| 1. |
- Welén, Karin, 1970, et al.
(författare)
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A Phase 2 Trial of the Effect of Antiandrogen Therapy on COVID-19 Outcome : No Evidence of Benefit, Supported by Epidemiology and In Vitro Data
- 2022
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Ingår i: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 81:3, s. 285-293
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Tidskriftsartikel (refereegranskat)abstract
- Background: Men are more severely affected by COVID-19. Testosterone may influence SARS-CoV-2 infection and the immune response.Objective: To clinically, epidemiologically, and experimentally evaluate the effect of antiandrogens on SARS-CoV-2 infection.Designs, settings, and participants: A randomized phase 2 clinical trial (COVIDENZA) enrolled 42 hospitalized COVID-19 patients before safety evaluation. We also conducted a population-based retrospective study of 7894 SARS-CoV-2–positive prostate cancer patients and an experimental study using an air-liquid interface three-dimensional culture model of primary lung cells.Intervention: In COVIDENZA, patients were randomized 2:1 to 5 d of enzalutamide or standard of care.Outcome measurements: The primary outcomes in COVIDENZA were the time to mechanical ventilation or discharge from hospital. The population-based study investigated risk of hospitalization, intensive care, and death from COVID-19 after androgen inhibition.Results and limitations: Enzalutamide-treated patients required longer hospitalization (hazard ratio [HR] for discharge from hospital 0.43, 95% confidence interval [CI] 0.20–0.93) and the trial was terminated early. In the epidemiological study, no preventive effects were observed. The frail population of patients treated with androgen deprivation therapy (ADT) in combination with abiraterone acetate or enzalutamide had a higher risk of dying from COVID-19 (HR 2.51, 95% CI 1.52–4.16). In vitro data showed no effect of enzalutamide on virus replication. The epidemiological study has limitations that include residual confounders.Conclusions: The results do not support a therapeutic effect of enzalutamide or preventive effects of bicalutamide or ADT in COVID-19. Thus, these antiandrogens should not be used for hospitalized COVID-19 patients or as prevention for COVID-19. Further research on these therapeutics in this setting are not warranted.Patient summary: We studied whether inhibition of testosterone could diminish COVID-19 symptoms. We found no evidence of an effect in a clinical study or in epidemiological or experimental investigations. We conclude that androgen inhibition should not be used for prevention or treatment of COVID-19.
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| 2. |
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| 3. |
- Welen, Karin, et al.
(författare)
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COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial.
- 2021
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- The main goal of the COVIDENZA trial is to evaluate if inhibition of testosterone signalling by enzalutamide can improve the outcome of patients hospitalised for COVID-19. The hypothesis is based on the observation that the majority of patients in need of intensive care are male, and the connection between androgen receptor signalling and expression of TMPRSS2, an enzyme important for SARS-CoV-2 host cell internalization.Hospitalised COVID-19 patients will be randomised (2:1) to enzalutamide plus standard of care vs. standard of care designed to identify superiority.Included participants, men or women above 50 years of age, must be hospitalised for PCR confirmed COVID-19 symptoms and not in need of immediate mechanical ventilation. Major exclusion criteria are breast-feeding or pregnant women, hormonal treatment for prostate or breast cancer, treatment with immunosuppressive drugs, current symptomatic unstable cardiovascular disease (see Additional file 1 for further details). The trial is registered at Umeå University Hospital, Region Västerbotten, Sweden and 8 hospitals are approved for inclusion in Sweden.Patients randomised to the treatment arm will be treated orally with 160 mg (4x40 mg) enzalutamide (Xtandi®) daily, for five consecutive days. The study is not placebo controlled. The comparator is standard of care treatment for patients hospitalised with COVID-19.The primary endpoints of the study are (time to) need of mechanical ventilation or discharge from hospital as assessed by a clinical 7-point ordinal scale (up to 30 days after inclusion).Randomisation was stratified by center and sex. Each strata was randomized separately with block size six with a 2:1 allocation ratio (enzalutamide + "standard of care": "standard of care"). The randomisation list, with consecutive subject numbers, was generated by an independent statistician using the PROC PLAN procedure of SAS version 9.4 software (SAS Institute, Inc, Cary, North Carolina) BLINDING (MASKING): This is an open-label trial.The trial is designed to have three phases. The first, an exploration phase of 45 participants (30 treatment and 15 control) will focus on safety and includes a more extensive laboratory assessment as well as more frequent safety evaluation. The second prolongation phase, includes the first 100 participants followed by an interim analysis to define the power of the study. The third phase is the continuation of the study up to maximum 600 participants included in total.The current protocol version is COVIDENZA v2.0 as of September 10, 2020. Recruitment started July 29, 2020 and is presently in safety pause after the first exploration phase. Recruitment is anticipated to be complete by 31 December 2021.Eudract number 2020-002027-10 ClinicalTrials.gov Identifier: NCT04475601 , registered June 8, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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| 4. |
- Ahlin, Rebecca, 1989, et al.
