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1.
J Urol ; : 101097JU0000000000004192, 2024 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-39172765
2.
Obes Surg ; 2024 Aug 19.
Artículo en Inglés | MEDLINE | ID: mdl-39160367

RESUMEN

PURPOSE: Women with obesity are more likely to experience bothersome urinary and sexual symptoms, but the long-term effect of metabolic and bariatric surgery (MBS) on these outcomes is poorly understood. We aimed to describe how MBS longitudinally impacted women's urinary and sexual health. METHODS: Patients who underwent MBS at the University of California, San Francisco Medical Center (UCSF) between 2009 and 2021 participated in a survey examining sexual health, pelvic organ prolapse (POP), and urinary health using three validated questionnaires: a modified version of the Female Sexual Function Index (FSFI), the Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), and the Urinary Distress Inventory 6 (UDI-6). All questions asked referenced two time points: before surgery and at the time of survey. Logistic regression identified predictors of symptom improvement. RESULTS: Of 162 participants contacted, 118 (73%) had complete survey data. Mean body mass index (BMI) decreased from 52.4 ± 12.6 to 36.3 ± 9.7 kg/m2 (p < 0.01) with an average follow-up of 6 years. The mean UDI-6 score amongst women was 24 ± 24 prior to MBS and 24 ± 26 at the time of survey administration (p = 0.458). Mean modified FSFI scores amongst women were 15 ± 5 prior to surgery and 14 ± 7 at the time of survey administration (p = 0.005). The overall mean POPDI-6 score amongst women was 13 ± 15 prior to surgery and 9 ± 14 at the time of survey administration (p = 0.056). CONCLUSION: Women who underwent MBS reported a high rate of sexual and urological dysfunction that did not improve longitudinally, despite significant weight loss.

3.
Urology ; 190: 142-147, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38878829

RESUMEN

OBJECTIVE: To assess changes in the urinary microbiota after buccal urethroplasty. METHODS: At the University of California San Francisco, we enrolled 9 adult males with urethral strictures undergoing buccal urethroplasty where we collected urine and oral swabs intraoperatively and 3 months postoperatively. 16S rRNA sequencing was used to profile the microbiota. RESULTS: At baseline, the mouth contains twice the number of unique bacteria (alpha diversity) and the microbial community is significantly distinct compared to the urinary tract. Despite having a buccal mucosa in the urinary tract after urethroplasty, the number of unique bacteria in the urine remained stable. However, the bacterial community composition and structure significantly changed in the urinary tract with the enrichment of Corynebacterium genus at 3 months post-urethroplasty procedure. CONCLUSION: In this pilot study, we showed that the alpha diversity in the urinary microbiota did not significantly change despite having a buccal tissue with the capacity to support high bacterial diversity in the urinary tract. To our surprise, the post-urethroplasty urinary microbiota was not a hybrid of baseline oral and urine microbiotas; the changes detected, such as an enrichment of the Corynebacterium genus, were more nuanced yet could profoundly impact surgical outcomes like graft changes and stricture recurrence. Our study not only established the feasibility but also outlined a blueprint for conducting a large-scale study to assess alterations in the urinary microbiome in relation to surgical outcomes.


Asunto(s)
Microbiota , Uretra , Estrechez Uretral , Humanos , Masculino , Estrechez Uretral/cirugía , Estrechez Uretral/microbiología , Uretra/microbiología , Uretra/cirugía , Proyectos Piloto , Adulto , Persona de Mediana Edad , Mucosa Bucal/microbiología , Mucosa Bucal/trasplante , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Boca/microbiología , Orina/microbiología
4.
Urol Case Rep ; 54: 102751, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38779690

RESUMEN

Management of urethral sounding related injuries continues to be a challenge due to the wide breath of objects implicated, the rarity of cases, and chance of significant complication. We present a particularly challenging and novel case where a patient inserted a round of live ammunition into his urethra. Non-surgical removal was limited over concern for accidental discharge of the round, and the patient was taken to the operating room where open removal was performed. Psychiatric evaluation should be considered for cases where sounding injury requires surgical intervention, and a patient-centered, prevention-focused approach is best for building physician-patient rapport and adherence.

