Level Of Bother Research Articles

Men’s Acceptance of Screening for Prostate Cancer with Prostate-specific Antigen, Magnetic Resonance Imaging, and Prostate Biopsy

BackgroundA prerequisite before introducing a screening program is that the screening examinations are acceptable to participants. ObjectiveTo evaluate the acceptance and bother of prostate cancer screening examinations. Design, setting, and participantsThe randomized population-based GÖTEBORG-2 prostate cancer screening trial invited >37 000 men for prostate-specific antigen (PSA) testing followed by magnetic resonance imaging (MRI) in case of elevated PSA and prostate biopsy (targeted and/or systematic) if indicated. Outcome measurements and statistical analysisParticipants were asked to fill out a questionnaire and rate the level of bother associated with each examination (PSA, MRI, and prostate biopsy) on a categorical scale ranging from 1 to 5 (1 = “not at all bothersome” and 5 = “very bothersome”), and to rate their willingness to repeat the examinations, by marking an X on a continuous scale ranging from 0 to 10 (0 = “yes, without any hesitation” and 10 = “no, absolutely not”). Wilcoxon signed rank test was used. Results and limitationsCompliance with MRI was 96% (1790/1872), compliance with biopsy was 89% (810/907), and the response rate to the questionnaire was 75% (608/810). Men who underwent all examinations (n = 577) responded that biopsy was more bothersome than PSA test (p < 0.001) and MRI (p < 0.001). High levels of bother (≥4 out of 5) were reported by 2% (12/577) for PSA test, 8% (46/577) for MRI, and 43% (247/577) for biopsy. Men were more willing to repeat MRI than biopsy (p < 0.001), but the difference was small (median 0.2 [interquartile range 0.1–0.6] vs 0.5 [0.1–2.0]). ConclusionsBiopsies are more bothersome than MRI, but a large majority of men accept to repeat both examinations if necessary. Omitting biopsy for MRI-negative men and shifting to targeted biopsies only will reduce bother for men participating in prostate cancer screening. Patient summaryWe asked men how bothersome they found the prostate-specific antigen (PSA) test, magnetic resonance imaging (MRI), and prostate biopsies. Biopsies were more bothersome than PSA and MRI, but most men were willing to repeat all procedures if necessary.

Constipation After Elective Laparoscopy for Benign Gynecological Indications–A Prospective Observational Study

Discover the rate of post-operative constipation in participants undergoing elective laparoscopy for benign gynecological indications DESIGN: Prospective observational study SETTING: Single site, tertiary level gynecology unit with a focus on pelvic pain and endometriosis. Recruited participants were patients of the institution over the age of 18 who had planned to undergo an elective laparoscopy for benign gynecological indications prior to enrolment in the study. Participants were excluded if they were not English speaking, had a chronic bowel condition (with the exception of irritable bowel syndrome), were planned to have bowel surgery, hysterectomy, or converted to laparotomy. In this prospective study, participants completed 3 consecutive surveys. One prior to surgery, one a week post-surgery, and a third 3 months post-surgery. The surveys collected data regarding the participant's bowel habits, pain relief used, laxatives used, and the distress or bother caused by their bowels. Constipation was defined by a modified ROME IV criteria. Opiate use and laxative use were defined by patient-reported tablet counts. The level of distress was measured as a continuously variable scale from 0 to 100. Variables adjusted for included subject's demographics, pre-operative constipation, indication for surgery, duration of surgery, estimated blood loss, opiate use (preoperative, peri-operative, and post-operative), laxative use, and length of stay. A total of 153 participants were recruited, of which 103 completed both the pre-operative and post-operative survey. Post-operative constipation was present in 70% of participants. The mean length of time to first bowel motion was 3 days, with 32% of participants having their first bowel motion after the third post-operative day. The level of bother caused by their bowel habit was higher in the constipation group compared to those without constipation. Post-operatively opiates were used in 84.9% of participants, and laxatives were used in 47.1%. Visits to the general practitioner for constipation occurred in 5.8% of participants. Post-operative constipation is common and bothersome in participants who undergo elective laparoscopy for benign gynecological indications. Analysis of individual variables failed to identify any factors that influenced the rate of constipation.

Patient-reported outcomes among virally suppressed people living with HIV after switching to Co-formulated bictegravir, emtricitabine and tenofovir alafenamide.

