerges","year":"2015","journal-title":"Br. J. Obstet. Gynaecol."},{"key":"ref_5","first-page":"385","article-title":"Does vaginal delivery damage the pelvic floor?","volume":"16","author":"Athanasiou","year":"1997","journal-title":"Neurourol. Urodyn."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"278","DOI":"10.1002\/ijgo.12810","article-title":"Correlates of vaginal laxity symptoms in women attending urogynecology clinic in Saudi Arabia","volume":"145","author":"Talab","year":"2016","journal-title":"Int. J. Gynecol. Obstet."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1007\/s00192-017-3426-0","article-title":"Vaginal laxity: What does this symptom mean?","volume":"29","author":"Dietz","year":"2018","journal-title":"Int. Urogyn. J."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1927","DOI":"10.1007\/s00192-021-04927-3","article-title":"Is vaginal laxity and early symptom of pelvic organ prolapsing?","volume":"33","author":"Alexander","year":"2022","journal-title":"Int. Urogyn. J."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"100443","DOI":"10.1016\/j.esxm.2021.100443","article-title":"Description of vaginal laxity and prolapse and correlation with sexual function (DeVeLoPS)","volume":"9","author":"Polland","year":"2021","journal-title":"Sex. Med."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1880","DOI":"10.12659\/MSM.896331","article-title":"Obesity and pelvic floor disorders: A review of the literature","volume":"22","author":"Pomian","year":"2016","journal-title":"Med. Sci. Monit."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1097\/PRS.0000000000000516","article-title":"Aesthetic surgery of the female genitalia: Labiaplasty and beyond","volume":"134","author":"Hamori","year":"2014","journal-title":"Plast. Reconstr. Surg."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"3088","DOI":"10.1111\/j.1743-6109.2010.01910.x","article-title":"Radiofrequency treatment of vaginal laxity after vaginal delivery: Nonsurgical vaginal tightening","volume":"7","author":"Millheiser","year":"2010","journal-title":"J. Sex Med."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1046\/j.1365-201X.2003.01093.x","article-title":"Electroporation: Theory and methods, perspectives for drug delivery, gene therapy and research","volume":"177","author":"Gehl","year":"2003","journal-title":"Acta Physiol. Scand."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"753","DOI":"10.17344\/acsi.2021.7198","article-title":"The good and the bad of cell membrane electroporation","volume":"68","author":"Blantic","year":"2021","journal-title":"Acta Chim. Slov."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1002\/nau.1930140206","article-title":"Short forms to assess life quality and symptom distress for urinary incontinence in women: The incontinence impact questionnaire and urogenital distress inventory","volume":"14","author":"Uebersax","year":"1995","journal-title":"Neurourol. Urodyn."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"191","DOI":"10.1080\/009262300278597","article-title":"The Female Sexual Function Index (FSFI): A Multidimensional Self-Report Instrument for the Assessment of Female Sexual Function","volume":"26","author":"Rosen","year":"2000","journal-title":"J. Sex Marit. Ther."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1515\/pjap-2015-0017","article-title":"The sexual satisfaction questionnaire\u2013psychometric propertie","volume":"12","author":"Nomejko","year":"2014","journal-title":"Pol. J. Appl. Psychol."},{"key":"ref_18","first-page":"175","article-title":"Graphic representation of pain","volume":"2","author":"Scott","year":"1976","journal-title":"Pian"},{"key":"ref_19","unstructured":"(2019). R Core Team: A Language and Environment for Statistical Computing, R Foundation for Statistical Computing. Available online: http:\/\/www.R-project.org\/."},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Wickham, H. (2016). ggplot2: Elegant999999 Graphics for Data Analysis, Springer.","DOI":"10.1007\/978-3-319-24277-4"},{"key":"ref_21","unstructured":"Zar, J.H. (1984). Biostatistical Analysis, Prentice-Hall Internat.. [2nd ed.]."},{"key":"ref_22","unstructured":"Faraway, J.J. (2005). Linear Models with R, Chapman & Hall\/CRC."},{"key":"ref_23","unstructured":"Pek\u00e1r, S., and Brabenec, M. (2016). Modern Analysis of Biological Data. Generalized Linear Models in R, Masaryk University Press."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1080\/00016340600622544","article-title":"Colpoperineoplasty in women with sensation of a wide vagina","volume":"85","author":"Pardo","year":"2006","journal-title":"Acta Obstet. Gynecol. Scand."