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2.
Urogynecology (Phila) ; 30(3): 245-250, 2024 03 01.
Artículo en Inglés | MEDLINE | ID: mdl-38484238

RESUMEN

IMPORTANCE: Large language models are artificial intelligence applications that can comprehend and produce human-like text and language. ChatGPT is one such model. Recent advances have increased interest in the utility of large language models in medicine. Urogynecology counseling is complex and time-consuming. Therefore, we evaluated ChatGPT as a potential adjunct for patient counseling. OBJECTIVE: Our primary objective was to compare the accuracy and completeness of ChatGPT responses to information in standard patient counseling leaflets regarding common urogynecological procedures. STUDY DESIGN: Seven urogynecologists compared the accuracy and completeness of ChatGPT responses to standard patient leaflets using 5-point Likert scales with a score of 3 being "equally accurate" and "equally complete," and a score of 5 being "much more accurate" and much more complete, respectively. This was repeated 3 months later to evaluate the consistency of ChatGPT. Additional analysis of the understandability and actionability was completed by 2 authors using the Patient Education Materials Assessment Tool. Analysis was primarily descriptive. First and second ChatGPT queries were compared with the Wilcoxon signed rank test. RESULTS: The median (interquartile range) accuracy was 3 (2-3) and completeness 3 (2-4) for the first ChatGPT query and 3 (3-3) and 4 (3-4), respectively, for the second query. Accuracy and completeness were significantly higher in the second query (P < 0.01). Understandability and actionability of ChatGPT responses were lower than the standard leaflets. CONCLUSIONS: ChatGPT is similarly accurate and complete when compared with standard patient information leaflets for common urogynecological procedures. Large language models may be a helpful adjunct to direct patient-provider counseling. Further research to determine the efficacy and patient satisfaction of ChatGPT for patient counseling is needed.


Asunto(s)
Inteligencia Artificial , Medicina , Humanos , Diafragma Pélvico/cirugía , Consejo , Lenguaje
3.
Neurourol Urodyn ; 43(4): 893-901, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38247366

RESUMEN

PURPOSE: This study tested the hypothesis that ecological momentary assessment (EMA) of pelvic pain (PP) and urinary urgency (UU) would reveal unique Urologic Chronic Pelvic Pain Syndrome (UCPPS) phenotypes that would be associated with disease specific quality of life (QOL) and illness impact metrics (IIM). MATERIALS AND METHODS: A previously validated smart phone app (M-app) was provided to willing Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) participants. M-app notifications were sent 4-times daily for 14 days inquiring about PP and UU severity. A clustering algorithm that accounted for variance placed participants into PP and UU variability? clusters. Associations between clusters and QOL and IIM were then determined. RESULTS: A total of 204 participants enrolled in the M-app study (64% female). M-app compliance was high (median 63% of surveys). Cluster analysis revealed k = 3 (high, low, none) PP clusters and k = 2 (high, low) UU clusters. When adjusting for baseline pain severity, high PP variability, but not UU variability, was strongly associated with QOL and IIM; specifically worse mood, worse sleep and higher anxiety. UU and PP clusters were associated with each other (p < 0.0001), but a large percentage (33%) of patients with high PP variability had low UU variability. CONCLUSIONS: PP variability is an independent predictor of worse QOL and more severe IIM in UCPPS participants after controlling for baseline pain severity and UU. These findings suggest alternative pain indices, such as pain variability and unpredictability, may be useful adjuncts to traditional measures of worst and average pain when assessing UCPPS treatment responses.


