Intravaginal nonablative radiofrequency in the treatment of genitourinary syndrome of menopause symptoms: a single-arm pilot study

Cintia Pinheiro, Teresa Costa, Raira Amorim de Jesus, Raquel Campos, Rosa Brim, Alcina Teles, Andrea Vilas Boas, Patrícia Lordêlo, Cintia Pinheiro, Teresa Costa, Raira Amorim de Jesus, Raquel Campos, Rosa Brim, Alcina Teles, Andrea Vilas Boas, Patrícia Lordêlo

Abstract

Background: Genitourinary syndrome of menopause (GSM) involves vaginal dryness (VD), pain during sexual activity (SAPain), vaginal itching (VI), burning, pain, and symptoms in the urinary organs. Non-ablative radiofrequency (RF) is a type of current with electromagnetic waves with a thermal effect that generates an acute inflammatory process with consequent neocolagenesis and neoelastogenesis. We aimed to describe the clinical response to VD, SAPain, vaginal laxity (VL), VI, burning sensation, pain in the vaginal opening, urinary incontinence, sexual dysfunction, cytological changes, and adverse effects of non-ablative RF in patients with GSM.

Methods: This single-arm pilot study included 11 women diagnosed with GSM with established menopause. Patients with hormone replacement initiation for six months, who used a pacemaker, or had metals in the pelvic region, were excluded. Subjective measures (numeric rating scale of symptoms, Vaginal Health Index-VHI) and objective measures (vaginal maturation index-VMI, vaginal pH, sexual function by the FSFI, and urinary function by the ICIQ-SF) were used. A Likert scale measures the degree of satisfaction with the treatment. Five sessions of monopolar non-ablative RF (41°C) were performed with an interval of one week between each application. The entire evaluation was performed before treatment (T0), one month (T1), and three months (T2) after treatment. Adverse effects were assessed during treatment and at T1 and T2.

Results: The symptoms and/or signs were reduced after treatment in most patients (T1/T2, respectively): VD 90.9%/81.8%, SAPain 83.3%/66.7, VL 100%/100%, VI 100%/100%, burning 75%/87.5%, pain 75%/75%, and VHI 90.9%/81.9%. Most patients did not show changes in VMI (54.5%) and pH (63.6%) at T1, but there was an improvement in VMI in most patients (54.5%) at T2. Nine patients were satisfied, and two were very satisfied at T1. The treatment was well tolerated, and no adverse effects were observed. There was an improvement in sexual function (72.7%) and urinary function (66.7% in T1 and 83.3% in T2).

Conclusion: Intravaginal RF reduced the clinical symptoms of GSM in most patients, especially during T1, and women reported satisfaction with treatment. The technique showed no adverse effects, and there were positive effects on sexual and urinary function. Trial registration This research was registered at clinicaltrial.gov (NCT03506594) and complete registration date was posted on April 24, 2018.

Keywords: Genitourinary syndrome of menopause; Menopause; Radiofrequency.

Conflict of interest statement

All authors declare that there is no competition from financial and/or non-financial interests concerning the work described.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Radiofrequency device (Capenergy®)
Fig. 2
Fig. 2
Radiofrequency application (Capenergy®) intracavitary with semicircular movements
Fig. 3
Fig. 3
Satisfaction with the treatment of 11 patients with GSM, 1 month and 3 months after 05 radiofrequency sessions

