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

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.

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Intravaginal Non-Ablative Radiofrequency In The Treatment Of Genitourinary Syndrome Of Menopausesymptoms: A Phase I Clinical Trial

10.21203/rs.3.rs-244088/v1 ◽

2021 ◽

Author(s):

Cintia Pinheiro ◽

Teresa Alencar ◽

Raira Amorim ◽

Raquel Campos ◽

Rosa Brim ◽

...

Keyword(s):

Adverse Effects ◽

Sexual Function ◽

Hormone Replacement ◽

Clinical Signs ◽

Signs And Symptoms ◽

Urinary Function ◽

Vaginal Dryness ◽

Positive Effects ◽

The Impact ◽

Genitourinary Syndrome

Abstract Background: Genitourinary Syndrome of Menopause (GSM) involves vaginal dryness, dyspareunia, itching, burning, pain, and also symptoms in urinary organs. Non-ablative radiofrequency (RF) is a type of current with electromagnetic waves with the thermal effect that generates an acute inflammatory process with consequent neocolagenesis and neoelastogenesis. We aimed to describe the clinical response, cytological changes, and adverse effects of applying nonablative RF in patients with GSM and to assess sexual and urinary function after treatment. Methods: This is a pilot study with 11 women diagnosed with GSM with established menopause. Patients with hormone replacement initiation less than six months, who used a pacemaker or had metals in the pelvic region, were excluded. Subjective measures (Visual Numerical Scale-VNS of symptoms, Vaginal Health Index-VHI) and objective measures (Vaginal Maturation Index-VMI and vaginal pH) were used. Sexual function was assessed by the FSFI, and the ICIQ-SF measured the impact on urinary function. A Likert scale measured 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 weekly. Results: There was a reduction in symptoms after treatment in most patients (T1/T2, respectively): vaginal dryness 90.9%/81.8%, dyspareunia 83.3%/66.7, vaginal laxity 100%/100%, pruritus 100%/100%, burning 75%/87.5%, pain 75%/75%, and in 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 in 72.7% and in urinary function in 66.7% in T1 and 83.3% in T2. Conclusion: Intravaginal RF reduced the clinical signs and symptoms of GSM 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 (first date posted) April 24, 2018.

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New therapeutic option in genitourinary syndrome of menopause: pilot study using microablative fractional radiofrequency

Einstein (São Paulo) ◽

10.1590/s1679-45082017ao4051 ◽

2017 ◽

Vol 15 (4) ◽

pp. 445-451 ◽

Cited By ~ 9

Author(s):

Márcia Farina Kamilos ◽

Celso Luiz Borrelli

Keyword(s):

Quality Of Life ◽

Pilot Study ◽

Sexual Function ◽

World Health ◽

World Health Organization Quality ◽

Satisfaction Questionnaire ◽

Genitourinary Syndrome Of Menopause ◽

Almost All ◽

Genitourinary Syndrome

ABSTRACT Objective: To evaluate the clinical response of patients with symptoms of genitourinary syndrome of menopause after application of microablative fractional radiofrequency in the vagina and vaginal introitus. Methods: Fourteen patients with symptoms of genitourinary syndrome of menopause underwent three applications of microablative fractional radiofrequency with a 30-day interval, using the Wavetronic 6000HF-FRAXX device and a fractional vaginal electrode. The questionnaires World Health Organization Quality of Life (for quality of life evaluation), Female Sexual Function Index and Quality of Life Adapted Questionnaire in the Domain of Sexual Satisfaction (for sexual function and satisfaction evaluation) were administered before and after the applications (30 to 60 days after the last procedure), in addition to the satisfaction questionnaire after procedure. Results: There was an increase in almost all dimensions on average in quality of life, with statistical significance only in the health domain. There was a significant improvement in the sexual domains in almost all dimensions. All patients stopped using lubricant during intercourse after treatment. In the satisfaction questionnaire after treatment, we observed that the vast majority felt cured or much better (29% and 64%, respectively, total of 92.6%) and were very satisfied or satisfied (43 and 57%, respectively, total of 100%). The only patient who reported little improvement had an 18-year postmenopausal history and was treatment naïve. Conclusion: Microablative fractional radiofrequency was effective in treating symptoms of vaginal dryness and dyspareunia, and eliminated the use of vaginal lubricant during the period observed. Since this is a pilot study with a small number of patients, further studies are required to corroborate our findings and evaluate the long-term effects of microablative fractional radiofrequency on the vaginal tissue.

