Comparison of promestriene with vaginal fractional CO2 laser and radiofrequency treatments of genitourinary syndrome of menopause.

OBJECTIVE: To compare the effects of fractional CO2 laser and microablative fractional radiofrequency treatment with promestriene topical estrogen on sexual function and genitourinary syndrome of menopause symptoms. METHODS: This was a prospective randomized open-label clinical trial conducted with 62 postmenopausal women assigned to three intervention groups: a) topical promestriene for 90 days (n = 17); b) fractional CO2 laser treatment (n = 24); and c) microablative fractional radiofrequency treatment (n = 21). Each of the latter two groups underwent three treatment sessions at 4-week intervals. At baseline and at the end of the study, all participants had a gynecological examination that included vaginal pH measurement, and the completion of the Vaginal Symptom Score, the Vaginal Health Index, and the Female Sexual Function Index. For the energy treatment groups, adverse effects were evaluated after each session. Group homogeneity was assessed at baseline, and results were evaluated over time (from baseline to the end of treatment) and between groups over time. RESULTS: All baseline parameters were similar among studied groups. At the end of the study, all 3 treatments had produced similar effects: a reduction of vaginal pH, and an improvement of vulvovaginal symptoms (Vaginal Symptom Score and Vaginal Health Index scores) as well as sexual function (higher total Female Sexual Function Index scores, and in the desire, arousal, lubrication and pain domain scores), with no differences observed between groups. Side-effects were slight for both energy treatment groups, mainly represented by vaginal discharge. CONCLUSION: The present study suggests that the two energy treatments were efficient along with promestriene at improving postmenopausal genitourinary and sexuality symptoms. Clinical trial identification numberNCT04717245.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study.

INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

A randomized clinical trial comparing internal and external pessaries in the treatment of pelvic organ prolapse in postmenopausal women: A pilot study

Abstract Introduction and hypothesis Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. Methods This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. Results The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). Conclusions The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.

A randomized trial comparing vaginal laser therapy and pelvic floor physical therapy for treating women with stress urinary incontinence.

INTRODUCTION: Female stress urinary incontinence (SUI) is considered a major public health issue. Physical therapy is an important conservative treatment; however, it is primarily limited by poor long-term compliance. Furthermore, surgical treatment entails significant risks. Therefore, new treatment techniques must be identified. OBJECTIVE: To compare the use of laser therapy and pelvic floor (PF) physical therapy for treating postmenopausal women with SUI. METHODS: This pilot study enrolled 40 women with a clinical and urodynamic diagnosis of SUI who were randomized into two groups: those who received erbium-doped yttrium-aluminum-garnet (Er:YAG) laser therapy implemented over three sessions with a 1-month interval (n = 20) and those who received physical therapy with supervision twice a week for 3 months (n = 20). In total, 16 women completed the treatment in each group. The patients were assessed for PF function using the modified Oxford scale and for pelvic organ prolapse using the Pelvic Organ Prolapse Quantification System. The 1-h pad test and quality of life questionnaires, King's Health Questionnaire (KHQ), and Incontinence Quality of Life (IQOL) were also administered. Patients were re-evaluated at 1, 3, 6, and 12 months after treatment. RESULTS: The mean patient age was 62.7 ± 9.1 and 57.9 ± 6.1 years, median Oxford score at baseline was 3 (2-4.5) and 4 (3-4), mean IQOL score was 79.8 ± 17 and 74.6 ± 18 for physical therapy group (PTG) and laser group (LG), respectively. For the amount of urine leak in the 1-h pad test evaluation, we found significance for the interaction of group and time points only for the Laser intragroup. The cure rate, that is, the rate of reaching an insignificant score in the pad test, at 6 and 12 months was 43.75% and 50% in PTG and 62.5% and 56.25% in the LG, respectively (p > 0.05). IQOL scores demonstrated considerable improvement in both groups (p > 0.05). Upon comparing the initial and follow-up results, the LG showed an improvement at all consultations, whereas the PTG showed improvements at 1, 3, and 6 months but not at 12 months after treatment. KHQ analysis revealed a considerable improvement in the quality of life (QOL) of patients over time, with no substantial difference between the groups. QOL comparison before and after treatment revealed that the vaginal LG improved more consistently in some domains. Only the PTG showed a significant increase in the mean Oxford score from pretreatment to 1 and 3 months after treatment (p < 0.001 and p = 0.002, respectively). However, no statistically significant difference was observed between the groups. CONCLUSION: Both treatments are safe and have a positive influence on the impact of UI on patients' QOL. The laser caused a greater reduction in the urinary loss, as measured using the weight of pad test, at 6-month and 12-month after treatment without difference with PTG at the end of the follow-up.