While some evidence has suggested the benefits of co-formulated bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in improving the quality of life of people living with HIV (PLWH), patient-reported outcome studies that focus on Asian population remain scarce. We aimed to determine the changes in HIV-related symptom burden in virally-suppressed PLWH switching to B/F/TAF in a real-world setting. PLWH on stable antiretroviral therapy (ART) for ≥6 months with plasma HIV RNA <200 copies/mL who decided to switch to B/F/TAF were eligible for the study. Participants' experience with 20 symptoms were assessed using HIV Symptom Index at baseline and weeks 24 and 48. Responses were dichotomized in two ways: 1) present vs. not present; and 2) bothersome vs. not bothersome, and compared across time points. Six hundred and thirty participants (prior regimen, 94.4% integrase inhibitor-based) who completed week 48 visit were included in the analysis. Forty-eight weeks after switching to B/F/TAF, six symptoms were significantly less prevalent, and seven symptoms were significantly less bothersome. Improvement was more pronounced in participants whose prior regimen was elvitegravir-based versus dolutegravir-based. Logistic regression results showed that prior dolutegravir-based ART and pre-existing diabetes independently predicted improvement in diarrhea/loose bowels and muscle aches/joint pain, respectively. Despite the overall improvement, some symptoms persisted in a substantial proportion of participants. Virally-suppressed PLWH might benefit from a regimen switch to B/F/TAF to reduce the prevalence and level of bother of HIV-related symptoms. Nevertheless, additional multidisciplinary interventions are warranted to further alleviate the symptom burden of PLWH.

(293) Limitations in Reporting and Assessment Tools for Retrograde Ejaculation after Surgical BPH treatment: A Scoping Review

Abstract Introduction Antegrade ejaculation is a fundamental aspect of sexual satisfaction for many individuals, but retrograde ejaculation (RE) occurs in up to 75 % of some surgical treatments of benign prostatic hyperplasia. Unfortunately, clinicians commonly focus only primarily on erection strength, and existing tools inadequately characterize rates and bother associated with RE after BPH treatment. Objective This review provides critical appraisal of existing tools used to assess RE and emphasizes the importance of preoperative counseling of this complication prior to surgical BPH treatment. Methods A literature review was conducted in June of 2022 using Embase, Medline, and Web of Science to identify relevant manuscripts on “men sexual health”, “men’s sexual health questionnaire (MSHQ), and “retrograde”, “dry”, or “backward” “ejaculate” or “orgasm” from 1946 to June 2022. Eligibility criteria were established by using Population, Intervention, Control, and Outcome (PICO) tool for men with BPH symptoms treated with surgical intervention and developed postoperative RE. Criteria for exclusion were manuscripts in non-English language and studies reporting rates of RE without specifying the criteria used to diagnose the condition. Results A literature review was conducted in June of 2022 using Embase, Medline, and Web of Science to identify relevant manuscripts on “men sexual health”, “men’s sexual health questionnaire (MSHQ), and “retrograde”, “dry”, or “backward” “ejaculate” or “orgasm” from 1946 to June 2022. Eligibility criteria were established by using Population, Intervention, Control, and Outcome (PICO) tool for men with BPH symptoms treated with surgical intervention and developed postoperative RE. Criteria for exclusion were manuscripts in non-English language and studies reporting rates of RE without specifying the criteria used to diagnose the condition. Conclusions Significant limitations exist in the tools presently available for the reporting of RE related to BPH treatment. With ejaculation playing a very important role in sexual satisfaction for many men, more robust and specific instruments are needed to help with the diagnosis. Through development of such tools, patients will be better counseled and satisfaction with treatments will be improved. Optimized questioning needs to take into consideration both baseline and post-treatment ejaculatory function – including granular specifics on force, volume, sensation, and level of bother rather than general questions on ejaculatory functioning measured on a very broad scale. Disclosure No

Overactive Bladder Patients With and Without Urgency Incontinence: A Spectrum of One Condition or Different Phenotypes?

ABSTRACT The International Continence Society classifies overactive bladder (OAB) as a storage symptom syndrome characterized by “urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturia.” Although heterogenous in nature, some OAB patients exhibit only frequency and urgency (“OAB-dry”), whereas others exhibit frequency and urgency with urgency incontinence (“OAB-wet”). This study aimed to further explore the unique features of each of these diagnoses via comparison of data for women seeking lower urinary tract symptom (LUTS) care, including data such as physical examination findings, self-reported symptoms, and demographic data. Better understanding of OAB-wet and OAB-dry definitive features may lead to more effective treatment. Through the LURN (Lower Urinary Tract Dysfunction Research Network)—sponsored via the research network NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases)—physical examination, demographic data, and questionnaire data were obtained for women seeking LUTS-based care at 6 centers in the United States. Enrollment entailed categorization of patients into urinary incontinence subtypes, as determined by LURN clinical staff from patient LUTS Tool responses. Subgroups included both OAB-dry and OAB-wet categories, as well as a control LUTS group lacking symptoms. The multicenter data set found 545 LUTS-presenting women, with 84 patients being defined as OAB-wet, 56 patients defined as OAB-dry, and 67 patients defined as the control population. The study population was predominantly White (83%), with mean age of the cohort as 58.8 ± 14.1 years. Demographics did not vary between the categories. The groups experienced very similar symptoms, except OAB-wet patients had urgency incontinence, and OAB-dry reported significantly more bladder pain, incomplete emptying, and straining to urinate. Both OAB groups exhibited identical levels of frequency, nocturnal, urgency, and level of bother. Both OAB groups experienced more bother than controls. However, bother for OAB-wet was directly related to severity of incontinence, and bother for OAB-dry was directly related to pelvic floor tenderness on examination. These results may indicate that the individual conditions hail from divergent etiologies, which contradicts traditional disease concepts. Since OAB-dry patients commonly report sensations of incomplete emptying, bladder pain, and straining to urinate, the authors hypothesized that these symptoms may represent a pelvic floor muscle dysfunction rather than a true bladder pathology. This hypothesis is based on the significant overlap between bladder symptoms of OAB-dry and bladder symptoms in high-tone pelvic floor dysfunction (HTPFD) patients (or those with myofascial pelvic pain). Possible causes were this to be the case might be changes in muscle function leading to alterations in the resting angle of the urethrovesical junction and irritation of the bladder neck or urethra. In addition, neuromuscular dysfunction may lead to symptoms of HTPFD and OAB. Strengths of this study include its large study parameters involving multiple centers across the nation, including all patients seeking care for LUTS. Because most women in the study were White, generalizability of the study to a more diverse patient population is limited. In addition, patient self-reporting of incontinence type lacked simultaneous objective testing. Moreover, significant pelvic pain excluded patients from this cohort, which may have excluded patients with more severe forms of OAB-dry from the study population. Although traditionally grouped and treated together under a larger OAB diagnosis, OAB-wet and OAB-dry have unique symptomatic features, suggesting divergent etiologies. Unique symptoms such as pain, a feeling of incomplete emptying, and straining with urination all suggest pelvic floor myofascial dysfunction for OAB-dry patients. Further examination of a distinct pathophysiology for these 2 groups is warranted.