Asunto(s)
Dolor Crónico , Calidad de Vida , Humanos , Femenino , Masculino , Evaluación Ecológica Momentánea , Dolor Crónico/diagnóstico , Dolor Pélvico/diagnóstico , Dimensión del Dolor
4.
Int Urogynecol J ; 35(1): 139-148, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37991567

RESUMEN

INTRODUCTION AND HYPOTHESIS: Although allusions to the importance of a good physician-patient relationship are present throughout the interstitial cystitis/bladder pain syndrome (IC/BPS) literature, qualitative analysis of patients' perspectives on the clinical encounter is lacking, particularly among women who are most commonly affected by IC/BPS. Therefore, we adopted a patient-centered experiential approach to understanding female patients' perception of clinical encounters. METHODS: We re-analyzed previously collected data from a qualitative study on patient flare experiences including eight focus groups of female IC/BPS patients (n = 57, mean = 7/group). Qualitative analysis applied grounded theory to index all physician-patient interactions, then thematically coded these interactions to elucidate common experiences of clinical encounters. RESULTS: Women with IC/BPS shared common experiences of provider disbelief and pain dismissal. Discussions with participants demonstrated the extent to which these negative encounters shape patients' health care-seeking behavior, outlook, and psychosocial well-being. Appearing in more than one guise, provider disbelief and dismissal occurred as tacit insinuations, explicit statements, silence, oversimplification, and an unwillingness to listen and discuss alternative treatment. As a result, women adopted several strategies including: rotating specialists; "testing" physicians; self-advocacy; self-management; avoiding the stigma of chronic pain; crying; and opting for alternative medicine over biomedicine. CONCLUSIONS: The prevalence of provider disbelief and pain dismissal among women with IC/BPS indicates a need to improve physician-patient communication, informed by the struggles, anxieties, and gendered inequities that female patients with chronic pain experience in their diagnostic journey. Results suggest that further investigation into the power dynamics of clinical encounters might be required.


Asunto(s)
Dolor Crónico , Cistitis Intersticial , Humanos , Femenino , Cistitis Intersticial/tratamiento farmacológico , Ansiedad , Grupos Focales , Investigación Cualitativa
5.
Urogynecology (Phila) ; 30(2): 123-131, 2024 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-37428882

RESUMEN

IMPORTANCE: Physical health and psychological health represent modifiable factors in the causal pathway of lower urinary tract symptoms (LUTS). OBJECTIVES: Understand the relationship between physical and psychological factors and LUTS over time. STUDY DESIGN: Adult women enrolled in the Symptoms of Lower Urinary Tract Dysfunction Research Network observational cohort study completed the LUTS Tool and Pelvic Floor Distress Inventory, including urinary (Urinary Distress Inventory), prolapse (Pelvic Organ Prolapse Distress Inventory), and colorectal anal (Colorectal-Anal Distress Inventory) subscales at baseline, 3 months, and 12 months. Physical functioning, depression, and sleep disturbance were measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires; relationships were assessed using multivariable linear mixed models. RESULTS: Of 545 women enrolled, 472 had follow-up. Median age was 57 years; 61% and 78% reported stress urinary incontinence and overactive bladder, respectively; and 81% reported obstructive symptoms. The PROMIS depression scores were positively associated with all urinary outcomes (range, 2.5- to 4.8-unit increase per 10-unit increase in depression score; P < 0.01 for all). Higher sleep disturbance scores were associated with higher urgency, obstruction, LUTS Total Severity, Urinary Distress Inventory, and Pelvic Floor Distress Inventory (1.9- to 3.4-point increase per 10-unit increase, all P < 0.02). Better physical functioning was associated with less severe urinary symptoms except stress urinary incontinence (2.3- to 5.2-point decrease per 10-unit increase, all P < 0.01). All symptoms decreased over time; however, no association was detected between baseline PROMIS scores and trajectories of LUTS over time. CONCLUSIONS: Nonurologic factors demonstrated small to medium cross-sectional associations with urinary symptom domains, but no significant association was detected with changes in LUTS. Further work is needed to determine whether interventions targeting nonurologic factors reduce LUTS in women.


