INNOVATIVE GYN THERAPIES

Innovative therapies in gynecology: The evidence and your practice

OBG Manag. 2021 September;33(9)

References

Preti M, Viera-Baptista P, Digesu GA, et al. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: an ICS/ISSVD best practice consensus document. J Lower Genital Tract Dis. 2019;23:151-160.
Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices: AUGS clinical consensus statement. Female Pelvic Med Reconstr Surg. 2020;26:287-298.
Streicher LF. Vulvar and vaginal fractional CO2 laser treatments for genitourinary syndrome of menopause: NAMS practice pearl. Menopause. 2018;25:571-573.
Gardner AN, Aschkenazi SO. The short-term efficacy and safety of fractional CO2 laser therapy for vulvovaginal symptoms in menopause, breast cancer, and lichen sclerosus. Menopause. 2021; 28:511-516.
Balchander D, Nyirjesy P. Fractionated CO2 laser therapy in recalcitrant lichen sclerosus. J Lower Genital Tract Disease. 2020;24:225-228.
Pieralli A, Fallani MG, Becorpi A, et al. Fractional CO2 laser for vulvovaginal atrophy (VVA) dyspareunia relief in breast cancer survivors. Arch Gynecol Obstet. 2016;294:841-846.
Pieralli A, Bianchi C, Longinotti M, et al. Long-term reliability of fractionated CO2 laser as a treatment of vulvovaginal atrophy (VVA) symptoms. Arch Gynecol Obstet. 2017; 296:973-978.
Sokol ER, Karram MM. Use of novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. Menopause. 2017;24: 810-814.
Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422.
Sindou-Faurie T, Louis-Vahdat C, Oueld Es Cheikh E, et al. Evaluation of the efficacy of fractional CO2 laser in the treatment of vulvar and vaginal menopausal symptoms. Arch Gynecol Obstet. 2021;303:955-963.
Paraiso MFR, Ferrando CA, Sokol ER, at al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET trial. Menopause. 2019;27:50-56.
Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978.
Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;136:979-987.
Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;7:CD003881.
Lose G, Mouritsen L, Nielson JB. A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women. BJU Int. 2006;98:100-104.
Sokol ER, Karram MM, Dmochowski R. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. J Urol. 2014;192:843-849.
Pai A, Al-Singary W. Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid) in the management of stress and mixed urinary incontinence: three year follow up outcomes. Cent European J Urol. 2015;68:428-433.
Brosche T, Kuhn A, Lobodasch K, et al. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021;40:502-508.
Kasi AD, Pergialiotis V, Perrea DN, et al. Polyacrylamide hydrogel (Bulkamid) for stress urinary incontinence in women: a systematic review of the literature. Int Urogynecol J. 2016;27:367-375.
Vecchioli-Scaldazza CV, Smaali C, Morosetti C, et al. Polyacrylamide hydrogel (Bulkamid) in female patients of 80 or more years with urinary incontinence. Int Braz J Urol. 2014;40:37-43.
Elmelund M, Sokol ER, Darram MM, et al. Patient characteristics that may influence the effect of urethral injection therapy for female stress urinary incontinence. J Urol. 2019;202:125-131.
Sanoulis V, Nikolettos N, Vlahos N. The use of platelet-rich plasma in the gynecological clinical setting: a review. HJOG. 2019;18:55-65.
Fanning J, Murrain L, Flora R, et al. Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery. J Minim Invasive Gynecol. 2007;14:633-637.
Runels CE, Melnick H, DeBourbon E, et al. A pilot study of the effect of localized injections of autologous platelet rich plasma (PRP) for the treatment of female sexual dysfunction. J Womens Health Care. 2014;3:4.
Long CY, Lin KL, Shen CR, et al. A pilot study: effectiveness of local injection of autologous platelet-rich plasma in treating women with stress urinary incontinence. Sci Rep. 2021;11:1584.