PD26-04 COMPARISON OF SEXUAL FUNCTION IN FEMALES AFTER REPRODUCTIVE ORGAN SPARING VERSUS NON-REPRODUCTIVE ORGAN SPARING RADICAL CYSTECTOMY

You have accessJournal of UrologyCME1 Apr 2023PD26-04 COMPARISON OF SEXUAL FUNCTION IN FEMALES AFTER REPRODUCTIVE ORGAN SPARING VERSUS NON-REPRODUCTIVE ORGAN SPARING RADICAL CYSTECTOMY Sajya Singh, Natasha Gupta, Shirley Wang, Isabella Florissi, Max Kates, Trinity Bivalacqua, and Sunil Patel Sajya SinghSajya Singh More articles by this author , Natasha GuptaNatasha Gupta More articles by this author , Shirley WangShirley Wang More articles by this author , Isabella FlorissiIsabella Florissi More articles by this author , Max KatesMax Kates More articles by this author , Trinity BivalacquaTrinity Bivalacqua More articles by this author , and Sunil PatelSunil Patel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003304.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Given recent data, reproductive organ sparing (ROS) radical cystectomy is a safe and effective treatment for bladder cancer in select women. In this study, we sought to better understand sexual function outcomes in females who underwent a ROS versus a non-reproductive organ sparing (non-ROS) radical cystectomy for the treatment of bladder cancer. METHODS: A cross-sectional questionnaire was administered in April 2022 to eligible participants selected from a retrospective single-institution cohort of female patients with a primary bladder malignancy who underwent radical cystectomy between 2016-2020. The study questionnaire included the short form of the Female Sexual Function Index (FSFI-6), a validated evaluation tool for diagnosing female sexual dysfunction (FSD) (score ≤19). Satisfaction with sex life was reported on a Likert scale with 5=dissatisfied and 1=satisfied. Bother with lack of sexual activity was reported as 4=a lot and 1=not at all. RESULTS: Among eligible patients (n=70), 45 women (64%) completed the questionnaire on average 3.1±1.0 and 3.4±1.4 years post-cystectomy for the ROS and non-ROS groups, respectively (p=0.59). Advanced-stage bladder cancer (≥pT3) was not statistically more prevalent in non-ROS (36%) compared to ROS patients (19%, p=0.25). Before surgery, significantly more women were sexually active in the ROS group (61%) than non-ROS (21%, p=0.01); however, post-cystectomy, this difference was not observed (29% vs. 21%, p=0.59). There was a trend towards more FSD among ROS patients by FSFI-6 (57% vs. 33%, p=0.49). In both the ROS and non-ROS groups, patients who were not sexually active reported low levels of bother regarding the absence of sexual activity (1.8±1.0 vs. 1.8±1.1, p=0.86). CONCLUSIONS: Within our limited cross-sectional cohort, we identified a higher prevalence of FSD in the ROS group, although this finding was not statistically significant. Consideration of patient-specific values when discussing post-operative sexual function is essential as most non-sexually active patients denied feeling concerned by a lack of sexual activity. Further research is needed to better understand the factors impacting post-cystectomy sexual function in women and to investigate interventions targeting the psychoeducational components of sexual health. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e736 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sajya Singh More articles by this author Natasha Gupta More articles by this author Shirley Wang More articles by this author Isabella Florissi More articles by this author Max Kates More articles by this author Trinity Bivalacqua More articles by this author Sunil Patel More articles by this author Expand All Advertisement PDF downloadLoading ...

Who is the individual that will complain about temporomandibular joint clicking?

