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OBJECTIVE: To report the protocol of a study evaluating the efficacy of transdermal oestradiol (E2) gel in reducing the adverse effects of androgen deprivation therapy (ADT), specifically on sexual function, and to assess the utility of E2 in combination with supervised exercise. STUDY DESIGN AND METHODS: The primary endpoint of this open-label Phase IIA randomized controlled trial is the efficacy of transdermal E2 gel. Secondary endpoints include: (i) the occurrence of ADT-induced adverse effects; (ii) the safety and tolerability of E2; (iii) the impact of E2 with or without exercise on physical, physiological, muscle, and systemic biomarkers; and (iv) quality of life. The trial will recruit high-risk PCa patients (n = 310) undergoing external beam radiation therapy with adjuvant subcutaneous ADT. Participants will be stratified and randomized in a 1:1 ratio to either the E2 + ADT arm or the ADT-only control arm. Additionally, a subset of patients (n = 120) will be randomized into a supervised exercise programme. RESULTS: The primary outcome is assessed according to the efficacy of E2 in mitigating the deterioration of Expanded Prostate Cancer Index Composite sexual function domain scores. Secondary outcomes are assessed according to the occurrence of ADT-induced adverse effects, safety and tolerability of E2, impact of E2 with or without exercise on physical performance, body composition, bone mineral density, muscle size, systematic biomarkers, and quality of life. CONCLUSION: The ESTRACISE study's innovative design can offer novel insights about the benefits of E2 gel, and the substudy can reinforce the benefits resistance training and deliver valuable new novel insights into the synergistic benefits of E2 gel and exercise, which are currently unknown. TRIAL REGISTRATION: The protocol has been registered in euclinicaltrials.eu (2023-504704-28-00) and in clinicaltrials.gov (NCT06271551).
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Administração Cutânea , Antagonistas de Androgênios , Estradiol , Terapia por Exercício , Neoplasias da Próstata , Humanos , Masculino , Antagonistas de Androgênios/efeitos adversos , Antagonistas de Androgênios/uso terapêutico , Neoplasias da Próstata/tratamento farmacológico , Estradiol/administração & dosagem , Terapia por Exercício/métodos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Terapia Combinada , Ensaios Clínicos Fase II como AssuntoRESUMO
BACKGROUND: Prostate cancer (PrCa) genomic heterogeneity causes resistance to therapies such as androgen deprivation. Such heterogeneity can be deciphered in the context of evolutionary principles, but current clinical trials do not include evolution as an essential feature. Whether or not analysis of genomic data in an evolutionary context in primary prostate cancer can provide unique added value in the research and clinical domains remains an open question. METHODS: We used novel processing techniques to obtain whole genome data together with 3D anatomic and histomorphologic analysis in two men (GP5 and GP12) with high-risk PrCa undergoing radical prostatectomy. A total of 22 whole genome-sequenced sites (16 primary cancer foci and 6 lymph node metastatic) were analyzed using evolutionary reconstruction tools and spatio-evolutionary models. Probability models were used to trace spatial and chronological origins of the primary tumor and metastases, chart their genetic drivers, and distinguish metastatic and non-metastatic subclones. RESULTS: In patient GP5, CDK12 inactivation was among the first mutations, leading to a PrCa tandem duplicator phenotype and initiating the cancer around age 50, followed by rapid cancer evolution after age 57, and metastasis around age 59, 5 years prior to prostatectomy. In patient GP12, accelerated cancer progression was detected after age 54, and metastasis occurred around age 56, 3 years prior to prostatectomy. Multiple metastasis-originating events were identified in each patient and tracked anatomically. Metastasis from prostate to lymph nodes occurred strictly ipsilaterally in all 12 detected events. In this pilot, metastatic subclone content analysis appears to substantially enhance the identification of key drivers. Evolutionary analysis' potential impact on therapy selection appears positive in these pilot cases. CONCLUSIONS: PrCa evolutionary analysis allows tracking of anatomic site of origin, timing of cancer origin and spread, and distinction of metastatic-capable from non-metastatic subclones. This enables better identification of actionable targets for therapy. If extended to larger cohorts, it appears likely that similar analyses could add substantial biological insight and clinically relevant value.
