Significant Improvement In Quality Of Life Research Articles

OCULAR DISCOMFORT IN PROFESSIONAL POLO-WATER PLAYERS: A PRACTICAL EXPERIENCE WITH TOPICAL HYALURONIC ACID AND GLYCURONATE ENOXOLONE.

Professional polo-water athletes are exposed to chlorine in the swimming pool. Chlorine is an irritant agent, so polo-water athletes commonly experience irritative eye symptoms. Hyaluronic acid and glycuronate enoxolone exert anti-inflammatory and cytoprotective activity. Therefore, the present practical experience explored the efficacy and safety of eye drops containing both components. The current study included 59 professional polo-water athletes. The ocular surface disease index (OSDI) and dry eye-related quality of life (QoL) score (DEQS) questionnaires were used to assess the efficacy. Subjects took the eye drops for one month. The study consisted of a baseline visit (T0) and an end-treatment one (T1). Athletes experienced a significant improvement in symptoms and QoL as assessed by OSDI and DEQS scores (p < 0.001 for both). The present study showed that professional polo-water athletes frequently experience ocular discomfort associated with swimming pool attendance. Eye drops with hyaluronic acid and glycuronate enoxolone can significantly relieve eye symptoms and improve the quality of life in these athletes.

Methodological and reporting standards for quality-of-life data eligible for European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) credit

The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) has been developed to grade clinical benefit of cancer therapies. Improvement in quality of life (QoL) is considered relevant, especially in the non-curative setting. This is reflected by an upgrade of the preliminary ESMO-MCBS score if QoL is improved compared to the control arm or a downgrade if an improvement in progression-free survival is not paralleled by an improvement in QoL or overall survival. Given the importance of QoL for the final score, a need to ensure the robustness of QoL data was recognised. A checklist was created based on existing guidelines for QoL research. Field testing was carried out using clinical trials that either received an adjustment of the preliminary ESMO-MCBS score based on QoL or had QoL as the primary endpoint. Several rounds of revision and re-testing of the checklist were undertaken until a final consensus was reached. The final checklist consists of four items and can be applied if three prerequisites are met: (i) QoL is at least a secondary endpoint, (ii) evidence of reliability and validity of the instrument is provided, and (iii) a statistically and clinically significant improvement in QoL is observed. The four items on the checklist pertain to the (i) hypothesis, (ii) compliance and missing data, (iii) presentation of the results, and (iv) statistical and clinical relevance. Field testing revealed that a clear QoL hypothesis and correction for multiple testing were mostly lacking, while the main statistical method was always described. Implementation of the ESMO-MCBS QoL checklist will facilitate objective and transparent decision making on QoL data within the ESMO-MCBS scoring process. Trials published until 1 January 2025 will have to meet the prerequisites and at least two items for crediting QoL benefit in the final ESMO-MCBS score. Trials published thereafter will have to meetall four items.

Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment

We evaluated the efficacy of once-daily (QD) upadacitinib 45 mg, an oral, reversible Janus kinase inhibitor, on early symptomatic improvement for ulcerative colitis (UC). Post hoc analyses were performed on pooled data from 2 replicate, phase 3, multicenter induction trials, U-ACHIEVE Induction and U-ACCOMPLISH, to determine the earliest time point of efficacy onset. Diary entry data through 14 days from the first dose of placebo or upadacitinib 45 mg QD were analyzed for daily improvement in UC symptoms (stool frequency, rectal bleeding, abdominal pain, and bowel urgency). Changes in inflammatory markers, high-sensitivity C-reactive protein (hs-CRP), and fecal calprotectin (FCP) were assessed at week 2 and quality of life (QoL) at weeks 2 and 8. Regression analysis determined the association between changes in UC symptoms and the likelihood of achieving clinical remission/response per Adapted Mayo score at week8. Overall, 988 patients (n= 328 placebo, n= 660 upadacitinib) were analyzed. Patients treated with upadacitinib demonstrated significant improvements vs placebo in all UC symptoms between days 1 and 3 and maintained through day 14. A >50% reduction from baseline in hs-CRP and FCP levels was achieved by 75.7% and 48.2% of patients, respectively (P < .001 vs placebo). Increased rates of clinical remission/response per Partial Mayo score from week 2 (26.9%/59.4% upadacitinib 45 mg QD vs 4.3%/22.3% placebo, P < .001) and significant improvements in QoL at weeks 2 and 8 were observed. Early improvement in stool frequency and bowel urgency by day 3 and reductions in hs-CRP and FCP by week 2 were significantly associated with clinical remission/response at week8. Upadacitinib 45 mg QD provided rapid relief of UC symptoms from day 1. gov: U-ACHIEVE Induction (NCT02819635) and U-ACCOMPLISH (NCT03653026).

