Vaginal microbiomes of breast cancer survivors treated with aromatase inhibitors with and without vulvovaginal symptoms.

Genitourinary syndrome of menopause (GSM) is the leading cause of vaginal symptoms in breast cancer survivors treated with aromatase inhibitors. However, there are currently no effective treatment options available for women with a history of breast cancer. Recent research has established that changes in the vaginal microbiome may be linked to GSM. Most studies have assessed the microbiome without accounting for the estrogen status. It remains unknown whether the vaginal microbiome differ among patients with a low estrogenic state with and without vulvovaginal symptoms. To address such research questions, our study compares the vaginal microbiomes among breast cancer survivors treated with aromatase inhibitors with and without vulvovaginal symptoms. A total of 50 breast cancer survivors treated with aromatase inhibitors were recruited, among whom 25 had vulvovaginal symptoms and 25 had no vulvovaginal symptoms. Vaginal swabs were collected. DNA extraction, followed by sequencing of the V3-V4 regions of the 16S ribosomal RNA gene, were performed. Differential abundance analysis was conducted by linear discriminant analysis effect size. Taxonomy assignment, alpha diversity and beta diversity were examined. The relative abundance of genus Sneathia and genus Gardnerella was significantly increased in vulvovaginal symptoms group with no differences in bacterial diversity and richness.

Defecatory dysfunction and anal incontinence symptoms among women with pelvic organ prolapse: 5-year retrospective study in a tertiary center.

OBJECTIVE: To investigate the prevalence of DD and AI with POP symptoms in females attending a urogynecology clinic, and to identify factors associated with DD and AI in POP symptoms patients. METHODS: Computer-based medical records of women with POP symptoms attending a urogynecology clinic in a referral tertiary center between January 2016 and December 2020 were reviewed. Demographic data were collected. Selected defecatory dysfunction (DD) and anal incontinence (AI) were recorded. The associations between patient characteristics, site and severity of prolapse, and DD and AI symptoms in POP patients were investigated for identified associated factors. RESULTS: The mean age of the 754 participants was 65.77 ± 9.44 years. Seven hundred and fifteen (94.83%) were menopause. The prevalence of DD and AI in patients with POP symptoms was 44.03% (332/754) and 42.04% (317/754) according to the PFBQ and medical history records, respectively. Advanced posterior wall prolapse (OR 1.59, 95% CI 1.10-2.30) and wider GH (OR1.23, 95% CI 1.05-1.43) were identified as risk factors for DD by multivariate analysis. Additionally, single-compartment prolapse (OR 0.4, 95% CI 0.21-0.76) and a stronger pelvic floor muscle assessed with brink score (OR 0.94, 95% CI 0.88-0.98) are protective factors for AI. CONCLUSION: DD and AI are prevalent among women with POP symptoms who visit a urogynecology clinic. DD should be evaluated in women with POP symptoms especially in women with increased genital hiatus and point Ap beyond the hymen. To prevent AI, women with POP should be encouraged to perform pelvic floor muscle training in order to increase pelvic floor muscle strength.

Autologous platelet rich plasma (A-PRP) combined with pelvic floor muscle training for the treatment of female stress urinary incontinence (SUI): A randomized control clinical trial.