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Neoplasias da Próstata , Masculino , Humanos , Pessoa de Meia-Idade , Neoplasias da Próstata/genética , Neoplasias da Próstata/terapia , Neoplasias da Próstata/patologia , Antagonistas de Androgênios/uso terapêutico , Medicina de Precisão , Prostatectomia/métodos , OncogenesRESUMO
OBJECTIVES: To compare functional and oncological outcomes of robot-assisted laparoscopic prostatectomy (RALP) to three-dimensional laparoscopic radical prostatectomy (3D-LRP) at 12 months after surgery. PATIENTS AND METHODS: Prospective randomised single-centre study of 145 consecutive men referred to radical prostatectomy in a tertiary referral centre in Finland. Patients were randomised 1:1 to the RALP (N = 75) and 3D-LRP (N = 70) groups. The primary outcome was urinary continence evaluated with the Expanded Prostate Cancer Index Composite 26-item version (EPIC-26) incontinence domain score at 12 months after surgery. Secondary outcomes included the use of protective pads at 12 months after surgery, EPIC-26 domain scores of irritative/obstructive, bowel, sexual and hormonal symptoms, positive surgical margin (PSM) rate, and biochemical recurrence (BCR). Complication frequency within the 3-month period after surgery was evaluated according to Clavien-Dindo classification. Statistical significance between groups was analysed using Mann-Whitney, chi-square and Fisher's exact tests. The trial was terminated after interim analysis based on no statistically significant difference in EPIC-26 urinary incontinence domain scores. Altogether 145 patients of the target accrual of 280 patients were recruited. RESULTS: Postoperative continence at 12 months after surgery according to the EPIC-26 incontinence domain was 79.25 in both groups (P = 0.4). Between group difference was -5.8 (95% confidence interval -15.2 to 3.6). There was no statistically significant difference in the rates of PSM or BCR between the two surgical modality groups. CONCLUSION: We were unable to demonstrate a difference between the RALP and 3D-LRP groups for functional and oncological outcomes at 12 months after surgery.
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BACKGROUND: Bacillus Calmette-Guérin (BCG) therapy using the Southwest Oncology Group (SWOG) maintenance protocol is the standard in non-muscle-invasive bladder cancer (NMIBC). Maintenance with monthly instillations is also widely used, but evidence comparing the two maintenance protocols is scarce. OBJECTIVE: To compare monthly and SWOG instillation schedules in maintenance BCG therapy. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively identified patients with NMIBC treated with maintenance BCG according to either the monthly or the SWOG instillation regimen in two tertiary care centers in Finland between 2009 and 2019. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We compared discontinuation rates of the monthly and SWOG maintenance protocols due to toxicity, and recurrence and progression rates by protocols. Baseline characteristics were compared with the Wilcoxon rank sum test, chi-square test, and Fisher's exact test. The Kaplan-Meier method and Cox proportional hazards model were used to evaluate the discontinuation of BCG due to toxicity and oncological efficacy. RESULTS AND LIMITATIONS: We identified 723 patients, of whom 545 (75%) and 178 (25%) received maintenance according to the monthly and SWOG protocols, respectively. The median follow-up time was 66 (interquartile range: 45-99) mo. In the monthly and SWOG groups, 131 (24%) and 50 (28%) patients, respectively, discontinued BCG due to toxicity, with no difference in a univariate or multivariate analysis (hazard ratio 1.01, 95% confidence interval [CI]: 0.73-1.40, p = 0.940). The 5-yr recurrence-free survival rates in the monthly and SWOG groups were 65% (95% CI: 61-69%) and 71% (95% CI: 64-79%, p = 0.370), respectively. The 5-yr progression-free survival rates were 89% (95% CI: 86-92%) and 91% (95% CI: 86-96%, p = 0.240), respectively. CONCLUSIONS: Monthly maintenance is a comparable alternative to the SWOG protocol. PATIENT SUMMARY: In this study, we compared two schedules of intravesical bacillus Calmette-Guérin (BCG) treatment used in the treatment of non-muscle-invasive bladder cancer. We found that there were no significant differences between the two instillation schedules in terms of tolerability or efficacy.
