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.

Rate of Postoperative Urinary Retention after Anterior Compartment Prolapse Surgery: A Randomized Controlled Trial Comparing Early versus Conventional Transurethral Catheter Removal.

BACKGROUND: Pelvic organ prolapse is a common condition of pelvic floor dysfunction in women, especially in adult vaginally parous and elderly women. Because of its anatomy, the anterior compartment has a significant effect on urinary symptoms. Anterior colporrhaphy and colpocleisis are major anterior compartment prolapse-related surgeries. As we know, postoperative urinary retention (POUR) is one of the most common complications following pelvic floor surgery. To prevent this complication, indwelling bladder catheterization is routinely applied. In contrast, to minimize risk of infection and the patient's discomfort, the catheter should be removed as soon as possible. However, there is a lack of clarity regarding the optimal timing for catheter removal. Therefore, the aim of this trial is to compare the rate of POUR after anterior prolapse surgery between early transurethral catheter removal (24 h postoperatively) and our standard practice (on postoperative day 3). METHODS: We conducted a randomized controlled trial among patients undergoing anterior compartment prolapse surgery between 2020 and 2021 at a university hospital. Women were randomized into two groups. After removal, if the second void residual urine volume exceeded 150 mL, POUR was diagnosed, and intermittent catheterization was performed. The primary outcome was the POUR rate. The secondary outcomes included urinary tract infection, asymptomatic bacteriuria, time to ambulation, time to spontaneous voiding, length of hospitalization, and patient satisfaction. Analysis was performed according to the intention to treat principle. The calculated sample size was 68 patients (34 patients in each group) for a 95% confidence interval, 80% power, 5% probability of type I error, and 10% data loss. DISCUSSION: This study demonstrated that early catheter removal was comparable in POUR rate to conventional treatment with shorter hospitalization among patients undergoing anterior compartment prolapse surgery. Additionally, we observed no re-hospitalization owing to POUR. Therefore, early transurethral catheter removal is preferable following anterior compartment prolapse-related surgery.

The effect of online video-assisted teaching program on medical students learning procedure of fractional curettage.

OBJECTIVES: Since 2020, with the entire world in crisis over the coronavirus pandemic (COVID-19), medical students have adapted to hybrid and distance learning. This study aims to compare the learning outcomes of students learning the procedure of fractional curettage in an online video-assisted teaching program to those of students learning the procedure in a traditional class. METHODS: A quasi-experimental study was conducted among fourth-year medical students who rotated to Obstetrics and Gynecology courses between April 2021 and October 2021. Participants in the first two rotations were enrolled in traditional classes, and the online video-assisted teaching program was introduced in the subsequent two rotations. Both study groups took OSCEs (objective structured clinical examinations), a pre-test and post-test with MCQs (multiple choice questions), and a confidence and satisfaction level questionnaire. RESULTS: A total of 106 fourth-year medical students, 54 in the traditional group and 52 in the online video-assisted teaching program, were recruited. The online video-assisted group showed a statistically better mean OSCE score (85.67 ± 11.29 vs. 73.87 ± 13.01, p < 0.001) and mean post-test MCQ score than the traditional group (4.21 ± 0.87 vs. 3.80 ± 0.98, p = 0.0232). Moreover, the mean difference between the two groups' pre and post-test MCQ scores was significantly different (0.96 ± 1.37 vs. 1.79 ± 1.50 in traditional and online video-assisted teaching program groups, respectively, P = 0.0038). The participants in the experimental group reported significantly greater confidence (P < 0.001) in performing the fractional curettage procedure. However, the mean satisfaction score was significantly higher in the control group (p = 0.0053). CONCLUSION: The online video-assisted teaching program on the fractional curettage procedure, a necessary and skill-demanding procedure, is an effective and advantageous education tool that improves skills, knowledge, and confidence in fourth-year medical students. We recommend that the video-assisted teaching program is another effectively procedural teaching method for medical students.

Preoperative clinical characteristics between uterine sarcoma and leiomyoma in patients with uterine mass, a case-control study.

