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.

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.

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).

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.

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.

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 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.

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.

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.

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."

Validation of the Thai version of the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS).

INTRODUCTION AND HYPOTHESIS: To provide a validated Thai language version of the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) following a standardized procedure and to evaluate its psychometric properties. METHODS: After IRB approval, the English ICIQ-FLUTS was translated into Thai according to the cross-cultural adaptation process for patient-reported outcome measures. The psychometric properties of the final version of the Thai ICIQ-FLUTS were tested for content validity, internal consistency, construct validity, and test-retest reliability. Patients attending an urogynecology clinic and women from two communities were recruited for this study. RESULTS: The final Thai version of the ICIQ-FLUTS was developed and assessed by a panel of clinicians fluent in both languages including the content expert. Women with and without female lower urinary tract symptoms (FLUTS), in whom the translation was pretested, agreed that the final version made sense and was understandable. Among the 288 women who received the questionnaires, 283 (142 attending the clinic and 141 living in the communities) returned the completed questionnaire. The overall internal consistency of the Thai-version questionnaire was high, with a Cronbach's alpha score of 0.849. Symptom scores for filling, voiding, and incontinence in patients attending the clinic were significantly higher than in individuals from the community (p < 0.001). The correlation coefficients between the test and retest among 136 participants for symptoms of filling, voiding, and incontinence were 0.925, 0.769, and 0.921, respectively (p < 0.05). CONCLUSIONS: The Thai ICIQ-FLUTS contained satisfactory content and exhibited construct validity, internal consistency, and test-retest reliability. It is equivalent to the original English version and will be a valuable tool for assessing LUTS in Thai-speaking women.

The effect of an educational video on long-acting reversible contraception (LARC) utilization at 6-8 weeks postpartum period: a randomized controlled trial.

PURPOSE: Long-acting reversible contraception is highly effective in preventing unintended pregnancy and unsafe abortion. An educational video administered during early postpartum period might be an effective tool to improve postpartum LARC use. The objectives were to evaluate whether a postpartum educational video about LARC could increase postpartum LARC utilization at 6-8 weeks postpartum and to assess why postpartum women did not receive LARC. METHODS: This randomized-controlled trial was conducted at the postpartum unit of a university Hospital between August 2016 and February 2017. Postpartum women who were aged > 20 years and willing to participate were recruited. Participants allocated to the study group watched the 7-min educational video on LARC methods while the control group did not. To assess LARC utilization, data were collected at 6-8 weeks postpartum using telephone calls and/or medical record review to determine postpartum contraception use and reasons for not using LARC. RESULTS: Two-hundred and seventy participants were enrolled, and the video (135) and non-video (135) groups had similar baseline characteristics. In the video group, 57.8% (95% CI 49.0-66.2) reported using a LARC method, compared to 25.9% (95% CI 18.8-34.2) in the non-video group (p < 0.05). The reasons for not using LARC in both groups were inconvenience of access (42.0-43.8%) and uncertainty about methods (17.0-24.6%). CONCLUSION: The educational video introduced at immediate postpartum period was efficacious in increasing the utilization of LARC at 6-8 weeks postpartum. Inconvenience of access was the most common reason cited for not using LARC. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.in.th TCTR20171225001 "retrospectively registered".

Urologic injuries during gynecologic surgery, a 10-year review.

AIMS: The study was conducted to evaluate the incidence of urologic injuries during gynecologic surgery, study the management and outcome of such injuries, and identify risk factors that may be associated with urologic injuries. METHODS: A case-control study was conducted in patients who underwent gynecologic surgery from 2005 to 2014 in the university hospital. The study cases referred to patients who had urologic injury during gynecologic surgery and the control cases referred to patients who had gynecologic surgery matching the same period, type of procedure, and etiological disease leading to surgery. The medical records were reviewed and analyzed. Odds ratios (ORs) and 95% confidence intervals (CI) were used to identify risk factors associated with urologic injury. RESULTS: During the study period, there were 86 cases of urologic injuries from a total of 28 819 cases. The overall 10-year incidence was 0.30%. The incidence of bladder injury was 0.18%, (0.083% for ureteric and 0.014% for combined ureter and bladder injury). Among 80 cases with complete data, 52 (65%) had bladder injury and 48 (92.3%) were recognized the time of surgery and underwent primary repair with successful outcome, whereas 18 (75%) of 24 ureteric injury were detected intraoperatively. Previous pelvic surgery and the presence of adhesion were significant risk factors of urologic injury with OR 3.436, 95% CI 2.037-5.796 and OR 2.185, 95% CI 1.319-3.621, respectively. CONCLUSION: Urinary bladder injury was the most common urinary tract injury during gynecologic surgery. Previous pelvic surgery and the presence of adhesion were significant risk factors.

Relationship between pelvic floor symptoms and POP-Q measurements.

AIM: To investigate the relationship between pelvic floor symptoms using the Pelvic Floor Bother Questionnaire (PFBQ) and the Pelvic Organ Prolapse Quantification system (POP-Q) measurements. METHODS: This was a retrospective study. Consecutive women seeking care for pelvic floor symptoms were evaluated. The PFBQ was self-administered by all patients before they were examined by three urogynecologists according to the POP-Q. Pearson's correlation and a receiver operating characteristic (ROC) curve were used to investigate relationship between symptoms and POP-Q findings. RESULTS: Four hundred and sixty-seven patients completed the questionnaire and underwent standardized pelvic examination. Anterior, posterior and apical compartment prolapse were found in 95.5%, 78.8% and 35.9%, respectively. Moderate correlations were found between a feeling of bulging and the increasing severity of prolapse of all compartments. For all 8 pelvic floor symptoms, the area under the curve for a feeling of bulge with point Ba and point C was significantly greater than 0.7, suggesting fair ability to predict symptomatic patients. The sensitivity and specificity of the symptom were 60% and 83% when point Ba was 1 cm below the hymen. Whereas they were 55% and 83% when point C was 3 cm above the hymen. CONCLUSIONS: The feeling of a bulge in the vagina is the only symptom that correlated with prolapse of all compartments. The specific thresholds for the feeling of a bulge appear to be 1 cm below the hymen for anterior vaginal wall prolapse, and 3 cm above the hymen for apical prolapse. Neurourol. Urodynam. 35:724-727, 2016. © 2015 Wiley Periodicals, Inc.