Understanding the profile of the individual complaining of TMJ clicking can help in the clinical approach of these patients. To identify clinical variables associated with individuals who complain about and seek treatment for TMJ clicking. Seventy-two individuals, composed the sample: Group 1 - patients with a complaint of TMJ clicking who sought treatment; (n=36); Group 2 - individuals with TMJ clicking who have no complaints about it (n=36). Three categories of data were evaluated: clinical (gender; age; side of TMJ clicking; TMJ pain; self-reported level of bother; previous TMJ clicking information); somatosensory (mechanical pain threshold [MPT], wind-up ratio [WUR], pressure pain threshold [PPT]); and, psychosocial (Pain Vigilance and Awareness Questionnaire [PVAQ]; Pain Catastrophising Scale [PCS]; Tampa Scale for Kinesiophobia for Temporomandibular Disorders [TSK/TMD]); The Perceived Stress Scale (PSS); The State-Trait Anxiety Inventory (STAI). Group 1 was composed mostly of female patients, with TMJ pain, without previous orientation about the condition, bothered by the clicking, with lower PPT and higher scores in the PVAQ, PCS, TKS/TMD, PSS and STAI scales than Group 2. The groups did not differ significantly for side of TMJ clicking, age, MPT and WUR. Individuals who have a TMJ clicking complaint and seek treatment are mostly female, have TMJ pain, have not received previous orientation about TMJ clicking, are bothered by the clicking, have a lower pain threshold and higher scores of hypervigilance, catastrophising, kinesiophobia, stress and anxiety than people with TMJ clicking who do not report it.

Benign Prostatic Enlargement, the International Prostate Symptoms Score and a Review of Other Symptom Scores

Benign prostatic hyperplasia (BPH) is the most common benign prostate disease in elderly men, and its incidence increases with age and is associated with lower urinary tract symptoms (LUTS). The international prostate symptoms score (IPSS) is the most common symptom score used to assess LUTS even though other symptom scores exist. This study aims to evaluate the LUTS of patients secondary to BPH presenting to the urology clinic of UPTH using the IPSS and to review other scoring systems. Materials and Methods: This was a prospective hospital based descriptive cross-sectional study carried out in University of Port Harcourt Teaching Hospital (UPTH). All adult male patients with LUTS secondary to BPE were given an IPSS questionnaire to fill. Another IPSS questionnaire was filled by the patient assisted by the researcher. The data were collated using Microsoft Excel 2016 version and they were analyzed using SPSS version 20. Results were presented in tables. Results: Sixty-nine (69%) patients had at least secondary level of education. Sixty-four (64%) could complete their questionnaire without any aid. The mean IPSS was 22.13 ± 6.34 as most patients presented with severe symptoms. The mean Quality of Life score was 4.60 ± 1.38. There was a significant positive correlation between Quality of Life and IPSS. Conclusion: A level of literacy is needed to complete the questionnaire. Most patients in our study presented late with severe symptoms and significant level of bother. Nocturia was the worst symptom.

The patient experience of Wilson disease: a conceptual model based on qualitative research

BackgroundWilson disease (WD) is a rare disease wherein copper accumulates in tissues, leading to hepatic degeneration, neurological impairments, and psychiatric symptoms. This study aimed to characterize the patient experience of WD and develop a conceptual model containing key symptoms and impacts of the disease.ResultsA targeted literature review was conducted to develop a preliminary conceptual model of WD that was subsequently refined through one-on-one interviews with 3 WD clinicians and finalized following concept elicitation interviews with 11 patients and 1 caregiver. The literature review returned 30 articles, from which 45 concepts (35 signs/symptoms and 10 impacts) were selected for inclusion in the preliminary conceptual model. After interviews with clinicians, the model was expanded to include 45 signs/symptoms and 14 impacts. The final comprehensive conceptual model developed after interviews with patients included 54 symptoms in total (n = 22 hepatic, n = 19 neurological, n = 13 psychiatric), and 21 impacts. Across symptoms, patients reported a high level of bother, with approximately 49% of symptoms reported by patients having an average peak bother rating of ≥ 7 out of 10 (10 = most bothersome). Patient interviews identified 2 subgroups of patients: those who experience neurological, psychiatric, and hepatic symptoms and those who experience mostly hepatic and some psychiatric symptoms, but no neurological symptoms.ConclusionsThis research underscores the substantial multisystemic symptoms and impacts that patients with WD describe as highly bothersome in their lives. Hepatic symptoms emerged as especially common and important to patients with WD, possibly beyond what is commonly understood in research and clinical practice. Further, the description of 2 distinct patient groups may help to inform patient management and support more targeted drug development processes.