Asunto(s)
Neoplasias Colorrectales , Síntomas del Sistema Urinario Inferior , Incontinencia Urinaria de Esfuerzo , Sistema Urinario , Adulto , Humanos , Femenino , Persona de Mediana Edad , Estudios Transversales
6.
J Urol ; 211(1): 111-123, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37796776

RESUMEN

PURPOSE: Overactive bladder (OAB) may be attributed to dysfunction in supraspinal brain circuits. Overactive bladder participants enrolled in the LURN (Symptoms of Lower Urinary Tract Dysfunction Research Network) study reported sensations of urinary urgency during a bladder-filling paradigm while undergoing brain functional MRI to map supraspinal dysfunction. MATERIALS AND METHODS: OAB participants and controls (CONs) completed 2 resting-state functional MRI scans following consumption of 350 mL water. Scans were conducted at fuller and emptier bladder states, interleaved with voiding. Urgency ratings (0-10) were assessed. Patterns of urgency during bladder filling were investigated using latent class trajectory models. Clusters of participants encompassing each pattern (ie, subtype) were derived from aggregated groups of OAB and CON independent of diagnosis. RESULTS: Two distinct patterns of urgency trajectories were revealed: first subtype with OAB and CON who were unresponsive to bladder filling (OAB-1 and CON-1) and second highly responsive subtype predominantly containing OAB (OAB-2). OAB-2 participants scored significantly higher on urinary symptoms but not pain or psychosocial measures. Neuroimaging analyses showed change in urgency due to both bladder filling and voided volume related to multiple loci of brain network connectivity in OAB-2, and in some cases, different than OAB-1 and/or CON-1. Sensorimotor to dorsomedial/dorsolateral prefrontal connectivity mediated the relationship between stimulus (voided volume) and percept (urgency) in OAB-2. CONCLUSIONS: Our results reveal different OAB subtypes with latent class trajectory models of urgency ratings during natural bladder filling. Functional MRI revealed differences in pathophysiology between subtypes, namely sensorimotor-prefrontal connectivity is a key locus in OAB patients with higher urinary symptoms.


Asunto(s)
Síntomas del Sistema Urinario Inferior , Vejiga Urinaria Hiperactiva , Humanos , Vejiga Urinaria/diagnóstico por imagen , Micción , Encéfalo/diagnóstico por imagen , Imagen por Resonancia Magnética
8.
Obstet Gynecol ; 142(5): 1135-1137, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37797334

RESUMEN

This quality-improvement retrospective cohort study of patients undergoing major elective nononcologic gynecologic surgery compares the proportion of patients receiving appropriate perioperative venous thromboembolism (VTE) chemoprophylaxis before and after a novel integration of the Caprini risk-assessment model (RAM) into the electronic medical record (EMR). A sample size of 83 patients in each group (166 total) was calculated to provide 80% power and show a 20% increase in appropriate administration of VTE prophylaxis, with an alpha of 0.05. Heparin was appropriately used in 24 patients (28.9%) in the pre-Caprini-RAM group and 39 patients (47.0%) in the post-Caprini-RAM group ( P =.016). There were no differences in bleeding events, transfusions, or other secondary outcomes. Integrating the Caprini-RAM into an EMR for patients undergoing nononcologic gynecologic surgery significantly improved appropriate use of VTE chemoprophylaxis.


Asunto(s)
Tromboembolia Venosa , Humanos , Femenino , Estudios Retrospectivos , Tromboembolia Venosa/prevención & control , Tromboembolia Venosa/tratamiento farmacológico , Registros Electrónicos de Salud , Anticoagulantes/uso terapéutico , Medición de Riesgo , Factores de Riesgo , Complicaciones Posoperatorias/prevención & control
9.
Urogynecology (Phila) ; 29(10): 787-799, 2023 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-37733440