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Neoplasias não Músculo Invasivas da Bexiga , Neoplasias da Bexiga Urinária , Humanos , Vacina BCG/uso terapêutico , Estudos Retrospectivos , Administração IntravesicalRESUMO
OBJECTIVE: To assess the correlation between the Visual Analogue Scale (VAS) and the Expanded Prostate Cancer Index Composite (EPIC)-26 in the evaluation of urinary continence (UC) recovery after 3-dimensional laparoscopic radical prostatectomy (3D-LRP). METHODS: 105 men underwent 3D-LRP in Seinäjoki Central Hospital Finland between November 2018 and February 2021. VAS forms and EPIC-26 questionnaires were used to assess UC preoperatively and at 6 weeks, 3-, 6-, 9-, 12-, 15-, 18-, 21-, and 24 months postoperatively. On the VAS form, the patient put a mark on the 10 cm long horizontal line in place, which described his experienced degree of UC (0 cm; fully incontinent-10 cm; fully continent). The scores for the urinary incontinence domain of EPIC-26 (UI-EPIC-26) were calculated and transformed to a scale of 0-100. Spearman´s rank correlation coefficient was used to evaluate the correlation between the VAS and UI-EPIC-26. RESULTS: A total of 915 VAS forms and 909 EPIC-26 questionnaires were evaluable. UC improved significantly during the first year but not after that. The medians for UI-EPIC-26 and VAS were 50.8 (0-100) and 7.2 cm (0-10 cm) at 3 months, 76.8 (14.5-100) and 8.7 cm (1.7-10 cm) at 12 months and 79.6 (8.25-100) and 9.0 cm (2.7-10 cm) at 24 months. The correlation coefficient (95% confidence interval) between VAS and UI-EPIC-26 preoperatively, at 12 months and at 24 months was 0.639 (0.505-0.743), 0.807 (0.716-0.871), and 0.831 (0.735-0.894), respectively (P < 0.001). CONCLUSION: The VAS can be utilized as an easy-to-use alternative to the EPIC-26 when evaluating UC recovery after 3D-LRP.
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Laparoscopia , Neoplasias da Próstata , Masculino , Humanos , Estudos Prospectivos , Escala Visual Analógica , Neoplasias da Próstata/cirurgia , Prostatectomia/métodos , Laparoscopia/métodosRESUMO
OBJECTIVE: To assess suitability of visual analog scale (VAS) in the evaluation of functional outcomes after 3D laparoscopic prostatectomy (3D LRP) METHODS: Two hundred men underwent 3D LRP for localised prostate cancer at Seinäjoki Central Hospital in Finland between December 2013 and September 2018. In October 2019, an EPIC-26 survey along with VAS scales enquiring urinary (VAS-incontinence) and sexual (VAS-sexual) symptoms was mailed to the patients, and the correlations between these 2 methods were evaluated. In the EPIC-26 survey, scores for incontinence-(EPIC-26 UI) and sexual (EPIC-26-sexual) domains were calculated using the University of Michigan scoring system. In the VAS questionnaires, patient put a mark on the 10 cm long horizontal line in place, which described his experience of continence and potency. The Spearman rank correlation coefficient was used to evaluate the correlation between methods. RESULTS: The median scores were as follows: EPIC-26-UI, 79.25 (14.5-100); EPIC-26-sexual, 36.17 (0.0-100); VAS-incontinence, 8.8 cm (1.4-10.0); and VAS-sexual, 3.2 cm (0.0-10). The correlation coefficient between EPIC-26 UI and VAS-incontinence was 0.722 (95% confidence interval [CI], 0.63-0.79; p <.0001) and 0.883 (95% CI, 0.84-0.91; p <.0001) between EPIC-26-sexual and VAS-sexual. CONCLUSION: Our study shows a strong correlation between VAS and EPIC-26 urinary incontinence and sexual domains. In daily clinical practice VAS-scale may serve as a simple tool to evaluate the key functional outcomes of radical prostatectomy.
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Laparoscopia , Neoplasias da Próstata , Incontinência Urinária , Masculino , Humanos , Escala Visual Analógica , Incontinência Urinária/etiologia , Incontinência Urinária/cirurgia , Prostatectomia/métodos , Comportamento Sexual , Neoplasias da Próstata/cirurgia , Laparoscopia/métodos , Qualidade de VidaRESUMO
OBJECTIVES: To investigate the timing of the clinical presentation of various types of bacille Calmette-Guérin (BCG) infections in a Finnish population of patients with bladder cancer treated with BCG instillation therapy. PATIENTS AND METHODS: We identified patients with a history of post-instillation BCG infection from 1996 to 2016 using the Finnish Cancer Registry and the Finnish National Infectious Diseases Registry. We categorised infections as systemic if the infection was found in the non-urogenital system and genitourinary (GU) if the infection affected the urogenital tract. We calculated the time interval between the last BCG instillation and the presentation of the infection. The infection was considered late if the time interval was ≥1 year. RESULTS: A total of 100 patients with BCG infection were identified during the study period. In all, 39 (39%) infections presented as systemic and 61 (61%) were in the GU tract. The majority of the systemic infections presented rapidly after the last instillation, while five (13%) presented after a latency of ≥1 year. The presentation of GU infections was more heterogeneous, with 12 (20%) presenting as late infections. CONCLUSION: This study confirms the concept of early and late infection types, especially among systemic infections. However, late infections appeared to be rarer than previously described. Urologists should be aware of the possibility of late BCG infection if patients develop symptoms even several years after the BCG regimen.