Matz EJ, Pearlman AM, Terlecki RP. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol. 2018;59:61-65.
Neto JB. O-Shot: platelets rich plasma in intimate female treatment. J Womens Health Care. 2017;6:5.
Nikolopoulos KI, Pergialiotis V, Perrea D, et al. Restoration of the pubourethral ligament with platelet rich plasma for the treatment of stress urinary incontinence. Med Hypotheses. 2016;90:29-31.
Hersant B, SidAhmed-Mezi M, Belkacemi Y, et al. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with a history of breast cancer: a phase 2 pilot study. Menopause. 2018;25:1124-1130.
Behnia-Willison F, Pour NR, Mohamadi B, et al. Use of platelet-rich plasma for vulvovaginal autoimmune conditions like lichen sclerosus. Plast Reconstr Surg Glob Open. 2016;4:e1124.
Goldstein AT, King M, Runels C, et al. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2017;76:158-160.
Casabona F, Priano V, Vallerino V, et al. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plast Reconstr Surg. 2010;126:210e-211e.
Franic D, Iternica Z, Franic-Ivanisevic M. Platelet-rich plasma (PRP) for the treatment of vulvar lichen sclerosus in a premenopausal woman: a case report. Case Rep Womens Health. 2018;18: e0062.
Posey LK, Runels C. In office surgery and use of platelet rich plasma for the treatment of vulvar lichen sclerosus to alleviate painful sexual intercourse. J Lower Genital Tract Dis. 2017;21(4S):S14.
Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021;32:1345-1350.
Tadir Y, Gaspar A, Lev-Sagie A, et al. Light and energy based therapeutics for genitourinary syndrome of menopause: consensus and controversies. Lasers Surg Med. 2017;49:137-159.
US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation.” https://www.fda.gov/news-events/pressannouncements/statement-fda-commissioner-scott-gottlieb-mdefforts-safeguard-womens-health-deceptive-health-claims. Updated August 2, 2018. Accessed August 13, 2021.
Vicariotto F, Raichi M. Technological evolution in the radiofrequency treatment of vaginal laxity and menopausal vulvo-vaginal atrophy and other genitourinary symptoms: first experiences with a novel dynamic quadripolar device. Minerva Ginecol. 2016;68:225-236.
Kamilos MF, Borrelli CL. New therapeutic option in genitourinary syndrome of menopause: pilot study using microablative fractional radiofrequency. Einstein (Sao Paulo). 2017;15:445-551.
Caruth JC. Evaluation of the safety and efficacy of a novel radiofrequency device for vaginal treatment. Surg Technol Int. 2018;32:145-149.
Shobeiri SA, Kerkhof MH, Minassian VA, et al. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019;30:371-376.
Allan BB, Bell S, Husarek K. Early feasibility study to evaluate the Viveve system for female stress urinary incontinence: interim 6-month report. J Womens Health (Larchmt). 2020;29:383-389.
Leibaschoff G, Izasa PG, Cardona JL, et al. Transcutaneous temperature controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. Surg Technol Int. 2016;29:149-159.
Desai SA, Vakil Z, Kroumpouzos G. Transcutaneous temperature-controlled radiofrequency treatment: improvement in female genital appearance, sexual dysfunction, and stress urinary incontinence. Aesthet Surg J. 2021;sjab174. doi: 10.1093/asj/sjab174.
Slongo H, Lunardi AL, Riccetto CL, et al. Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2021. doi: 10.1007 /s00192-021-04758-2.
Krychman M, Rowan CG, Allan BB, et al. 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.
Zerbinati N, Serati M, Origoni M, et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015;30: 429-436.
Juhasz ML, Korta DZ, Mesinkovska NA. Vaginal rejuvenation: a retrospective review of lasers and radiofrequency devices. Dermatol Surg. 2021;47:489-494.
Sarmento AC, Fernandes FS, Marconi C, et al. Impact of microablative fractional radiofrequency on the vaginal health, microbiota, and cellularity of postmenopausal women. Clinics (Sao Paulo). 2020;75:e1750.