Impact of COVID-19 on the physical activity, quality of life and mental health of adolescent athletes: a 2-year evaluation of over 17 000 athletes

PurposeTo evaluate the changes in mental health, quality of life (QOL) and physical activity (PA) among adolescent athletes during the COVID-19 pandemic as organised sports resumed.MethodsAdolescent athletes completed surveys including...

Novel, disposable, self-inserted, vaginal device for the non-surgical management of pelvic organ prolapse: efficacy, safety, and quality of life

BackgroundWe evaluated a novel disposable, collapsible, ring-shaped vaginal device that is self-inserted within an applicator and removed with a string. The device was developed to overcome the drawbacks of existing ring pessaries for non-surgical pelvic organ prolapse management (POP).MethodsThe primary objective efficacy endpoint of this prospective, interventional, multicenter, self-controlled, and home-use study was the proportion of subjects with improved staging on the Pelvic Organ Prolapse Quantification (POP-Q) scale. Subjective efficacy was assessed using the POP symptoms alleviation score. Safety was evaluated by recording the rate and incidence of adverse events (AEs) in a daily diary, and quality of life (QoL) was evaluated using the modified Pelvic Floor Impact (PFIQ-7) and Pelvic Floor Disability Index (PFDI-20) questionnaires.ResultsA total of 94 usage cycles were observed in a group of 52 participants (mean age 60.2 ± 10.5 years, 81.1% postmenopausal) who used the device for 3558 days. Of these, 24 participants completed one usage cycle, 14 completed two usage cycles, and 14 completed three usage cycles with 28–45 days of ProVate use in each usage cycle. All patients experienced greater than two POP-Q stage reductions. The descent was completely reduced to POP-Q stage 0 in 97.8% of participants. The POP symptom alleviation questionnaire showed significant subjective efficacy (P < 0.0001). The modified PFDI-20 and PFIQ-7 scores also improved substantially (P < 0.0001 for both). There were 91 nonserious device-related AEs: 98.9% were mild and 87.9% anticipated, with no vaginal infection, and one case of urinary tract infection.ConclusionThe novel device substantially reduces prolapse and provides significant subjective POP symptom relief and QoL improvement, with minimal AEs. The device may enable women to self-manage their prolapse with a small, disposable device that minimizes self-touching and frequent dependency on the clinic.Trial registrationClinical.Trials.gov, NCT02239133, posted September 12, 2014 (retrospectively registered).

Cannabidiol Treatment for Neurological, Cognitive, and Psychiatric Symptoms in Sturge-Weber Syndrome

BackgroundA prior drug trial of cannabidiol for treatment-resistant epilepsy in patients with Sturge-Weber syndrome (SWS), a rare neurovascular condition, implicated improvements in neurological, quality of life (QOL), neuropsychologic, psychiatric, and motor outcomes. MethodsTen subjects with SWS brain involvement, controlled seizures, and cognitive impairments received study drug in this Johns Hopkins institutional review board-approved, open-label, prospective drug trial. Oral cannabidiol was taken for six months (dose ranged from 5 to 20 mg/kg/day). SWS neuroscore, port-wine birthmark score, QOL, and adverse events were recorded every four to 12 weeks. Neuropsychologic, psychiatric, and motor assessments were administered at baseline and six months’ follow-up. Most evaluations were conducted virtually due to the coronavirus disease 2019 pandemic. ResultsCannabidiol was generally well tolerated. Six subjects reported mild to moderate side effects related to study drug and continued on drug; one subject withdrew early due to moderate side effects. No seizures were reported. Significant improvements in SWS neuroscore, patient-reported QOL, anxiety and emotional regulation, and report of bimanual ability use were noted. Migraine QOL scores were high at baseline in these subjects, and remained high. Neuropsychologic and other QOL and motor outcomes remained stable, with some within-subject improvements noted. ConclusionsFurther studies are needed to determine whether Epidiolex can improve quality of life and be beneficial for neurological, anxiety, and motor impairments in SWS independent of seizure control. Large multicentered studies are needed to extend these preliminary findings.