},{"key":"ref_25","doi-asserted-by":"crossref","unstructured":"Jamali, S., Abedi, P., Rasekh, A., and Mohammadjafari, R. (2014). The Long-Term Effect of Elective Colpoperineoplasty on Sexual Function in the Reproductive Aged Women in Iran. Int. Sch. Res. Not., 912786.","DOI":"10.1155\/2014\/912786"},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Ulubay, M., Keskin, U., Fidan, U., Ozturk, M., Bodur, S., Y\u0131lmaz, A., Kinci, M.F., and Yenen, M.C. (2016). Safety, Efficiency, and Outcomes of Perineoplasty: Treatment of the Sensation of a Wide Vagina. Biomed. Res. Int.","DOI":"10.1155\/2016\/2495105"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1184","DOI":"10.1186\/s40064-016-2840-y","article-title":"Novel technique of vulvo-vaginal rejuvenation by lipofilling and injection of combined platelet-rich-plasma and hyaluronic acid: A case-report","volume":"5","author":"Aguilar","year":"2016","journal-title":"Springerplus"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1007\/s00266-015-0502-z","article-title":"Vaginal rejuvenation with Gore-Mycromesh","volume":"39","author":"Park","year":"2015","journal-title":"Aesthet. Plast. Surg."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"36","DOI":"10.3109\/2000656X.2014.944187","article-title":"Functional vaginal rejuvenation with elastic silikone threads: A 4year experience with 180 patients","volume":"49","author":"Park","year":"2015","journal-title":"J. Plast. Surg. Hand. Surg."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"634","DOI":"10.1111\/1471-0528.13823","article-title":"Effect of postpartum pelvic floor muscle training on vaginal symptoms and sexual dysfunction-secondary analysis of a randomised trial","volume":"123","author":"Hilde","year":"2016","journal-title":"Brit. J. Obstet. Gynecol."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1016\/0002-9378(48)90266-X","article-title":"Progressive resistance exercise in the functional restoration of the perineal muscles","volume":"56","author":"Kegel","year":"1948","journal-title":"Am. J. Obstet. Gynecol."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1111\/jocd.12524","article-title":"Review and clinical experience exploring evidence, clinical efficacy, and safety regarding nonsurgical treatment of feminine rejuvenation","volume":"17","author":"Gold","year":"2018","journal-title":"J. Cosmet. Dermatol."},{"key":"ref_33","first-page":"489","article-title":"Vaginal rejuvenation: A retrospective review of lasers and radiofrequency devices","volume":"42","author":"Korta","year":"2021","journal-title":"Dermatol. Surg."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"940","DOI":"10.1002\/lsm.22940","article-title":"Fractional CO2 laser treatment for vaginal laxity: A preclinical study","volume":"50","author":"Kwon","year":"2018","journal-title":"Lasers Surg. Med."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"129","DOI":"10.5978\/islsm.14-OR-11","article-title":"Treatment of Vaginal Relaxation Syndrome switch an Erbium: YAG Laser Using 90\u00b0 and 360\u00b0 Scanning Scopes: A Pilot Study & Short-term Results","volume":"23","author":"Lee","year":"2014","journal-title":"Laser Ther."},{"key":"ref_36","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1089\/jwh.2012.4123","article-title":"Laxity of the vaginal introitus after childbirth: Nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy","volume":"22","author":"Sekiguchi","year":"2013","journal-title":"J. Womens Health"},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Gao, L., Wen, W., Wang, Y., Li, Z., Dang, E., Yu, L., Zhou, C., Lu, M., and Wang, G. (2022). Fractional Carbon Dioxide Laser Improves Vaginal Laxity via Remodeling of Vaginal Tissues in Asian Women. J. Clin. Med., 11.","DOI":"10.3390\/jcm11175201"},{"key":"ref_38","first-page":"175","article-title":"Safety and mechanisms of action supporting nonablative radiofrequency thermal therapy for vaginal introitus laxity occurring in women after childbirth: Histological study in the sheep vaginal model","volume":"10","author":"Coad","year":"2013","journal-title":"J. Sex Med."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/19\/6234\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T20:59:57Z","timestamp":1760129997000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/19\/6234"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,27]]},"references-count":38,"journal-issue":{"issue":"19","published-online":{"date-parts":[[2023,10]]}},"alternative-id":["jcm12196234"],"URL":"https:\/\/doi.org\/10.3390\/jcm12196234","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,27]]}}}