The factors associated with the quality of life among postmenopausal women

ObjectiveThe present work aimed at determining the prevalence of menopausal symptoms and factors associated with the Quality of life among postmenopausal women.Materials and methodsThis cross-sectional work was carried out on 270 postmenopausal females referring to health centers of Hamadan city chosen by stratified random sampling. A questionnaire of the Menopausal Quality of Life Questionnaire (MENQOL) was used as the data collection method. Although, the Mann–Whitney test and the Kruskal–Wallis tests were used to compare MENQOL item scores. The significance level of statistical tests was regarded as less than 0.05.ResultsThe mean MENQOL Score in menopausal was 2.45 ± 1.04. Also, vasomotor symptoms had the highest score, and sexual symptoms had the lowest score rather than other dimensions. There was a significant association between the total menopausal quality of life score and job, economy status, smoking, exercise, supplemental Omega-3 s intake, and Postmenopausal stage (p < 0.01). As smokers, women had increasing levels of bother experienced from the MENQOL symptom than non-smokers (mean = 3.67 ± 0.85 vs. 2.36 ± 0.99; p < 0.001). While the MENQOL scores for menopausal females who exercised more often (mean = 1.56 ± 0.7) had lower than those who exercised less than 3 times per week (mean = 3.27 ± 0.9; p < 0.001). However the lowest score was menopausal females who had taking supplemental Omega-3 s than those who hadn't taken it (mean = 2.15 ± 1.06 vs. 2.65 ± 0.97; p < 0.001). Though women who had postmenopausal stage less than 5 years stage (mean = 2.28 ± 0.87) had significantly lower MENQOL scores from those who had postmenopausal stage 5 or more years (mean = 2.63 ± 1.16; p < 0.001).ConclusionBased on the results, vasomotor symptoms were the most dominant symptom. Therefore, it is necessary to improve physical activity levels, focusing on job status, recommend taking an omega 3 s supplement, and planning education and promotion intervention for cessation or prevention of smoking among postmenopausal women to increase the MENQOL is essential.

Patterns of care for prostate cancer treatment and improving outcomes - are national registries the answer?

Patterns of care for prostate cancer treatment and improving outcomes - are national registries the answer?

Abstract GS3-02: Patient-reported outcomes (PROs) from the Ph 3 IMpassion031 trial of neoadjuvant (NA) atezolizumab + chemo in early triple-negative breast cancer (eTNBC)

Abstract Background: In IMpassion031 (NCT03197935), patients (pts) (N = 333) with invasive stage II or III eTNBC who received NA treatment (tx) with atezolizumab (A) + nab-paclitaxel (nP) followed by doxorubicin + cyclophosphamide (AC; A-chemo) had significantly improved pathologic complete response (pCR, primary endpoint) regardless of PD-L1 status vs placebo (P) with nP and AC (P-chemo). Balancing efficacy and toxicity is key in this potentially curable eTNBC setting. PROs were collected to comprehensively assess tx burden from the pts’ perspective, inform clinical benefit and decision-making and address the lack of pt-reported data in this setting. Methods: Pts received double-blind A 840 mg or P every 2 weeks (q2w) with nP 125 mg/m2 once weekly for 12 wk followed by A 840 mg or P q2w with AC q2w for 4 doses. After surgery and pathological evaluation, pts in the A-chemo arm received open-label A 1200 mg every 3 weeks for 11 doses. The P-chemo arm was observed. To capture pts’ experience of tx-related symptoms, associated bother, and impact on day-to-day functioning and health-related quality of life (HRQoL), pts completed the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and single-item GP5 from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at baseline (BL) and day (D)1 of each cycle (C) of NA and adjuvant (adj) tx, at end of tx and in follow-up every 3 mo (year 1), every 6 mo (years 2-3), then annually. Mean and mean change from BL scores (≥ 10-point change considered clinically meaningful) by C and between tx arms in the QLQ-C30 function (role and physical) and global health status/QoL scales were predefined secondary endpoints. Mean and mean change from BL scores in tx-related symptoms, as well as an assessment of tx side-effect bother, were exploratory endpoints. Results: QLQ-C30 completion rates (ITT) in both arms were 100% at BL and &amp;gt; 90% in the NA phase and &amp;gt; 89% in the adj phase through C16. GP5 completion rates in both arms were &amp;gt; 98% at BL (C2D1) and &amp;gt; 88% in the NA and adj phases. BL mean [95% CI] values were high for physical function (A-chemo, 91 [89-93]; P-chemo, 90 [88-92]), role function (A-chemo, 89 [86-93]; P-chemo, 89 [86-92]), and HRQoL (A-chemo, 79 [76-82]; P-chemo, 76 [73-79]). Physical and role function, and HRQoL mean values were similar between arms across on-tx assessments to C16 and through follow up. Mean change from BL values for physical and role function, and HRQoL were similar between arms and of the same magnitude. In both arms mean physical function had a clinically meaningful decline during the NA period from C3 to C5, rebounding in the adj period, and stabilizing starting C7. In both arms mean role function had a clinically meaningful decline in the NA period from C2 (A-chemo) or C3 (P-chemo) to C5, rebounding in the adj period, and stabilizing at C9 in the P-chemo arm only. In both arms mean HRQoL had a clinically meaningful decline in the NA period from C3 to C5, rebounding in the adj period and stabilizing from C6. Tx symptoms of fatigue, diarrhea, nausea, and vomiting in the NA period worsened through C5 in both arms with trends in mean and mean change from BL values similar to the functional and HRQoL data. In the adj period, mean symptom scores in both arms through C16 were similar to BL except for fatigue. 65% (A-chemo) and 66% (P-chemo) of pts reported their level of bother with tx side effects to be “somewhat” or “quite a bit” by C5. During the adj period, no added side-effect bother was experienced by pts receiving A compared with the P-chemo arm under observation, with a similar % of pts in each arm reporting being bothered “somewhat,” “quite a bit,” or “very much” by C16. Conclusions: Adding A to nP-AC improved pCR without added tx burden to pts. These results address the paucity of PRO data informing clinical benefit and decision-making in this potentially curable setting. Citation Format: Elizabeth A. Mittendorf, Nadia Harbeck, Hong Zhang, Shigehira Saji, Kyung Hae Jung, Sheetal Patel, Shilpen Patel, Anh Nguyen Duc, Mario Liste-Hermoso, Stephen Y. Chui, Carlos H. Barrios. Patient-reported outcomes (PROs) from the Ph 3 IMpassion031 trial of neoadjuvant (NA) atezolizumab + chemo in early triple-negative breast cancer (eTNBC) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr GS3-02.