O011 Effect of Continuous Positive Airway Pressure on Quality of Life and Treatment Burden in Children with Obstructive Sleep Apnoea

Abstract Introduction Increasing numbers of children with obstructive sleep apnoea (OSA) require treatment with continuous positive airway pressure (CPAP). We aimed to assess the impact on quality of life (QOL) and treatment burden for caregivers of children requiring CPAP. Methods Prospective study of children commencing outpatient CPAP in a tertiary sleep unit 2020-2022. Questionnaires regarding sleep-related symptoms (PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment), QOL (OSA-18, QI-Disability), caregiver burden (Caregiver Strain Questionnaire) and overall health impact (Glasgow Children’s Benefit Inventory) were completed by caregivers at commencement of CPAP and 6 weeks later. Progress Complete data available to date in 24 children (6F; median age 12.5y, range 6-18y; median OAHI 9.2/hr; median BMI 30.7). OSA-related QOL significantly improved at follow-up (OSA-18 total and domain scores all p&amp;lt;0.001). There were significant improvements in child general QOL (p&amp;lt;0.0001), sleep disturbance (p&amp;lt;0.01) and sleep-related impairment (p&amp;lt;0.001). Caregivers rated CPAP as beneficial to their child’s general condition (mean 30, where maximum harm -100, maximum benefit +100). Caregiver strain reduced at follow-up (p&amp;lt;0.001) and benefit outweighed inconvenience (p&amp;lt;0.0001). 3 caregivers scored inconvenience higher than benefit; 1 scored them equally. 1 caregiver rated CPAP harmful and 3 caregivers reported no effect on their child’s general health. Outcome CPAP results in significant improvements in QOL and sleep-related symptoms in children with OSA, and reductions in caregiver strain. Perceived benefits generally outweighed the burden of treatment, but not for all families. Further analysis will investigate how the balance of benefit to burden relates to adherence and the effect of co-morbidities.

Abstract 14310: Patient Reported Outcomes of Catheter Ablation for Atrial Fibrillation in Patients With Chronic Kidney Disease

Introduction: Increasingly, catheter ablation for atrial fibrillation (AF) has been utilized for rhythm control and to improve quality of life (QoL). Data are limited on patient-centered ablation outcomes in individuals with chronic kidney disease (CKD). Objective: To examine clinical outcomes and QoL following AF ablation in CKD patients from a large patient-reported outcomes (PRO) database. Methods: All patients undergoing AF ablation (2013-2016) at our center were enrolled and assessed for outcomes using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). This analysis captured data at 1- and 3-year follow-up. CKD was defined as estimated glomerular filtration rate (eGFR) &lt;60 ml/min using the 2021 CKD-EPI equation. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL assessment. In addition, data were collected on clinical improvement by patient report, AF burden, and healthcare utilization. Results: A total of 488 patients were identified (66% male, mean age 68.5, 56.2% persistent AF). QoL was significantly improved from baseline median (IQR) AFSSS of 14 (6-19.5) to 3 (0-9) at 1-year and 4 (0-9.5) at 3-year; P≤0.0001 for both. About 90% of patients reported improvement in their overall AF-related symptoms both at 1- and 3-year follow up. The proportion of patients in AF at the time of completion of the baseline survey was 51.2%, and this decreased to 6.2% at 1-year and 9.7% at 3-year follow up (P&lt;0.0001 for both). AF burden was significantly reduced at 1-year and 3-year including frequency and duration of episodes (P&lt;0.05 for both), with associated decrease in ER visits and hospitalizations; P&lt;0.0001 for all comparisons. The proportion of patients on antiarrhythmics decreased from 61.8% at baseline to 35.6% and 22.7% at 1-year and 3-year, respectively (P&lt;0.0001 for both). Conclusions: In a large AF-specific PRO system, catheter ablation for AF was associated with a significant improvement of QoL in most patients with CKD; with a decrease in AF burden and healthcare utilization.

Abstract 11974: A Randomized, Controlled Trial of Resistance Training Added to Caloric Restriction Plus Aerobic Exercise Training in Obese Heart Failure With Preserved Ejection Fraction