Uses for PRP in gynecology

In gynecology, dating back to 2007 PRP was shown to facilitate wound healing, when Fanning and colleagues reported PRP applications in gynecologic operative wounds, such as hysterectomies and urogynecologic procedures, to reduce postoperative pain.²³ In the last decade, there has been a dramatic increasing trend in the application of PRP injections as an alternative therapy in gynecology to improve intimate health. PRP has been used to treat lichen sclerosus, atrophic vaginitis, SUI, and female sexual dysfunction; however, there is a dearth of studies that compare PRP with traditional therapies.

Runels and colleagues described the effects of localized injections of autologous PRP for the treatment of sexual dysfunction early in 2014.²⁴ Those authors pioneered PRP use in women with dyspareunia and other symptoms related to sexual dysfunction. Women were offered PRP injections into the periurethral area of the Skene glands and the clitoris. Sexual satisfaction and pain were improved but results did not reach statistical significance. The results of this pilot study of 11 patients suggested that PRP injections could perhaps be an effective method to treat certain types of female sexual dysfunction, including desire, arousal, lubrication, and orgasm.

In another pilot study, Long and colleagues looked at the effectiveness of local injection of PRP for treating women with SUI.²⁵ In that study, younger patients with mild severity of SUI had promising results, with up to 75% cured or improved. Results in the older group, with 50% cured or improved, did not reach statistical significance. Other small, limited studies have been conducted under the hypothesis that PRP as an “O-shot” may be a promising treatment that is a safe, effective, nonsurgical, and nonhormonal option for women with dyspareunia from lack of lubrication and related sexual dysfunction, such as decreased libido or arousal.^26-29 A pilot study by Behnia-Willison and colleagues demonstrated clinical improvement in PRP use as an alternative to topical steroids for lichen sclerosus.³⁰ Several other studies also have shown efficacy for the treatment of lichen sclerosus.^31-34

More evidence of efficacy needed

To date, preliminary studies suggest that PRP holds promise for a host of gynecologic conditions. Since PRP is autologous, there are no significant contraindications, and thus far there have been no known serious adverse effects. However, most health insurers still do not cover this therapy, so for now patients must pay out-of-pocket fees for these treatments.

As we continue to investigate therapies in regenerative medicine, the continued efforts of our discipline are required to conduct well-designed prospective, randomized controlled studies. While initial series suggest that PRP is safe, it is unlikely that this therapy will be embraced widely in the paradigm as an alternative treatment option for many genitourinary symptoms of menopause and vulvar disorders until efficacy is better established.

Radiofrequency therapy

For the past 20 years, radiofrequency (RF) energy has been used through the vagina, urethra, and periurethral tissues for the treatment of genitourinary symptoms, with limited success. More recently, because some patients hesitate to receive mesh implants for treatment of urinary incontinence,³⁵ there has been gravitation to office-based procedures.

In contrast to lasers, which transmit energy through light, RF waves (measured in hertz) transform the kinetic energy of the intracellular atoms, which move and collide, generating thermal energy.^36,37 RF therapy has been shown to increase the proportion of smooth muscle and connective tissue; stimulate proliferation of the epithelium, neovascularization, and collagen formation in the lamina propria; and improve natural lubrication.^36,38 In addition, RF is:

ablative when the heat is capable of generating ablation and/or necrosis of the epidermis and dermis
microablative when energy fractionation produces microscopic columns of ablative thermal lesions in the epidermis and upper dermis, resulting in microscopic columns of treated tissue interspersed with areas of untreated skin,³⁹ and
nonablative when trauma occurs only in the dermis by heating without causing ablation of the epidermis.³⁹

The RF devices discussed below are used with settings for microablation in the treatment of SUI and sexual health/vaginal laxity, and with nonablative settings in the treatment of GSM.