Spectral-Domain OCT Lens Meridian Position as a Metric to Estimate Postoperative Anatomical Lens Position.

PURPOSE: To evaluate the prediction of postoperative anatomical lens position (ALP) using intraoperative spectral-domain optical coherence tomography (SD-OCT) lens anatomy metrics in patients who underwent femtosecond laser-assisted cataract surgery. METHODS: Intraoperative SD-OCT (Catalys; Johnson & Johnson Vision) and postoperative optical biometry (IOLMaster 700; Carl Zeiss Meditec AG) were used to assess anterior segment landmarks, including lens thickness, lens volume, anterior chamber depth, lens meridian position (LMP), and measured ALP. LMP was defined as the distance from the corneal epithelium to the lens equator, and ALP was defined as the distance from the corneal epithelium to the IOL surface. Eyes were divided into groups according to axial length (> 22.5 mm, 22.5 to 24.5 mm, and > 24.5 mm) and IOL type (Tecnis ZCB00 [Johnson & Johnson Vision]; AcrySof SN-60WF [Alcon Laboratories, Inc], or enVista MX60E [Bausch & Lomb]) to further analyze the correlation between LMP and ALP. Theoretical effective lens position was back-calculated using a specific formula. Primary outcome was correlation between postoperative measured ALP and LMP. RESULTS: A total of 97 eyes were included in this study. Linear regression analysis displayed a statistically significant correlation between intraoperative LMP and postoperative ALP (R2 = 0.522; P < .01). No statistically significant correlation was observed between LMP and lens thickness (R2 = 0.039; P = .06) or between ALP and lens thickness (R2 = 0.02; P = .992). The greatest predictor for ALP was LMP (ß = 0.766, P < .001; R2 = 0.523). CONCLUSIONS: Intraoperative SD-OCT-measured LMP correlated better than anterior chamber depth and axial length to postoperative ALP. Further studies are necessary to analyze the impact of preoperative or intraoperative LMP measurements on postoperative refractive outcomes. [J Refract Surg. 2023;39(3):165-170.].

Comparison between anterior and posterior vaginal approach in apical prolapse repair in relation to anatomical structures and points of fixation to the sacrospinous ligament in fresh postmenopausal female cadavers.

INTRODUCTION AND HYPOTHESIS: The high prevalence of pelvic organ prolapse (POP) in women requires attention and constant review of treatment options. Sacrospinous ligament fixation (SSLF) for apical prolapse has benefits, high efficacy, and low cost. Our objective is to compare anterior and posterior vaginal approach in SSLF in relation to anatomical structures and to correlate them with body mass index (BMI). METHODS: Sacrospinous ligament fixation was performed in fresh female cadavers via anterior and posterior vaginal approaches, using the CAPIO®SLIM device (Boston Scientific, Natick, MA, USA). The distances from the point of fixation to the pudendal artery, pudendal nerve, and inferior gluteal artery were measured. RESULTS: We evaluated 11 cadavers with a mean age of 70.1 ± 9.9 years and mean BMI 22.4 ± 4.6 kg/m2. The mean distance from the posterior SSLF to the ischial spine, pudendal artery, pudendal nerve, and inferior gluteal artery were 21.18 ± 2.22 mm, 17.9 ± 7.3 mm, 19.2 ± 6.8 mm, and 18.9 ± 6.9 mm respectively. The same measurements relative to the anterior SSLF were 19.7 ± 2.7 mm, 18.6 ± 6.7 mm, 19.2 ± 6.9 mm, and 18.3 ± 6.7 mm. Statistical analysis showed no difference between the distances in the two approaches. The distances from the fixation point to the pudendal artery and nerve were directly proportional to the BMI. CONCLUSIONS: There was no difference in the measurements obtained in the anterior and posterior vaginal approaches. A direct correlation between BMI and the distances to the pudendal artery and pudendal nerve was found.

Optimized Artificial Intelligence for Enhanced Ectasia Detection Using Scheimpflug-Based Corneal Tomography and Biomechanical Data.

