Changes In Questionnaire Scores Research Articles

Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial.

Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30days; P = .049, 6 months; PFMT: P < .001, 30days and 6 months), with better results in the PFMT group. Sexual, vaginal, and urinary symptoms were improved after 30days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. After 30days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30days; however, this result was not maintained after 6 months of treatment.

Advantages of Totally Stapled Collard Over Circular Stapled Technique for Cervical Esophagectomy Anastomosis

BackgroundThe quality of life between the totally stapled Collard (TSC) and circular stapled (CS) techniques from the patient’s perspective has not been assessed. This longitudinal patient-reported outcome and objective data assessment study aimed to compare the effects of TSC vs CS for cervical anastomosis with minimally invasive esophagectomy (MIE) on the quality of life. MethodsThis single-center, retrospective study included patients with esophageal cancer who underwent MIE and cervical anastomosis between April 2019 and February 2021; of whom, 105 and 216 patients received TSC and CS anastomosis, respectively. The objective metrics were evaluated based on postoperative complications. Patient-reported outcomes instruments using the European Organization for Research and Treatment of Cancer modules were assessed preoperatively. The Quality of Life Questionnaire (QLQ) Core 30 and the QLQ-Oesophagus Module 18 assessed the quality of life. Mixed-effects models examined changes in questionnaire scores. ResultsThe stenosis rate in the TSC group was significantly lower than that in the CS group. There were no significant differences in other postoperative complications between the groups. In the QLQ Core 30 scale, the TSC group had better emotional function, less fatigue, less appetite loss, and better function than the CS group, with significant differences in different time points between the groups. QLQ-Oesophagus Module 18 revealed that the TSC group had significantly less appetite loss, dysphagia, dry mouth, pain, and obstruction, and better eating and speech than the CS group. ConclusionsTSC has significant advantages over the CS technique in lowering postoperative symptom burden and improving quality of life for cervical anastomosis on patient-reported outcomes.

Bi-weekly Glycated Albumin Measurement was Useful to Encourage Behavioral Changes in People with Type2 Diabetes Mellitus.

HemoglobinA1c (HbA1c), representing the average blood glucose over 1-2months, is the most commonly used glycemic marker in people with diabetes. Glycated albumin (GA) reflects the average blood glucose over the most recent 1-2weeks. We considered whether the faster response of GA compared with HbA1c could make people with diabetes realize their glycemic control intuitively and effectively. We randomized 61 people with diabetes into the control and intervention groups. Blood samples were collected from both every fortnight over an 8-week period (five times; visit1-5). Only the intervention group was notified of the GA levels on the same day. At the beginning and end of the study, International Physical Activity Questionnaire and Eating Behavior Questionnaire assessments, and body composition measurements were conducted. The body weight change was significantly lower in the intervention group at visit2 and visit5. The percent body fat change was lower, while the percent skeletal muscle mass change at visit5 was higher in the intervention group. Increasing GA trend was observed in the control group, but not in the intervention group. The fasting plasma glucose and HbA1c changes at visit5 were similar in the two groups. Physical activity level change tended to be higher in the intervention group. The YN Eating Behavior Questionnaire score changes were similar in the two groups. Bi-weekly GA measurement over an 8-week period in people with type2 diabetes induced behavioral changes. Development of this method is expected to improve diabetes management. UMIN000037795.

Battlefield Acupuncture as a Treatment Option forChronic Tinnitus: A Pilot Study.