IMPORTANCE: Autologous platelet-rich plasma (A-PRP) injection is a novel intervention for stress urinary incontinence (SUI) in women. However, no Phase II clinical trial has compared the outcomes of A-PRP injection combined with pelvic floor muscle training (PFMT) with those of PFMT alone in these women. OBJECTIVE: The primary aim was to compare the efficacy of A-PRP + PFMT versus PFMT alone in women with SUI. The secondary aim was to determine any adverse effects of A-PRP injection. DESIGN: Randomized clinical trial, single-blind assessment. SETTING: Urogynecology clinic at a tertiary medical center. PARTICIPANTS: Women with previously untreated SUI. Women in whom there was any suspicion of urgency, those with an Overactive Bladder Symptoms Score of ≥1, and those with obesity, pelvic organ prolapse, thrombocytopenia, or coagulopathy were excluded. INTERVENTIONS: Two injections of A-PRP were administered with a 1-month interval between injections in the A-PRP injection + PFMT group. Both groups received PFMT. MAIN OUTCOMES AND MEASURES: The primary outcome was determined using the 1-h pad weight test (PWT). Secondary outcomes were measured using the Incontinence Quality of Life Questionnaire, item 11 on the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms questionnaire, Patient Global Impression of Improvement, and the percentage subjective improvement score. RESULTS: Data for 60 study participants were available for analysis (A-PRP + PFMT group, n = 31; PFMT group, n = 29). The 1-h PWT decreased significantly in the A-PRP + PFMT group but only slightly in the PFMT group at the 5-month follow-up. There was a statistically significant between-group difference in the 1-h pad weight of about 8 g in favor of the A-PRP + PFMT group. A statistically significant difference in symptoms of SUI measured by the questionnaires was found between the A-PRP + PFMT group and the PFMT group at the 2- and 5-month follow-up assessments. There were no reports of adverse events following injection of A-PRP. CONCLUSIONS AND RELEVANCE: A-PRP + PFMT could be a treatment option for women with SUI. Large Phase III randomized controlled trials are required to confirm our findings.

Effects of an animated educational video on knowledge of cell-free DNA screening among Thai pregnant women: a randomized control trial.

BACKGROUND: In developing countries, pregnant women have insufficient knowledge about cell-free DNA screening. Reports from developed countries have found that various tools in prenatal genetic counseling can improve the knowledge of pregnant women who undergo cell-free DNA screening. Data are limited from developing countries where women have different baseline socio-educational backgrounds. The objective of this study was to compare the effects of an animated educational video combined with traditional counseling versus traditional counseling alone in changing pregnant women's knowledge of cell-free DNA screening. METHODS: This study was a randomized control trial at an antenatal clinic. Eligible subjects who were Thai pregnant women, were randomized to either view or not view the 4-minute animated educational video explaining cell-free DNA screening. Both groups received traditional counseling. The women were asked to complete a Thai questionnaire assessing knowledge of the screening before and after intervention. The questionnaire consisted of three sections: demographic data of the research participants and their existing awareness about cell-free DNA testing; performance and limitations of cell-free DNA screening; and participants' attitudes toward the positive screening. Primary outcome was the change in knowledge scores. Secondary outcomes were attitudes toward positive screening test, levels of satisfaction with counseling, and screening acceptance rates. RESULTS: Data from 83 women in the video group and 82 in the non-video group were analyzed. The knowledge score (range 0-18) change after counseling was significantly higher in the video group than the non-video group (+ 7.1 ± 3.3 vs + 4.2 ± 2.5; p = 0.03). There were no significant differences in attitudes toward positive screening test (p = 0.83), levels of satisfaction (p = 0.24), or screening acceptance rates (p = 0.15) between the groups. CONCLUSIONS: Adding the video to traditional counseling was better than traditional counseling alone in improving pregnant women's knowledge about cell-free DNA screening. TRIAL REGISTRATION: The study was retrospectively registered with the Thai Clinical Trials Registry (TCTR20210917001, 17/09/2021).

Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial.

Introduction and Hypothesis: Low-energy radiofrequency (RF) thermal vaginal therapy for vaginal laxity and the genitourinary syndrome of menopause denatures collagen fibrils in the endopelvic fascia; fiber tightening during healing may stabilize the urethra and bladder neck, thereby resolving female stress urinary incontinence (SUI), especially in postmenopausal women. This study compared RF vaginal therapy with sham treatment for mild to moderate SUI. Methods: This double-blinded, randomized controlled trial, conducted at a tertiary center from September 2018 to April 2021, recruited postmenopausal women with mild to moderate degree of SUI who had never undergone surgery, energy-based therapy, or vaginal estrogen treatment. The intervention group received vaginal RF laser treatment; the sham group did not. The primary outcome was the 1-hour pad-weight test (PWT) result. Secondary outcomes were Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Patient Global Impression of Improvement (PGI-I), percentage of improvement among all participants, and adverse events. Data were analyzed using STATA 17.0. Results: Forty-nine participants randomized to RF (n = 23) and sham (n = 26) groups were eligible for analysis. PWT decreased during follow-up in the RF group but remained stable in the sham group; PWT did not significantly differ between groups. The 1-year post-treatment success rate was higher in the RF group (69.6%) than in the sham group (38.5%). At 1 year post-treatment, there were no statistically significant differences in any secondary outcomes. Conclusion: Low-energy RF vaginal therapy is an alternative treatment for mild to moderate SUI in postmenopausal women without serious adverse events. Larger randomized controlled trials should be conducted.