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Vacina BCG , Neoplasias da Bexiga Urinária , Humanos , Vacina BCG/uso terapêutico , Administração Intravesical , Neoplasias da Bexiga Urinária/terapiaRESUMO
BACKGROUND: Allopurinol is gout medication that inhibits uric acid formation. Its possible anti-carcinogenic properties have been under research in past years. Studies based on Taiwanese registries showed that long term allopurinol use might reduce prostate cancer (PCa) incidence. However, our studies based on Finnish registries did not support those findings. In this study, we evaluate whether allopurinol use is associated with prostate cancer-specific survival (CSS) or overall survival (OS) in a Finnish population-based cohort. METHODS: The study cohort was originally enrolled for the Finnish Randomized Study of Screening for Prostate Cancer (FinRSPC). We included all newly diagnosed PCa cases during 1996-2015, 9252 men in total. Information on allopurinol purchases was from the national prescription registry of the Social Insurance Institution of Finland. Information about deaths, treatments, and use of other medications was obtained from registries, and tumor stage and PSA at diagnosis from medical records. Follow-up started at diagnosis, and we analysed separately two endpoints: PCa-specific death and overall death. We used an extended Cox regression with adjustment for age at diagnosis, Charlson comorbidity index, FinRSPC trial arm, use of other drugs and EAU PCa risk group. RESULTS: During a median follow-up of 9.86 years, 2942 deaths occurred, including 883 from PCa. There was no difference in CSS between allopurinol user and non-users, but allopurinol users had lower OS (multivariable-adjusted hazard ratio 1.77; 95% CI: 1.57-2.00). However, this decrease in OS was mitigated along with increasing intensity of allopurinol use. CONCLUSIONS: We found no marked difference in CSS by allopurinol use. Allopurinol users had lower OS but there were no significant differences by duration or intensity of allopurinol use. Allopurinol use may not have anticancer effects against prostate cancer; instead, it may be a surrogate for metabolic problems causing shorter OS among men with PCa.
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BACKGROUND: Evaluation of regional variation of prostate cancer (PCa) incidence and PCa-specific mortality is essential in the assessment of equity in a national healthcare system. We evaluated PCa incidence and PCa-specific mortality between different municipalities and hospital districts in Finland over 1985-2019. MATERIAL AND METHODS: Men diagnosed with PCa in Finland from 1985 through 2019 were retrieved from Finnish Cancer Registry. Age-standardized PCa incidence and mortality rates were estimated by municipality and hospital district as well as municipality urbanization, education, and income level using hierarchical Bayesian modeling. Standard deviations (SD) of the regional rates were compared between periods from 1985-1989 to 2015-2019. RESULTS: We identified 123,185 men diagnosed with any stage PCa between 1985 and 2019. SD of PCa incidence rate (per 100,000 person-years) showed that the total variation of PCa incidence between different municipalities was substantial and varied over time: from 22.2 (95% CI, 17.1-27.8) in 1985-1989 to 56.5 (95% CI, 49.8-64.5) in 2000-2004. The SD of PCa mortality rate between all municipalities was from 9.0 (95% CI, 6.6-11.8) in 2005-2009 to 2.4 (95% CI, 0.9-4.8) in 2015-2019. There was a trend toward a lower PCa-specific mortality rate in municipalities with higher education level. DISCUSSION: Regional variation in the incidence rate of PCa became more evident after initiation of PSA testing in Finland, which indicates that early diagnostic practice (PSA testing) of PCa has been different in different parts of the country. Variation in the national PCa mortality rate was indeed recognizable, however, this variation diminished at the same time as the mortality rate declined in Finland. It seems that after the initiation period of PSA testing, PSA has equalized PCa mortality outcomes in Finland.