There is no cure for tinnitus, which is a highly prevalent condition in service members and veterans. Battlefield acupuncture (BFA) can be used to manage pain and stress-related symptoms. We investigated BFA as a safe, low-cost treatment for tinnitus perception and coping in eight chronic tinnitus patients who were followed for 6 months after two BFA treatments to identify changes in tinnitus severity or impact. Patients completed case history, Tinnitus Screener, Tinnitus Functional Index (TFI), Tinnitus Reaction Questionnaire (TRQ), and Hospital Anxiety and Depression Scale (HADS) questionnaires at baseline, at two BFA treatment sessions (2 weeks apart), and at four follow-up sessions (at 1, 2, 4 and 6 months after treatment). Questionnaire score changes were evaluated over time by using restricted maximum likelihood hierarchical regression modeling from baseline to 1-, 2-, 4-, and 6-month post-treatment follow-ups. TFI and TRQ group means were both significantly reduced at 1 month after treatment, and these reductions persisted through the 2- and 4-month follow-ups. The TRQ group mean remained significantly reduced after 6 months. Findings from eight chronic tinnitus sufferers who received two BFA treatment sessions are reported here, suggesting at least short-term treatment benefits observed as reductions in tinnitus-related psychological distress and impact. Although these findings are constrained by the study's small sample size and limited treatment period, its findings underscore the need for further research to determine the potential benefits of BFA for individuals who suffer from chronic tinnitus. Future research should consider the possibility of more lasting benefits through extended BFA treatment, with a comparison of BFA treatment against other treatment methods.

Efficacy of testosterone replacement treatment for patients with symptoms of late-onset hypogonadism based on real-world patient satisfaction.

Late-onset hypogonadism is generally treated with testosterone replacement treatment. However, the efficacy rate of treatment for patients with low testosterone is not clear because patients without low testosterone are also treated in real-world clinical settings. This study comprised 110 men with low testosterone concentration of <3.0 ng/mL who underwent testosterone replacement treatment. Physical factors, laboratory and endocrinologic profiles, and scores of several questionnaires were assessed. Testosterone replacement treatment was performed with intramuscular injection of 250 mg of testosterone esters every 2-4 weeks, and efficacy was judged by patient satisfaction. After confirming efficacy, changes in several factors by the treatment were evaluated. Finally, the comparison between evaluation by patient satisfaction and by that with the questionnaires was assessed. Among the 110 patients, 77 (70.0%) were satisfied with the treatment, which was effective in 65.7%, 71.4%, and 73.1% of patients with mental, physical, and sexual dysfunction, respectively. The questionnaire scores including the Aging Males Symptoms rating scale were significantly improved in both the satisfaction and non-satisfaction group. However, no significant differences in the amount of change in questionnaire scores were found for all questionnaire scores improved by testosterone replacement treatment between the groups. Patient satisfaction was not associated with improvement of the Aging Males Symptoms score. Although testosterone replacement treatment was effective for 70.0% of the hypogonadal patients, patient satisfaction did not correlate with improvement of questionnaire scores. We concluded that not only questionnaire results but also patient satisfaction is important when evaluating efficacy in patients undergoing testosterone replacement treatment.

Evaluation of secondary complication awareness among individuals with spinal cord injury.

Secondary complications (SCs) are common and cause high morbidity and mortality in individuals with spinal cord injury (SCI). There is no information or a satisfactory scale of measurement for evaluating the opinions of individuals with SCI on whether they have sufficient knowledge about these complications. This study aimed to evaluate the opinions of individuals with SCI about whether they have sufficient information on SCI-related SCs. Demographic and clinical characteristics of 64 SCI individuals were recorded. A questionnaire was applied to evaluate the opinions of the participants and whether they have sufficient information about SCs before and after a multidisciplinary rehabilitation for SCI. A test was performed to measure the knowledge level at admission to the hospital and discharge. The mean value of the total questionnaire score, which was 6.2 at admission, increased to 7.91 at discharge ( P < 0.001). All subgroup scores of the questionnaire were higher at discharge than at admission (all P < 0.05). Total, neurogenic bladder, neurogenic bowel and spasticity test scores increased at discharge compared to admission (all P < 0.05). There is a relationship between the change in questionnaire scores and some demographic and injury characteristics. The opinions of the individuals with SCI on having sufficient information about SCs and their knowledge levels increased after a multidisciplinary rehabilitation program. Applying such a questionnaire and test at admission may have increased the awareness of the participants about SCs and contributed to a higher level of knowledge and opinion.