Relationships Between Vasomotor Symptoms and Mood in Midlife Urban Chinese Women: Observations in a Prospective Study.

During the menopausal transition, there is a greater likelihood of the prevalence of various bothersome symptoms, including vasomotor symptoms (VMS) and mood symptoms. To investigate the association among bothersome VMS and symptoms of anxiety and depression in Chinese women during perimenopause and early in menopause. This study included 430 midlife Chinese women who had experienced natural menopause and were followed up for 10 years. A structured questionnaire was provided annually, comprising the VMS Bother Score (range 1-8) from the Menopause-Specific Quality of Life questionnaire, the Hospital Anxiety and Depression Scale, and other physical and behavioral factors. Among the 430 women evaluated, 78.8% had experienced VMS during long-term follow-up. The overall level of VMS bother score was relatively low (1.92 ± 1.32). Both anxiety and depressive symptoms were significantly associated with VMS bother. After adjusting for potential covariates, the association between anxiety or depression symptoms and VMS bother remained highly significant. Menopausal stage, body mass index, general health, follicle-stimulating hormone, and estradiol were independent contributors to VMS. In time-lagged (1-year) models, VMS bother scores significantly predicted the risk of symptoms of both anxiety and depression the following year. In contrast, anxiety symptoms, rather than depressive symptoms, could predict VMS bother the following year. The prevalence of VMS in our cohort was higher than has been previously reported; however, the overall level of bother was relatively low. This study demonstrated a strong relationship between VMS bother and mood symptoms in Chinese women progressing from perimenopause through natural menopause.

Night-time voids, level of bother and sleep characteristics in a non-patient population of wearable devices users.

IntroductionNocturia is a highly prevalent and bothersome medical condition characterised mainly by the need to wake up to pass urine during the main sleep period. Using data from wearable devices, it is possible to examine the sleep of large cohorts in natural settings. This study seeks to use data from connected smartwatches combined with a one‐time survey to explore the presence of nocturia and associated level of bother and sleep characteristics in a non‐patient cohort of wearable device users representing a broad age range.MethodsThe data used come from a retrospective dataset containing sleep data from Withings watches of 250 000 users and a prospective dataset containing answers to a 10‐item questionnaire completed by a subset of users in the retrospective dataset.ResultsThe prospective dataset contained 6230 users. Overall, 6.0%, 15.3% and 38.9% of users in the age groups 18‐44 years, 45‐64 years and 65‐90 years, respectively, reported 2 or more nocturnal voids as their customary voiding pattern, corresponding to levels of nocturia consistent with previous literature. The level of bother associated with nocturia was higher among younger users with 27.8% of users aged 18‐44 years reporting that their daytime activity was highly affected versus just 14.1% among those aged 65‐90 years. A higher number of reported voids per night was associated with watch‐derived measures of a lower sleep efficiency, a longer awake duration at night and a shorter first uninterrupted sleep period.ConclusionThis study suggests not only that nocturia is present among the younger population but also that the younger are more bothered by this medical condition. Using data from wearables it was possible to establish that there is an association between the number of nocturnal voids and sleep characteristics.

Momentary Analysis of Tinnitus: Considering the Patient.

Ecological momentary assessment is a valuable research technique meant to capture real-time data and contextualize disease. While more common in neuropsychiatric research, this methodology is exceptionally fit for tinnitus. Tinnitus has been shown to be affected by many patient-level and environment-specific factors. From an individual's baseline anxiety to the level of ambient noise in their environment, the level of bother experienced by those with tinnitus can vary widely. Only assessing tinnitus within a clinical environment can distort the true impact of the disease. Ecological data can minimize bias while generating an individualistic picture of the burden being experienced by the patient. Individual data can also compliment new research methods rooted in precision medicine, providing clearer, better-suited treatments for each patient on the tinnitus spectrum.