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Antígeno Prostático Específico , Neoplasias da Próstata , Masculino , Humanos , Incidência , Finlândia/epidemiologia , Teorema de BayesRESUMO
OBJECTIVES: Basic tools that measure a hospital's performance are required in order to benchmark or compare hospitals, but multispecialty institutional registries are rarely reported, and there is no consensus on their standard definitions and methodology. This study aimed to describe the setting up and first results of a hospital-wide surgical complication register that uses a minimal set of patient-related risk factors based on bedside data and produces outcomes data based on severity of complications. DESIGN: Cohort study. SETTING: Perioperative data related to all adult surgical procedures in a tertiary referral centre in Finland for 3 years (2016-2018) were included in the study. Complications were recorded according to a modified Clavien-Dindo classification, and the preoperative risk factors were compiled based on the literature and coded as numerical measures. The associations of preoperative risk factors with postoperative complications were analysed using the χ2 test or Fisher's exact test. RESULTS: In total, 19 158 operations were performed between 2016 and 2018. Data on complications (Clavien 0-9) were recorded for 4529 surgical patients (23.6%), and 779 complications were reported (Clavien 1-9), leading to an overall complication rate of 17.2%. Of these, 4.6% were graded as major (Clavien 4-7). Patient-related risk factors with the strongest association with complications were growing American Society of Anesthesiologists Physical Status Classification System score (p<0.001), growing Charlson Index (p<0.001), poor nutritional status (Nutritional Risk Screening 2002), p=0.041) and urgency of surgery (p<0.001). CONCLUSIONS: We describe an inexpensive hospital-wide surgical complication monitoring system that can produce valid numerical data for monitoring risk-adjusted surgical quality. The results showed that only a few patient-related risk factors were sufficient to account for the case mix.
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Hospitais , Complicações Pós-Operatórias , Adulto , Estudos de Coortes , Humanos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Fatores de RiscoRESUMO
INTRODUCTION: Three-dimensional laparoscopic prostatectomy (3D LRP) is a potentially cost-effective option for robot-assisted laparoscopic prostatectomy (RALP). Results for two-dimensional LRP and RALP are well documented; however, little has been published on the outcomes of 3D LRP. Our objective was to report the perioperative and short-term results of 3D LRP in a multicentre study. MATERIALS AND METHODS: In total, 496 unselected men with prostate cancer underwent 3D LRP by three surgeons between December 2013 and December 2018. Median age was 64 (43-76) years. Median prostate-specific antigen (PSA) was 7.9 (0.7-148) ng/ml. Preoperative and perioperative data and complications according to the Clavien-Dindo classification were collected. PSA and continence results were reported at 3 and 12 months postoperatively. Data were analysed with IBM SPSS statistics (25). RESULTS: Pathological Gleason score was 6 in 29%, 7 in 55.4%, 8 in 9.1%, 9 in 5.2% and 10 in 1.2% of patients. Pathological tumour classification was T2c in 59.5%, T3a in 19.5% and T3b in 10.9% of cases. Positive surgical margins occurred in 27.2%. Lymphadenectomy was performed in 36.3%, with positive lymph nodes in 11.8%. Median operative time was 137 (78-334) min and median blood loss 200 (10-1100) ml. Clavien-Dindo IIIa and IIIb complications occurred in 6.9% and 1.6%, respectively. At 3 and 12 months postoperatively, 90.2% and 91.4% of patients, respectively, had PSA <0.2 ng/ml, while 77.1% and 87.7% of patients were completely dry or using a maximum of one pad daily. CONCLUSIONS: 3D LRP shows promising results, comparable to similar studies published on RALP.
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Laparoscopia , Neoplasias da Próstata , Robótica , Adulto , Idoso , Humanos , Laparoscopia/métodos , Masculino , Pessoa de Meia-Idade , Antígeno Prostático Específico , Prostatectomia/métodos , Neoplasias da Próstata/patologia , Neoplasias da Próstata/cirurgia , Robótica/métodos , Resultado do TratamentoRESUMO
INTRODUCTION: European Association of Urology and UK National Institute for Health and Care Excellence guidelines recommend that all men with suspicions of prostate cancer should undergo prebiopsy contrast enhanced, that is, multiparametric prostate MRI. Subsequent prostate biopsies should also be performed if MRI is positive, that is, Prostate Imaging-Reporting and Data System (PI-RADS) scores 3-5. However, several retrospective post hoc analyses have shown that this approach still leads to many unnecessary biopsy procedures. For example, 88%-96% of men with PI-RADS, three findings are still diagnosed with clinically non-significant prostate cancer or no cancer at all. METHODS AND ANALYSIS: This is a prospective, randomised, controlled, multicentre trial, being conducted in Finland, to demonstrate non-inferiority in clinically significant cancer detection rates among men undergoing prostate biopsies post-MRI and men undergoing prostate biopsies post-MRI only after a shared decision based on individualised risk estimation. Men without previous diagnosis of prostate cancer and with abnormal digital rectal examination findings and/or prostate-specific antigen between 2.5 ug/L and 20.0 ug/L are included. We aim to recruit 830 men who are randomised at a 1:1 ratio into control (all undergo biopsies after MRI) and intervention arms (the decision to perform biopsies is based on risk estimation and shared decision-making). The primary outcome of the study is the proportion of men with clinically significant prostate cancer (Gleason 4+3 prostate cancer or higher). We will also compare the overall biopsy rate, benign biopsy rate and the detection of non-significant prostate cancer between the two study groups. ETHICS AND DISSEMINATION: The study (protocol V.2.0, 4 January 2021) was approved by the Ethics Committee of the Hospital District of Southwest Finland (IORG number: 0001744, IBR number: 00002216; trial number: 99/1801/2019). Participants are required to provide written informed consent. Full reports of this study will be submitted to peer-reviewed journals, mainly urology and radiology. TRIAL REGISTRATION NUMBER: NCT04287088; the study is registered at ClinicalTrials.gov.