Investigating the Impact of the TUITEK® Patient Support Programme, Designed to Support Caregivers of Children Prescribed Recombinant Human Growth Hormone Treatment in Taiwan.

PurposePoor adherence to recombinant human growth hormone (r-hGH) treatment presents a significant barrier to achieving optimal growth outcomes. It is important to identify and address the treatment adherence-related needs of children prescribed r-hGH treatment, and develop new approaches to improve adherence. We aimed to measure the impact of the TUITEK® patient support programme, a multi-component personalized service intervention, on caregivers’ knowledge, beliefs, and perceptions of short stature and adherence to its treatment.Patients and MethodsThe evaluation of the TUITEK® patient support programme was conducted among 31 caregivers of children with short stature and receiving r-hGH treatment via the easypod™ auto-injector device in Taiwan. Caregivers within the ‘high risk’ category for knowledge, beliefs and perception factors influencing adherence to r-hGH treatment (disease and treatment coherence, emotional burden, self-administration, and treatment-related anxiety) were identified via the TUITEK® personalization questionnaire and followed up with bi-weekly telephone calls by a nurse practitioner over a 3-month period. A Wilcoxon signed-rank test was used to compare changes in questionnaire-based scoring patterns between baseline and follow-up.ResultsBetween baseline and follow-up, the percentage of caregivers scoring as ‘high risk’ for emotional burden reduced by 37%; there was an improvement in confidence of self-administration by 57% and the percentage of caregivers scoring as ‘high risk’ for treatment-related anxiety reduced by 52%. At follow-up, all caregivers classified as ‘high risk’ within the disease and treatment coherence item at baseline moved into the ‘low risk’ category. Statistically significant changes in questionnaire scores between baseline and follow-up for disease and treatment understanding, emotional burden, self-administration, and treatment-related anxiety were also observed.ConclusionThese findings indicate that the TUITEK® patient support programme can positively address disease and treatment-related barriers amongst caregivers regarding optimal adherence of their children to r-hGH treatment, which has the potential to positively impact on adherence levels and patient clinical health outcomes.

Artificial vision: the effectiveness of the OrCam in patients with advanced inherited retinal dystrophies.

PurposeTo investigate the impact of the OrCam MyEye 2.0 (OrCam) on the quality of life and rehabilitation needs in patients with advanced retinitis pigmentosa (RP) or cone‐rod dystrophies (CRD). The OrCam is a wearable low‐vision aid that converts visual information to auditive feedback (e.g. text‐to‐speech, barcode and facial recognition).MethodsPatients with a clinical diagnosis of RP (n = 9, 45%) or CRD (n = 11; 55%), and a best‐corrected visual acuity of ≤20/400 Snellen were invited to participate in this study. Questionnaires were administered at baseline and after 5.2 (standard deviation ± 1.5) weeks, which included the Dutch version of the National Eye Institute Visual Functioning Questionnaire (NEI‐VFQ), the Participation and Activity Inventory (PAI) and the OrCam Function Questionnaire (OFQ).ResultsFollowing OrCam testing, significant improvements were observed in the ‘near activities’ subscale of the NEI‐VFQ (p < 0.001); the ‘visual functioning’ subscale of the re‐engineered NEI‐VFQ (p = 0.001); the ‘reading’ rehabilitation goal of the PAI (p = 0.005) and the overall score of the OFQ (p < 0.001). The observed changes in questionnaire scores did not differ between phenotypes. Advantages and limitations of the OrCam were reported by patients. Three patients (15%) continued rehabilitation with the OrCam after completion of this study.ConclusionsThe OrCam mainly improves reading domains in patients with advanced stages of RP or CRD. Further improvements in the OrCam are needed to address current limitations, which may enhance its utility for patients with RP or CRD.