RESUMEN

OBJECTIVE: The aim of the study was to compare 12-month subjective and objective outcomes between 3 approaches to apical pelvic organ prolapse (POP) surgery in patients presenting with uterovaginal or posthysterectomy vaginal prolapse enrolled in the Pelvic Floor Disorders Registry for Research. STUDY DESIGN: This was an analysis of a multicenter, prospective registry that collected both patient- and physician-reported data for up to 3 years after conservative (pessary) and surgical treatment for POP. Twelve-month subjective and anatomic outcomes for patients who underwent surgical treatment were extracted from the registry for analysis. Pelvic organ prolapse recurrence was defined as a composite outcome and compared between the 3 apical surgery groups (native tissue repair, sacrocolpopexy, colpocleisis) as well as the 2 reconstructive surgery groups (native tissue repair and sacrocolpopexy). RESULTS: A total of 1,153 women were enrolled in the registry and 777 (67%) opted for surgical treatment, of whom 641 underwent apical repair and were included in this analysis (404 native tissue repair, 187 sacrocolpopexy, and 50 colpocleisis). The overall incidence of recurrence was as follows: subjective 6.5%, anatomic 4.7%, retreatment 7.2%, and composite 13.6%. The incidence of recurrence was not different between the 3 surgical groups. When baseline patient characteristics were controlled for, composite POP recurrence between the native tissue and sacrocolpopexy groups remained statistically nonsignificant. Concurrent perineorrhaphy with any type of apical POP surgery was associated with a lower risk of recurrence (adjusted odds ratio, 0.43; 95% confidence interval, 0.25-0.74; P = 0.002) and prior hysterectomy was associated with a higher risk (adjusted odds ratio, 1.77, 95% confidence interval, 1.04-3.03; P = 0.036). CONCLUSION: Pelvic Floor Disorders Registry for Research participants undergoing native tissue apical POP repair, sacrocolpopexy, and colpocleisis surgery had similar rates of POP recurrence 12 months after surgery.


Asunto(s)
Trastornos del Suelo Pélvico , Prolapso de Órgano Pélvico , Prolapso Uterino , Humanos , Femenino , Embarazo , Prolapso Uterino/epidemiología , Prolapso de Órgano Pélvico/epidemiología , Sistema de Registros , Colpotomía
10.
Artículo en Inglés | MEDLINE | ID: mdl-37737833

RESUMEN

IMPORTANCE: Prolapse surgery and sling surgery both lead to improvement in overactive bladder. However, less is known regarding how slings performed concurrently with less is know about how overactive bladder symptoms change in patients having prolapse surgery with a sling compared to prolapse surgery without a sling. OBJECTIVE: The primary aim was to compare change in postoperative overactive bladder symptoms in patients with preoperative overactive bladder who underwent sling placement versus no sling with prolapse surgery. STUDY DESIGN: This was a secondary analysis of a cohort study evaluating overactive bladder in patients undergoing prolapse surgery. Sling procedures were performed concomitantly for treatment or prevention of stress incontinence. Baseline and 3-month follow-up urinary symptoms were assessed with the Overactive Bladder Questionnaire Short Form (OAB-q SF) and Urinary Distress Inventory-6 (UDI-6). RESULTS: Of patients with overactive bladder, 26 (40.0%) underwent midurethral sling (MUS) placement and 39 (60.0%) no sling. Preoperative OAB-q SF bother (score [SD], 46.8 [20.2] vs 40.2 [22.1]; P = 0.23) was similar between groups, but UDI-6 scores (59.2 [28.8] vs 43.8 [29.1]; P = 0.04) were higher in the sling group. At 3 months, the change (improvement) in OABq-SF bother (-16.9 [24.1] vs -22.4 [23.0]; P = 0.36), OABq-SF health-related quality of life (22.8 [28.6] vs 22.9 [23.9]; P = 0.99), and UDI-6 (-38.8 [32.9] vs -34.0 [27.8]; P = 0.53) were similar in the MUS and no MUS groups. CONCLUSION: Patients with prolapse and overactive bladder undergoing prolapse surgery with a sling had similar improvements in OAB-q SF bother scores compared with those who did not have a sling.