PURPOSE: To optimize artificial intelligence (AI) algorithms to integrate Scheimpflug-based corneal tomography and biomechanics to enhance ectasia detection. DESIGN: Multicenter cross-sectional case-control retrospective study. METHODS: A total of 3886 unoperated eyes from 3412 patients had Pentacam and Corvis ST (Oculus Optikgeräte GmbH) examinations. The database included 1 eye randomly selected from 1680 normal patients (N) and from 1181 "bilateral" keratoconus (KC) patients, along with 551 normal topography eyes from patients with very asymmetric ectasia (VAE-NT), and their 474 unoperated ectatic (VAE-E) eyes. The current TBIv1 (tomographic-biomechanical index) was tested, and an optimized AI algorithm was developed for augmenting accuracy. RESULTS: The area under the receiver operating characteristic curve (AUC) of the TBIv1 for discriminating clinical ectasia (KC and VAE-E) was 0.999 (98.5% sensitivity; 98.6% specificity [cutoff: 0.5]), and for VAE-NT, 0.899 (76% sensitivity; 89.1% specificity [cutoff: 0.29]). A novel random forest algorithm (TBIv2), developed with 18 features in 156 trees using 10-fold cross-validation, had a significantly higher AUC (0.945; DeLong, P < .0001) for detecting VAE-NT (84.4% sensitivity and 90.1% specificity; cutoff: 0.43; DeLong, P < .0001) and a similar AUC for clinical ectasia (0.999; DeLong, P = .818; 98.7% sensitivity; 99.2% specificity [cutoff: 0.8]). Considering all cases, the TBIv2 had a higher AUC (0.985) than TBIv1 (0.974; DeLong, P < .0001). CONCLUSIONS: AI optimization to integrate Scheimpflug-based corneal tomography and biomechanical assessments augments accuracy for ectasia detection, characterizing ectasia susceptibility in the diverse VAE-NT group. Some patients with VAE may have true unilateral ectasia. Machine learning considering additional data, including epithelial thickness or other parameters from multimodal refractive imaging, will continuously enhance accuracy. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.

Ray-tracing Analysis of Accommodation and Pseudoaccommodation in Phakic and Pseudophakic Eyes.

PURPOSE: To compare objective measurements of accommodation and pseudoaccommodation in phakic and pseudo-phakic eyes using ray-tracing aberrometry. METHODS: Patients with normal and hyperprolate corneas (post-hyperopic laser in situ keratomileusis) who underwent cataract surgery from March 2018 to October 2019 at the Medical University of South Carolina were examined and received either a diffractive intraocular lens (IOL) with an echelette design (Tecnis ZXR00 Symfony; Johnson & Johnson Vision), a monofocal IOL with negative spherical aberration (Tecnis ZCB00; Johnson & Johnson Vision), or an aberration-free IOL (MX60E; Bausch & Lomb). The control groups consisted of young and presbyopic phakic patients. Ray-tracing wavefront analysis was performed 1 to 3 months postoperatively. Objective ray-tracing metrics of accommodation and pseudoaccommodation included the effective range of focus, sphere shift accommodation, and depth of focus. RESULTS: Sixty-two eyes received a Tecnis ZCB00, 39 a MX60E, and 43 a Tecnic ZXR00 Symfony IOL; furthermore, 20 young phakic eyes and 19 presbyopic eyes were included in this study. The effective range of focus and sphere shift accommodation in the young control group were statistically larger than in the presbyopic group (P = .005 and P < .001, respectively). There was no difference in effective range of focus, sphere shift accommodation, and pseudoaccommodations between the different IOL groups. The young control group had the highest visual Strehl optical transfer function for near and distant targets (0.64 ± 0.24 and 0.56 ± 0.19, respectively), whereas the aberration-free IOL in the MX60E hyperprolate cornea group presented the lowest visual Strehl optical transfer function value for near (0.49 ± 0.19). CONCLUSIONS: Ray-tracing aberrometry can objectively assess accommodative amplitude in phakic eyes and pseudoaccommodation (depth of focus) in pseudophakic eyes. [J Refract Surg. 2022;38(10):661-667.].

Correlations of Immediate Corneal Tomography Changes with Preoperative and the Elapsed Phaco Parameters.