References

    1. Ef AM. Genitourinary syndrome of menopause. Clinical. 2017;46(7):481–484.
    1. The North American Menopause Society Management of symptomatic vulvovaginal atrophy: 2013 position statement of NAMS. Menopause. 2013;20(9):888–902. doi: 10.1097/GME.0b013e3182a122c2.
    1. Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009;6(8):2133–2142. doi: 10.1111/j.1743-6109.2009.01335.x.
    1. North American Menopause Society The role of local vaginal estrogen for treatment of vaginal atrophy in postmenopausal women. Menopause. 2007;14(3):357–369. doi: 10.1097/gme.0b013e31805170eb.
    1. Sturdee DW, Panay N. Recommendations for the management of postmenopausal vaginal atrophy. Climacteric. 2010;13(6):509–522. doi: 10.3109/13697137.2010.522875.
    1. Tan O, Bradshaw K, Carr BR. Management of vulvovaginal atrophy-related sexual dysfunction in postmenopausal women. Menopause J N Am Menopause Soc. 2012;19(1):109–117. doi: 10.1097/gme.0b013e31821f92df.
    1. Lev-Sagie A. Vulvar and vaginal atrophy: physiology, clinical presentation, and treatment considerations. Clin Obstet Gynecol. 2015;58(3):476–491. doi: 10.1097/GRF.0000000000000126.
    1. Kingsberg SA, Wysocki S, Magnus L, Krychman ML. Vulvar and vaginal atrophy in postmenopausal women: findings from the REVIVE (REal Women’s VIews of Treatment Options for Menopausal Vaginal ChangEs) survey. J Sex Med. 2013;10:1790–1799. doi: 10.1111/jsm.12190.
    1. Vanaman M, Bolton J, Placik O, Fabi SG. Emerging trends in nonsurgical female genital rejuvenation. Dermatol Surg. 2016;42(9):1019–1029. doi: 10.1097/DSS.0000000000000697.
    1. Carvalho G, Silva R, Mesquita Filho J, Meyer PF, Ronzio OA, Medeiros JO, et al. Avaliação dos efeitos da radiofrequência no tecido conjuntivo. RBM. 2011;68:10–25.
    1. Lordelo P, Leal MRD, Brasil CA, Santos JM, Lima MCNPC, Sartori MGF. Radiofrequency in female external genital cosmetics and sexual function: a randomized clinical trial. Int Urogynecol J. 2016;27(11):1681–1687. doi: 10.1007/s00192-016-3020-x.
    1. Carruthers J, Fabi S, Weiss R. Monopolar radiofrequency for skin tightening. Dermatol Surg. 2014;40:S168–S173. doi: 10.1097/DSS.0000000000000232.
    1. Bachmann G. Urogenital ageing: an old problem newly recognized. Maturitas. 1995;22:S1–S5. doi: 10.1016/0378-5122(95)00956-6.
    1. Consolaro MEL, Silva MSV. Citologia hormonal. In: Citologia Clínica Cérvico-vaginal: texto e atlas. 1a ed. 2012. p. 15–30.
    1. Hentschel H, Alberton DL, Capp E, Goldim JR, Passos EP. Validação do Female Sexual Function Index (FSFI) Para Uso Em Língua Portuguesa. Rev HCPA. 2007;27(1):10–14.
    1. Abdo C. Elaboração e Validação do Quociente Sexual – versão feminina. Rev Bras Med. 2006;63(9):477–482.
    1. Tamanini JTN, Dambros M, D’Ancona CAL, Palma PCR, Rodrigues Netto N. Validação para o português do “International Consultation on Incontinence Questionnaire - Short Form” (ICIQ-SF) Rev Saúde Pública. 2004;38(3):438–44. doi: 10.1590/S0034-89102004000300015.
    1. Meric HJ. The effect of scale form choice on psychometric properties of patient satisfaction measurement. Health Mark Q. 1994;11(3–4):27–39. doi: 10.1300/J026v11n03_04.
    1. Coad JE, Vos J. Non-invasive radiofrequency tightening of the vagina in a sheep model. J Sex Med. 2010;7(Suppl 3):131.
    1. Vanaman Wilson MJ, Bolton J, Jones IT, Wu DC, Calame A, Goldman MP. Histologic and clinical changes in vulvovaginal tissue after treatment with a transcutaneous temperature-controlled radiofrequency device. Dermatol Surg. 2018;44(5):705–713. doi: 10.1097/DSS.0000000000001453.
    1. González-Suárez A, Gutierrez-Herrera E, Berjano E, Jimenez Lozano JN, Franco W. Thermal and elastic response of subcutaneous tissue with different fibrous septa architectures to RF heating: numerical study. Lasers Surg Med. 2015;47(2):183–195. doi: 10.1002/lsm.22301.
    1. Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010;85(1):87–94. doi: 10.4065/mcp.2009.0413.
    1. Mitchell CM, Waetjen LE. Genitourinary changes with aging. Obstet Gynecol Clin N Am. 2018;45(4):737–750. doi: 10.1016/j.ogc.2018.07.010.
    1. Alinsod RM. Transcutaneous temperature controlled radiofrequency for atrophic vaginitis and dyspareunia. J Minim Invasive Gynecol. 2015;22(6S):S226–S227. doi: 10.1016/j.jmig.2015.08.798.
    1. Leibaschoff G, Izasa PG, Cardona JL, Miklos JR, Moore RD. Transcutaneous Temperature Controlled Radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary Symptoms. Surg Technol Int. 2016;XXIX:149–159.