Engaging Women in Pelvic Floor Disorders Research Using the Internet

The objective of this study were (1) to assess the feasibility of using online platforms as recruitment tools for pelvic floor disorder studies and (2) to compare the prevalence of symptoms of incontinence and care-seeking behavior by online platform to previously published prevalence estimates. We conducted a cross-sectional study among women to assess the prevalence of incontinence symptoms, level of bother, and care-seeking behavior. Participants were recruited through Facebook ads, ResearchMatch, or Reddit. The effectiveness of Facebook ads was assessed using the click through rate and an overall completion rate (number of completes over number of times an ad was shown). A nontargeted ad was posted to a Reddit thread in which research opportunities are advertised. For ResearchMatch, investigators sent a recruitment email. Effectiveness of this method was assessed by observing how many women completed the survey compared with the number of women who received it. Among the 7361 women who initiated the questionnaire, 6650 (90%) completed it. A majority of participants were recruited through ResearchMatch. Online platforms were successful in recruiting women across a wide age range (ages, 18-93 years). The overall prevalence of incontinence was 46.1% with women 45 years and older having the highest prevalence (64.6%). Common reasons for not seeking care included "not bothersome enough," "other health problems," and "being unsure about treatment." Internet-based recruitment was found to be feasible. The prevalence of incontinence was higher than has been reported in other population-based samples. Significant barriers to care exist, and further studies should focus on educational strategies.

Novel Treatment for Premature Ejaculation in the Light of Currently Used Therapies: A Review

Besides erectile dysfunction, premature ejaculation (PE) is the most frequent male sexual disorder and shows a high level of bother and distress. The negative consequences of long-term and unsuccessfully treated PE on both patient and partner are well established in the literature and include personal distress, impairment of the partner's sexual function, and interpersonal difficulties. To outline the consequences of untreated PE and the advantages and disadvantages of currently available treatment options with a special focus on a new topical eutectic lidocaine/prilocaine metered dose spray (Fortacin; Lidocaine/Prilocaine, Recordati, Milan, Italy) which represents the second officially approved drug in this indication. Narrative overview of the literature synthesizing the findings of literature retrieved from searches of computerized databases such as Web of Science, Medline, PubMed, and Google Scholar, hand searches, and authoritative texts. Combinations of keywords including premature ejaculation, ejaculatory control, intravaginal ejaculation latency time, IELT, PE, PDE5 inhibitors (PDE5i), SSRIs, topical anesthetics, lidocaine, prilocaine, and treatment were used. In the end, 59 studies published between 2000 and 2018 were considered relevant for this review. Published studies on PE-related negative psychosocial outcomes, as well as advantages and disadvantages of currently available off-label and officially approved treatment options. Although a variety of treatment options for PE have shown marked improvements in stopwatch-measured intravaginal ejaculation latency time (IELT) and patient-reported outcomes as assessed by the Premature Ejaculation Profile (PEP), none of the investigated drugs has reached market approval. The only so far officially approved medication-dapoxetine-is characterized by high discontinuation rates of up to 90%, mostly because of high side effects, cost issues, efficacy below expectations, and the need for scheduling sexual intercourse. With the official approval in Europe the new dose-metered lidocaine-prilocaine spray (Fortacin) may become a real first-line therapy option for PE and may offer a satisfactory and affordable solution, especially because of its unique galenic preparation, making its handling easy and customer friendly. In addition, it has the potential to significantly increase the currently low patients' acceptance of available monotherapies and become an established second-line therapy for the severe PE patients with IELTs <1 to 2 minutes or with ante-portal ejaculation in combination with oral therapy. Porst H, Burri A. Novel treatment for premature ejaculation in the light of currently used therapies: A review. Sex Med Rev 2019; 7:129-140.

Abstract A62: Differences in sexual dysfunction between lesbian, bisexual, and heterosexual female breast cancer survivors

Abstract Purpose: The purpose of this study was to examine (1) differences in sexual dysfunction between lesbian, bisexual, and heterosexual female breast cancer survivors including (2) patient-provider communication regarding sexual problems, and (3) receipt of treatment for sexual complaints. Methods: Dr. Susan Love Research Foundation's The Health of Women (HOW) Study™ is a cohort study of approximately 40,000 women with and without breast cancer who have responded to one or more online, self-administered surveys. This study includes data from women who completed the baseline and quality-of-life surveys. Women were included if they had a previous diagnosis of breast cancer and if they self-identified as lesbian, bisexual, or heterosexual (N=3,833). Sexual dysfunction was defined as “ever [having] significant problems with change in sexual interest.” We also examined whether women (1) thought that their cancer/cancer treatment was “the primary cause of [her] most significant problems with changes in sexual interest”, (2) “talked to [her] doctor about [her] problems with change in sexual interest”, and (3) “received treatment for [her] problems with change in sexual interest.” Analyses included chi-square test of independence and bivariate logistic regression. Differences were considered significant at p&amp;lt;0.10. Results: Distribution of sexual orientation was as follows: heterosexual (96%), lesbian (3%), and bisexual (1%). Over a third of women reported sexual dysfunction (34%); 78% of them attributed these changes in sexual interest to their breast cancer treatment. Bisexual women were most likely to report changes in sexual interest (48%) when compared to lesbian (34%) and heterosexual (34%) women. Bisexual women were 77% more likely to report changes in sexual interest compared to heterosexual women (OR=1.77; 95%CI: 0.99-3.17, p&amp;lt;0.10); however, bisexual women were less likely than heterosexual women to talk to their doctor about this (OR=0.40; 95% CI: 0.16-0.94, p&amp;lt;0.10). All women reported similar levels of bother from changes in sexual interest (62% reporting being bothered by changes in sexual interest “quite a bit” or “very much”). Irrespective of sexual orientation, less than 20% of women received treatment for changes in sexual interest. Conclusion: Sexual dysfunction was a common issue identified by women breast cancer survivors, particularly among bisexual women who were also less likely to report sexual dysfunction to their provider. Overall, treatment for sexual dysfunction was low for all women, suggesting a potential gap in survivorship care more broadly. These findings suggest that experiencing problematic changes in sexual interest was more common among bisexual breast cancer survivors, who may face unique challenges in receiving needed survivorship care. Targeted interventions for these women may be warranted to increase patient-provider communication about sexual dysfunction and to improve the burden of sexual dysfunction among bisexual women. Citation Format: Christopher W. Wheldon, Megan C. Roberts, Michelle I. Silver, Ulrike Boehmer. Differences in sexual dysfunction between lesbian, bisexual, and heterosexual female breast cancer survivors [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr A62.