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Intraurethral Erbium:YAG laser for the management of urinary symptoms of genitourinary syndrome of menopause: A pilot study

Lasers in Surgery and Medicine ◽

10.1002/lsm.22826 ◽

2018 ◽

Vol 50 (8) ◽

pp. 802-807 ◽

Cited By ~ 12

Author(s):

Adrian Gaspar ◽

Sandra Maestri ◽

Joaquin Silva ◽

Hugo Brandi ◽

Daniel Luque ◽

...

Keyword(s):

Pilot Study ◽

Urinary Symptoms ◽

Genitourinary Syndrome Of Menopause ◽

Erbium:Yag Laser ◽

Genitourinary Syndrome

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Patient-reported sexual function of breast cancer survivors with genitourinary syndrome of menopause after fractional CO2 laser therapy

Menopause ◽

10.1097/gme.0000000000001738 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Allison M. Quick ◽

Filadelfiya Zvinovski ◽

Catherine Hudson ◽

Andrew Hundley ◽

Cynthia Evans ◽

...

Keyword(s):

Breast Cancer ◽

Sexual Function ◽

Cancer Survivors ◽

Laser Therapy ◽

Co2 Laser ◽

Breast Cancer Survivors ◽

Genitourinary Syndrome Of Menopause ◽

Fractional Co2 Laser ◽

Patient Reported ◽

Genitourinary Syndrome

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Non-hormonal treatment for genitourinary syndrome of menopause

Voprosy ginekologii akušerstva i perinatologii ◽

10.20953/1726-1678-2021-2-141-146 ◽

2021 ◽

Vol 20 (2) ◽

pp. 141-146

Author(s):

N.A. Tatarova ◽

◽

V.A. Linde ◽

S.N. Gusev ◽

◽

...

Keyword(s):

Quality Of Life ◽

Hormonal Treatment ◽

Therapeutic Effects ◽

Life Questionnaire ◽

Genitourinary Syndrome Of Menopause ◽

Quality Of Life Questionnaire ◽

Vulvovaginal Atrophy ◽

Positive Effects ◽

Genitourinary Syndrome

The genitourinary syndrome of menopause (GSM) is due to the development of atrophic and dystrophic processes in estrogendependent tissues and structures of the lower third of urinary tract in different periods of aging of the reproductive system. Nonhormonal treatment for GSM is considered as a first-line treatment and includes the use of gels, creams and suppositories that contribute to the restoration of hydrolipid balance, stimulating the collagen production that have an anti-inflammatory, antiseptic, regenerating effect, as well as increasing mucosal resistance and reducing the risk of adhesion of conditionally pathogenic infection. Objective. To evaluate the effectiveness, safety and acceptability of the vaginal cream for intimate hygiene EstrogialTM Plus in women with symptoms of vulvovaginal atrophy (VVA) and GSM. Patients and methods. 24 women aged 43 to 58 were examined. The inclusion criteria were the symptoms of GSM and VVA, the vaginal health index – no more than 20 points. During the course of the study, four visits were carried out, including standard observational procedures, filling the Quality of Life Questionnaire, the administration of treatment. The application of the cream Estrogial™ Plus in doses was prescribed 1 time per day on the vulvar vestibule for 30 days. The effectiveness of therapy was evaluated, all patients continued therapy for up to 60 days. According to the modified questionnaire for general clinical assessment, the state «very much improved» was revealed in 83.3% of patients with a severe form of GSM and VVA and in 66.7% with moderate VVA, «much improved» – in the rest. After treatment, 52% of patients had no symptoms of VVA, and 48% had symptoms in a mild form. Filling the Menopause-Specific Quality of Life Questionnaire (MENQOL), all 24 patients reported positive effects in the form of increased libido and reduced vaginal dryness during sexual intercourses. The study presents clinical cases of cured patients with GSM and VVA. Conclusion. The data obtained during the study make it possible to conclude that the intravaginal administration of the cream EstrogialTM Plus in doses is effective for the treatment of GSM and VVA. The proven therapeutic effects and safety of the use of local non-hormonal treatment enhance the prospects for providing treatment and preventive care for women during the menopausal transition and menopause. Key words: vulvovaginal atrophy, genitourinary syndrome of menopause, non-hormonal treatment, Estrogial™ Plus

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Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors

Maturitas ◽

10.1016/j.maturitas.2020.10.018 ◽

2021 ◽

Vol 144 ◽

pp. 37-44

Author(s):

Allison M. Quick ◽

Travis Dockter ◽

Jennifer Le-Rademacher ◽

Ritu Salani ◽

Catherine Hudson ◽

...