(författare)
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Effects on Serum Hormone Concentrations after a Dietary Phytoestrogen Intervention in Patients with Prostate Cancer: A Randomized Controlled Trial
- 2023
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Ingår i: Nutrients. - : MDPI. - 2072-6643 .- 2072-6643. ; 15:7
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Tidskriftsartikel (refereegranskat)abstract
- Phytoestrogens have been suggested to have an anti-proliferative role in prostate cancer, potentially by acting through estrogen receptor beta (ERβ) and modulating several hormones. We primarily aimed to investigate the effect of a phytoestrogen intervention on hormone concentrations in blood depending on the ERβ genotype. Patients with low and intermediate-risk prostate cancer, scheduled for radical prostatectomy, were randomized to an intervention group provided with soybeans and flaxseeds (∼200 mg phytoestrogens/d) added to their diet until their surgery, or a control group that was not provided with any food items. Both groups received official dietary recommendations. Blood samples were collected at baseline and endpoint and blood concentrations of different hormones and phytoestrogens were analyzed. The phytoestrogen-rich diet did not affect serum concentrations of testosterone, insulin-like growth factor 1, or sex hormone-binding globulin (SHBG). However, we found a trend of decreased risk of increased serum concentration of estradiol in the intervention group compared to the control group but only in a specific genotype of ERβ (p = 0.058). In conclusion, a high daily intake of phytoestrogen-rich foods has no major effect on hormone concentrations but may lower the concentration of estradiol in patients with prostate cancer with a specific genetic upset of ERβ.
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| 5. |
- Ahlin, Rebecca, 1989, et al.
(författare)
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The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer : study protocol for the randomized controlled PRODICA trial
- 2022
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Ingår i: Trials. - : BioMed Central (BMC). - 1745-6215. ; 23:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: A high intake of phytoestrogens, found in soy, rye, and seeds, is associated with a reduced risk of a prostate cancer diagnosis. Previously, we found that the overall decreased risk of prostate cancer diagnosis in males with a high intake of phytoestrogens was strongly modified by a nucleotide sequence variant in the estrogen receptor-beta (ERβ) gene. However, we do not know if phytoestrogens can inhibit the growth of prostate cancer in males with established diseases. If there is an inhibition or a delay, there is reason to believe that different variants of the ERβ gene will modify the effect. Therefore, we designed an intervention study to investigate the effect of the addition of foods high in phytoestrogens and their interaction with the ERβ genotype on prostate tumor proliferation in patients with prostate cancer.Method: The PRODICA trial is a randomized ongoing intervention study in patients with low- and intermediate-risk prostate cancer with a Gleason score < 8, prostate-specific antigen (PSA) < 20, and scheduled for radical prostatectomy. The study is conducted at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention consists of a daily intake of soybeans and flaxseeds (~ 200 mg of phytoestrogens) until the surgery, approximately 6 weeks. The aim is to recruit 200 participants. The primary outcome is the difference in the proliferation marker Ki-67 between the intervention and the control groups. The genotype of ERβ will be investigated as an effect-modifying factor. Secondary outcomes include, e.g., concentrations of PSA and steroid hormones in the blood.Discussion: The results of the PRODICA trial will contribute important information on the relevance of increasing the intake of phytoestrogens in patients with prostate cancer who want to make dietary changes to improve the prognosis of their cancer. If genetic factors turn out to influence the effect of the intervention diet, dietary advice can be given to patients who most likely benefit from it. Dietary interventions are cost-effective, non-invasive, and result in few mild side effects. Lastly, the project will provide basic pathophysiological insights which could be relevant to the development of treatment strategies for patients with prostate cancer.Trial registration. ClinicalTrials.gov NCT02759380. Registered on 3 May 2016.
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| 6. |
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| 7. |
- Andreasson, Anders, et al.
(författare)
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High revision rate following artificial urethral sphincter implantation.