5.
Pharmacoepidemiol Drug Saf ; 33(1): e5721, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37909414

RESUMEN

PURPOSE: To explore the differences of priapism events among a diverse cohort taking erectogenic medicines (i.e., phosphodiesterase type 5 inhibitors [PDE5i] and intracavernousal drugs). METHODS: We queried the World Health Organization global database of individual case safety reports (VigiBase) for records of the adverse drug reactions (ADR) with sildenafil, tadalafil, avanafil, vardenafil, papaverine, and alprostadil. Disproportionality analyses (case/non-case approach) were performed to assess the reporting odds ratio (ROR) of priapism reporting in PDE5i consumers compared to intracavernousal drug recipients. RESULTS: From a total of 133 819 ADR events for erectogenic medications, 632 were priapism (PDE5is: n = 550, 0.41%; intracavernousal drugs: n = 82, 9.92%). Priapism disproportionality signals from intracavernousal drugs were 25 times stronger than PDE5is (ROR = 34.7; confidence interval [CI] 95%: 27.12-43.94 vs. ROR = 1.38; 95% CI: 1.24-1.54). For all PDE5i agents, the 12-17 years age group had the highest ROR (9.49, 95% CI: 3.76-19.93) followed by 2-11 years (4.31, 95% CI: 1.57-9.4). Disproportionality signals for consumers under 18 for both all PDE5is as a whole (ROR = 4.57, 95% CI: 2.48-7.73) and sildenafil (ROR = 4.89, 95% CI: 2.51-8.62) were stronger than individuals 18 or older (ROR = 1.06, 95% CI: 0.93-1.21 and ROR = 1.08, 95% CI: 0.91-1.26, respectively). CONCLUSIONS: PDE5i use shows disproportionate priapism signals which are higher in young patients.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Disfunción Eréctil , Priapismo , Masculino , Humanos , Preescolar , Niño , Inhibidores de Fosfodiesterasa 5/efectos adversos , Citrato de Sildenafil/efectos adversos , Priapismo/inducido químicamente , Priapismo/epidemiología , Priapismo/tratamiento farmacológico , Disfunción Eréctil/inducido químicamente , Disfunción Eréctil/tratamiento farmacológico , Disfunción Eréctil/epidemiología , Tadalafilo/efectos adversos
6.
J Urol ; 211(3): 354-363, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38079459

RESUMEN

PURPOSE: We evaluate the efficacy and safety profiles of currently available conservative management options for penile and urethral lichen sclerosus. MATERIALS AND METHODS: A systematic review of existing literature on lichen sclerosus was conducted utilizing the PubMed, Embase, and Web of Science databases. References were assessed for relevance to nonsurgical management of male genital lichen sclerosus by title and abstract by 3 independent reviewers, then reviewed in full and in duplicate by 5 independent reviewers. RESULTS: Seventeen studies describing conservative management of histologically confirmed penile and urethral lichen sclerosus in male patients were included in the final review. We present available evidence supporting the use of 4 major treatment modalities represented in the existing literature: topical corticosteroids, tacrolimus, platelet-rich plasma, and CO2 laser. We also briefly discuss the limited studies on the use of oral acitretin and polydeoxyribonucleotide injections. Outcomes assessed include symptoms, clinical appearance, quality of life, sexual satisfaction, adverse effects, and long-term efficacy of treatment. CONCLUSIONS: Topical corticosteroids remain the mainstay of conservative management of penile and urethral lichen sclerosus, with current literature supporting the use of other therapies such as tacrolimus and platelet-rich plasma as alternatives or adjuvant treatments when escalation of treatment is necessary. Future research should further explore the efficacy and safety of newer therapies through additional controlled clinical trials in the targeted population.