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Imageamento por Ressonância Magnética , Neoplasias da Próstata , Humanos , Biópsia Guiada por Imagem/métodos , Imageamento por Ressonância Magnética/métodos , Masculino , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos RetrospectivosRESUMO
OBJECTIVE: Surgery is the primary treatment for invasive penile cancer (PC). Postoperative changes in genital anatomy and function may lead to altered body and self-image, compromised sexual function and subsequent psychological problems. The aim of this study is to describe men's experiences of the impact of PC surgical treatment on their lives. METHODS: The institutional databases of two Finnish university hospitals were searched for patients who underwent surgery for invasive PC between 2009 and 2019. Of 107 men, 29 agreed to an interview or a response letter. The data were analysed by thematic analysis. RESULTS: The men experienced that their self-image had changed after PC diagnosis and treatment to a 'cancer-modified me'. They also experienced that physical symptoms after surgery defined their everyday, as well as sexual, lives and that the whole content of life changed. CONCLUSION: Support and counselling for physical, mental, sexual and social factors should be part of the treatment of men with PC.
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Neoplasias Penianas , Aconselhamento , Humanos , Masculino , Homens , Neoplasias Penianas/cirurgia , Pesquisa Qualitativa , AutoimagemRESUMO
BACKGROUND: Penile cancer surgery affects physical, psychological, and sexual well-being, but the patient- and treatment-related factors predisposing to worse health-related quality of life (HRQoL) have not been well characterized. AIM: We report treatment-related HRQoL changes among penile cancer survivors compared to the general population and the specific deficits that have the most profound effect, and we identify patient-related factors that predispose to a worse perceived HRQoL. METHODS: Patients (n = 107) who underwent operations for invasive penile cancer in two Finnish university hospitals from 2009 to 2019 were sent the Patient Reported Outcomes (PROs) questionnaire designed to measure HRQoL, self-esteem, overall sexual functioning, erections, and change in sexual function. We collected clinical information and socio-demographic characteristics, including age, partner status, children, vocational education, and employment status. Associations between patient- and treatment-related factors and HRQoL were analyzed using descriptive statistics and non-parametric tests. Linear regression models were used to compare the HRQoL differences between patients with penile cancer and the age-standardized average for the Finnish population. OUTCOMES: A generic measure of HRQoL (15D), the Rosenberg Self-Esteem Scale, Overall Sexual Functioning Questionnaire, the Erection Hardness Score, and self-reported change in sexual functioning. RESULTS: Low scores in overall sexual functioning, erectile function, and changes in sexual functioning were associated with a lower HRQoL. An association was found between HRQoL and age, educational level, employment status, and place of residence. The HRQoL had a negative correlation with age. Patients with a high educational level, who were employed, or who lived in urban areas reported higher HRQoL. The mean HRQoL of penile cancer survivors was significantly lower than the age-standardized average HRQoL of the Finnish population. CLINICAL IMPLICATIONS: Enhanced support and counseling is needed among penile cancer patients to improve the HRQoL during survivorship. STRENGTHS & LIMITATIONS: A nationwide sample with detailed information allowed comparisons of HRQoL between penile cancer patients and the general population. Due to cross-sectional nature of the study, the time between the surgery and the study intervention was heterogeneous, and this may have affected the results. CONCLUSION: Penile cancer patients exhibit significant physical and psychological dysfunction, and the lack of sexual activity in general is what most compromises the QoL of penile cancer survivors. Harju E, Pakarainen T, Vasarainen H, et al. Health-Related Quality of Life, Self-esteem and Sexual Functioning Among Patients Operated for Penile Cancer - A Cross-sectional Study. J Sex Med 2021;18:1524-1531.