RF for the treatment of urinary incontinence

Studies with RF have shown its benefits in urinary symptoms as secondary outcomes, such as improvement of SUI.^38,40 One theory that favors energy devices as a treatment for SUI is that the treatment strengthens suburethral and pubocervical support, thereby decreasing urethral mobility.⁴¹

In 2016, the Viveve system (Viveve) received FDA 510(k) clearance for “use in general surgical procedures for electrocoagulation and hemostasis.” A single-site, randomized, nonblinded pilot study compared 1 treatment (group 1) versus 2 treatments (group 2) with the Viveve system for SUI in 35 participants.⁴² At 12 months, only for group 2 did mean scores on the Incontinence Impact Questionnaire Short Form (IIQ-7) and the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) decrease by the minimum clinically important difference of 16 and 2.52 points, respectively, compared with baseline.

The ThermiVa device (ThermiGen, LLC) received FDA clearance for “use in dermatological and general surgical procedures for electrocoagulation and hemostasis” in 2017. A single-site, prospective, double-blind, randomized controlled pilot trial evaluated the efficacy of this device for the treatment of SUI in 20 participants randomly assigned in a 1:1 fashion to active and sham groups.⁴³ At 12 weeks, mean scores of the Urogenital Distress Inventory (UDI-6) and the ICIQ-UI-SF decreased by the minimal clinically important difference only in the treatment group arm. Additionally, 70% of treatment group participants had a negative stress test at 12 weeks compared with 0% of control group participants.⁴³ In another study of 48 patients who were followed longitudinally for 5 months, a substantial improvement in genital appearance was observed.⁴⁴ Assessment based on validated instruments demonstrated significant improvements in sexual function and SUI.⁴⁴

A microablative RF device (Wavetronic 6000 Touch Device, Megapulse HF FRAXX system; Loktal Medical Electronics) consists of a vaginal probe with 64 microneedles at the tip, each capable of penetrating to a depth of 1 mm. During activation, delivery of RF energy, which results in vaporization of tissue at 100 °C, occurs in a preset sequence of 8 needles at a time, preventing the overheating of intervening tissue between adjacent needles.

Slongo and colleagues conducted a 3-arm randomized clinical trial that included 117 climacteric women with SUI.⁴⁵ In group 1, treatment consisted of 3 monthly sessions of RF; group 2 received 12 weekly sessions of pelvic floor muscle training (PFMT); and group 3 received RF treatment plus PFMT simultaneously. Assessments were conducted at baseline and 30 days after the end of therapy using validated questionnaires and scales for urinary, vaginal, and sexual functions, and cytology was used to assess vaginal atrophy. The association between RF and PFMT showed significant improvement in the SUI symptoms assessed by questionnaire. The vaginal symptoms and dryness showed more substantial improvement with the RF treatment, and vaginal laxity showed similar improvement in the 3 treatment groups.⁴⁵

Continue to: RF for the treatment of GSM...