Asunto(s)
Liquen Escleroso y Atrófico , Estrechez Uretral , Humanos , Masculino , Liquen Escleroso y Atrófico/tratamiento farmacológico , Tacrolimus/uso terapéutico , Tratamiento Conservador , Calidad de Vida , Estrechez Uretral/cirugía , Glucocorticoides
7.
Neurourol Urodyn ; 43(1): 11-21, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38014566

RESUMEN

OBJECTIVES: To explore the context in which older men navigate treatment for stress urinary incontinence (SUI) following prostate surgery by characterizing lived experience of men with symptomatic SUI. SUBJECTS/PATIENTS AND METHODS: Mixed method study using surveys and semistructured interviews to examine a cohort of men who underwent evaluation for treatment of postprostatectomy SUI. RESULTS: Thirty-six men were interviewed after consultation for SUI and 31 had complete quantitative clinical data. Twenty-six underwent surgery and 10 chose no surgical intervention. In qualitative interviews, respondents experienced substantial decline in quality of life due to incontinence citing concerns associated with use of pads and worrying about incontinence. Most patients reported "workarounds"-efforts to mitigate or manage incontinence including Kegels, physical therapy, and garments. Participants also reported lifestyle changes including less strenuous physical activity, less sexual activity, and/or fewer social gatherings. Patients then described a "breaking point" where incontinence workarounds were no longer sufficient. After seeking evaluation, men described challenges in exploring treatment for SUI, including access to care and provider knowledge of treatment options. CONCLUSION: In a novel study of patients living with SUI a predictable lived experience was observed that culminated in a desire for change or "breaking point." In all men, this led to treatment-seeking behaviors and for many it led to SUI intervention. Despite effective treatments, patients continue to meet barriers gaining access to SUI evaluation and treatment.


Asunto(s)
Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Esfínter Urinario Artificial , Masculino , Humanos , Anciano , Incontinencia Urinaria de Esfuerzo/cirugía , Calidad de Vida , Resultado del Tratamiento , Evaluación del Resultado de la Atención al Paciente
8.
Urology ; 184: 235-243, 2024 02.
Artículo en Inglés | MEDLINE | ID: mdl-38160765

RESUMEN

Optimal ergonomics are essential to improving clinical performance and longevity among urologists, as poor ergonomics can contribute to work-related injury and physician burnout. While a majority of urologists experience muscular injury throughout their career, women and trainees are disproportionately affected. These disparities are exacerbated by the lack of formal ergonomics education within urologic training programs. This review provides an overview of practical approaches to optimize ergonomics across working environments for urologists and trainees. We highlight intraoperative techniques and novel devices which have been shown to reduce work-related injury, and we identify knowledge gaps to guide future areas of ergonomic research.


Asunto(s)
Traumatismos Ocupacionales , Médicos , Urología , Femenino , Humanos , Urólogos , Ergonomía
9.
Plast Reconstr Surg Glob Open ; 11(12): e5472, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38093723

RESUMEN

Adult-acquired buried penis (AABP) is an acquired clinical entity where a normal sized phallus is concealed by prepubic skin, fat, or subcutaneous tissue, often caused by obesity, lymphedema, or trauma. Surgical repair is the standard of care in management of AABP; however, up to 60% of patients have developed bothersome genital lymphedema postoperatively. Despite the rates of postoperative scrotal lymphedema, and lymphedema itself representing a risk for AABP, very little data exist on the role of lymphatic evaluation in this patient population. We present the previously unreported use of indocyanine green (ICG) for lymphatic mapping as an adjunct to buried penis repair. Using 0.1 mL 25 mg per mL of indocyanine green and SPY Portable Handled Imaging, lymph mapping is performed, identifying lymph channels that seem obstructed as possible targets for lymphovenous bypass. In addition, lymph mapping can be used as an adjunct to surgical resection so as to not disrupt the intact channels, reducing the risk of postoperative lymphedema. Through this article, we offer emerging clinical insight into the possible use of lymphovenous bypass, particularly in patients with AABP due to lymphedema or those who experience lymphedema as a complication of AABP repair.