- 2014
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Ingår i: Scandinavian journal of urology. - : Medical Journals Sweden AB. - 2168-1813 .- 2168-1805. ; 48:6, s. 544-548
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Objective. In severe cases of stress urinary incontinence (SUI), with sphincter dysfunction, the artificial urinary sphincter AMS 800™ may be the last solution. The purpose of this study was to evaluate the outcome of surgical intervention for SUI with the AMS 800 in patients who were treated at Sahlgrenska University Hospital, Gothenburg. The primary aim of the study was to determine the complications related to the operation. Material and methods. A retrospective follow-up was done by reviewing medical records. The material comprised 97 men, who underwent their first AMS 800 implantation between May 1997 and June 2010 at Sahlgrenska University Hospital. Results. The revision rate was 28%, including an infection rate of 3% and an erosion rate of 7%. The mean follow-up for revised patients was 3 years. The median time until revision was 1 year. Seventy-five per cent of all patients were satisfied with the operation at 6 months' follow-up. Radical prostatectomy was the reason behind incontinence in 84% of patients in this series. Conclusion. The results clearly demonstrate a need for revision procedures in a considerable proportion of patients implanted with an AMS 800 device. Patient satisfaction was high, but although this operation has extremely low mortality it has its complications and the system will need to be replaced in time.
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| 8. |
- Aus, Gunnar, 1958, et al.
(författare)
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Individualized screening interval for prostate cancer based on prostate-specific antigen level.
- 2005
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Ingår i: Arch Intern Med. ; 165:16, s. 1857-1861
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Tidskriftsartikel (refereegranskat)abstract
- Background The aim of the present study was to evaluate the future cumulative risk of prostate cancer in relation to levels of prostate-specific antigen (PSA) in blood and to determine whether this information could be used to individualize the PSA testing interval. Methods The study included 5855 of 9972 men (aged 50-66 years) who accepted an invitation to participate in a prospective, randomized study of early detection for prostate cancer. We used a protocol based on biennial PSA measurements starting from 1995 and 1996. Men with serum PSA levels of 3.0 ng/mL or more were offered prostate biopsies. Results Among the 5855 men, 539 cases of prostate cancer (9.2%) were detected after a median follow-up of 7.6 years (up to July 1, 2003). Cancer detection rates during the follow-up period in relation to PSA levels were as follows: 0 to 0.49 ng/mL, 0% (0/958); 0.50 to 0.99 ng/mL, 0.9% (17/1992); 1.00 to 1.49 ng/mL, 4.7% (54/1138); 1.50 to 1.99 ng/mL, 12.3% (70/571); 2.00 to 2.49 ng/mL, 21.4% (67/313); 2.50 to 2.99 ng/mL, 25.2% (56/222); 3.00 to 3.99 ng/mL, 33.3% (89/267); 4.00 to 6.99 ng/mL, 38.9% (103/265); 7.00 to 9.99 ng/mL, 50.0% (30/60); and for men with an initial PSA of 10.00 ng/mL or higher, 76.8% (53/69). Not a single case of prostate cancer was detected within 3 years in 2950 men (50.4% of the screened population) with an initial PSA level less than 1 ng/mL. Conclusions Retesting intervals should be individualized on the basis of the PSA level, and the large group of men with PSA levels of less than 1 ng/mL can safely be scheduled for a 3-year testing interval.
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| 9. |
- Axén, Elin, et al.
(författare)
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Biochemical recurrence after radical prostatectomy - a large, comprehensive, population-based study with long follow-up
- 2022
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 56:4, s. 287-292
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Tidskriftsartikel (refereegranskat)abstract
- Objective We evaluated long-term risk for biochemical recurrence and subsequent prognosis in a population-based cohort. Material and Methods We used register-based data to evaluate 6 675 consecutive patients having radical prostatectomy in Vastra Gotaland county in Sweden during 1995-2014. Patients were followed until death or end of study, 31 December 2014. Data were collected from registers on national, regional and local level and linked by means of the Swedish personal identity number. Biochemical recurrence was defined as PSA >= 0.2 ng/ml; failure as hormonal treatment, metastasis or prostate cancer death. Survival analysis was used to estimate time to biochemical recurrence and time to failure after biochemical recurrence for patients with 0 - 2 years, 2-5 years, 5-10 years and >10 years interval to biochemical recurrence, respectively. Results A total of 1214 men had biochemical recurrence during follow-up. Biochemical recurrence-free survival was 83% (95% confidence interval [CI] 82-84%), 75% (95% CI 74-77%) and 69% (95% CI 67-71%) at 5, 10 and 15 years, respectively. Cumulative incidence of failure for all patients 15 years after biochemical recurrence was 50% (95% CI 43-55%) in competing risk analysis .The risk of failure after biochemical recurrence was highest among patients having biochemical recurrence within 2 years from surgery. Incomplete data on PSA-history is a limitation. Conclusions The risk for biochemical recurrence persists 15 years after surgery. Follow-up should continue as long as treatment would be considered in case of recurrent disease.