Transcriptome genetic differences between responders and non-responders before bronchial thermoplasty

Background Bronchial thermoplasty (BT) is an endoscopic therapy used for the treatment of refractory asthma. Some predictive factors, for example the number of activations and severity of disease at baseline, have been used to determine the effectiveness of BT in treating patients with asthma. The aim of the present study was to comprehensively analyze RNA samples from the airway bronchial tissues of patients with severe asthma treated by BT, and to characterize each patient as a BT responder or non-responder. Methods Eight patients with severe asthma scheduled to undergo BT and bronchus biopsies were recruited before the procedures were conducted. Extracted RNA samples from bronchial tissues were sequenced and differential gene expression analysis was carried out. Results/discussion: Subjects with Asthma Quality of Life Questionnaire score changes ≥0.5 for a period of 12 months were considered BT responders. Non-responders had score changes <0.5 for 12 months. Histopathology findings were similar to those reported previously, and no significant differences in the expression of α-smooth muscle actin and protein gene product 9.5 were observed between responders and non-responders. Transcriptome analysis at baseline identified 67 genes that were differentially expressed between responders and non-responders, including SLPI, MMP3, and MUC19, which were upregulated in responders. Although the differentially expressed gene products may have conflicting effects, genes in the airway epithelium and extracellular matrix of patients with severe asthma may determine the BT response. Our results identified possible transcriptomic changes that could be used to identify BT responders.

Quality of Life in Adult and Pediatric Patients with Tropomyosin Receptor Kinase Fusion Cancer Receiving Larotrectinib

Neurotrophic tyrosine receptor kinase (NTRK) gene fusions lead to chimeric tropomyosin receptor kinase (TRK) fusion proteins, which act as primary oncogenic drivers in diverse tumor types in adults and children. Larotrectinib, a highly selective and central nervous system-active TRK inhibitor, has shown high objective response rates, durable disease control, and a favorable safety profile in patients with TRK fusion cancer. The impact of larotrectinib on health-related quality of life (HRQoL) was evaluated in adult and pediatric patients in two phase I/II clinical trials (NAVIGATE; NCT02576431 and SCOUT; NCT02637687). Patients completed HRQoL questionnaires (EORTC QLQ-C30, EQ-5D-5L, and PedsQL) at baseline and at planned treatment cycle visits. Changes in questionnaire scores were evaluated over time, and by tumor type and treatment response. Questionnaires from 40 adult and 17 pediatric (2-19 years of age) patients receiving larotrectinib were completed at baseline and at least one post-baseline timepoint. Meaningful within-patient HRQoL improvements occurred at one or more timepoints in 60% of adults and 76% of pediatric patients. Sustained improvements in EORTC QLQ-C30 and PedsQL scores were rapid, occurring within 2 months of treatment initiation in 68% and 71% of patients, respectively. Improvements were observed regardless of tumor type and appeared to correlate with clinical efficacy. The rapid within-patient HRQoL improvements in adult and pediatric patients with TRK fusion cancer are consistent with the clinical profile of larotrectinib. Our results provide valuable information for use of this agent in this patient population. A plain language summary of this article is available in the supplementary appendix.

Responsiveness and minimal clinically important difference of the EQ-5D-5L in cervical intraepithelial neoplasia: a longitudinal study

