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.

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.

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.

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.

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.

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.

Effects of probiotic supplements on insulin resistance in gestational diabetes mellitus: A double-blind randomized controlled trial.

AIMS/INTRODUCTION: To evaluate the effect of probiotic supplements on insulin resistance in pregnant women with diet-controlled gestational diabetes mellitus. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was carried out between June 2016 and February 2017. Pregnant women with diet-controlled gestational diabetes mellitus were enrolled in the study at 24-28 weeks-of-gestation and randomized to receive either probiotic supplements containing Bifidobacterium and Lactobacillus or a placebo daily for four consecutive weeks. Primary outcomes were mean differences in insulin resistance (homeostatic model assessment for insulin resistance), fasting insulin and fasting plasma glucose between the two groups. Secondary outcomes were changes in maternal weight after the intervention. RESULTS: Data from 28 patients in the probiotic group and 29 in the placebo group were analyzed. The changes in metabolic parameters after randomization showed significant improvement in glucose metabolism in the probiotic group compared with the placebo group, including fasting plasma glucose (0.68 ± 5.88 vs 4.620 ± 7.78 mg/dL, mean difference -3.94 mg/dL, 95% confidence interval -7.62, -0.27, P = 0.034), fasting plasma insulin (1.11 ± 1.71 vs 3.77 ± 1.70 mIU/L, mean difference -2.67 mIU/L, 95% confidence interval -3.57, -1.76, P = 0.001) and homeostatic model assessment for insulin resistance (0.25 ± 0.37 vs 0.89 ± 0.46, mean difference -0.63, 95% confidence interval -0.86, -0.41, P = 0.001). Weight gain during randomization was similar between the two groups. CONCLUSIONS: Four weeks of probiotic supplements in women with diet-controlled gestational diabetes in the late second and early third trimester lowered fasting glucose and increased insulin sensitivity. Probiotic supplements may be considered as an adjunct treatment for glycemic control in these patients.