Mobile Application Based Pelvic Floor Muscle Training for Treatment of Stress Urinary Incontinence: An Assessor-Blind, Randomized, Controlled Trial.

A first-line treatment for stress urinary incontinence (SUI) is pelvic floor muscle training (PFMT) for at least three months. The key problem is that patients do not understand the importance of these exercises and their effectiveness. Mobile health apps offer new possibilities to increase treatment adherence. This study compared a reduction in SUI, exercise adherence, and quality of life in PFMT with animation vs. standard instruction. A prospective, single-blind, randomized control trial was collected. SUI patients were randomized into the application or control groups confirmed using a one-hour pad test. In the intervention group, the PFMT application was applied via mobile phone (PFMT with animations, recording system, and reminder system). The standard exercise protocol was similar in both groups. Additional follow-up was conducted at 4, 8, and 12 weeks. A total of 51 participants were randomized to the application (n = 26) and control groups (n = 25), respectively. At the 12-week follow-up, there was no significant difference between the two groups in terms of SUI cure rate, SUI severity by pad test, and daily SUI episodes from the bladder diary (p-value of 0.695, 0.472, and 0.338, respectively). The mean PFME adherence in the application group was higher than the control group at 8 weeks (66.3 ± 13.6 vs. 52.7 ± 16.6, p = 0.002) and 12 weeks (59.1 ± 13.9 vs. 37.8 ± 11.0, p = 0.001). The application group reported no difference from the conventional PFMT group in terms of improvements in SUI cure rate, symptom severity, and quality of life effects at 12-week follow-up. However, the improvement evaluated by the mean difference in SUI episodes and quality of life effects (ICIQ-UI SF) reported a better outcome in the mobile app group. The PFMT application has been proven to be an effective tool that improves PFMT adherence.

A Retrospective Cohort Study on the Prevalence, Risk Factors, and Improvement of Overactive Bladder Symptoms in Women with Pelvic Organ Prolapse.

Background: Overactive bladder (OAB) symptoms are common in women with pelvic organ prolapse (POP), but the explanation is unclear. It is also uncertain whether OAB symptoms improve or persist after POP reduction. This study aimed to determine the prevalence and risk factors for OAB symptoms in women with POP, and to compare the improvement of OAB symptoms among women in three treatment groups: pelvic floor exercise, pessary, and surgery. Methods: This retrospective cohort study included patients who visited our urogynecology clinic from January 2016 to December 2020. The Pelvic Floor Bother Questionnaire was used to evaluate selected pelvic floor symptoms (OAB and POP). Demographic characteristics and clinical findings, including Pelvic Organ Prolapse Quantification System and number of prolapsed compartments, were analyzed. Univariate and multivariate analyses were conducted to identify risk factors for OAB symptoms in women with POP. Subgroup analyses were performed in 533 patients to evaluate the improvement of OAB symptoms following POP treatment. Results: A total of 754 patients were analyzed. The incidence of OAB symptoms was 70% (533/754) and two-thirds (65%) reported moderate to severe bother. The lowest points of the anterior wall (OR 0.60; 95% CI 0.41-0.87; p = 0.01), longer perineal body (OR 0.78; 95% CI 0.21-0.76; p = 0.02), and previous vaginal delivery (OR 2.10; 95% CI 1.14-3.89; p = 0.02) were identified as significant risk factors. In the subgroup analyses, improvement in OAB symptoms was observed in 36.6% (195/533) of women who underwent POP treatment. Compared with pelvic floor exercise, pessary (OR 1.40; 95% CI 0.94-2.07; p = 0.10) and surgery (OR 1.30; 95% CI 0.80-2.12; p = 0.28) had higher odd ratios but the effects were not significant. Conclusion: The prevalence of OAB symptoms in women with POP was high at 70%. Improvement in OAB symptoms was observed in one-third of women who underwent POP treatment. However, there were no significant differences between the treatment methods.