Background: We previously showed that the combination of caloric restriction (CR) and aerobic exercise training (AT) produce robust improvements in exercise capacity and quality of life (QOL) in patients with obese Heart Failure with Preserved Ejection Fraction (HFpEF). However, ~ 35% of weight lost during CR+AT was from skeletal muscle (SM) mass, which may have adverse long-term consequences. Hypothesis: The addition of resistance training (RT) to CR+AT would reduce SM loss and further improve exercise capacity and QOL. Methods: Randomized, controlled, single blind trial of 20 weeks of RT+CR+AT vs. CR+AT in 88 patients with HFpEF and body mass index (BMI) ≥28 kg/m 2 . Measurements were: peak exercise O 2 consumption (VO 2 ); body composition by MRI and dual X-ray absorptiometry; leg muscle strength; leg muscle quality (leg strength ÷ leg SM area); Kansas City Cardiomyopathy Questionnaire (KCCQ) total score. Results: 77 participants completed the trial: age 68±5 years; 85% women; BMI 39.6±5.8 kg/m 2 . Both RT+CR+AT and CR+AT had substantial weight loss, mean (95% CI): -8.1 (-9.3, -6.8) vs. -9.2 (-10.5, -7.9) kg with no significant intergroup difference (p=0.21). Both RT+CR+AT and CR+AT had substantial loss of total body fat [-6.5 (-7.2, -5.8) vs. -7.4 (-8.1, -6.7) kg] and SM [-2.1 (-2.7,- 1.5) vs. -2.1 (-2.7, -1.4) kg], with no intergroup differences (p=0.20 and 0.23, respectively). Despite similar relative loss of SM (26% vs. 23% of total weight lost), RT+CR+AT vs. CR+AT alone produced significantly greater increases in leg muscle strength [4.9 (0.7, 9.0) vs. -1.1 (-5.5, 3.2) Nm, p=0.05] and leg muscle quality [0.07 (0.03, 0.11) vs. 0.02 (-0.02, 0.06) Nm/cm 2 , p=0.04]. Both RT+CR+AT and CR+AT produced large, significant improvements in peak VO 2 [108 (958, 157) vs. 80 (30, 130) ml/min; p=0.001 and 0.002, respectively], and in KCCQ score [17 (12, 22) vs. 23 (17, 28); p=0.001 for both], with no significant intergroup differences (p=0.21 and p=0.07, respectively). There were no study related serious adverse events. Conclusion: In older obese HFpEF patients, CR+AT produces large, significant improvements in exercise capacity and QOL. Addition of RT to CR+AT increased leg strength and leg muscle quality without attenuating SM loss or further increasing peak VO 2 or KCCQ score.

Impact of redo ablation for atrial fibrillation on patient-reported outcomes and quality of life.

Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry. All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations. A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables). Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Transcutaneous electrical nerve stimulation for at-home treatment of nocturnal enuresis in children: Determining optimal pad placement

Introduction:Nocturnal enuresis (NE) is a common problem encountered in children that can be recalcitrant to currently available treatment options. Neuromodulation techniques are used to treat various urologic disorders but can be limited by convenience and compliance. Transcutaneous electrical nerve stimulation (TENS) is a neuromodulator that can be used at home to treat various conditions. The aim of this study was to determine if TENS can be offered as an effective at-home option that shows durability for NE in children, and to determine which pad placement is the most efficacious. Materials & Methods:A randomized clinical trial including 90 patients aged 5–18 years presenting with monosymptomatic NE was performed. After one month of behavioral therapy, they were treated with TENS therapy after randomization to three groups based on pad placement: suprapubic (SP), parasacral (PS), and ankle/posterior tibial (PT). TENS therapy was performed nightly for one month. Voiding diaries recording the number of wet nights, wet scale severity score (0–3), TENS compliance, quality of life (QOL) questionnaires, and any adverse reactions were collected monthly at baseline, during TENS therapy, and after TENS for durability assessment, and statistically analyzed after study completion. Results:No patient was cured of NE, and our study failed to show a statistical difference between the study arms in enuresis frequency during TENS. The only statistically significant improvement was QOL during TENS therapy (2.95 improvement for the PT group versus 1.2 and 1.5 regression for SP and PS groups, respectively, p=0.003). PT TENS therapy also showed improvements for enuresis frequency with 2.7 less episodes/month (versus 4.1 and 8.2 more episodes/month in the SP and PS groups, respectively, p=0.06) and the severity of wetness each night with a 0.17 improvement (versus 0.06 and 0.13 regression in the SP and PS groups, respectively, p=0.06) after TENS therapy was completed, however these did not meet statistical significance. Patients were compliant with using TENS therapy (90% or more in all groups) and there were no adverse events. Discussion:This study found that patients who used the PT pad placement for TENS showed significant improvements in QOL during therapy, however we were unable to show a significant difference in enuresis frequency during TENS between groups. The major limitation of our study was the high number of patients lost to follow-up during the COVID-19 pandemic. Conclusion:TENS therapy when combined with behavioral techniques can be an easy and safe tool that can be used at home to help treat NE, however, further studies are needed to optimize this type of therapy to show a clinically significant benefit.