BackgroundWith the widespread clinical application of the five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L), whether the questionnaire scores are responsive to changes in patients’ health and how much changes in questionnaire scores represent patients’ real health changes require consideration. Consequently, we assessed responsiveness and estimated the minimal clinically important difference (MCID) of the EQ-5D-5L in surgically treated patients with cervical intraepithelial neoplasia (CIN) to determine the relationship between MCID and minimal detectable change (MDC).MethodsWe conducted a longitudinal, observational study. Participants were patients with CIN from the gynecology inpatient department of a grade-A tertiary hospital in Shihezi, Xinjiang, China. Participants completed the EQ-5D-5L and the Global Rating of Change Questionnaire (GRCQ) at baseline and one month post-surgery. The Wilcoxon signed-rank test was used to compare EQ-5D-5L scores pre- and post-treatment. We calculated the effect size (ES) and the standardized response mean (SRM) to quantitatively assess responsiveness. Distribution-based, anchor-based, and instrument-defined methods were used to estimate MCID. MCID to MDC ratios at individual- and group-levels were also calculated.ResultsFifty patients with CIN completed the follow-up investigation (mean age 44.76 ± 8.72 years; mean follow-up time 32.28 ± 1.43 days). The index value and EQ visual analogue scale (EQ VAS) of the EQ-5D-5L improved by 0.025 and 6.92 (all p < 0.05) at follow-up as compared to baseline respectively. The ES and the SRM of the index value were 0.47 and 0.42 respectively, indicating small responsiveness; while the ES and the SRM of EQ VAS were 0.50 and 0.49 respectively, indicating small to moderate responsiveness. The average (range) of MCIDs for index value and EQ VAS were 0.039 (0.023–0.064) and 5.35 (3.12–6.99) respectively. These values can only be used to determine whether patients have experienced clinically meaningful health improvements at the group level.ConclusionsThe EQ-5D-5L has only small to moderate responsiveness in post-surgical patients with CIN, and the MCIDs developed in this study can be used for group-level health assessment. However, further study is needed concerning health changes at the individual level.

Comparison of nebivolol versus diltiazem in improving coronary artery spasm and quality of life in patients with hypertension and vasospastic angina: A prospective, randomized, double-blind pilot study.

Beta-blockers are often not the preferred treatment for patients with vasospastic angina. However, nebivolol, beta-blocker with nitric oxide-releasing effect, could theoretically improve coronary vasospasm. We compared nebivolol versus diltiazem in improving coronary vasospasm and quality of life in patients with hypertensive vasospastic angina during a 12-week follow-up. Fifty-one hypertensive patients with documented coronary vasospasm were randomly allocated into 3 treatment groups: (1) Nebivolol Group (5mg for 2 weeks/10mg for 10 weeks); (2) Diltiazem Group (90mg for 2 weeks/180mg for 10 weeks); (3) Low-dose Combination Group (2.5mg + 45mg for 2 weeks/5mg + 90mg for 10 weeks). The primary endpoint was to compare the percent changes in coronary vasospasm at 12 weeks from baseline among the 3 groups. The secondary endpoints included changes in quality of life based on the Seattle Angina Questionnaire and changes in blood pressure at 12 weeks from baseline. Significant improvements in coronary vasospasm were found in all groups; however, the improvement in percent changes in coronary artery spasm was greatest in the Diltiazem Group (50.4±8.8% vs. 67.8±12.8% vs. 46.8±12.3%, Nebivolol Group vs. Diltiazem Group p = 0.008; Nebivolol Group vs. Low-dose Combination Group p = 0.999; Diltiazem Group vs. Low-dose Combination Group p = 0.017). The overall Seattle Angina Questionnaire scores were significantly elevated at 12 weeks compared to the baseline in entire study population. There were no significant differences between the three groups in the overall Seattle Angina Questionnaire score changes and blood pressure changes. Both nebivolol and diltiazem showed significant coronary vasospasm reduction effect, but the effect was greater for diltiazem.

Comparison of QoL Between Substernal and Posterior Mediastinal Routes in Esophagogastrostomy