Quality of Life After Treatment for Pelvic Organ Prolapse: Vaginal Pessary versus Surgery.

Background: Pelvic organ prolapse (POP) is quite common and has an impact on quality of life (QoL). The evaluation of QoL after treatment for prolapse is important. The objective was to compare patient's prolapse symptoms, functional outcomes, and quality of life between pessary and surgery using standardized questionnaires at 1 and 6 months after treatment. Methods: We conducted a prospective study including women with symptomatic POP who chose pessary or surgery as the first-line treatment. We evaluated QoL using the International Consultation on Incontinence Questionnaire-Vaginal Symptoms and Prolapse Quality of Life questionnaires. Results: Seventy-two participants were enrolled, with 36 in each group. Body mass index, menopausal status, marital status, number of vaginal deliveries, and stage of pelvic organ prolapse were not significantly different between the groups. At 1 and 6 months after treatment, participants in both groups reported significant improvement in prolapse symptoms, functional outcomes, and overall quality of life. At 1 month after treatment, absolute changes in vaginal symptom scores in the pessary and surgery groups were -16.67 and -19.03, respectively (p > 0.05); at 6 months, the absolute changes were -19.21 and -19.25, respectively (p > 0.05). Significant improvement was only found in role limitation and physical and social domains at both follow-up times after surgery. Conclusion: At 1 and 6 month(s) after treatment, women with symptomatic POP reported substantial improvement in prolapse symptoms and functional outcomes when treated with pessary or surgical correction.

Attitudes and barriers to pelvic floor muscle exercises of women with stress urinary incontinence.

BACKGROUND: Pelvic floor muscle exercise (PFME) is a first-line treatment for stress urinary incontinence (SUI), but adherence to PFME is often problematic. The aim of this study was to better understand the attitudes and barriers to practicing pelvic floor muscle exercise among women with SUI. METHODS: We conducted a qualitative study using semi-structured interviews. Purposive sampling was used to approach eligible participants. The interview included questions focused on women's perceptions regarding SUI and PFME, sources of information, support, and barriers and motivators of PFME. In-depth interviews were conducted until data saturation occurred. After several readings of written interview transcripts, codes were retrieved, and thematic analysis was conducted. RESULTS: Seven women participated in the study (average age 53.2 years), and most (4/7) were retired. Three salient themes emerged from the data: (1) perception of SUI, (2) barriers to PFME, and (3) motivators to exercise. Participants highlighted various barriers to PFME: (1) lack of self-discipline owing to both intrinsic and extrinsic factors, (2) lack of confidence in how to perform the exercises properly, and (3) skepticism regarding the efficacy of treatment according to women's direct and indirect experiences. Achievement of desired outcomes, symptom severity, women's expectations, and fear of surgery were motivators to regularly perform PFME. CONCLUSIONS: The main barriers to regular PFME were inadequate self-discipline, knowledge, and confidence in performing the exercises, and a poor perception about the effectiveness of PFME.

Factors influencing parental decisions to terminate pregnancies following prenatal diagnoses of major fetal anomalies at Ramathibodi Hospital, Bangkok, Thailand.

BACKGROUND: The rate of termination of pregnancy (TOP) for fetal anomalies and the factors affecting TOP vary among different populations. Optimisation of prenatal care and counselling requires understanding the factors influencing parental decisions in the relevant population. This study aimed to evaluate the rate of TOP after diagnoses of major fetal anomalies and assess factors associated with TOP-related decisions at a university hospital in Thailand. METHODS: A retrospective chart review was conducted at the Fetal Anomaly Clinic of Ramathibodi Hospital, Bangkok, Thailand. Medical records of all women with singleton pregnancies prenatally diagnosed with major fetal anomalies before 24 gestational weeks between 2010 and 2020 were reviewed. RESULTS: During the study period, 461 cases of major fetal anomalies were diagnosed, and 264 (57.3%) of these pregnancies were terminated. Three factors influencing parental TOP decisions were lethal anomalies (odds ratio [OR], 197.39; 95% confidence interval [CI], 49.95-779.95; p < 0.001), presence of genetic abnormalities (OR, 10.19; 95% CI, 4.17-24.87; p < 0.001) and gestational age at diagnosis (OR, 0.74; 95% CI, 0.65-0.84; p < 0.001). CONCLUSIONS: Over half of the pregnant women whose records were reviewed and who were prenatally diagnosed with major fetal anomalies terminated their pregnancies. Fetal factors, particularly lethality, genetic abnormalities and early gestational age at diagnosis, showed the most powerful associations with parental TOP decisions. Other maternal background factors were not key considerations.