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Neoplasias Penianas , Qualidade de Vida , Criança , Estudos Transversais , Humanos , Masculino , Ereção Peniana , Neoplasias Penianas/cirurgia , Pênis , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Erectile dysfunction (ED) is strongly associated with physiological and metabolic disturbances, and hyperuricemia has been proposed to predict the onset of ED. AIM: To investigate if hyperuricemia is an independent predictor for ED when all relevant confounding factors are taken into account. METHODS: This is a cross-sectional study of men aged between 45 and 70 years. The population was well characterized for established cardiovascular risk factors, metabolic syndrome, as well as kidney function, depression, and socioeconomic factors. Analysis was limited to 254 men with complete data and also serum uric acid (SUA) measurements were available. This included 150 men with and 104 without ED. The presence and severity of ED was evaluated using International Index of Erectile Function-5 questionnaire. Risk of ED by SUA level was calculated using univariate and multivariable-adjusted logistic regression. Effect modification by participant characteristics were evaluated in subgroup analyses. MAIN OUTCOME MEASURES: The main outcome measures of this study are prevalence and severity of erectile dysfunction. RESULTS: Patients with ED (59% of the study population) were older than men without ED (59 vs 54 years) and had lower serum testosterone (14.3, 95% CI 11.3-17.3 vs 15.1 nmol/l, 95% CI 12.1-18.8, respectively). Regarding all other variables, the groups were comparable. No significant difference was found for SUA by ED. SUA was not associated with ED risk in univariate or multivariable analysis (multivariable-adjusted OR 1.14, 95% CI 0.59-2.19, P = .7) for SUA level higher than median compared with median or lesser (OR 1.00, 95% CI 0.997-1.006, P = .7 for continuous variable). No subgroup analysis modified the association. After multivariable adjustment age, education level and depression were statistically significant predictors of ED. CONCLUSIONS: Elevated SUA was not found to be an independent risk factor for ED. Metabolic syndrome, glomerular filtration rate, or cardiovascular risk factors did not modify this result. ED cannot be predicted based on the level of SUA. A Tuokko, T Murtola, P Korhonen, et al. Hyperuricemia Is Not an Independent Predictor of Erectile Dysfunction. Sex Med 2021;9:100319.
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OBJECTIVE: To study if patient-related factors are associated with patient-evaluated quality of care in surgery. To examine if there is an association with postoperative complications and patient-evaluated low quality of care. DESIGN: A correlation cross-sectional study, in addition, a phone call interview at 30 days postoperatively to examine complications. SETTING: The data on patients admitted for non-cardiac general and orthopaedic surgery at a central hospital in Southwestern Finland were collected in two phases during an 8-month period. PARTICIPANTS: 436 consecutive consenting and eligible in-ward non-cardiac general surgery and orthopaedic surgery adult patients. Ambulatory, paediatric and memory disorder patients were excluded. 378 patients completed the questionnaire (Good Nursing Care Scale for Patients (GNCS-P)). METHODS: Perceived quality of care was examined by the GNCS-P questionnaire. Patient-related factors were obtained from electronic patient records and questionnaire. A telephone interview related to postdischarge complications was conducted 30 days after discharge. MAIN OUTCOME MEASURES: Patient evaluation of quality of care at discharge, its association with patient-related factors and patient-reported postdischarge complications. RESULTS: The overall quality was evaluated high or very high by the patients. The lowest overall quality of care rate was assessed by surgical patients living alone (p=0.0088) and patients who evaluated their state of health moderate or poor (p=0.0047). Surgical patients reporting postoperative complications after discharge evaluated lower overall quality of care (p=0.0105) than patients with no complications. CONCLUSION: Patient demographic factors do not seem to influence the perceptions of the quality of care. Instead, subjective state of health and living conditions (living alone) may have an influence on the patient experience of quality of care. The perceived quality of care in healthcare staff technical and communication skills may have an association with reported postoperative complications.