OBJECTIVES: To determine the preoperative clinical characteristics associated with uterine sarcoma in patients with uterine mass. STUDY DESIGN: We retrospectively reviewed medical records of patients who presented with uterine mass undergoing surgery at Ramathibodi Hospital, with a pathologically confirmed diagnosis, from April 1, 2000 to October 31, 2019. The cases are patients with uterine sarcoma, whereas the controls are patients with leiomyoma diagnosed in the same year, with a proportion of 1 case per 4 controls. The association between preoperative clinical characteristics and uterine sarcoma were analyzed. RESULTS: There were 18,218 patients with uterine mass undergoing surgery at Ramathibodi Hospital during the study period. Uterine sarcoma was diagnosed in 68 patients. Thus, the incidence of uterine sarcoma was 0.37%. Following multivariate regression analysis, the following factors seemed to be independently associated with increased risk of uterine sarcoma. Patients with uterine mass, age ≥ 40 years old, postmenopause, postmenopausal bleeding, abnormal uterine bleeding, palpable mass, recognition of rapid growing mass, and with single uterine mass identified by ultrasonography were more likely to be diagnosed with uterine sarcoma with adjusted odds ratio (95% confidence interval) of 3.30 (1.29-8.43), 8.57 (2.38-30.82), 35.35 (2.94-425.13), 3.39 (1.40-8.23), 4.50 (1.78-11.36), 6.91 (2.08-22.91) and 4.70 (1.91-11.60), respectively. CONCLUSIONS: Clinical characteristics, ie, age ≥ 40 years old, postmenopause, postmenopausal bleeding, abnormal uterine bleeding, palpable mass, mass with rapid growth, or single uterine nodule identified by ultrasonography were considered the independently strong association with uterine sarcoma in women who presented with uterine mass.

Association of Hormonal Contraceptive Use With Adverse Health Outcomes: An Umbrella Review of Meta-analyses of Randomized Clinical Trials and Cohort Studies.

Importance: Meta-analyses have reported conflicting data on the safety of hormonal contraception, but the quality of evidence for the associations between hormonal contraceptive use and adverse health outcomes has not been quantified in aggregate. Objective: To grade the evidence from meta-analyses of randomized clinical trials (RCTs) and cohort studies that assessed the associations between hormonal contraceptive use and adverse health outcomes among women. Data Sources: MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched from database inception to August 2020. Search terms included hormonal contraception, contraceptive agents, progesterone, desogestrel, norethindrone, megestrol, algestone, norprogesterones, and levonorgestrel combined with terms such as systematic review or meta-analysis. Evidence Review: The methodological quality of each meta-analysis was graded using the Assessment of Multiple Systematic Reviews, version 2, which rated quality as critically low, low, moderate, or high. The Grading of Recommendation, Assessment, Development and Evaluations approach was used to assess the certainty of evidence in meta-analyses of RCTs, with evidence graded as very low, low, moderate, or high. Evidence of associations from meta-analyses of cohort studies was ranked according to established criteria as nonsignificant, weak, suggestive, highly suggestive, or convincing. Results: A total of 2996 records were screened; of those, 310 full-text articles were assessed for eligibility, and 58 articles (13 meta-analyses of RCTs and 45 meta-analyses of cohort studies) were selected for evidence synthesis. Sixty associations were described in meta-analyses of RCTs, and 96 associations were described in meta-analyses of cohort studies. Among meta-analyses of RCTs, 14 of the 60 associations were nominally statistically significant (P ≤ .05); no associations between hormonal contraceptive use and adverse outcomes were supported by high-quality evidence. The association between the use of a levonorgestrel-releasing intrauterine system and reductions in endometrial polyps associated with tamoxifen use (odds ratio [OR], 0.22; 95% CI, 0.13-0.38) was graded as having high-quality evidence, and this evidence ranking was retained in the subgroup analysis. Among meta-analyses of cohort studies, 40 of the 96 associations were nominally statistically significant; however, no associations between hormonal contraceptive use and adverse outcomes were supported by convincing evidence in the primary and subgroup analyses. The risk of venous thromboembolism among those using vs not using oral contraception (OR, 2.42; 95% CI, 1.76-3.32) was initially supported by highly suggestive evidence, but this evidence was downgraded to weak in the sensitivity analysis. Conclusions And Relevance: The results of this umbrella review supported preexisting understandings of the risks and benefits associated with hormonal contraceptive use. Overall, the associations between hormonal contraceptive use and cardiovascular risk, cancer risk, and other major adverse health outcomes were not supported by high-quality evidence.