Validation of the Thai version of the Female Genital Self-Image Scale (FGSIS).

BACKGROUND: Female genital self-image is associated with sexual health, sexual behavior, and gynecologic health behavior. The Female Genital Self-Image Scale (FGSIS) is a simple, validated instrument that quantifies genital self-image in women. The study aim was to translate the original English FGSIS into Thai and test its psychometric properties among Thai-speaking women. METHODS: A cross-sectional, psychometric study of sexually active women attending a health check-up clinic at a university hospital in Thailand was conducted. On a volunteer basis and convenience sampling, 90 sexually active women were recruited between December 2020 and January 2021. Translation and transcultural adaptation of the English FGSIS into Thai were performed. The validity and reliability of the Thai FGSIS were assessed by examining content validity, face validity, internal consistency, construct validity, and test-retest reliability. The content validity of the Thai FGSIS was evaluated by assessing missing values, and internal consistency was evaluated using Cronbach's alpha. Scores on the FGSIS and the Female Sexual Function Index (FSFI) were compared to examine convergent validity (using Pearson correlations). Confirmatory factor analysis (CFA) was also conducted. Test-retest reliability was measured by re-administering the Thai FGSIS to the same group of respondents after a 2-week interval. RESULTS: The final Thai FGSIS was developed and assessed by a panel of experts. Data were examined for 86 respondents with average age of 32.5 ± 9.11 years. Content validity assessed using the level of missing data demonstrated no missing items. The overall internal consistency was high (Cronbach's alpha: 0.847). Strong correlations (r = 0.61-0.83) between FSFI and FGSIS total scores (p < 0.01) were demonstrated. In addition, five domains of sexual functioning and the FSFI total score showed high correlations ranging from r = 0.089 to r = 0.383 (p < 0.05), which confirmed convergent validity. CFA identified a two-factor structure for the Thai FGSIS. The test-retest reliability for 38 participants was 0.937 (p < 0.05). CONCLUSION: The Thai FGSIS was found to be a highly valid and reliable instrument with which to measure female genital self-image in Thai-speaking women.

Effects of Pueraria mirifica on vaginal artery vascularization in postmenopausal women with genitourinary syndrome of menopause.

OBJECTIVE: To compare the effects of 6% Pueraria mirifica vaginal gel with those of placebo gel on vaginal blood flow, vaginal maturation index (VMI), vaginal health index (VHI), endometrial thickness and genitourinary symptoms in postmenopausal women. STUDY DESIGN: In a randomized, double-blinded, placebo-controlled study (TCTR20200624007), 72 postmenopausal women were randomized into the P. mirifica or the placebo gel group. Both groups were followed up at week 4 and week 12. MAIN OUTCOME MEASURE: Doppler ultrasonography pulsatility index (PI) and resistance index (RI), VMI, VHI, endometrial thickness and genitourinary symptoms were evaluated at baseline, at week 4 and week 12 of treatment. RESULTS: Sixty-three participants completed the study. After 4 and 12 weeks of treatment, PI and RI had significantly decreased in the P. mirifica group compared with the placebo group. At week 12, PI in the P. mirifica group and in the placebo group were 3.03 + 1.09 and 6.88 + 2.16, respectively (p = 0.002). Similar changes were also demonstrated in the resistance indices. The P. mirifica group demonstrated a markedly higher mean VMI at week 12 compared with the placebo group, 55.19 ± 18.53 and 20.29 ± 28.46 (p = 0.012). In addition, all parameters of VHI based on the vaginal physical findings at week 12 in the P. mirifica group were significantly higher than in the placebo group (p < 0.001). CONCLUSION: In this study, 6% P. mirifica vaginal gel for 12 weeks in postmenopausal women with GSM appeared to increase vaginal artery circulation and restore atrophic vaginal tissue. CLINICAL TRIAL REGISTRATION NUMBER: TCTR20200624007.