11.
Urology ; 180: 262-269, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37543118

RESUMEN

OBJECTIVE: To systematically compare success, cure and complication rates of urethral sling surgeries in stress urinary incontinence patients with and without a history of pelvic radiotherapy (RT). MATERIALS AND METHODS: We searched PUBMED, EMBASE, and Web of Science to identify relevant articles. The primary outcomes were the success and cure rates. The secondary outcomes included the rates of infection, urethral erosion, total complications, explantation, and satisfaction. Outcomes were analyzed using a random-effects model to calculate the unadjusted odds ratio (OR) in patients with a history of RT compared with those without prior RT. RESULTS: On pooled analysis, we found significantly lower odds of success (OR 0.68; 95% confidence interval [CI] 0.53-0.87, P < .001) and cure (OR 0.67; 95% CI 0.55-0.82, P < .001) in radiated patients than in nonirradiated patients. Subgroup analysis by type of sling showed significantly lower odds of success in Advance subgroup (OR 0.66; 95% CI 0.45-0.95, P < .001) and significantly lower odds of cure in Advance (OR 0.59; 95% CI 0.36-0.95, P < .001) and Atoms subgroups (OR 0.70; 95% CI 0.54-0.93, P < .001). We also found significantly greater odds of sling explantation (OR 2.93; 95% CI 1.62-5.29, P < .001) and infection (OR 3.06, 95% CI 1.03-9.07, P < .001) in radiated patients than in nonradiated patients. CONCLUSION: Patients with a history of pelvic RT have lower odds of success and cure and higher odds of infection and sling explantation than those without a history of pelvic RT.


Asunto(s)
Cabestrillo Suburetral , Incontinencia Urinaria de Esfuerzo , Humanos , Masculino , Incontinencia Urinaria de Esfuerzo/etiología , Incontinencia Urinaria de Esfuerzo/cirugía , Cabestrillo Suburetral/efectos adversos , Procedimientos Quirúrgicos Urológicos , Uretra , Oportunidad Relativa , Resultado del Tratamiento
12.
Transl Androl Urol ; 12(5): 840-848, 2023 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-37305619

RESUMEN

Background: Frailty is common among urology patients in general as well as among men seeking evaluation for stress urinary incontinence (SUI), with 6.1% of men undergoing artificial urinary sphincter placement considered frail. It is unclear if and how patient views on frailty and incontinence severity impact decision-making with regards to SUI treatment. Methods: We undertook a mixed methods analysis to evaluate the intersection of frailty, incontinence severity, and treatment decision-making is presented. To do so, we utilized a previously published cohort of men undergoing evaluation for SUI at the University of California, San Francisco between 2015 and 2020, selecting those who had evaluation with timed up and go test (TUGT), objective measures of incontinence, and patient-reported outcome measures (PROMs). A subset of these participants had additionally undergone semi-structured interviews, and these interviews were re-examined to thematically code them with a focus on the impact of frailty and incontinence severity on SUI treatment decision-making. Results: Among the original cohort of 130 patients, 72 had an objective measure of frailty and were included in our analysis; 18 of these individuals had corresponding qualitative interviews. Common themes identified included (I) impact of incontinence severity on decision-making; (II) the interaction between frailty and incontinence; (III) the impact of comorbidity on treatment decision-making; and (IV) age as a construct of frailty and impact on surgical choice and/or recovery. Direct quotations regarding each theme provides insight into patients' views and drivers of SUI treatment decision-making. Conclusions: The impact of frailty on treatment decision-making for patients with SUI is complex. This mixed methods study highlights the variety of patient views on frailty with regards to surgical intervention for male SUI. Urologists should make a concerted effort to personalize patient counseling for SUI management and take time to understand each patient's perspective in order to individualize SUI treatment decision-making. More research is needed to help identify factors that influence decision-making for frail male patients with SUI.