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."

Feasibility and learning curve of performing first trimester fetal anatomy screening among operators with varying experience using the protocol of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG).

OBJECTIVE: To compare the feasibility of performing a complete first trimester fetal anatomy screening between two operators with different levels of experience using the protocol of the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG), and to compare the duration of scan and learning curve of each operator as secondary outcomes. METHODS: A prospective study was conducted on singleton pregnancies at 11+0-13+6 weeks of gestation. Transabdominal ultrasound anatomy screening was performed by a maternal fetal medicine (MFM) staff (operator 1) or a first year MFM fellow (operator 2) following ISUOG guidelines. The visibility of fetal structures and time taken by each operator were recorded and analyzed. RESULTS: Data from 98 participants in operator 1 group and 96 participants in operator 2 group were analyzed. The success rate of visualizing all structures was feasible in 87.8% and 91.7% (p = .370) of cases in operator 1 and operator 2, respectively. The significant improvement in visualization success rate was observed between the first 50 and the last 50 scans in both groups (p = .004 vs. p = .006). Average time spent on the exam by operator 1 was significantly shorter than the time spent by operator 2 (11.3 ± 4.8 min vs. 15.0 ± 6.2 min; p < .001). CONCLUSION: Completeness of first trimester fetal anatomy screening following ISUOG protocol were feasible with no statistical difference between the two different levels of experienced operators. Moreover, time allocatable with a brief learning curve were demonstrated in both groups.

Medical and non-medical interventions for post-operative urinary retention prevention: network meta-analysis and risk-benefit analysis.

AIMS: To assess the efficacy in lowering post-operative urinary retention, urinary tract infection and lower urinary tract symptoms and the incidence of adverse events among 12 interventions and to perform risk-benefit analysis. METHODS: Previous randomized controlled trials were identified from MEDLINE, Scopus and CENTRAL database up to January 2020. The interventions of interest included early ambulation, fluid adjustment, neuromodulation, acupuncture, cholinergic drugs, benzodiazepine, antispasmodic agents, opioid antagonist agents, alpha-adrenergic antagonists, non-steroidal anti-inflammatory drugs (NSAIDs) and combination of any interventions. The comparators were placebo or standard care or any of these interventions. Network meta-analysis was performed. The probability of being the best intervention was estimated and ranked using rankogram and surface under the cumulative ranking curve. Risk-benefit analysis was done. Incremental risk-benefit ratio (IRBR) was calculated and risk-benefit acceptability curve was constructed. RESULTS: A total of 45 randomized controlled trials with 5387 patients was included in the study. Network meta-analysis showed that early ambulation, acupuncture, alpha-blockers and NSAIDs significantly reduced the post-operative urinary retention. Regarding urinary tract infection and lower urinary tract symptoms, no statistical significance was found among interventions. Regarding the side effects, only alpha-adrenergic antagonists significantly increased the adverse events compared with acupuncture and opioid antagonist agents from the indirect comparison. According to the cluster ranking plot, acupuncture and early ambulation were considered high efficacy with low adverse events, corresponding to the IRBR. CONCLUSION: Early ambulation, acupuncture, opioid antagonist agents, alpha-adrenergic antagonists and NSAIDs significantly reduce the incidence of post-operative urinary retention with no difference in adverse events. Regarding the risk-benefit analysis of the medical treatment, alpha-adrenergic antagonists have the highest probability of net benefit at the acceptable threshold of side effect of 15%, followed by opioid antagonist agents, NSAIDs and cholinergic drugs.

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".

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.

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.

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.