International Urogynecological Consultation (IUC): pathophysiology of pelvic organ prolapse (POP).

INTRODUCTION AND HYPOTHESIS: This manuscript is the International Urogynecology Consultation (IUC) on pelvic organ prolapse (POP) chapter one, committee three, on the Pathophysiology of Pelvic Organ Prolapse assessing genetics, pregnancy, labor and delivery, age and menopause and animal models. MATERIALS AND METHODS: An international group of urogynecologists and basic scientists performed comprehensive literature searches using pre-specified terms in selected biomedical databases to summarize the current knowledge on the pathophysiology of the development of POP, exploring specifically factors including (1) genetics, (2) pregnancy, labor and delivery, (3) age and menopause and (4) non-genetic animal models. This manuscript represents the summary of three systematic reviews with meta-analyses and one narrative review, to which a basic scientific comment on the current understanding of pathophysiologic mechanisms was added. RESULTS: The original searches revealed over 15,000 manuscripts and abstracts which were screened, resulting in 202 manuscripts that were ultimately used. In the area of genetics the DNA polymorphisms rs2228480 at the ESR1 gene, rs12589592 at the FBLN5 gene, rs1036819 at the PGR gene and rs1800215 at the COL1A1 gene are significantly associated to POP. In the area of pregnancy, labor and delivery, the analysis confirmed a strong etiologic link between vaginal birth and symptoms of POP, with the first vaginal delivery (OR: 2.65; 95% CI: 1.81-3.88) and forceps delivery (OR: 2.51; 95% CI: 1.24-3.83) being the main determinants. Regarding age and menopause, only age was identified as a risk factor (OR : 1.102; 95% CI: 1.02-1.19) but current data do not identify postmenopausal status as being statistically associated with POP. In several animal models, there are measurable effects of pregnancy, delivery and iatrogenic menopause on the structure/function of vaginal support components, though not on the development of POP. CONCLUSIONS: Genetics, vaginal birth and age all have a strong etiologic link to the development of POP, to which other factors may add or protect against the risk.

Factors Predicting Successful Vaginal Delivery Following Induction of Labor in Term Pregnancy.

PURPOSE: This study was proposed to evaluate factors predicting a successful vaginal delivery following labor induction and develop induction prediction model in term pregnancy among Thai pregnant women. PATIENTS AND METHODS: We conducted a retrospective cohort study using electronic medical records of 23,833 deliveries from April 2010 to July 2021 at tertiary care university hospital in Bangkok, Thailand. Univariate regression was performed to identify the association of individual parameters to successful vaginal delivery. Multiple logistic regression analysis of all possible variables from univariate analysis was performed to develop a prediction model with statistically significant of p value <0.05. RESULTS: Of the total 809 labor-induced pregnancies, the vaginal delivery rate was 56.6%. Among predicting variables, history of previous vaginal delivery (aOR 5.75, 95% CI 3.701-8.961), maternal delivery BMI <25 kg/m2 (aOR 2.010, 95% CI 1.303-3.286), estimated fetal weight <3500 g (aOR 2.193, 95% CI 1.246-3.860), and gestational age ≤39 weeks (aOR 1.501, 95% CI 1.038-2.173) significantly increased the probability of a successful vaginal delivery following labor induction. The final prediction model has been internally validated. Model calibration and discrimination were satisfactory with Hosmer-Lemeshow test P = 0.21 and with AUC of 0.756 (95% CI 0.695-0.816). CONCLUSION: This study determined the pragmatic predictors for successful vaginal delivery following labor induction comprised history of previous vaginal delivery, maternal delivery BMI <25 kg/m2, estimated fetal weight <3500 g, and gestational age ≤39 weeks. The final induction prediction model was well-performing internally validated prediction model to estimate individual probability when undergoing induction of labor. Despite restricted population, the predicting factors and model could be useful for further prospective study and clinical practice to improve induction outcomes.

The efficacy and safety of a combined multipolar radiofrequency with pulsed electromagnetic field technology for the treatment of vaginal laxity: a double-blinded, randomized, sham-controlled trial.