Clinical and ultrasonographic study of patients presenting with transvaginal mesh complications.

AIM: The objective of this study was to investigate the clinical and ultrasonographic findings of women who had three-dimensional endovaginal ultrasound (EVUS) for the management of vaginal mesh complications. METHODS: This was a retrospective study of patients that had EVUS due to mesh complications at a tertiary care center. The clinical charts were reviewed. The stored 3D volumes were reviewed regarding mesh information by two examiners independently. The predictive value of physical examination for detection of vaginal mesh was calculated. Patient outcomes were reviewed. RESULTS: Seventy-nine patients presented to our center because of their, or their physicians' concern regarding mesh complications. Forty-one (51.9%) had vaginal/pelvic pain, and 51/62 (82.2%) of sexually active women experienced dyspareunia. According to ultrasonographic findings, mesh or sling was not demonstrated in six patients who believed they have had mesh/sling implantation. The positive predictive value for vaginal examination was 94.5% (95% CI: 84.9%-98.8%), negative predictive value was 12.5% (95% CI: 2.8%-32.4%), sensitivity was 72.2% (95% CI: 59.4%-81.2%), and specificity was 50.0% (95% CI: 12.4%-87.6%). Fifty-four patients were indicated for surgical treatment. Median postoperative review was 12 (range, 3-18) months and 38/53 (71.7%) patients were satisfied. CONCLUSIONS: The most common complaints of vaginal mesh complications were pain and dyspareunia. EVUS appeared to be helpful for assessing mesh presence, location, and extent including planning for surgical intervention.

The FIGO assessment scoring system (FASS): a new holistic classification tool to assess women with pelvic floor dysfunction: validity and reliability.

INTRODUCTION AND HYPOTHESIS: The aim of our study was to assess the interobserver and intraobserver reliability as well as the content and construct validity of the FIGO prolapse assessment scoring system (FASS). METHODS: Women with and without (controls) symptoms of pelvic organ prolapse (POP) attending gynaecology outpatient clinics in four different countries were recruited prospectively. Each woman was assessed using the FASS which included: (1) physical examination findings designated with the letter P; (2) presence of symptoms of prolapse, urinary and bowel symptoms designated with the letter S; and (3) assessment of degree of bother designated with the letter B. A scoring system was also developed. For interobserver reliability women were examined by two separate examiners using the FASS. For intraobserver reliability the FASS was repeated by the same examiner within 2 weeks. The interclass correlation coefficient (ICC) was also calculated to assess limits of agreements. Validity was assessed by comparing the FASS scores between symptomatic and asymptomatic women using the Mann-Whitney U test (p value <0.001). RESULTS: A total of 177 women (98 symptomatic and 79 controls) were recruited. Intraobserver reliability had ICCs between 0.716 and 1. Interobserver reliability had ICCs between 0.795 and 0.909. Domain and total scores were significantly different between symptomatic and asymptomatic women (p < 0.001, Mann-Whitney U test). There was a good correlation between FASS P scores and POP-Q scores (rho 0.763, p < 0.001). CONCLUSIONS: The FIGO prolapse assessment scoring system has good intraobserver and interobserver agreement and has demonstrated both content and construct validity.

Development of a pelvic floor muscle strength evaluation device.

OBJECTIVE: To validate the device and investigate the effect of this device on symptoms, quality of life, and pelvic floor muscle strength. MATERIAL AND METHOD: The device was designed to measure vaginal pressure changes using air-pressure balloon and abdominal wall muscle activities using surface electromyography. To test the accuracy of the device, for vaginal pressure measurement, a Mercury sphygmomanometer was used as a gold standard, and for abdominal wall muscle activity, a standard biofeedback machine was used as a reference device. A randomized, controlled trial was conducted in sixty-one women with stress urinary incontinence. They were randomly divided into two groups undergoing PFMT with a single 15-minute biofeedback session (BF + PFMT group) or without biofeedback (PFMT group). The pelvic floor muscle strength, abdominal wall muscle activity and incontinence-specific quality of life questionnaire (I-QOL), measurements were evaluated at baseline and at 8- and 16-week after treatment. RESULTS: The accuracy of vaginal probe pressure perineometry was 98% compared to a standard sphygmomanometer. The device could detect abdominal wall muscles activities at 10 milliseconds (100 Hz), 20 milliseconds (50 Hz), and 50 milliseconds (20 Hz). After 8 and 16 weeks of treatment, there were statistically significant intra-group differences in the maximum vaginal squeeze pressure in both groups. However, the inter-group differences were not demonstrated. The proportion of women who performed pelvic floor muscle exercise correctly was significantly higher in the BF + PFMT group (72.41%) compared to the PFMT group (21.88%) at week 16 (p < 0.05). CONCLUSION: The simple pelvic floor muscle strength evaluation device might be helpful in pelvic floor muscle training in a low resource setting.

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.

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.

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.