Dynamic changes in quality of life, psychological status, and body image in women who underwent a mastectomy as compared with breast reconstruction: an 8-year follow up.

Surgical decisions and methods of surgery highly influence long term QoL for breast cancer (BC) survivors. This study is aimed towards an exploration of the dynamic changes in quality of life (QoL), anxiety/depression status, and body image (BI) among women with BC who received a mastectomy compared with those receiving breast reconstruction (BR) within an 8-year follow-up period. Women with major BC surgeries were invited to complete the World Health Organization Quality of Life-Brief (WHOQOL-BREF), the European quality of life five dimensions questionnaire (EQ-5D), and a body image scale within 8years of surgery. Kernel smoothing methods were applied to describe dynamic changes in QoL, anxiety/depression, and BI at different time points. Linear mixed effects models were constructed to identify the interaction between time, different types of surgery, and the determinants of QoL in these patients. After 1:10 propensity score matching, a total of 741 women who had undergone a BR and mastectomy were included. The BR group exhibiteda high WHOQOL QoL score one to five years after surgery with some fluctuations. The mastectomy group had comparatively stable QoL scores on WHOQOL items and were less depressed/anxious. The BR group generally showed fluctuating, higher BI scores two years after surgery, but they exhibited more anxiety/depression during follow up for 8years. Medical comorbidities, the status of anxiety/depression, and BI were the major factors influencing all domains and items of the WHOQOL BREF among women with BC. The mastectomy group showed a decreased trend toward depression in patients with BC. The BR group showed a significant improvement in QoL in the first 5years with massive fluctuations. These findings should be considered and discussed in patient participatory decision-making and promotion of QoL for breast cancer survivors.

Quality of life among cervical cancer patients following completion of chemoradiotherapy at Ocean Road Cancer Institute (ORCI) in Tanzania

ObjectiveEffective cancer treatment involves aggressive chemo-radiotherapy protocols that alter survivors’ quality of life (QOL). This has recently aroused the attention not only to focus on clinical care but rather to be holistic and client-centered, looking beyond morbidity and mortality. The study assessed the QOL and associated factors among patients with cervical cancer (CC) after the completion of chemoradiotherapy.MethodsA cross-sectional analytical study was conducted at Ocean Road Cancer Institute (ORCI) from September to November 2020. A total of 323 CC patients were interviewed with a structured questionnaire of QOL, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), and its cervical cancer module (EORTC QLQ-CX24). The QOL domains, socio-demographic and clinical variables were analyzed with Mann–Whitney and Kruskal–Wallis on SPSS version 23, and a P < 0.05 was considered significant.ResultsMore than half (54.8%) of the CC patients had a good overall QOL. Overall, QOL was affected by education (P = 0.019), smoking (0.044), sexual partner (P = 0.000), treatment modality (P = 0.018), and time since completion of treatment (P = 0.021). Patients who underwent external beam radiation suffered from significant side effect symptoms (P < 0.05) while those who underwent combined external beam radiation and brachytherapy had higher functioning in most domains (P < 0.05).ConclusionsA significant improvement in QOL was observed after chemoradiotherapy and was affected by socio-demographic and clinical variables. Thus, calls for individualized care in addressing these distressing symptoms.

A Multicenter Prospective Trial of Electronic Skin Surface Brachytherapy (ESSB) for Cutaneous Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC): Cosmesis, Quality of Life (QoL) and Adverse Events (AEs)

