Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial

Sarmento, Ayane Cristine Alves; Fernandes, Fabíola Sephora; Costa, Ana Paula Ferreira; Medeiros, Kleyton Santos de; Crispim, Juliane de Almeida; Gonçalves, Ana Katherine

doi:10.1136/bmjopen-2020-046372

Cited by 8 publications

(13 citation statements)

References 30 publications

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“…In women undergoing hysterectomy, the onset of menopause occurs artificially, although the ovaries keep functioning. In situations of bilateral oophorectomy, menopause may be accompanied by the clinical manifestations of hypoestrogenism, occurring more frequently and more intensely than in menopause natural (5)(6)(7)(8).…”

Section: Physiopathologymentioning

confidence: 99%

“…The latter changes can provoke burning, fissuring, dyspareunia, and post-coital bleeding. Additionally, the hypoestrogenism induces a decline in the vaginal epithelium glycogen level, which is the substrate for lactobacilli ( 7 , 8 ).…”

Section: Physiopathologymentioning

confidence: 99%

“…The GSM includes symptoms such as genital alterations of dryness, burning, and irritation, sexual changes, such as the absence of lubrication, discomfort, pain, impaired function until urinary symptoms (urgency, dysuria) ( 8 , 30 , 31 ) ( Table 1 ).…”

Section: Clinical Manifestationsmentioning

confidence: 99%

“…Besides the use of standardized questionnaires and laboratory exams, such as the vaginal pH and the VMI. Questions about sexual function (including decreased libido), and dyspareunia should be including in the anamnesis ( 2 , 8 , 12 , 20 , 21 , 31 , 46 ).…”

Section: Diagnosticmentioning

confidence: 99%

“…However, a minimum number of signs/symptoms required for the diagnosis of the syndrome was not defined. One of the major concerns is that given the lack of specificity of the vulvovaginal signs and symptoms, other conditions may easily be overlooked or inappropriate treatments may be provided ( 7 , 8 ). Another critical question that needs to be taken into account is that VVA can occur also in hypoestrogenic states other than menopause: chemotherapy, pelvic radiation, progestin-only contraceptives, breastfeeding, or anti-estrogenic therapies.…”

Section: Introductionmentioning

confidence: 99%

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Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

Sarmento

Costa

Vieira‐Baptista

et al. 2021

Front. Reprod. Health

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Genitourinary syndrome of menopause (GSM) is a term used to define a compilation of signs and symptoms arising from decreased estrogenic stimulation of the vulvovaginal and lower urinary tract. Among 27–84% of women in postmenopausal are affected for symptoms of GSM, and these can unquestionably impair health, sexual function, consequently the quality of life of these women. The main signs and symptoms of GSM include, among others, burning, irritation, vulvovaginal dryness, dyspareunia, urinary symptoms of urgency, dysuria, or recurrent urinary tract infection. The diagnosis can be made through anamnesis, questionnaires, physical exams, and, sometimes, complementary exams. Objective vaginal assessment is essential and can be complemented by using the Vaginal Health Index (VHI), Vaginal Maturation Index (VMI), or vaginal pH measurement. The acknowledgment of this condition by health professionals is crucial for its identification and proper management and exclusion of other conditions that make a differential diagnosis with it.

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Section: Physiopathologymentioning

confidence: 99%

Section: Physiopathologymentioning

confidence: 99%

Section: Clinical Manifestationsmentioning

confidence: 99%

Section: Diagnosticmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

Sarmento

Costa

Vieira‐Baptista

et al. 2021

Front. Reprod. Health

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Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial

Pereira,

Almeida,

Martinho

et al. 2024

The Journal of Sexual Medicine

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Background Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. Aim The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. Methods From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. Outcomes The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. Results Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference −0.08 [95% confidence interval, −2.58 to 2.42]) in the per-protocol analysis (mean difference −0.46 [95% confidence interval, −2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. Clinical Implications Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. Strengths & Limitations The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. Conclusion After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.

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Should I stay for local hormone therapy or should I go for radiofrequency to treat vulvovaginal atrophy? A patient preference trial

Dell'Utri,

Manzoni,

Bonfanti

et al. 2024

Menopause

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Objective To compare patient satisfaction rate in postmenopausal women who chose dynamic quadripolar radiofrequency or topical estrogens as their preferred treatment for genitourinary syndrome of menopause. Methods Patients were divided into two groups according to their preference: one was treated with estrogen therapy (ET) and the other with dynamic quadripolar radiofrequency treatment (RF). All patients included fulfilled a series of validated questionnaires, at baseline and at the 6-mo follow-up, in order to evaluate the discomfort degree associated with the presence of vulvovaginal atrophy and the impact of the reported symptoms on QoL and sexuality. Results After propensity score matching, the proportion of women considering themselves satisfied with their genital health conditions was extremely small at study entry (5.2% of the RF group and 6.9% of the ET group), while at a 6-mo follow-up, it increased to 46.7% and 46.6%, respectively. No statistically significant between-group differences were found regarding mean numerical rating scale scores for dryness and dyspareunia at follow-up (5.6 ± 2.6 vs 5.3 ± 2.3, P = 0.5; and 2.9 ± 2.5 vs 3.0 ± 2.7, P = 0.46). At 6-mo follow-up, we observed no statistically significant differences between the two groups regarding the other items evaluated. RF treatment was overall well tolerated. Conclusion The use of quadripolar radiofrequency devices seems effective, but it is not associated with better clinical outcomes compared with topical hormone treatment, which is a substantially cheaper and more convenient treatment for genitourinary syndrome of menopause. Therefore, we suggest limiting the use of dynamic quadripolar radiofrequency selectively when topical estrogens are not effective, not tolerated, or contraindicated.

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Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial

Cited by 8 publications

References 30 publications

Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

Genitourinary Syndrome of Menopause: Epidemiology, Physiopathology, Clinical Manifestation and Diagnostic

Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial

Should I stay for local hormone therapy or should I go for radiofrequency to treat vulvovaginal atrophy? A patient preference trial

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