    1. Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening. J Sex Med. 2010;7:3088–3095. doi: 10.1111/j.1743-6109.2010.01910.x.
    1. Coad J, Vos J, Curtis A, Krychman M. 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. J Sex Med. 2013;10(Suppl 2):175.
    1. Kent DE, Bernardy J. Safety and mechanism of action of noninvasive radiofrequency treatment for vaginal laxity: histological study in the swine vaginal model. J Cosmet Dermatol. 2019;00:1–6.
    1. Krychman M, Rowan CG, Allan BB, DeRogatis L, Durbin S, Yacoubian A, Wilkerson D. Effect of single-treatment, surface-cooled radiofrequency therapy on vaginal laxity and female sexual function: the VIVEVE I randomized controlled trial. J Sex Med. 2017;14:215–225. doi: 10.1016/j.jsxm.2016.11.322.
    1. Alinsod RM. Temperature controlled radiofrequency for vulvovaginal laxity. Prime Int J Aesthet Anti-Ageing Med. 2015. .
    1. Clobes A, DeLancey JO, Morgan DM. Urethral circular smooth muscle in young and old women. Am J Obstet Gynecol. 2008;198:587. doi: 10.1016/j.ajog.2008.03.009.
    1. Ting AY, Blacklock AD, Smith PG. Estrogen regulates vaginal sensory and autonomic nerve density in the rat. Biol Reprod. 2004;71:1397–1404. doi: 10.1095/biolreprod.104.030023.
    1. Cagnacci A, Xholli A, Sclauzero M, Venier M, Palma F, Gambacciani M, Writing Group of the angel Study Vaginal atrophy across the menopausal age: results from the ANGEL study. Climacteric. 2019;22(1):85–89. doi: 10.1080/13697137.2018.1529748.
    1. Vos JA, Livengood RH, Jessop M, Coad JE. Non-ablative hyperthermic mesenchymal regeneration: a proposed mechanism of action based on the Viveve model. In: Ryan TP, editor. Energy-based treatment of tissue and assessment. Proceedinsg of SPIE, vol. 7901; 2011. p. 1–8.
    1. Rea W, Kapur S, Mutagi H. Radiofrequency therapies in chronic pain. Contin Educ Anaesth Crit Care Pain J. 2011;11(2):35–38. doi: 10.1093/bjaceaccp/mkq057.
    1. Nilsson K, Risbergb B, Heimerc G. The vaginal epithelium in the postmenopause: cytology, histology and pH as methods of assessment. Maturitas. 1995;21:51–56. doi: 10.1016/0378-5122(94)00863-3.
    1. Panay N. Genitourinary syndrome of the menopause: dawn of a new era? Climacteric. 2015;18(Suppl 1):13–17. doi: 10.3109/13697137.2015.1070564.
    1. Brizzolara S, Killeen J, Severino R. Vaginal pH and parabasal cells in postmenopausal women. Obstet Gynecol. 1999;94(5):700–703.
    1. Romero-Otero J, Lauterbach R, Aversa A, Serefoglu EC, García-Gómez B, Parnhan A, Skrodzka M, Krychman M, Reisman Y, Corona G, Lowenstein L. Radiofrequency-based devices for female genito-urinary indications: position statements from the European society of sexual medicine. J Sex Med. 2020;17(3):393–399. doi: 10.1016/j.jsxm.2019.12.015.
    1. Qureshi AA, Tenenbaum MM, Myckatyn TM. Nonsurgical vulvovaginal rejuvenation with radiofrequency and laser devices: a literature review and comprehensive update for aesthetic surgeons. Aesthet Surg J. 2018;38(3):302–311. doi: 10.1093/asj/sjx138.
    1. Lalji S, Lozanova P. Evaluation of the safety and efficacy of a monopolar nonablative radiofrequency device for the improvement of vulvo-vaginal laxity and urinary incontinence. J Cosmet Dermatol. 2017;00:1–5.
    1. Lordelo P, Vilas Boas A, Sodré D, Lemos A, Tozetto S, Brasil C. New concept for treating female stress urinary incontinence with radiofrequency. Int Braz J Urol Sept/Oct. 2017;43(5):896–902. doi: 10.1590/s1677-5538.ibju.2016.0621.
    1. Fitzgerald MP, Mollenhauer J, Hale DS, Benson JT, Brubaker L. Urethral collagen morphologic characteristics among women with genuine stress incontinence. Am J Obstet Gynecol. 2000;182:1565–1574. doi: 10.1067/mob.2000.107327.
    1. Coombs S, Smith I. The hawthorne effect: is it a help or hindrance in social science research? Change Transform Educ. 2003;6(1):97–111.
    1. Umscheid CA, Margolis DJ, Grossman CE. Key concepts of clinical trials: a narrative review. Postgrad Med. 2011;123(5):194–204. doi: 10.3810/pgm.2011.09.2475.
    1. Escribano JJ, González-Isaza P, Tserotas K, Athanasiou S, Zerbinati N, Leibaschoff G, Salvatore S, Sánchez-Borrego R. In response to the FDA warning about the use of photomedicine in gynecology. Lasers Med Sci. 2019;34(7):1509–1511. doi: 10.1007/s10103-019-02744-1.
    1. [No authors listed] Radiofrequency hyperthermia for cancer. Lancet. 1984;1(8382):885–6.

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