<h3>Purpose/Objective(s)</h3> SCC and BCC are amenable to a variety of treatments. ESSB has emerged as a novel option which enables precise delivery of radiotherapy (RT), potentially limiting side effects. In a prospective multicenter clinical trial, we characterized early outcomes of ESSB, hypothesizing that it affords cosmesis superior to what has been previously reported. <h3>Materials/Methods</h3> Patients ≥60 years old with clinical stage T1N0M0 SCC or BCC were recruited. Patient and clinician-reported cosmesis was evaluated with a previously reported subjective 3 tier system. QoL was assessed by the Skindex-16 (S16) and Skin Cancer Index (SCI). Assessments were performed before treatment and 2, 6 and 12 weeks post-treatment. AEs were assessed using CTCAE v4.0. A primary endpoint was patient-reported cosmesis, with the hypothesis that ESSB would be associated with a 12 week post-treatment patient-report of "good" cosmesis in ≥90% of patients. A sample size of 34 patients was calculated to determine if the rate of "good" cosmesis was superior to a previously reported 73% rate of "good" cosmesis with a type I error rate of 0.07 and a type II error rate of 0.12. Comparisons of QoL before and post-treatment were done using Wilcoxon signed rank tests. <h3>Results</h3> 34 patients were treated with ESSB prescribing 42 Gy in 6 fractions twice or thrice a week to a depth of 3 mm below skin surface. Patients were mostly women (59%); all were white and non-Hispanic. Most were treated for BCC (94%), on the face (97%) and nose (68%). Cosmesis and QoL was collected at 99 of 102 (97%) possible patient-time points. Patient and clinician-reported "good" cosmesis 12 weeks post-treatment was reported in 93% and 97% of cases, respectively. Significant decreases in QoL were noted 2 weeks post-treatment in the symptom and function subscales of the S16, but thereafter significant increases in QoL were noted in almost all subscales of S16 and SCI (see Table). The most severe AEs were grade 3 and occurred in week 3 of treatment (skin pain, 6%) and 2 weeks post-treatment (dermatitis, 42%). All AEs resolved to grade ≤1 by 12 weeks post-treatment. <h3>Conclusion</h3> This prospective study with very complete data collection supports the hypothesis that ESSB is associated with a superior rate of early patient-reported cosmesis compared to previously reported forms of RT for skin cancer. Validated assessments demonstrated a significant improvement in QoL and resolution of moderate early AEs by 6-12 weeks post-treatment and corroborate the observation of favorable cosmesis.

Randomized, Double-Blind Placebo-Controlled Trial to Assess the Effect of Probiotics on Irritable Bowel Syndrome in Veterans With Gulf War Illness.

Many veterans who served in Operation Desert Storm (August 1990 to March 1991) experienced a complex of symptoms of unknown etiology called Gulf War illness (GWI), which significantly impacts the health and quality of life (QOL) and may have contributed to irritable bowel syndrome (IBS). We performed a prospective, double-blind placebocontrolled study to determine the efficacy of the multistrain De Simone Formulation probiotic containing 8 strains of bacteria on symptoms of IBS and GWI. Veterans of Operation Desert Storm who had IBS and ≥ 2 nonintestinal symptoms of GWI were included. The primary study endpoint was change in bowel symptom score. The secondary endpoints were mean change in symptoms, QOL, and extra-intestinal and posttraumatic stress disorder (PTSD) symptoms. A total of 101 Gulf War veterans with IBS and GWI were screened at the Veteran Affairs Medical Center in Salt Lake City, Utah. The study was completed by 53 veterans; 47 (89%) were male with a mean (SD) age of 55 (8) years. The probiotic did not improve IBS symptoms or other extra-intestinal symptoms common to IBS and GWI. Our study did not demonstrate statistically significant improvement in IBS symptoms or QOL after treatment with the probiotic. We also did not find any improvement in symptoms of GWI or PTSD.

Quality of life and psychological aspects in children with overactive bladder treated with parasacral transcutaneous electrical nerve stimulation - A prospective multicenter study

To assess the impact of parasacral transcutaneous electrical nerve stimulation (parasacral TENS) on quality of life (QoL) and psychological aspects in children treated for overactive bladder (OAB). This international, multicenter, prospective cohort study involved individuals of 6-16 years of age under TENS treatment for OAB. The study was conducted between June 2016 and December 2019 in four participating centers: two in Australia, one in Germany and one in Brazil. Patients with anatomical and/or neurological abnormalities of the urinary tract were excluded. Questionnaires were applied before and after parasacral TENS treatment: the Dysfunctional Voiding Symptom Score (DVSS), used in Brazil, or the International Consultation on Incontinence Questionnaire - Pediatric Lower Urinary Tract Symptoms (ICIQ-CLUTS), used in Germany and Australia, to analyze urinary symptoms; the Strengths and Difficulties Questionnaire (SDQ) to assess emotional and behavioral aspects; and the Pediatric Incontinence Questionnaire (PinQ) for bladder-specific Qol. Fifty-three patients (28 girls and 25 boys) with a mean age of 8.64±2.63 years were included. Median DVSS was 11 (range 6-13.5) and 3 (range 0-7), (p<0.001), and median ICIQ-CLUTS was 12 (range 9-14) and 9 (range 5.7-12), (p<0.001), before and after treatment, respectively. Median PinQ score decreased from 47.8 (range 38.9-59.7) to 39 (range 29-53.15) following treatment (p=0.04). Median total SDQ score before and after treatment was 17 (range 13.5-21) and 15 (range 12-21), respectively (p=0.939). Parasacral TENS was associated with a significant improvement in urinary symptoms and QoL; however, there was no change in psychological symptoms, as measured using the SDQ.