13.
Pain ; 164(9): 1995-2008, 2023 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-37144687

RESUMEN

ABSTRACT: Urologic chronic pelvic pain syndrome (UCPPS) is a complex, debilitating condition in which patients often report nonpelvic pain in addition to localized pelvic pain. Understanding differential predictors of pelvic pain only vs widespread pain may provide novel pathways for intervention. This study leveraged baseline data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network's Symptom Pattern Study to investigate the impact of childhood sexual and nonsexual violent trauma on pelvic and nonpelvic pain sensitivity among adult patients with UCPPS, as well as potential mediators of this association. Study participants who met inclusion criteria for UCPPS completed questionnaires assessing childhood and recent trauma, affective distress, cognitive dysfunction, and generalized sensory sensitivity. Experimental pain sensitivity was also evaluated using standardized pressure pain applied to the pubic region and the arm. Bivariate analyses showed that childhood violent trauma was associated with more nonviolent childhood trauma, more recent trauma, poorer adult functioning, and greater pain sensitivity at the pubic region, but not pain sensitivity at the arm. Path analysis suggested that childhood violent trauma was indirectly associated with pain sensitivity at both sites and that this indirect association was primarily mediated by generalized sensory sensitivity. More experiences of recent trauma also contributed to these indirect effects. The findings suggest that, among participants with UCPPS, childhood violent trauma may be associated with heightened pain sensitivity to the extent that trauma history is associated with a subsequent increase in generalized sensory sensitivity.


Asunto(s)
Experiencias Adversas de la Infancia , Dolor Crónico , Umbral del Dolor , Dolor Pélvico , Trauma Psicológico , Trauma Sexual , Adulto , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Experiencias Adversas de la Infancia/psicología , Dolor Crónico/diagnóstico , Dolor Crónico/fisiopatología , Dolor Crónico/psicología , Umbral del Dolor/fisiología , Dolor Pélvico/diagnóstico , Dolor Pélvico/fisiopatología , Dolor Pélvico/psicología , Trauma Psicológico/fisiopatología , Trauma Sexual/fisiopatología
14.
Brain Behav Immun ; 111: 116-123, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37001828

RESUMEN

Both early (ELA) and recent life adversity (RLA) have been linked with chronic pain conditions and persistent alterations of neuroendocrine and inflammatory responses. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic urologic disorder characterized by bladder and/or pelvic pain, and excessive urinary frequency and/or urgency. IC/BPS has been associated with high levels of ELA as well as a distinct inflammatory signature. However, associations between ELA and RLA with inflammatory mechanisms in IC/BPS that might underlie the link between adversity and symptoms have not been examined. Here we investigated ELA and RLA in women with IC/BPS as potential risk factors for inflammatory processes and hypothalamic-pituitaryadrenal (HPA) abnormalities using data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. Women with IC/BPS and healthy controls (n = 154 and 32, respectively) completed surveys, collected salivary cortisol at awakening and bedtime for 3 days, and gave a blood sample which was analyzed for 7 LPS-stimulated cytokines and chemokines (IL-6, TNFα, IL-1ß, MIP1α, MCP1, IL-8, and IL-10). Two cytokine/chemokine composites were identified using principal components analysis. Patients with greater exposure to RLA or cumulative ELA and RLA of at least moderate severity showed elevated levels of a composite of all cytokines, adjusting for age, body mass index, and study site. Furthermore, there was a trending relationship between ELA and the pro-inflammatory composite score. Nocturnal cortisol and cortisol slope were not associated with ELA, RLA, or inflammation. The present findings support the importance of adverse events in IC/BPS via a biological mechanism and suggest that ELA and RLA should be assessed as risk factors for inflammation as part of a clinical workup for IC/BPS.