BackgroundAfter esophagectomy, various reconstruction routes can be considered for technical and oncologic objectives. The substernal route is believed to cause more dysphagia or delayed gastric emptying symptoms than the posterior mediastinal route. We evaluated and compared the quality of life (QoL) after reconstruction by either the substernal or posterior mediastinal routes in the McKeown procedure. MethodsBetween 2011 and 2018, 378 patients who received an esophagectomy and cervical esophagogastrostomy for esophageal cancer were followed up. Among these patients, 278 received reconstruction via the substernal route and 100 via the posterior mediastinal route. Patients completed the validated questionnaires, EORTC QLQ-C30 and QLQ-OES18, before surgery and at 1, 2, 3, 6, 12, and 24 months after surgery. Linear mixed-effects models were used to examine changes in questionnaire scores over time. ResultsOne month after surgery, patients QoL deteriorated and more symptoms were observed than at baseline. Global health status, nausea and vomiting, and esophageal pain gradually recovered from 2 months and recovered to initial levels at 2 years. However, the other functional and symptom scales of the QLQ-C30 and OES18 were not normalized at 2 years after the operation. When comparing the substernal and posterior mediastinal routes, QLQ-OES18 symptom scales, such as eating, dysphagia, trouble with swallowing saliva trouble with taste and reflux, were no different between the two groups, even after adjusting confounding factors at 2 years after the operation. ConclusionThe cervical esophagogastrostomy with a substernal route showed comparable QoL to reconstruction with a posterior mediastinal route.

Clinically significant differences in patient-reported outcomes evaluations in chronic spontaneous urticaria.

The aim of this review is to highlight the conceptual and practical knowledge for interpreting score changes in patient-reported outcomes (PROs) that have been validated for chronic spontaneous urticaria (CSU). The urticaria guidelines recommends to assess PROs as Health-Related Quality of Life, disease activity and disease control, to detect the CSU impact and the overall treatment effect. To this aim it is crucial to determine the minimal important difference (MID) to assess if changes in questionnaire scores represent either perceived improvement or deterioration for patients. Methods for establishing the MID are well defined and are clustered into two broad categories: distribution-based and anchor-based. For the majority of the available questionnaires for CSU, an MID has been defined, according to the results of various approaches. In most of the studies in our review, anchor-based methods, either alone or in combination with distribution ones, were used. The available information regarding MIDs across validated tools for CSU patients helps to interpret measurement scores and allows the implementation of PROs in routine practices.

Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins

ObjectiveThe objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. MethodsThe patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. ResultsThe total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. ConclusionsRFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.

A Randomized Trial of Modified-Release Versus Immediate-Release Tolvaptan in ADPKD

IntroductionTolvaptan, for treatment of autosomal dominant polycystic kidney disease (ADPKD), is provided as immediate-release (IR) tablets administered twice daily in split-dose regimens to suppress urine osmolality to <300 mOsm/kg. A modified-release (MR) formulation was developed for once-daily (QD) dosing to increase compliance and mitigate urinary symptom burden. This phase 2, dose-ranging study (NCT01210560) compared pharmacokinetics, pharmacodynamics, and tolerability of several MR regimens with IR in patients with ADPKD.MethodsThis was a multicenter, parallel-arm, randomized, crossover, double-blind, placebo-controlled trial. Each of 2 study arms had 12 subjects and 3 crossover periods. Dose regimens were administered for 7 days; placebo-masked QD versus split-dose treatments. Endpoints included pharmacokinetic parameters, percentage of subjects with urine osmolality <300 mOsm/kg, urine volume, number of daily urine voids, and tolerability.ResultsTolvaptan MR 20 to 120 mg exhibited dose-proportional pharmacokinetics. Percentage of subjects with spot urine osmolality <300 mOsm/kg increased with dose, with tolvaptan MR 120 mg and IR 90+30 mg each suppressing 91.7% of subjects below this level. Urinary burden on the ADPKD Nocturia Quality of Life, ADPKD Urinary Urgency, and ADPKD Urinary Frequency Questionnaires correlated with tolvaptan exposure, with high interindividual variability in responses. Changes in questionnaire scores were sensitive to changes in urine volume but not proportional to volume change, reflecting differences in subject tolerance to increased urine volume.ConclusionTolvaptan MR exhibited predictable and dose-proportional pharmacokinetics and no improvement in tolerability versus tolvaptan IR. Tolerability of the urinary effects of treatment within the high-dose MR and IR groups exhibited substantial interindividual variability.

Men's Sexual Health Questionnaire score changes vs spontaneous sexual adverse event reporting in men treated with dutasteride/tamsulosin combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A post hoc analysis of a prospective, randomised, placebo-controlled study.