Purpose: The ability to predict corneal edema and understand its relationship with imaging parameters enables optimization of decision-making in terms of cataract surgery. Therefore, we aimed to elucidate the immediate tomographic alterations after phacoemulsification. Patients and Methods: In this prospective study, we evaluated clinical and corneal tomographic data of 30 patients with cataracts, obtained using a rotating Scheimpflug tomographic system before and after cataract surgery with a phacoemulsification system. Corneal thickness and volume were measured, and Pentacam Nucleus Staging, keratometry, and specular microscopy were performed preoperatively and immediately postoperatively. The Wilcoxon signed-rank test was used to compare pre-and postoperative values. We calculated the correlations between the changes in these values and multiple parameters related to phacodynamics, including "ultrasound (US) elapsed" (phaco time), "US average" (average power used), and "US absolute" (energy effectively dissipated, a product of the other two parameters). Results: There were increases in corneal volume (p<0.0001) and pachymetry (p<0.0001), and a decrease in endothelial cell count (p<0.0001) after surgery. The mean differences in pre- and postoperative specular microscopy, corneal volume, and pachymetry were -335.13±236.21 cells/mm3, 1.33±0.56 mm3, and 61.33±23.73 microns, respectively. The difference in pre-and postoperative corneal volume in patients with US elapsed ≥40 s was 0.75 mm3 greater than that in patients with US elapsed <40 s (95% confidence interval [CI]: 0.24-1.25; p=0.005); that of pachymetry in patients with US elapsed ≥40 s was 31.76 microns greater than that in patients with US elapsed <40 s (95% CI: 9.55-53.97; p=0.007). Spearman correlation revealed that, for every 1% increase in cataract density, the US average value increased by 0.31% (coef.: 0.3110; 95% CI: 0.0741-0.5490; p=0.012). Conclusion: Knowledge of Pentacam Nucleus Staging and the effect of US elapsed on differences in corneal volume and pachymetry before and after cataract surgery should be of particular value for surgeons who routinely encounter patients with hard cataracts.

Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS).

INTRODUCTION AND HYPOTHESIS: Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS). METHODS: RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores. RESULTS: Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%). A statistically significant correlation was found between JADAD and MOMENT (Spearman's rho = 0.548, p < 0.05) scores. This indicates that higher methodological quality is associated with higher outcome reporting quality. CONCLUSIONS: Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

A meta-synthesis of qualitative studies on stress urinary incontinence in women for the development of a Core Outcome Set: A systematic review.

OBJECTIVE: Given the high variation of perceptions of women with stress urinary incontinence (SUI), qualitative meta-synthesis in this field appears warranted. We aimed to synthesize evidence on women's experiences of SUI by analyzing qualitative data. METHODS: A literature search of Medline, Embase, Scopus, PsycInfo, and CINAHL databases was performed by a CHORUS Working Group, from inception to August 2020. Qualitative studies on women's perspectives on SUI were included. Thematic analysis was used as a conceptual approach to analyze the data and develop a set of overarching themes. The quality of studies was assessed based on the Critical Appraisal Skills Program tool. RESULTS: Seven studies were included. Six themes encompassing women's perspectives on SUI emerged: experiencing SUI, awareness of SUI, treatments for SUI, sexuality, communication, and psychosocial effects. The quality appraisal of the studies showed good coherence. CONCLUSION: This study revealed six overarching themes, of which treatment had the highest prevalence. Assessment of women's perceptions of SUI in the context of a qualitative meta-synthesis may inform policy and practice around this condition, may guide and help set research priorities, and will ideally contribute to the development of a Core Outcome Set for SUI.

Outcome reporting in trials on conservative interventions for pelvic organ prolapse: A systematic review for the development of a core outcome set.

BACKGROUND: Significant risk of bias and limitations in outcome selections in trials evaluating conservative treatments for the management of Pelvic Organ Prolapse (POP) have been highlighted and preclude comparability of outcomes, synthesis of primary studies and high quality evidence. OBJECTIVES: As systematic review of the reported outcomes is the first step in the process of development of a Core Outcome Set (COS), we aimed to systematically review reporting of outcomes and outcome measures in Randomised Control Trials (RCTs) on conservative treatments for POP and develop an inventory of them for consideration as core outcome and outcome measures sets. We evaluated methodological quality, outcome reporting quality and publication characteristics and their associations among published RCTs. STUDY DESIGN: Systematic review of RCTs identified from the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE and MEDLINE (Pubmed). RCTs evaluating the effectiveness of conservative interventions for the management of POP were considered for inclusion. Outcomes and outcome measures were obtained from the RCTs and an inventory was created. Outcomes were grouped in domains and themes. Methodological quality, outcome reporting quality and publication characteristics were evaluated and statistically analysed. RESULTS: Twenty-five trials (3179 women) were included and reported 31 outcomes and 50 outcome measures. Reporting rates of the outcomes investigated ranged between 4% and 56%. The most commonly reported outcome domains were patient reported symptoms, stage of POP expressed as POP-Q stage, and quality of life. Univariate analysis demonstrated no significant correlations of methodological and outcome reporting parameters. CONCLUSIONS: There is a need to increase comparability of RCTs. Reporting standardized outcomes included in a COS for conservative interventions for POP will facilitate the comparability across RCTs. While the process of developing COS is in progress, we propose the interim use of the three most commonly reported outcomes in each domain: patient-reported outcomes (symptom distress including bowel and urinary symptoms, sexual function), stage of prolapse and quality of life parameters using validated questionnaires (Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire/Health related quality of life (PFIQ-7/HRQOL) and Pelvic Organ Prolapse Impact Questionnaire (POPIQ-7).