Keyword(s):

Pilot Study ◽

Cancer Survivors ◽

Laser Therapy ◽

Co2 Laser ◽

Gynecologic Cancer ◽

Genitourinary Syndrome Of Menopause ◽

Fractional Co2 Laser ◽

Genitourinary Syndrome

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The Effects of a Sensory Integration Programme with Applied Interactive Metronome Training for Children with Developmental Disabilities: A Pilot Study

Hong Kong Journal of Occupational Therapy ◽

10.1016/j.hkjot.2012.05.001 ◽

2012 ◽

Vol 22 (1) ◽

pp. 25-30 ◽

Cited By ~ 4

Author(s):

Hyun Ho Kim ◽

Gak Hwang Bo ◽

Byung Kook Yoo

Keyword(s):

Pilot Study ◽

Developmental Disabilities ◽

Sensory Integration ◽

Rating Scale ◽

Teacher Rating ◽

Sensory Profile ◽

Positive Effects ◽

Interactive Metronome ◽

Before And After ◽

Children With Developmental Disabilities

Objective To assess the effects of a sensory integration programme involving applied interactive metronome training in a group of children with developmental disabilities. Methods Ten children with various developmental disabilities participated in this study. Participants received sensory integration treatment in a group programme with applied interactive metronome training for 45 minutes a day for 4 weeks, exclusive of Saturday and Sunday. The treatments consisted of stimulations of the vestibular and tactile senses, and proprioceptive applied metronome training. Results The effects of the programme were evaluated via measurements of short sensory profile, Corner's teacher rating scale, and DeGangi-Berk test. The data obtained before and after the treatment were analyzed using Wilcoxon's test. The findings of this study were that there were significantly positive effects on sensory processing, concentration, motor control, bilateral coordination, and reflex integration in the study group. Conclusion Our results indicated that the sensory integration programme with applied interactive metronome training might be useful and improved the performance of the children with developmental disabilities. The results demonstrated the efficacy of this new approach. This pilot study provides new insights into the effective treatment of children with developmental disabilities.

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Efficacy and safety of long-term cabergoline treatment of antipsychotic-induced hyperprolactinemia (naturalistic study)

European Psychiatry ◽

10.1016/j.eurpsy.2016.01.571 ◽

2016 ◽

Vol 33 (S1) ◽

pp. s230-s230

Author(s):

O. Yunilaynen ◽

E. Starostina ◽

L. Dzeranova ◽

P. Baranov ◽

I. Dedov

Keyword(s):

Sexual Function ◽

Rating Scale ◽

Clinical Symptoms ◽

Psychiatric Patients ◽

Control Group ◽

Efficacy And Safety ◽

Menstrual Disorders ◽

Prospective Comparison ◽

Sf 36

IntroductionAntipsychotic-induced hyperpolactinemia (AIH) is associated with disturbing clinical symptoms, such as sexual dysfunctions, menstrual disorders and galactorrhea. Long-term studies of dopamine agonists in AIH are scarce.ObjectivesTo assess efficacy and safety of cabergoline use in psychiatric patients with AIH, including impact on sexual function and quality of life(QoL).MethodsIt was an open-labeled non-randomized naturalistic prospective comparison of cabergoline vs nо treatment in 84 chronic psychiatric patients (F/M = 77/7) with AIH. Cabergoline treatment was started in 44 patients, the сontrol group included 40 patients who rejected the treatment with cabergoline. For assessment of QoL, sexual dysfunction and other hyperprolactinemia symptoms, UKU side effects rating scale (UKU) and SF-36 were used.ResultsThe main and control groups were comparable on all main clinical and psychiatric characteristics. The effective cabergoline dose was 0,25-3 (median-0,5) mg weekly; total cabergoline exposure–534 patient-weeks. Normal prolactin levels were achieved after 4-44 (median-14) weeks in 95% of patients. At 3 months after cabergoline discontinuation, prolactin remained normal in 71%, and AIH recurred in 29% of patients. Prolactin normalization was associated with significant reduction of menstrual disorders, galactorrhea, improvement of UKU scores on sexual desire, orgastic dysfunction, total UKU score and SF-36 scores on subscales of social functioning (P = 0,006), role-emotional (P = 0,042), and mental health (P = 0,049). The rate of psychosis exacerbation in control group was higher than in the treatment group (37,5% vs 0%; P < 0,001).ConclusionsCabergoline is effective and safe in majority of AIH patients. Long-term cabergoline treatment is not associated with psychosis exacerbation. Beyond reversal of typical AIH symptoms, treatment with cabergolin improves sexual function and QoL.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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