13.
Transl Androl Urol ; 12(5): 849-858, 2023 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-37305624

RESUMEN

Background: Male stress urinary incontinence (SUI) is a known complication following surgical intervention on the prostate, particularly following surgery for prostate cancer. Effective surgical treatments for SUI include artificial urinary sphincter (AUS) and male urethral sling. Prior data suggest that men may forego available treatment despite bothersome symptoms. The objective was to explore how men who underwent surgical correction for post-prostatectomy SUI navigated SUI treatment decisions. Methods: Mixed method study was employed. Semi-structured interviews, participant surveys and objective clinical assessment of SUI were performed among a group of men living with incontinence after prostate cancer surgery who underwent surgery for SUI at the University of California in 2017. Results: Eleven men were interviewed after consultation for SUI and all had complete quantitative clinical data. Surgery for SUI included AUS (n=8) and sling (n=3). There was a decrease in pads per day from 3.2 to 0.9 and no major complications. Most patients found that the impact on activities and their treating urologist were of great importance. Sexual and relationships played a variable role with some participants ranking these as "great deal of influence" and others "little or no influence". Participants who underwent AUS were more likely to cite a higher importance on "being very dry" in choosing that surgery while sling patients had more variable ranking of important factors. Participants found a variety of inputs helpful in hearing information about SUI treatment options. Conclusions: Among a group of 11 men who underwent surgical correction for post-prostatectomy SUI, there were identifiable themes on how men make decisions, evaluate quality of life (QoL) changes and approach treatment options. Men value more than being dry with measures of individual success that can include sexual and relationship health. Furthermore the role of the Urologist remains crucial as patients relied heavily on input and discussion with their Urologist to assist in treatment decisions. These findings can be used to inform future studies of the experience of men with SUI.

14.
World J Urol ; 41(7): 1983-1989, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37356027

RESUMEN

PURPOSE: To investigate management trends for American Association for the Surgery of Trauma (AAST) grade V renal trauma with focus on non-operative management. METHODS: We used prospectively collected data as part of the Multi-institutional Genito-Urinary Trauma Study (MiGUTS). We included patients with grade V renal trauma according to the AAST Injury Scoring Scale 2018 update. All cases submitted by participating centers with radiology images available were independently reviewed to confirm renal trauma grade. Management was classified as expectant, conservative (minimally invasive, endoscopic or percutaneous procedures), or operative (renal-related surgery). RESULTS: Eighty patients were included, 25 of whom had complete imaging and had independent confirmation of AAST grade V renal trauma. Median age was 35 years (Interquartile range (IQR) 25-50) and 23 (92%) had blunt trauma. Ten patients (40%) were managed operatively with nephrectomy. Conservative management was used in nine patients (36%) of which six received angioembolization and three had a stent or drainage tube placed. Expectant management was followed in six (24%) patients. Transfusion requirements were progressively higher with groups requiring more aggressive treatment, and injury characteristics differed significantly across management groups in terms of hematoma size and laceration size. Vascular contrast extravasation was more likely in operatively managed patients though a statistically significant association was not found. CONCLUSION: Successful use of nonoperative management for grade V injuries is used for a substantial subset of patients. Lower transfusion requirement and less severe injury radiologic phenotype appear to be important characteristics delineating this group.


Asunto(s)
Traumatismo Múltiple , Centros Traumatológicos , Humanos , Puntaje de Gravedad del Traumatismo , Riñón/cirugía , Nefrectomía , Estudios Retrospectivos , Sistema Urogenital/lesiones , Adulto , Persona de Mediana Edad
15.
Artículo en Inglés | MEDLINE | ID: mdl-37341950