Non-invasive vaginal rejuvenation with radiofrequency (RF) and lasers devices have gained popularity, but well-designed studies confirming their effectiveness are lacking. The aim of this study was to compare the efficacy and safety of a multipolar RF and pulsed electromagnetic field-based device (PEMF) versus sham for vaginal laxity. Thirty-two premenopausal females with ≥ 1 vaginal delivery and self-reported vaginal laxity were randomized into 2 groups: active (RF + PEMF) and sham. Both groups received 3 vaginal treatments at 3-week interval. The Vaginal Laxity Questionnaire (VLQ), perineometer measurements, and Brink score were conducted at baseline, 4, and 12 weeks after treatments. Pre and post-treatment vaginal histology, Female Sexual Function Index (FSFI), subjects' satisfaction, pain, and adverse events were assessed. The active group VLQ scores increased and were significantly better than the sham group (p < 0.001). At the final follow-up, 50% of the active group reported no vaginal laxity (VLQ > 4) versus 12% in the sham group (p = 0.054). In the active group, all domains of perineometer measurements and Brink scores (p < 0.001), FSFI scores (p < 0.05), and patients' satisfaction (p < 0.001) were significantly increased and higher in the active group. Mild adverse effects including pain and burning sensation were not different between groups except for itch which was significantly higher in the sham arm (p = 0.014). Histology after RF + PEMF treatments demonstrated neocollagenesis, neoelastogenesis, and neoangiogenesis. In conclusion, combination RF + PEMF therapy was safe, improved vaginal laxity, strengthened pelvic floor muscles, and improved female sexual function for at least 12-week post-procedures with confirmed histological improvements. This study was registered on the Thai Clinical Trials Registry, TCTR20200803002 on 2020-07-30 "retrospectively registered."

Age and/or postmenopausal status as risk factors for pelvic organ prolapse development: systematic review with meta-analysis.

INTRODUCTION AND HYPOTHESIS: Age is named as a risk factor for pelvic organ prolapse (POP), despite not being the primary outcome for many observational studies. Postmenopausal status is another associated factor but has many confounders. We aimed to systematically review the role of age and/or postmenopausal status in POP development. METHODS: Systematic review addressing age and hormones, more specifically by postmenopausal status, from inception to March 2020 in four databases (PubMed, Embase, WOS, Cochrane Library). Quality of evidence was classified by the ROBINS-I classification for non-randomized studies. Experimental studies, animal studies, studies linking age with recurrent POP and case series were excluded. Effect estimates were collected from adjusted odds ratio plus 95% confidence intervals. Significance level was 5%. A discussion exploring mechanistic factors was also included. RESULTS: Nineteen studies (11 cross sectional, 6 cohort and 2 case control) were included for quantitative analysis. Only two studies presented a low overall risk of bias for age; most of the domains were of moderate risk. Every additional year was responsible for a 10% increase in the risk to develop POP (OR = 1.102 [1.021-1.190]; i2 = 80%, random analysis, p = 0.012). This trend was confirmed when age was dichotomized into a cutoff of 35 (p = 0.035) and 50 (p < 0.001) years. Although an increase in the risk for POP was noted in postmenopausal women, this did not reach statistical significance (OR = 2.080 [0.927-4.668], i2 = 0%, p = 0.076). CONCLUSION: Age is a risk factor for POP; postmenopausal status was not statistically associated with POP, prompting the need for further studies addressing this factor.

Validation of the Thai version of the Prolapse and Incontinence Knowledge Questionnaire (PIKQ).

INTRODUCTION AND HYPOTHESIS: The Prolapse and Incontinence Knowledge Questionnaire (PIKQ) was developed and validated to assess women's knowledge regarding etiology, diagnosis and treatment of pelvic organ prolapse (POP) and urinary incontinence (UI). We aimed to translate and validate a Thai version of the PIKQ to use as a tool to evaluate knowledge of POP and UI among Thai-speaking women. METHODS: The English PIKQ, which comprises the PIKQ-POP and PIKQ-UI sections, was translated into Thai. Psychometric properties of the final version of the Thai PIKQ were tested for content validity, construct validity, internal consistency and test-retest reliability among 168 women attending a gynecology clinic and 150 nurses. RESULTS: Regarding content validity of the final Thai PIKQ, the number of missing items was 0. Participants in the nurse group were more likely than those in the patient group to select the correct answer for all items for the POP scale and UI scale (P < 0.001). For internal consistency testing, Cronbach's alpha coefficient was 0.745 for the PIKQ-POP and 0.754 for the PIKQ-UI scales, suggesting that the items had relatively high internal consistency. The item-total correlation values ranged from 0.204 to 0.539, showing an adequate correlation of each item with the scale overall. The correlation coefficients between the test and retest for PIKQ-POP and PIKQ-UI were 0.685 and 0.735, respectively (P < 0.001). CONCLUSIONS: The Thai PIKQ is a simple instrument which shows good validity and high reliability and could be a useful tool for assessing knowledge regarding POP and UI in clinical practice.