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

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

Aspirin plus verapamil relieves angina and perfusion abnormalities in patients with coronary microvascular dysfunction and Chagas disease: a pilot non-randomized study.

INTRODUCTION: Most patients with chronic cardiomyopathy of Chagas disease (CCCD) harbor a secondary cause of coronary microvascular dysfunction (CMD), for which there is no evidence-based therapy. We evaluated the impact of verapamil plus aspirin on symptoms and perfusion abnormalities in patients with CCCD and CMD. METHODS: Consecutive patients with angina pectoris, who had neither coronary artery obstructions nor moderate-severe left ventricular dysfunction (left ventricular ejection fraction > 40%) despite showing wall motion abnormalities on ventriculography, were referred for invasive angiography and tested for Chagas disease. Thirty-two patients with confirmed CCCD and ischemia on stress-rest SPECT myocardial perfusion scintigraphy (MPS) were included. Clinical evaluation, quality of life (EQ-5D/ Seattle Angina Questionnaire), and MPS were assessed before and after 3 months of treatment with oral verapamil plus aspirin (n=26) or placebo (n=6). RESULTS: The mean patient age was 64 years, and 18 (56%) were female. The ischemic index summed difference score (SDS) in MPS was significantly reduced by 55.6% after aspirin+verapamil treatment. A decrease in SDS was observed in 20 (77%) participants, and in 10 participants, no more ischemia could be detected. Enhancements in quality of life were also detected. No change in symptoms or MPS was observed in the placebo group. CONCLUSIONS: This low-cost 3-month treatment for patients diagnosed with CCCD and CMD was safe and resulted in a 55.6% reduction in ischemic burden, symptomatic improvement, and better quality of life.

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment.

OBJECTIVE: To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance. METHODS: This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. They underwent 12 sessions of 30-min TENS application and were assigned to five groups: one leg, once a week (n=26); one leg, twice a week (n=27); two legs, once a week (n=26); two legs, twice a week (n=28); and placebo (n=30). Symptoms of overactive bladder and its impact on quality of life were evaluated before and after 6 or 12 weeks of treatment using the Overactive Bladder Questionnaire-V8 and voiding diary. ClinicalTrials.gov: NCT01912885. RESULTS: The use of one leg, once a week TENS application reduced the frequency of urgency episodes compared with the placebo (1.0±1.6 vs. 1.4±1.9; p=0.046) and frequency of incontinence episodes compared with the placebo (0.7±1.4 vs.1.4±2.2; p<0.0001). The one-leg, twice a week protocol decreased the urinary frequency compared with the two legs, once a week protocol (8.2±3.5 vs. 9.0±5.1; p=0.026) and placebo (8.2±3.5 vs. 7.9±2.7; p=0.02). Nocturia improved using the two legs, once a week protocol (1.5±1.8) when compared with the one leg, twice a week protocol (1.9±2.0) and placebo (1.7±1.6) (p=0.005 and p=0.027, respectively). Nocturia also improved using the two legs, twice a week protocol when compared with the one leg, twice a week protocol (1.3±1.2 vs.1.9±2.0; p=0.011). CONCLUSION: One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia.

Patient-reported outcomes and outcome measures in childbirth perineal trauma research: a systematic review.