Completion of a validated pelvic floor symptom and bother instrument in real-life practice.

Validated questionnaires are commonly used in research, but successful completion rates in clinical settings are largely unknown. The primary goal of this study was to assess the frequency of appropriate completion of a validated research survey. We secondarily examined relationships between demographics and successful questionnaire completion. New patients completed a paper form of the Pelvic Floor Bother Questionnaire (PFBQ) to assess pelvic floor symptoms and level of bother. Various aspects of successful survey completion were assessed, including unanswered questions, affirmative responses without selection of a level of bother, or choosing a level of bother despite reporting not having a symptom. Relationships between self-reported demographic characteristics and completion of the survey were also evaluated. Five hundred and fourteen questionnaires were completed by a cohort of women with a mean age of 57.5 ± 14.4years (range 19-97). Overall, 45.3% of women (n = 233) completed the entire PFBQ properly as originally described. Women skipped at least one entire question 16.5% of the time. On logistic regression, older age was significantly associated with improper questionnaire completion (55.0years ±14.9 successful vs 59.6years ±13.6 unsuccessful completion, p < 0.001 for overall completion). Age was significantly associated with proper completion of every individual PFBQ question, except question 8 concerning fecal incontinence (p = 0.06). Education level was not significantly associated with successful questionnaire completion. Overall successful completion of the survey as designed and validated was low, even in a highly educated population. Ways to simplify the instrument to enhance completion, such as electronic smart questionnaires, should be further investigated.

Evaluation of Ecological Momentary Assessment for Tinnitus Severity

ImportanceExisting patient-reported outcome measures of tinnitus assess the severity and disability retrospectively, which may result in adequate reliability, but cannot capture the fluctuating and individualized nature of tinnitus. Experience sampling may provide an alternative.ObjectiveTo use an ecological momentary assessment (EMA) to measure tinnitus disability and associated constructs. Design, Setting, and ParticipantsForty adults with tinnitus provided self-report of their tinnitus bother using 5 questions measured by EMA, as well as standard retrospective outcome measures. In this 6-week longitudinal observational study conducted from July 15 to December 22, 2014, participants provided EMA data for 2 weeks (part 1); then after a 2-week break, they provided EMA data for an additional 2 weeks (part 2). A text message with a link to the EMA survey was sent for a total of 56 assessments during each 2-week assessment period. Ecological momentary assessment responses were evaluated using multilevel confirmatory factor analysis to assess the fluctuating nature of bothersome tinnitus across the group and within the pool of individuals over time. Main Outcomes and MeasuresEcological momentary assessment questions measured tinnitus disability and associated constructs. Compliance in each study part was assessed based on response rates. The Tinnitus Functional Index and the Overall Global Rating of Bother Scale were assessed at the beginning and end of each 2-week assessment period to explore the effect of the frequent EMAs on the perceived level of bother from tinnitus.ResultsOf the 40 participants in the study (10 women and 30 men; mean [SD] age, 60.0 [10.5] years), the median survey response rate was high (49 responses to 56 surveys sent [88%] for part 1 and 47 responses of 56 surveys sent [84%] for part 2). The latent factor identified by the 2-level confirmatory factor analysis models demonstrates that within-individual tinnitus bother, loudness, and stress vary together over time. In addition, tinnitus bother, feeling, and stress symptoms all vary together across individuals, which means that bother and stress covary strongly both across time and across individuals.Conclusions and RelevanceEcological momentary assessment evaluates the moment-to-moment perception of tinnitus and the effect of emotional and environmental factors, which suggests that it is a superior tool to measure tinnitus outcomes compared with standard retrospective self-reports. Taken together, information from emotional and environmental factors can be summarized in an underlying (latent) factor that represents a vulnerability to bothersome tinnitus and that can be used to comprehensively describe the tinnitus experience. Momentary variability in tinnitus bother is strongly associated with levels of perceived stress.