A quality-of-life questionnaire for heavy menstrual bleeding in Thai women receiving oral antithrombotics: Assessment of the translated Menstrual Bleeding Questionnaire.

BACKGROUND: Heavy menstrual bleeding (HMB) is common among reproductive-aged women receiving oral antithrombotics and frequently results in a negative impact on quality of life. METHODS: We translated the Menstrual Bleeding Questionnaire (MBQ) into Thai by forward translation, back-translation, pretesting, and cognitive interviewing. The translated questionnaire was content validated by a gynecologist. A validation study was conducted for the translated MBQ and defined the optimal score for the diagnosis of HMB. We then performed a cross-sectional study to determine the prevalence of HMB using the translated MBQ. Reproductive-aged Thai women who visited outpatient clinics receiving oral antithrombotics were asked to assess menstrual characteristics after receiving antithrombotics. The impact of menstruation on quality of life was assessed by using the MBQ. RESULTS: The translated MBQ had excellent reliability (intraclass correlation coefficient = 0.93) and discriminated between women with and without HMB (area under the receiver operating characteristic curve = 0.93). A score of 21.5 had 82.9% sensitivity and 83.1% specificity in the diagnosis of HMB. The mean (standard deviation) of the score was significantly higher in the HMB group than in the normal menstrual bleeding group (30.4 [9.4] vs 15.4 [5.6]; P < .001, respectively). Of the 49 women, the prevalence of HMB in patients receiving warfarin (n = 29), direct oral anticoagulants (n = 4), or antiplatelet agents (n = 16) was 27.6%, 25.0%, and 25.0%, respectively. CONCLUSIONS: MBQ is a simple and valid tool that can be applied to screen women experiencing HMB. One-fourth of reproductive-aged women who received oral antithrombotics experienced HMB that impacted their quality of life.

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study.

BACKGROUND: Studies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions. OBJECTIVE: This protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions. METHODS: An international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing "core" outcomes. RESULTS: Dissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed. CONCLUSIONS: This protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/28032.

Vaginal microbiota affects urinary tract infection risk in women with systemic lupus erythematosus: a pilot cross-sectional study from Thailand.

OBJECTIVE: The risk factors associated with urinary tract infections (UTIs) in patients with SLE remain uncertain. We evaluated the vaginal microbiota pattern and its potential UTI-associated risk factors. METHODS: A pilot cross-sectional study of patients with SLE was conducted at Ramathibodi Hospital, Bangkok, Thailand, during 2019-2020. Patients' demographic data and relevant information were collected. Vaginal microbiota was assessed in all patients and in 10 healthy volunteers. RESULTS: Fifty-two patients were enrolled (mean age: 46.1 years). All patients had SLE that was in low disease activity. As per the Simpson_e index, the within-group alpha diversity of the vaginal microbiota was low in the SLE with UTI and SLE receiving trimethoprim-sulfamethoxazole (TMP-SMX) prophylaxis groups. Multivariate logistic regression analysis revealed that TMP-SMX prophylaxis (adjusted OR (AOR), 30.96; 95% CI 3.63 to 264.11; p=0.002), elevated C3 levels (AOR, 35.33; 95% CI 1.33 to 936.67; p=0.033) and presence of Veillonella dispar in the vaginal microbiota (AOR, 6.68; 95% CI 1.27 to 35.07; p=0.025) were associated with UTI. CONCLUSIONS: The vaginal microbiota diversity differed between patients with lupus with and without UTI, and unnecessary administration of TMP-SMX prophylaxis may affect the alpha diversity of the vaginal microbiota.