SummaryAimTo assess the impact of baseline characteristics on Men's Sexual Health Questionnaire (MSHQ) total scores and to evaluate the clinical relevance of MSHQ changes and their association with spontaneously reported sexual adverse events (SexAEs) in patients with benign prostatic hyperplasia.MethodsThis was a post hoc analysis of the Phase 4 FDC116115 study, in which patients aged ≥50 years were randomised 1:1 to receive a fixed‐dose combination of dutasteride 0.5 mg and tamsulosin 0.4 mg (DUT‐TAM FDC), or placebo. End‐points included: change in MSHQ total scores by baseline characteristics and SexAEs; cumulative distribution function for change from baseline to month 12 in MSHQ total score and the ejaculation, erection, satisfaction and sexual desire (libido) domain scores; and relationship between changes in MSHQ scores and SexAEs.ResultsThe intent‐to‐treat population comprised 489 patients (DUT‐TAM FDC, n = 243; placebo, n = 246). The mean reduction in total MSHQ score was greater in patients with SexAEs across both groups, compared with patients without SexAEs. Most patients reporting any SexAE (86% DUT‐TAM FDC, 67% placebo) had a worsening of the MSHQ total score at month 12 compared with baseline. Specifically, 90% (DUT‐TAM FDC) and 75% (placebo) of patients reporting an ejaculation SexAE and 73% (DUT‐TAM FDC) and 87% (placebo) of patients reporting an erection SexAE had a worsening of MSHQ ejaculation and erection domain scores, respectively, at month 12. A threshold effect for incident SexAE was observed; patients showing a decrease of approximately 6‐10 points in the total MSHQ score were more likely to report SexAEs.ConclusionFindings support the clinical utility of the MSHQ tool in assessing the impact of DUT‐TAM on sexual function by linking numerical changes in MSHQ scores to spontaneously reported SexAEs for the first time. The threshold effect for incidence of SexAEs warrants further investigation to determine its clinical relevance.

Study on the difference of green laser in the treatment of prostatic hyperplasia

Objective To compare the safety and efficacy of different green laser surgery in the treatment of benign prostatic hyperplasia. Methods A retrospective comparative analysis was made of the data of patients who underwent various green laser prostatectomy(GL-PVP), green laser vaporization of the prostate(GL-PVRP) and green laser enucleation of the prostate(GEL-EP) in our hospital during May 2016 and May 2018. The short-term clinical indexes such as operation time, bleeding volume, bladder irrigation time and indwelling time of urethral catheter after prostatectomy were compared and analyzed.The long-term clinical data, such as urodynamic data, postoperative IPSS score, postoperative QOL score, international erectile function index questionnaire score, postoperative complications were analyzed between groups. Results There was no statistically significant difference between preoperative general data(age, preoperative prostate volume, preoperative PSA, preoperative IPSS score, preoperative QOL score, preoperative maximum urine flow rate, preoperative residual bladder urine, international erectile function index questionnaire score) of patients in GL-PVP group, GL-PVRP group and GEL-EP group(P>0.05). Compared with the preoperative patients in postoperative maximum urinary flow rate, postoperative bladder residual urine, postoperative IPSS score, postoperative QOL scores improved were statistically significant(P<0.01). The mean operative time of PVP, PVRP and EP in BPH treatment, .intraoperative mean blood loss, duration of continuous bladder irrigation and indwelling catheter time were statistically significant(P<0.05). However, there was no statistically significant difference in postoperative IPSS change value, postoperative QOL change value, urinary flow rate change value, and bladder residual urine change value, international erectile function index questionnaire score change value and incidence of postoperative complications. Conclusions Green laser can effectively and safely treat prostatic hyperplasia. Compared with PVRP and GL-EP, PVP has advantages of shorter operative time, less intraoperative blood loss, shorter postoperative bladder rinsing time and shorter time of indwelling urinary catheter. Key words: Prostatic Hyperplasia; Lasers, Solid-State