Asunto(s)
Cistitis Intersticial , Humanos , Femenino , Cistitis Intersticial/complicaciones , Cistitis Intersticial/diagnóstico , Hidrocortisona , Receptor Toll-Like 4 , Inflamación/complicaciones , Dolor Pélvico/complicaciones , Citocinas
15.
Urogynecology (Phila) ; 29(2): 225-233, 2023 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-36735438

RESUMEN

IMPORTANCE: Pelvic floor muscle dysfunction (PFMD) can cause pelvic pain, but its associations with pelvic organ prolapse (POP) and POP treatment outcomes are poorly understood. OBJECTIVES: The objectives of this study were to determine (1) if pelvic pain is associated with PFMD in women seeking POP treatment and (2) if baseline PFMD in women seeking management of POP is associated with improvement in pelvic pain at 12 months. STUDY DESIGN: This was an ambispective cohort study of women enrolled at one site of the Pelvic Floor Disorders Registry. Pelvic floor muscle dysfunction was identified if tenderness was reported on a standardized pelvic floor muscle examination at baseline. Outcomes included a pelvic pain questionnaire (score 0-70, assessed pain in the past 24 hours in 7 pelvic locations) and the Global Health-10 overall average pain rating (0-10). RESULTS: One hundred forty-four women planning surgery (118) or pessary (26) were included. Twenty (13.9%) had baseline PFMD. Women with PFMD versus no PFMD had greater baseline Pelvic Pain scores (median [IQR], 9.7 [4-23] vs 2.5 [0-7], P < 0.001) and overall average pain (4 [3-6] vs 1 [0-3], P < 0.001). In 107 women with 12-month treatment outcomes, those with PFMD at baseline had greater improvement in pelvic pain compared with those without PFMD (change score -6.5 [-15.2 to 0] vs 0 [-3 to 0] respectively, P = 0.03). Overall pain improved after treatment in the no PFMD group but not in the PFMD group. CONCLUSIONS: Patients with baseline PFMD vs none undergoing treatment for prolapse had higher baseline pelvic pain and greater improvement in pelvic pain at 12 months.


Asunto(s)
Diafragma Pélvico , Prolapso de Órgano Pélvico , Humanos , Femenino , Estudios de Cohortes , Prolapso de Órgano Pélvico/complicaciones , Dolor Pélvico/terapia , Terapia por Ejercicio
16.
Urogynecology (Phila) ; 29(2): 266-272, 2023 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-36735443

RESUMEN

IMPORTANCE: Women with pelvic organ prolapse (POP) have increased prevalence of overactive bladder (OAB) and the evaluation of urinary biomarkers associated with OAB in the setting of POP is limited. OBJECTIVE: The objective is to determine whether associations exist between urinary biomarkers measured before POP surgery with postoperative OAB symptoms. STUDY DESIGN: In this prospective cohort study, women with anterior and/or apical POP beyond the hymen undergoing POP surgery were assessed using the OAB Questionnaire Short Form (OAB-q SF) and the Urogenital Distress Inventory 6 (UDI-6) preoperatively and 3 months postoperatively. A first morning voided urine specimen was collected preoperatively and 3 months postoperatively. Urinary biomarkers for inflammation, neuroinflammation, and tissue remodeling were measured. Univariate generalized linear models measured the relationship between biomarkers and symptoms. Between- and within-cohort assessments were made using 2-sample paired and unpaired t tests, respectively. RESULTS: Seventy-seven participants with OAB (n = 67, 87.0%) and without OAB (n = 10, 13.0%) were enrolled. Seventy-four participants (96%) completed 3-month follow up. The OAB-q SF and UDI-6 scores significantly improved between preoperative and postoperative measures. Preoperative urinary biomarkers did not demonstrate significant correlations with postoperative OAB-q SF or UDI-6 scores. No significant differences were measured in preoperative biomarkers between patients with and without OAB or when comparing preoperative and postoperative biomarkers in patients with OAB. CONCLUSIONS: Urinary biomarkers for tissue remodeling, inflammation, and neuroinflammation were not significantly correlated with OAB symptoms in a population of patients with OAB and POP.