References

Preti M, Viera-Baptista P, Digesu GA, et al. The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: an ICS/ISSVD best practice consensus document. J Lower Genital Tract Dis. 2019;23:151-160.
Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices: AUGS clinical consensus statement. Female Pelvic Med Reconstr Surg. 2020;26:287-298.
Streicher LF. Vulvar and vaginal fractional CO2 laser treatments for genitourinary syndrome of menopause: NAMS practice pearl. Menopause. 2018;25:571-573.
Gardner AN, Aschkenazi SO. The short-term efficacy and safety of fractional CO2 laser therapy for vulvovaginal symptoms in menopause, breast cancer, and lichen sclerosus. Menopause. 2021; 28:511-516.
Balchander D, Nyirjesy P. Fractionated CO2 laser therapy in recalcitrant lichen sclerosus. J Lower Genital Tract Disease. 2020;24:225-228.
Pieralli A, Fallani MG, Becorpi A, et al. Fractional CO2 laser for vulvovaginal atrophy (VVA) dyspareunia relief in breast cancer survivors. Arch Gynecol Obstet. 2016;294:841-846.
Pieralli A, Bianchi C, Longinotti M, et al. Long-term reliability of fractionated CO2 laser as a treatment of vulvovaginal atrophy (VVA) symptoms. Arch Gynecol Obstet. 2017; 296:973-978.
Sokol ER, Karram MM. Use of novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. Menopause. 2017;24: 810-814.
Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422.
Sindou-Faurie T, Louis-Vahdat C, Oueld Es Cheikh E, et al. Evaluation of the efficacy of fractional CO2 laser in the treatment of vulvar and vaginal menopausal symptoms. Arch Gynecol Obstet. 2021;303:955-963.
Paraiso MFR, Ferrando CA, Sokol ER, at al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET trial. Menopause. 2019;27:50-56.
Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978.
Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;136:979-987.
Kirchin V, Page T, Keegan PE, et al. Urethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev. 2017;7:CD003881.
Lose G, Mouritsen L, Nielson JB. A new bulking agent (polyacrylamide hydrogel) for treating stress urinary incontinence in women. BJU Int. 2006;98:100-104.
Sokol ER, Karram MM, Dmochowski R. Efficacy and safety of polyacrylamide hydrogel for the treatment of female stress incontinence: a randomized, prospective, multicenter North American study. J Urol. 2014;192:843-849.
Pai A, Al-Singary W. Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid) in the management of stress and mixed urinary incontinence: three year follow up outcomes. Cent European J Urol. 2015;68:428-433.
Brosche T, Kuhn A, Lobodasch K, et al. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021;40:502-508.
Kasi AD, Pergialiotis V, Perrea DN, et al. Polyacrylamide hydrogel (Bulkamid) for stress urinary incontinence in women: a systematic review of the literature. Int Urogynecol J. 2016;27:367-375.
Vecchioli-Scaldazza CV, Smaali C, Morosetti C, et al. Polyacrylamide hydrogel (Bulkamid) in female patients of 80 or more years with urinary incontinence. Int Braz J Urol. 2014;40:37-43.
Elmelund M, Sokol ER, Darram MM, et al. Patient characteristics that may influence the effect of urethral injection therapy for female stress urinary incontinence. J Urol. 2019;202:125-131.
Sanoulis V, Nikolettos N, Vlahos N. The use of platelet-rich plasma in the gynecological clinical setting: a review. HJOG. 2019;18:55-65.
Fanning J, Murrain L, Flora R, et al. Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery. J Minim Invasive Gynecol. 2007;14:633-637.
Runels CE, Melnick H, DeBourbon E, et al. A pilot study of the effect of localized injections of autologous platelet rich plasma (PRP) for the treatment of female sexual dysfunction. J Womens Health Care. 2014;3:4.
Long CY, Lin KL, Shen CR, et al. A pilot study: effectiveness of local injection of autologous platelet-rich plasma in treating women with stress urinary incontinence. Sci Rep. 2021;11:1584.
Matz EJ, Pearlman AM, Terlecki RP. Safety and feasibility of platelet rich fibrin matrix injections for treatment of common urologic conditions. Investig Clin Urol. 2018;59:61-65.
Neto JB. O-Shot: platelets rich plasma in intimate female treatment. J Womens Health Care. 2017;6:5.
Nikolopoulos KI, Pergialiotis V, Perrea D, et al. Restoration of the pubourethral ligament with platelet rich plasma for the treatment of stress urinary incontinence. Med Hypotheses. 2016;90:29-31.