INTRODUCTION AND HYPOTHESIS: In evaluating the effectiveness of interventions in perineal trauma research, outcomes reported by patients should have a prominent focus. There is no international consensus regarding the use of either patient-reported outcomes (PROs) or tools used to determine these outcomes (patient-reported outcome measures, PROMs). The objective was to evaluate the selection, reporting and geographical variations of PROs and PROMs in randomised controlled trials (RCTs) on perineal trauma. METHODS: We performed a systematic review of RCTs in perineal trauma research evaluating outcome and outcome measure reporting. We identified PROs and PROMs and grouped PROs into domains and themes, a classification system based on a medical outcome taxonomy. RESULTS: Of 48 included RCTs, 47 reported PROs. In total, we identified 51 PROs. Outcome reporting consistency was low, with 27 PROs reported only once. Nine PROs were reported more than five times, the most frequent being perineal pain, with no geographical variation in reporting. Four themes encompassing 12 domains were identified. The most frequently reported theme was "Clinical", with 25 PROs grouped within four domains. "Resource use" and "Adverse events" themes were rarely reported, with only five PROs. PROMs also exhibited variation. Most common were visual analogue scale (VAS; 100 mm), Cleveland Clinic Continence Score, The Faecal Incontinence Quality of Life scale, VAS (0-10) and the McGill Pain Questionnaire. CONCLUSIONS: Significant heterogeneity in PROs and PROMs was observed among RCTs. Despite inconsistency, PROs are the most prevalent outcome in perineal trauma research. Patient-reported adverse events are underreported. Their use in determining the effectiveness and safety of interventions makes their integration important in perineal trauma core outcome sets. Identification and grouping of outcomes will assist future core outcome consensus studies.

Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets.

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets.

Comparison of stress urinary incontinence between urban women and women of indigenous origin in the Brazilian Amazon.

INTRODUCTION AND HYPOTHESIS: This study compared two populations in the Brazilian Amazon, one comprising urban women and the other indigenous origin women from a riparian population, to assess the prevalence of and risk factors associated with stress urinary incontinence (SUI). METHODS: Following sample calculation, 120 indigenous and 260 urban women underwent evaluations including medical history, UI-oriented physical examination, pelvic organ prolapse, and functional assessment of the pelvic floor. Women with complaints of SUI underwent a urodynamic study and completed a quality of life questionnaire (King's Health Questionnaire). Univariate ORs were calculated, and multiple logistic regression models were then built using the stepwise backward method. RESULTS: The prevalence of SUI was similar in both groups (25.8% in indigenous origin women and 20.4% in the urban group (P > 0.05). The parity and number of spontaneous deliveries and home births were higher in the indigenous origin group. Multivariate analysis showed a decreased prevalence of SUI in patients with modified Oxford Scale scores ≥ 3. Women with homebirths had a 3.45-fold higher likelihood of having SUI than women with hospital deliveries (OR 3.45 -CI 1.78-6.70). Quality of life was worse in the domains of SUI impact, hindering daily and physical activities as well as jeopardizing personal and emotional relationships in urban women. CONCLUSIONS: No significant difference in SUI was observed between the groups, despite significantly higher risk factors for SUI in the indigenous origin group.

A guide to physiotherapy in urogynecology for patient care during the COVID-19 pandemic.

INTRODUCTION AND AIM: Physiotherapy in urogynecology faces challenges to safely continuing its work, considering the adoption of social distancing measures during the COVID-19 pandemic. Some guidelines have already been published for urogynecology; however, no specific documents have been produced on physiotherapy in urogynecology. This article aimed to offer guidance regarding physiotherapy in urogynecology during the COVID-19 pandemic. METHODS: A group of experts in physiotherapy in women's health performed a literature search in the Pubmed, PEDro, Web of Science and Embase databases and proposed a clinical guideline for physiotherapy management of urogynecological disorders during the COVID-19 pandemic. This document was reviewed by other physiotherapists and a multidisciplinary panel, which analyzed the suggested topics and reached consensus. The recommendations were grouped according to their similarities and allocated into categories. RESULTS: Four categories of recommendations (ethics and regulation issues, assessment of pelvic floor muscle function and dysfunction, health education and return to in-person care) were proposed. Telephysiotherapy and situations that need in-person care were also discussed. Regionalization is another topic that was considered. CONCLUSION: This study provides some guidance for continuity of the physiotherapist's work in urogynecology during the COVID-19 pandemic, considering the World Health Organization recommendations and the epidemiological public health situation of each region. Telephysiotherapy can also be used to provide continuity of the care in this area during the COVID-19 pandemic, opening new perspectives for physiotherapy in urogynecology.