RESUMEN

BACKGROUND: Patient and provider race and gender concordance (patient and physician identify as the same race/ethnicity or gender) may impact patient experience and satisfaction. OBJECTIVE: We sought to examine how patient and physician racial and gender concordance effect patient satisfaction with outpatient clinical encounters. Furthermore, we examined factors that changed satisfaction among concordant and discordant dyads. DESIGN: Consumer Assessment of Healthcare Provider and Systems (CAHPS) Patient Satisfaction Survey Scores were collected from outpatient clinical encounters between January 2017 and January 2019 at the University of California, San Francisco. PARTICIPANTS: Patients who were seen in the eligible time period, who voluntarily provided physician satisfaction scores. Providers with fewer than 30 reviews and encounters with missing data were excluded. MAIN MEASURES: Primary outcome was rate of top satisfaction score. The provider score (1-10 scale) was dichotomized as "top score (9-10)" and "low scores (<9)." KEY RESULTS: A total of 77,543 evaluations met inclusion criteria. Most patients identified as White (73.5%) and female (55.4%) with a median age of 60 (IQR 45, 70). Compared to White patients, Asian patients were less likely to give a top score even when controlling for racial concordance (OR: 0.67; CI 0.63-0.714). Telehealth was associated with increased odds of a top score relative to in-person visits (OR 1.25; CI 1.07-1.48). The odds of a top score decreased by 11% in racially discordant dyads. CONCLUSIONS: Racial concordance, particularly among older, White, male patients, is a nonmodifiable predictor of patient satisfaction. Physicians of color are at a disadvantage, as they receive lower patient satisfaction scores, even in race concordant pairs, with Asian physicians seeing Asian patients receiving the lowest scores. Patient satisfaction data is likely an inappropriate means of determining physician incentives as such may perpetuate racial and gender disadvantages.

16.
Urology ; 177: 195-196, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37236815
17.
Telemed J E Health ; 29(12): 1897-1900, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37172307

RESUMEN

Introduction: Patient satisfaction has been shown to changes based on the distance a patient to see their physician. We sought to examine the effects of telehealth on patient satisfaction. Methods: We examined patient satisfaction survey scores from outpatient clinics at University of California, San Francisco. Patient home and clinic addresses were used to calculate distance in kilometers (km). Outcomes were "top scores (9-10)" and "low scores (<9)." Results: Of 103,124 evaluations that met inclusion criteria, those where patient traveled >100 km for in-person visits had more top scores (84%) than those traveled <10 km (80.2%). Relative to in-person visits, telehealth was associated with an increased odds (odds ratio [OR]: 1.48) of receiving a top score at all distances. Those traveling >100 km had the highest odds of top score for telehealth (OR: 1.86). Conclusions: Patients receiving care through telehealth, particularly those far from the outpatient clinic, are more likely to provide high patient satisfaction scores for the visit provider.


Asunto(s)
Pacientes Ambulatorios , Telemedicina , Humanos , Satisfacción del Paciente , Instituciones de Atención Ambulatoria , Viaje
18.
Urology ; 177: 189-196, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-37076021

RESUMEN

OBJECTIVE: To investigate which treatment attributes matter to patients with stress urinary incontinence (SUI), why and how they matter, and the context in which patients consider treatment attributes. Nearly a quarter of older men have decisional regret following SUI treatment. Knowledge of what matters to patients when making SUI treatment decisions is necessary to improve goal-concordant care. METHODS: We conducted semi-structured interviews with 36 men ≥65 years of age with SUI. Semi-structured interviews were conducted by telephone and transcribed. Four researchers (L.H., N.S., E.A., C.B.) coded the transcripts using both deductive and inductive codes to identify and describe treatment attributes. RESULTS: We identified 5 patient-derived treatment attributes of interest among older men with SUI who have faced treatment decisions: (1) dryness, (2) simplicity, (3) potential need for future intervention, (4) treatment regret/satisfaction, and (5) surgical avoidance. These themes reliably emerged in our patient-centered interviews from within various contexts, including prior negative healthcare experiences, the impact of incontinence on daily and quality of life, and the mental health burden of incontinence, among others. CONCLUSION: Men with SUI weigh a variety of treatment attributes in addition to dryness, a traditional clinical endpoint, and do so within the context of their individual experience. These additional attributes, such as simplicity, may run counter to the goal of dryness. This suggests that traditional clinical endpoints alone are not adequate for counseling patients. Contextualized patient-identified treatment attributes should be used to create decision-support materials to promote goal-concordant SUI treatment.