Comparison of the Effects of an Exergame-Based Program with Conventional Physiotherapy Protocol Based on Core Areas of the European Guideline on Postural Control, Functional Mobility, and Quality of Life in Patients with Parkinson's Disease: Randomized Clinical Trial.

Introduction: Impairment of postural control and functional mobility are debilitating symptoms of Parkinson's disease (PD). In addition to limiting performance in activities of daily living, it is associated with a higher prevalence of falls in this population. Particularly, dysfunction in postural control does not respond to dopaminergic replacement therapy, but physiotherapy can improve this outcome in patients with PD. Objective: The aim of this study was to analyze the effects of training based on Kinect Adventures games compared with a conventional physiotherapy protocol based on the core areas of the European physiotherapy guideline in patients with PD on postural control, functional mobility, self-perception of confidence in the balance, quality of life (QoL), lower limb muscle strength, transfer skill and motor function, as well as to observe adherence and safety interventions. Methods: Thirty-eight patients diagnosed with idiopathic PD were randomized into two groups, and performed 14 training sessions, twice a week for 60 minutes. The primary outcome assessed postural control using the Mini-Balance Evaluation Systems Test (Mini-BESTest). The following were evaluated as secondary outcomes: limit of stability; balance functional reserve and center of pressure area by computerized posturography; functional mobility by the Timed Up and Go test; self-confidence in balance through the Activities-specific Balance Confidence scale; QoL through the Parkinson's Disease Questionnaire; lower limb muscle strength by the Five Times Sit-To-Stand test; and motor function by the Unified Parkinson's Disease Rating Scale. Results: Patients completed training sessions with high rates of safety and adherence. After training, there was a significant improvement in postural control, motor function, and QoL. Conclusion: Both interventions proved to be safe, applicable, and effective to improve postural control, QoL, and motor function in patients with PD. However, there was no difference between the effects of Kinect Adventures games and conventional physiotherapeutic protocol in patients with PD. Brazilian Registry of Clinical Trials (RBR-27kqv5).

Rezum Outcomes in Relationship to Number of Injections: Is Less More?

Objectives: To assess efficacy and safety outcomes in relationship to the number of injections given during Rezum treatment. Methods: A retrospective study was conducted on patients with moderate to severe lower urinary tract symptoms (LUTS) treated with Rezum. Patients were stratified into cohorts based on the number of injections received per lateral prostatic lobe: 1, 2, 3, or 4 injections. International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), International Index of Erectile Function (IIEF)-Erectile Function, IIEF-Orgasmic Function, and adverse events were collected at baseline, 1, 3, 6, and/or 12 months postoperatively. Results: A total of 179 patients were included: 58, 91, 22, and 8 patients in the 1, 2, 3, and 4 injections cohorts, respectively. Baseline demographics significantly different across cohorts were age, history of urinary retention, prostate-specific antigen, prostate volume, prostatic urethral length, and presence of median lobe. At 3 months, all cohorts reported significant improvements in IPSS and QoL, which remained durable to 12 months. There were no significant differences in changes in IPSS, QoL, PVR, and IIEF-Erectile and Orgasmic Function between the cohorts at any follow-up. Multiple linear regression showed that the number of injections did not predict changes in IPSS, QoL, PVR, and IIEF-Erectile and Orgasmic Function at any follow-up (p > 0.05) but predicted change in Qmax at 3 months (β = 5.7, p = 0.019). Multiple logistic regression showed that for each additional injection, the odds of gross hematuria, penile burning, penile pain, and dysuria increased by 3.8, 2.6, 2.2, and 3.0, respectively. Conclusions: Utilizing less injections represents a safe treatment strategy without compromising Rezum's efficacy in providing durable relief in LUTS.