Hersant B, SidAhmed-Mezi M, Belkacemi Y, et al. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with a history of breast cancer: a phase 2 pilot study. Menopause. 2018;25:1124-1130.
Behnia-Willison F, Pour NR, Mohamadi B, et al. Use of platelet-rich plasma for vulvovaginal autoimmune conditions like lichen sclerosus. Plast Reconstr Surg Glob Open. 2016;4:e1124.
Goldstein AT, King M, Runels C, et al. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2017;76:158-160.
Casabona F, Priano V, Vallerino V, et al. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plast Reconstr Surg. 2010;126:210e-211e.
Franic D, Iternica Z, Franic-Ivanisevic M. Platelet-rich plasma (PRP) for the treatment of vulvar lichen sclerosus in a premenopausal woman: a case report. Case Rep Womens Health. 2018;18: e0062.
Posey LK, Runels C. In office surgery and use of platelet rich plasma for the treatment of vulvar lichen sclerosus to alleviate painful sexual intercourse. J Lower Genital Tract Dis. 2017;21(4S):S14.
Stachowicz AM, Hoover ML, Karram MM. Clinical utility of radiofrequency energy for female genitourinary dysfunction: past, present, and future. Int Urogynecol J. 2021;32:1345-1350.
Tadir Y, Gaspar A, Lev-Sagie A, et al. Light and energy based therapeutics for genitourinary syndrome of menopause: consensus and controversies. Lasers Surg Med. 2017;49:137-159.
US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, MD, on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation.” https://www.fda.gov/news-events/pressannouncements/statement-fda-commissioner-scott-gottlieb-mdefforts-safeguard-womens-health-deceptive-health-claims. Updated August 2, 2018. Accessed August 13, 2021.
Vicariotto F, Raichi M. Technological evolution in the radiofrequency treatment of vaginal laxity and menopausal vulvo-vaginal atrophy and other genitourinary symptoms: first experiences with a novel dynamic quadripolar device. Minerva Ginecol. 2016;68:225-236.
Kamilos MF, Borrelli CL. New therapeutic option in genitourinary syndrome of menopause: pilot study using microablative fractional radiofrequency. Einstein (Sao Paulo). 2017;15:445-551.
Caruth JC. Evaluation of the safety and efficacy of a novel radiofrequency device for vaginal treatment. Surg Technol Int. 2018;32:145-149.
Shobeiri SA, Kerkhof MH, Minassian VA, et al. IUGA committee opinion: laser-based vaginal devices for treatment of stress urinary incontinence, genitourinary syndrome of menopause, and vaginal laxity. Int Urogynecol J. 2019;30:371-376.
Allan BB, Bell S, Husarek K. Early feasibility study to evaluate the Viveve system for female stress urinary incontinence: interim 6-month report. J Womens Health (Larchmt). 2020;29:383-389.
Leibaschoff G, Izasa PG, Cardona JL, et al. Transcutaneous temperature controlled radiofrequency (TTCRF) for the treatment of menopausal vaginal/genitourinary symptoms. Surg Technol Int. 2016;29:149-159.
Desai SA, Vakil Z, Kroumpouzos G. Transcutaneous temperature-controlled radiofrequency treatment: improvement in female genital appearance, sexual dysfunction, and stress urinary incontinence. Aesthet Surg J. 2021;sjab174. doi: 10.1093/asj/sjab174.
Slongo H, Lunardi AL, Riccetto CL, et al. Microablative radiofrequency versus pelvic floor muscle training for stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2021. doi: 10.1007 /s00192-021-04758-2.
Krychman M, Rowan CG, Allan BB, et al. 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.
Zerbinati N, Serati M, Origoni M, et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015;30: 429-436.
Juhasz ML, Korta DZ, Mesinkovska NA. Vaginal rejuvenation: a retrospective review of lasers and radiofrequency devices. Dermatol Surg. 2021;47:489-494.
Sarmento AC, Fernandes FS, Marconi C, et al. Impact of microablative fractional radiofrequency on the vaginal health, microbiota, and cellularity of postmenopausal women. Clinics (Sao Paulo). 2020;75:e1750.

Supreme Court Case: Dobbs v Jackson Women’s Health Organization: What you need to know

Innovative therapies in gynecology: The evidence and your practice

References

Uses for PRP in gynecology

More evidence of efficacy needed

Radiofrequency therapy

RF for the treatment of urinary incontinence

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