Asunto(s)
Incontinencia Urinaria de Esfuerzo , Incontinencia Urinaria , Masculino , Humanos , Anciano , Incontinencia Urinaria de Esfuerzo/cirugía , Calidad de Vida
19.
Urol Pract ; 10(2): 144-145, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-37103413
20.
Andrology ; 11(7): 1408-1417, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-36905319

RESUMEN

BACKGROUND: Despite their efficacy and general safety, rare but devastating adverse drug reactions have been associated with phosphodiesterase type 5 inhibitors. OBJECTIVES: To determine the safety profile of oral phosphodiesterase type 5 inhibitors with a particular focus on priapism and malignant melanoma. MATERIALS AND METHODS: In this case-non-case study, we queried the individual case safety reports for phosphodiesterase type 5 inhibitors within the World Health Organization global database of individual case safety reports (VigiBase) between 1983 and 2021. We included all individual case safety reports for sildenafil, tadalafil, vardenafil, and avanafil in men. For comparison, we also extracted the safety data from the Food and Drug Administration trials for these drugs. We assessed the safety profile of phosphodiesterase type 5 inhibitors by disproportionality analysis by measuring reporting odds ratio for their most commonly reported adverse drug reactions, once for all phosphodiesterase type 5 inhibitor reports and once for reports of oral phosphodiesterase type 5 inhibitor use in adult men (≥18 years old) with sexual dysfunction. RESULTS: A total of 94,713 individual case safety reports for phosphodiesterase type 5 inhibitors were extracted. A total of 31,827 individual case safety reports were identified relating to adult men taking oral sildenafil, tadalafil, vardenafil, or avanafil for sexual dysfunction. The most common adverse drug reactions included poor drug efficacy (42.5%), headache (10.4% vs. 8.5%-27.6% [Food and Drug Administration]), abnormal vision (8.4% vs. ≤4.6% [Food and Drug Administration]), flushing (5.2% vs. 5.1%-16.5% [Food and Drug Administration]), and dyspepsia (4.2% vs. 3.4%-11.1% [Food and Drug Administration]). Priapism showed significant signals for sildenafil (reporting odds ratio = 13.81, 95% confidence interval: 11.75-16.24), tadalafil (reporting odds ratio = 14.54, 95% confidence interval: 11.56-18.06), and vardenafil (reporting odds ratio = 14.12, 95% confidence interval: 8.36-22.35). Comparing with other medications in VigiBase, sildenafil (reporting odds ratio = 8.73, 95% confidence interval: 7.63-9.99) and tadalafil (reporting odds ratio = 4.25, 95% confidence interval: 3.19-5.55) had significantly higher reporting odds ratios for malignant melanoma. CONCLUSION: Phosphodiesterase type 5 inhibitors show significant signals correlating with priapism among a large international cohort. Further clinical study is needed to elucidate whether this is from proper or inappropriate use or other confounding conditions, as analysis of pharmacovigilance data does not allow for quantifying the clinical risk. Also, there appears to be a relationship between phosphodiesterase type 5 inhibitor use and malignant melanoma, which warrants additional study to better understand causation.


Asunto(s)
Disfunción Eréctil , Melanoma , Priapismo , Masculino , Adulto , Humanos , Adolescente , Inhibidores de Fosfodiesterasa 5/uso terapéutico , Citrato de Sildenafil/efectos adversos , Tadalafilo/efectos adversos , Diclorhidrato de Vardenafil/efectos adversos , Farmacovigilancia , Disfunción Eréctil/inducido químicamente , Disfunción Eréctil/tratamiento farmacológico , Melanoma/inducido químicamente , Melanoma/tratamiento farmacológico , Organización Mundial de la Salud , Melanoma Cutáneo Maligno
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