S514 Virtual Reality Improves Symptoms of Functional Dyspepsia: Results of a Randomized, Controlled, Double-Blind Pilot Study

Introduction: Functional dyspepsia (FD) is a common functional GI disorder, characterized by symptoms of abdominal pain, nausea, and/or early satiety. Virtual reality (VR) is a promising intervention which has been shown to alleviate pain in various clinical settings. There are currently no studies assessing VR for the treatment of FD. The aim of this study was to investigate the effectiveness and safety of VR for the treatment of FD. Methods: This is a prospective, single-center, randomized, controlled, double-blinded study of adult patients with FD (Rome IV criteria). Enrolled patients were randomized 2:1 (experimental to control). Experimental patients were given a VR headset with software consisting of immersive audiovisual programs. Control patients were given an identical headset with 2-D nature videos. Patients were asked to use their headset at least daily and completed Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) and Nepean Dyspepsia Index (NDI) questionnaires at their initial visit, after 1 week of use, and at the conclusion of the 2-week study. Paired sample t-tests were used to compare questionnaire scores. Results: Thirty-seven patients were enrolled in the study (27 experimental, 10 controls); demographic data are shown in Table (Table). Patients used the VR headset an average of 1.3 times/day for a mean of 23.2 minutes/day. Total PAGI-SYM scores significantly decreased for all patients [2.51 (baseline) to 0.62 (week 2); p=0.000]. Notably, patients in the experimental group had greater improvement in mean total PAGI-SYM scores [2.51 baseline) to 1.83 (week 2); mean difference -0.68; p=0.000], compared to the control group [2.50 (baseline) to 2.04 (week 2); mean difference -0.46; p=0.046]. Further, quality of life (QoL) significantly improved for all patients, as the total NDI QoL score increased from 40.97 (baseline) to 57.14 (week 2), p=0.000, though experimental patients saw greater improvement in QoL, compared to control patients (Figure). Seventeen patients (45.9%; 11 experimental, 6 controls) reported non-serious adverse effects (AE), with headache and dizziness being the most common; 1 experimental patient withdrew due to AEs (migraines). Conclusion: In the first randomized, controlled, double-blind study to assess VR for the treatment of FD, VR was shown to be safe and result in statistically significant overall improvement in symptoms and QoL in FD patients. We propose VR as a novel treatment for FD worthy of further investigation.Figure 1.: Total PAGI-SYM and NDI Quality of Life Scores Table 1. - Study Population Demographic Data Mean Age 45 years (± 14) Mean BMI 24.56 (± 6.79) SexFemaleMale 30 (81.1%)7 FD subtypeEPSPDSMixed EPS/PDS 12 (32.4%)20 (54.1%)5 (13.5%) Anxiety 17 (45.9%) Depression 9 (24.3%) PTSD 2 (5.4%) Fibromyalgia 4 (10.8%) Prior H. pylori infection 5 (13.5%) MedicationsPPIAntidepressantsGabapentinOpioidsNSAIDs 16 (43.2%)11 (29.7%)4 (10.8%)2 (5.4%)0 Alcohol Use 7 (18.9%) Marijuana Use 4 (10.8%)

Risk Factors and Real-World Short-Term Outcomes of a Failed Trial of Void After Rezum Therapy in a Multiethnic Population.

Background: Postoperative urinary retention is a common complication following surgery for benign prostatic hyperplasia. We aimed to identify risk factors for a failed trial of void (TOV) following treatment with the Rezum system and assess the impact of a failed TOV on short-term outcomes. Methods: A single-office retrospective study was conducted on patients treated with Rezum therapy between 2017 and 2019. A urinary catheter was placed in all patients following Rezum therapy. Demographic data and outcome measures, including the International Prostate Symptom Score (IPSS), quality of life (QoL), maximum urinary flow rate (Qmax), postvoid residual (PVR), and adverse events, were analyzed at baseline and 1, 3, and/or 6 months postoperatively. Risk factors were identified through multivariate logistic regression analysis. Results: A total of 289 patients were included. Thirty-five patients (12.1%) failed a TOV, while 254 (87.9%) had an effective TOV. All patients were given a TOV after a median of 5 days (4-5). Those who failed the TOV spent an additional mean of 13.7 ± 13.3 days with a catheter. Patients who failed the TOV were more likely to get a urinary tract infection compared with those who had an effective TOV (20.0% vs 4.7%, p < 0.001). All patients experienced significant improvements in IPSS, QoL, and Qmax at 1, 3, and/or 6 months. On multivariate analysis, a high baseline PVR was the only independent predictor of a failed TOV (odds ratio: 1.01, 95% confidence interval 1.00-1.01). A greater proportion of patients with a baseline PVR >200 mL failed the TOV (40.0%) compared with patients with a baseline PVR <200 mL (10.9%, p = 0.008). Conclusions: Approximately one in eight patients failed the TOV following Rezum therapy. Baseline PVR was the only independent risk factor for a failed TOV. Nevertheless, all patients experienced significant relief of urinary symptoms. Patients with high baseline PVR, particularly >200 mL, may require a catheter for an extended duration.