Effect of Colpexin Sphere on pelvic floor muscle strength and quality of life in women with pelvic organ prolapse stage I/II: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Colpexin Sphere was effective for advanced pelvic organ prolapse. The aim of this study was to assess the effect of Colpexin Sphere in women with pelvic organ prolapse (POP) stage I or II on pelvic floor muscle strength, quality of life, and POP stage. METHODS: Women were randomly divided into Colpexin Sphere with pelvic floor muscle exercise group and exercise only group for a 16-week period. They had Colpexin pull test and digital test every 4 weeks. Quality of life and POP stage were re-evaluated at the end of treatment. RESULTS: Ninety-one women were recruited and 85 completed. Colpexin Sphere plus pelvic floor exercise improved pelvic floor muscle strength. There was no significant difference between both groups. Vaginal symptom score decreased in both groups while the stages of prolapse did not change. CONCLUSIONS: Colpexin Sphere plus pelvic floor exercise and exercise alone improved pelvic floor muscle strength.

Effect of colpexin sphere on pelvic floor muscle strength in women with pelvic organ prolapse: a randomized controlled trial (a preliminary report).

OBJECTIVE: The aim of this study was to assess the effect of Colpexin Sphere with pelvic floor exercise in women with stage I and II pelvic organ prolapse on improving pelvic floor muscle strength compared with the pelvic floor exercise only. METHODS: The women were divided into two groups: one group used Colpexin Sphere with pelvic floor muscle exercise, and the other group did pelvic floor exercise only for a 16-week period. The efficacy was evaluated at baseline and 16-week for comparison of pelvic floor muscle strength. RESULTS: A total of 50 women were enrolled and 48 women completed the full 16-week assessment. A statistically significant improvement in pelvic floor muscle strength as compared with baseline values and at 16 weeks was shown in both groups, with mean difference pull test contraction values of 2.25 + 3.28 N (P < 0.05) in the study group and 1.38 + 2.17 N (P < 0.05) in the control group. There was no statistically significant difference in improving pelvic floor muscle strength between the study and the control groups. CONCLUSION: Even though Colpexin Sphere plus pelvic floor exercise improved pelvic floor muscle strength, the improvement was not statistically different from exercise alone.

Prevalence and risk factors of anorectal dysfunction in women with urinary incontinence.

PURPOSE: To evaluate the prevalence and risk factors of anorectal dysfunction among women with urinary incontinence. METHOD: This cross-sectional study was conducted among women attending the urogynecology clinic. Women with symptoms of urinary incontinence were requested to complete a structured questionnaire. RESULTS: Four hundred and thirteen women participated in the study and 43.8% had at least one anorectal symptom. The prevalence rates of anal incontinence, constipation, and difficult defecation were 8.0, 38.0, and 25.7%, respectively. The risk factors associated with anorectal dysfunction were age and number of parity. CONCLUSION: Anorectal dysfunction was prevalent among women with urinary incontinence; age and number of parity were the risk factors. All women with symptoms of urinary incontinence should be evaluated about anorectal symptoms.

The characteristics and satisfaction of the patients using vaginal pessaries.

OBJECTIVE: To study the characteristics of pelvic organ prolapse (POP) patients that used a pessary. DESIGN: Prospective, descriptive study. SETTING: Urogynecology Clinic, Ramathibodi Hospital, Faculty of Medicine, Mahidol University. MATERIAL AND METHOD: The authors conducted a prospective, observational study. The average age, parity, average body mass index, menopausal age, pessary type, and reasons for pessary use were collected in the present study. The symptoms, satisfaction, complication, and continuation rates after use were recorded. RESULTS: For the 40 subjects, the average age was 70.4 years, the average of parity, body mass index, and menopausal age were 4, 24.5 kg/m2, and 22 years, respectively. The reasons for choosing a pessary included mostly risks and reluctance to undergo surgery. The complications from using a pessary were vaginal erosion, which was found in one case. Thirty-seven patients (92.5%) were satisfied and continued to use pessaries. CONCLUSION: Most POP patients had a favorable outcome in terms of satisfaction with the pessary use and continued to use pessaries.