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| 10. |
- Axén, Elin, et al.
(författare)
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Degree of Preservation of Neurovascular Bundles in Radical Prostatectomy and Recurrence of Prostate Cancer
- 2021
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Ingår i: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 30, s. 25-33
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Tidskriftsartikel (refereegranskat)abstract
- Background: Reports on possible benefits for continence with nerve-sparing (NS) radical prostatectomy have expanded the indications beyond preservation of erectile function. It is unclear whether NS surgery affects oncological outcomes. Objective: To determine whether the degree of NS during radical prostatectomy influences oncological outcomes. Design, setting, and participants: Of 4003 patients enrolled in a prospective, controlled trial comparing open and robotic radical prostatectomy during 2008–2011, we evaluated 2401 patients who received robotic radical prostatectomy at seven Swedish centres. Patients were followed for 8 yr. Outcome measurements and statistical analysis: Data for recurrence and positive surgical margin status were assessed using validated patient questionnaires, patient interviews, and clinical record forms before and at 3, 12, and 24 mo and 6 and 8 yr after surgery. Cox and logistic regressions were used to model the effect on recurrence and positive surgical margins (PSM), respectively. Results and limitations: A total of 481 men had PSM and 467 experienced recurrence during follow-up. Median follow-up for men without recurrence was 6.6 yr. There were no statistically significant differences in recurrence rate between degrees of NS. The PSM rate was significantly higher with a higher degree of NS: interfascial NS, odds ratio (OR) 2.32 (95% confidence interval [CI] 1.69–3.16); intrafascial NS, OR 3.23 (95% CI 2.17–4.80). Recurrence rates were higher for patients with pT2 disease and PSM (hazard ratio [HR] 3.32, 95% CI 2.43–4.53) than for patients with pT3 disease without PSM (HR 2.08, 95% CI 1.66–2.62). The lack of central review of pathological specimens is a limitation. Conclusions: A higher degree of NS significantly increased the risk of PSM but did not significantly increase the risk of cancer recurrence. Combined with the known functional benefits of NS surgery, these results underscore the need to identify an individualised balance. Patient summary: In this report we looked at the effect of a nerve-sparing approach during removal of the prostate on cancer outcomes for patients having robot-assisted surgery at seven Swedish hospitals. We found that a high degree of nerve-sparing increased the rate of cancer positivity at the margins of surgical specimens and that positive surgical margins increased the risk of recurrence of prostate cancer. © 2021 The Authors
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| 11. |
- Bock, David, 1976, et al.
(författare)
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Habits and self-assessed quality of life, negative intrusive thoughts and depressed mood in patients with prostate cancer: a longitudinal study
- 2017
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 51:5, s. 353-359
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The aim of this study was to evaluate the association of self-assessed preoperative physical activity, alcohol consumption and smoking with self-assessed quality of life, negative intrusive thoughts and depressed mood after radical prostatectomy.Materials and methods: The Laparoscopic Prostatectomy Robot Open (LAPPRO) trial was a prospective, controlled, non-randomized longitudinal trial of patients (n=4003) undergoing radical prostatectomy at 14 centers in Sweden. Validated patient questionnaires were collected at baseline, and 3, 12 and 24 months after surgery.Results: Preoperative medium or high physical activity or low alcohol consumption or non-smoking was associated with a lower risk of depressed mood. High alcohol consumption was associated with increased risk of negative intrusive thoughts. Postoperatively, quality of life and negative intrusive thoughts improved gradually in all groups. Depressed mood appeared to be relatively unaffected.Conclusions: Evaluation of preoperative physical activity, tobacco and alcohol consumption habits can be used to identify patients with a depressed mood in need of psychological support before and immediately after surgery. Quality of life and intrusive thoughts improved postoperatively.
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| 12. |
- Bock, David, 1976, et al.