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Assistência ao Convalescente , Alta do Paciente , Adulto , Criança , Estudos Transversais , Finlândia , Humanos , Complicações Pós-Operatórias/epidemiologiaRESUMO
Testicular cancer (TC) is the most common form of cancer in men aged 15-35 years. Familial risk for TC is among highest of all cancers. MATERIAL AND METHODS: A prospective observational cohort of 9111 relatives in 2,188 families of early-onset TC patients, called probands, diagnosed at age ≤40 years in Finland between 1970 and 2012. Standardized incidence ratios (SIR) were used as measures of familial aggregation for early-onset (≤40 years) TC. Follow-up ended at diagnosis of TC, death or 31 December 2014 whichever earliest. RESULTS: Among first-degree relatives of early-onset TCs, in all 12 early-onset TC cases (0.24%) were diagnosed over the follow-up; the SIR for any first-degree relative was 4.59 (95% confidence interval (CI): 2.37-8.01) and for brothers the SIR was 6.51 (95% CI 3.12-11.96). DISCUSSION: Familial aggregation of TC shows substantial risk for early-onset TC among first-degree relatives of early-onset TC patients in Finland. This is important to acknowledge to avoid diagnostic delay especially of TC.
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Neoplasias Testiculares/epidemiologia , Adolescente , Adulto , Sobreviventes de Câncer , Estudos de Coortes , Finlândia/epidemiologia , Humanos , Masculino , Estudos Prospectivos , Adulto JovemRESUMO
PURPOSE: To evaluate the feasibility, efficacy, and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). METHODS: Eleven patients with CP/CPPS were enrolled in this prospective clinical study. rTMS was performed for 5 consecutive days in 20-minute sessions. Patients were evaluated at baseline, after treatment, and at 1, 4, 8, and 12 weeks after the last session with questionnaires concerning pain (numerical rating scale [NRS], the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], and the Short Form-36 [SF-36]), urinary symptoms (NIH-CPSI, Danish Prostatic Symptom Score [DAN-PSS-1]), quality of life (NIH-CPSI, SF-36), and psychometrics (Beck Depression Index [BDI]). Telephone-based interviews were used to evaluate side effects, subjective response, and changes in drug consumption. RESULTS: All patients completed the planned treatment and follow-up according to protocol. No patients experienced serious side effects or significant pain increase during or after treatment. Mild transient tension headache responsive to oral pain medication was reported by 2 patients. Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04). Improvement in lower urinary tract symptoms was observed after treatment in the NIH-CPSI urinary domain (P=0.02) but not with the DANPSS-1. No significant changes in the BDI were observed. Nine patients reported a positive overall subjective response (82%) and 6 patients (55%) were able to reduce pain medication. Higher age was associated with lower NRS scores after treatment (R=0.605, P=0.048) and at 8 weeks (R=0.659, P=0.028). CONCLUSION: rTMS for patients with CP/CPPS seemed to be well tolerated, at least moderately effective in pain reduction, and might be of interest in patients with chronic pelvic pain resistant to conventional treatment. These findings remain to be confirmed by a randomized trial.
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BACKGROUND: Androgen deprivation therapy (ADT) remains a primary treatment for localized prostate cancer (PCa) even though there is no evidence that its use is beneficial in the absence of curative treatment. METHODS: Men aged ≥70 years (n = 16,534) diagnosed with localized PCa from 1985 to 2014 and managed either with primary observation or ADT in the absence of curative treatment were included. The cases were identified from the population-based Finnish Cancer Registry. We estimated the standardized mortality ratios (SMR) for overall mortality by treatment group. We determined the relative risk (RR) of PCa-specific mortality (PCSM) and other-cause mortality between the two treatment groups. Survival was determined using the life table method. Two age groups (70-79 years and ≥ 80 years) and three calendar time cohorts (1985-1994, 1995-2004, and 2005-2014) were compared following adjustment of propensity score matching between the treatment groups with four covariates (age, year of diagnosis, educational level, and hospital district). Follow-up continued until death or until December 31, 2015. RESULTS: Patients in the observation group had lower overall SMRs than those in the ADT group in both age cohorts over the entire study period. PCSM was higher in men aged 70-79 years undergoing primary ADT compared to those managed by observation only (RR: 1.70, 95% confidence interval [CI]: 1.29-2.23 [1985-1994]; RR 1.55, 95% CI: 1.35-1.84 [1995-2004]; and RR 2.71, 95% CI: 2.08-3.53 [2005-2014]); p = 0.005 for periodic trend. A similar trend over time was also observed in men aged > 80 years; (p for age-period interaction = 0.237). Overall survival was also higher among men in their 70's managed by observation compared to those undergoing ADT. CONCLUSIONS: Primary ADT within four months period from diagnosis is not associated with improved long-term overall survival or decreased PCSM compared to primary conservative management for men with localized PCa. However, this observational study's conclusions should be weighted with confounding factors related to cancer aggressiveness and comorbidities.