Asunto(s)
Prolapso de Órgano Pélvico , Vejiga Urinaria Hiperactiva , Humanos , Femenino , Vejiga Urinaria Hiperactiva/diagnóstico , Estudios Prospectivos , Enfermedades Neuroinflamatorias , Prolapso de Órgano Pélvico/cirugía , Inflamación/diagnóstico , Biomarcadores
17.
J Urol ; 209(6): 1132-1140, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-36848118

RESUMEN

PURPOSE: Symptom heterogeneity in interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively termed urological chronic pelvic pain syndrome, has resulted in difficulty in defining appropriate clinical trial endpoints. We determine clinically important differences for 2 primary symptom measures, pelvic pain severity and urinary symptom severity, and evaluate subgroup differences. MATERIALS AND METHODS: The Multidisciplinary Approach to the Study of Chronic Pelvic Pain Symptom Patterns Study enrolled individuals with urological chronic pelvic pain syndrome. We defined clinically important differences by associating changes in pelvic pain severity and urinary symptom severity over 3 to 6 months with marked improvement on a global response assessment using regression and receiver operating characteristic curves. We evaluated clinically important differences for absolute and percent change and examined differences in clinically important differences by sex-diagnosis, presence of Hunner lesions, pain type, pain widespreadness, and baseline symptom severity. RESULTS: An absolute change of -4 was clinically important in pelvic pain severity among all patients, but clinically important difference estimates differed by pain type, presence of Hunner lesions, and baseline severity. Pelvic pain severity clinically important difference estimates for percent change were more consistent across subgroups and ranged from 30% to 57%. The absolute change urinary symptom severity clinically important difference was -3 for female participants and -2 for male participants with chronic prostatitis/chronic pelvic pain syndrome only. Patients with greater baseline severity required larger decreases in symptoms to feel improved. Estimated clinically important differences had lower accuracy among participants with low baseline symptoms. CONCLUSIONS: A reduction of 30%-50% in pelvic pain severity is a clinically meaningful endpoint for future therapeutic trials in urological chronic pelvic pain syndrome. Urinary symptom severity clinically important differences are more appropriately defined separately for male and female participants.


Asunto(s)
Dolor Crónico , Cistitis Intersticial , Prostatitis , Humanos , Masculino , Femenino , Prostatitis/complicaciones , Prostatitis/diagnóstico , Dolor Pélvico/diagnóstico , Dolor Pélvico/etiología , Dolor Crónico/diagnóstico , Dolor Crónico/etiología , Cistitis Intersticial/complicaciones , Cistitis Intersticial/diagnóstico , Depresión/diagnóstico
18.
J Urol ; : 101097JU0000000000003155, 2023 Jan 11.
Artículo en Inglés | MEDLINE | ID: mdl-36630590

RESUMEN

PURPOSE: Most studies on interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome use typical or average levels of pelvic pain or urological symptom intensity as their outcome, as both are associated with reduced quality of life. Symptom exacerbations or "flares" have also been found to be associated with reduced quality of life, but no studies, to our knowledge, have investigated whether these associations are independent of typical pelvic pain levels and thus might be useful additional outcome measures (or stated differently, whether reducing flare frequency even without reducing mean pain intensity may be important to patients). MATERIALS AND METHODS: We used screening visit and weekly run-in period data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain Symptom Patterns Study to investigate associations between flare frequency and multiple measures of illness impact and health care seeking activity, independent of typical nonflare and overall pelvic pain levels. RESULTS: Among the 613 eligible participants, greater flare frequency was associated with worse condition-specific illness impact (standardized ß coefficients=0.11-0.68, P trends < .0001) and health care seeking activity (odds ratios=1.52-3.94, P trends .0039 to < .0001) in analyses adjusted for typical nonflare and overall pelvic pain levels. Experiencing ≥1/d was also independently associated with worse general illness impact (standardized ß coefficients=0.11-0.25). CONCLUSIONS: Our findings suggest that flare frequency and possibly other flare characteristics may be worth considering as additional outcome measures in urological chronic pelvic pain syndrome research to support the development of new preventive and therapeutic flare strategies.

19.
BMJ Surg Interv Health Technol ; 4(Suppl 1): e000076, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36393893

RESUMEN

Objectives: The accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements important to assess POP technologies. Design: A Delphi method approach was employed to achieve consensus on a core minimum dataset for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved. Results: Twenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors. Conclusions: The CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety.

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