7: Impact of second stage pushing timing on maternal pelvic floor morbidity: Multicenter randomized controlled trial

Childbirth is the most significant risk factor for pelvic floor disorders in women, yet the impact of labor management such as timing of pushing in the second stage is unknown. We sought to determine whether immediate or delayed pushing results in higher measures of pelvic floor morbidity. Multicenter randomized trial in which nulliparous women at term with neuraxial analgesia were randomly assigned at complete cervical dilation to immediate pushing or delay for 1 hour. Participants were assessed at baseline (for questionnaire), 6 weeks and 6 months postpartum. Outcome measures were rates and extent of pelvic organ prolapse (POP) based on the Pelvic Organ Prolapse Quantification (POP-Q) system, and patient-reported symptoms of urinary incontinence (UI), fecal incontinence (FI), and POP using validated symptom-specific distress and quality-of-life pelvic floor questionnaires: Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Fecal Incontinence Severity Index (FISI). Rates and severity of POP, and changes in questionnaire scores from baseline at 6 weeks and 6 months were compared between the 2 groups. Of the 2414 subjects randomized, 941 (39.0%) participated in the pelvic floor assessments; 452 immediate and 489 delayed pushing. Baseline characteristics were comparable in the 2 groups. There were no differences in overt perineal lacerations and objective measures of POP at 6 weeks and 6 months (Figure). None of the changes from baseline in the total and subscale scores for the PFDI and PFIQ were significantly different at 6 weeks and 6 months postpartum (Table). The change in FISI score from baseline was statistically higher with immediate pushing at 6 months (0-61 points: 2.91 ± 5.7 vs 1.99 ± 4.5, P=0.01), but this difference was less than the minimal important difference of 4 for this instrument. Among nulliparous women at term with neuraxial analgesia, neither immediate nor delayed pushing in the second stage resulted in significant differences in POP, and patient-reported symptoms of UI and FI at 6 weeks and 6 months.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

PBI14 COST-EFFECTIVENESS OF SECUKINUMAB VERSUS OTHER BIOLOGICS AND APREMILAST IN THE TREATMENT OF ACTIVE PSORIATIC ARTHRITIS: A SPANISH PERSPECTIVE

To assess the cost-effectiveness of secukinumab, an interleukin-17A inhibitor, with other biologics and apremilast in psoriatic arthritis (PsA) patients from a Spanish payers’ perspective. Secukinumab 150 mg and 300 mg were evaluated against etanercept, certolizumab pegol, adalimumab, golimumab, ustekinumab, infliximab, and apremilast over a lifetime horizon in a semi-Markov model. Both biologic-naïve (with or without moderate to severe psoriasis) and biologic-experienced PsA patients were considered. To assess treatment response, the 12-week PsA Response Criteria (PsARC) was used as a primary criterion. Model inputs were derived from PsA clinical trials, published literature, and other Spanish sources. Quality-adjusted life years (QALYs) gained and incremental cost-effectiveness ratio were key model outcomes. Impact of input variations were evaluated through sensitivity analyses and alternative scenario analyses. Secukinumab 150 mg dominated all subcutaneous (S.C.) biologics and apremilast with highest QALYs of 9.22 and lowest lifetime cost of €192,445, while it was cost-effective against the intravenous (I.V.) infliximab in biologic-naïve patients without psoriasis. Among biologic-naïve patients with psoriasis and biologic-experienced patients, secukinumab 300 mg was cost-effective against all S.C. branded biologics and apremilast, while it dominated I.V. infliximab. PsARC response at 3-months, drug acquisition costs, and Health Assessment Questionnaire score change were identified as the most important parameters affecting model results as per one-way sensitivity analysis. Probabilistic sensitivity analysis showed maximum net monetary benefits with both secukinumab doses. Results from scenario analyses confirmed these results. Secukinumab is a cost-effective biologic treatment for PsA patients from a Spanish payer’s perspective.