(författare)
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Learning curve for robot-assisted laparoscopic radical prostatectomy in a large prospective multicentre study
- 2022
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 56:3, s. 182-190
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Tidskriftsartikel (refereegranskat)abstract
- Objective Differences in outcome after radical prostatectomy for prostate cancer can partly be explained by intersurgeon differences, where degree of experience is one important aspect. This study aims to define the learning curve of robot-assisted laparoscopic prostatectomy (RALP) regarding oncological and functional outcomes. Materials and methods Out of 4003 enrolled patients in the LAPPRO trial, 3583 met the inclusion criteria, of whom 885 were operated on by an open technique. In total, 2672 patients with clinically localized prostate cancer from seven Swedish centres were operated on by RALP and followed for 8 years (LAPPRO trial). Oncological outcomes were pathology-reported surgical margins and biochemical recurrence at 8 years. Functional outcomes included patient-reported urinary incontinence and erectile dysfunction at 3, 12 and 24 months. Experience was surgeon-reported experience before and during the study. The relationship between surgeon experience and functional outcomes and surgical margin status was analysed by mixed-effects logistic regression. Biochemical recurrence was analysed by Cox regression, with robust standard errors. Results The learning curve for positive surgical margins was relatively flat, with rates of 21% for surgeons who had performed 0-74 cases and 24% for surgeons with > 300 cases. Biochemical recurrence at 4 years was 11% (0-74 cases) and 13% (> 300 cases). Incontinence was stable over the learning curve, but erectile function improved at 2 years, from 38% (0-74 cases) to 53% (> 300 cases). Conclusions Analysis of the learning curve for surgeons performing RALP showed that erectile function improved with increasing number of procedures, which was not the case for oncological outcomes.
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| 13. |
- Bratt, Ola, 1963, et al.
(författare)
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The Swedish national guidelines on prostate cancer, part 1: early detection, diagnostics, staging, patient support and primary management of non-metastatic disease
- 2022
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 56:4, s. 265-273
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Tidskriftsartikel (refereegranskat)abstract
- Objective There is now an unprecedented amount of evidence to consider when revising prostate cancer guidelines. We believe that there is a value in publishing summaries of national clinical guidelines in English for others to read and comment on. Methods This is part 1 of a summary of the Swedish prostate cancer guidelines that were published in June 2022. It covers the early detection, diagnostics, staging, patient support and management of the non-metastatic disease. Part 2 covers recurrence after local treatment and management of the metastatic disease. Results The 2022 Swedish guidelines include several new recommendations: rectal iodine-povidone to reduce post-biopsy infections, external beam radiation with focal boost to the tumour, use of a pre-rectal spacer to reduce rectal side effects after external beam radiotherapy in some expert centres, 6 months' concomitant and adjuvant rather than neoadjuvant and concomitant hormonal treatment together with radiotherapy for unfavourable intermediate and high-risk disease, and adjuvant abiraterone plus prednisolone together with a GnRH agonist for a subgroup of men with very high-risk disease. The Swedish guidelines differ from the European by having more restrictive recommendations regarding genetic testing and pelvic lymph node dissection, the risk group classification, recommending ultra-hypofractionated (7 fractions) external radiotherapy for intermediate and selected high-risk cancers, by not recommending any hormonal treatment together with radiotherapy for favourable intermediate-risk disease, and by recommending bicalutamide monotherapy instead of a GnRH agonist for some patient groups. Conclusions The 2022 Swedish prostate cancer guidelines include several new recommendations and some that differ from the European guidelines.
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| 14. |
- Bratt, Ola, 1963, et al.
(författare)
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The Swedish national guidelines on prostate cancer, part 2: recurrent, metastatic and castration resistant disease
- 2022
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Ingår i: Scandinavian Journal of Urology. - : Medical Journals Sweden AB. - 2168-1805 .- 2168-1813. ; 56:4, s. 278-284
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Tidskriftsartikel (refereegranskat)abstract
- Objective There is now an unprecedented amount of evidence to consider when revising prostate cancer guidelines. We believe that there is a value in publishing summaries of national clinical guidelines in English for others to read and comment on. Methods This is part 2 of a summary of the Swedish prostate cancer guidelines that were published in June 2022. This part covers recurrence after local treatment and management of metastatic and castration resistant disease. Part 1 covers early detection, diagnostics, staging, patient support and management of non-metastatic disease. Results The 2022 Swedish guidelines include several new recommendations. Among these is a recommendation of a period of observation with repeated PSA tests for patients with approximately 10 years' life expectancy who experience a BCR more than 2-5 years after radical prostatectomy, to allow for estimating the PSA doubling time before deciding whether to give salvage radiotherapy or not. Recent results from the PEACE-1 trial led to the recommendation of triple-treatment with a GnRH agonist, abiraterone plus prednisolone and 6 cycles of docetaxel for patients with high-volume metastatic disease who are fit for chemotherapy. The Swedish guidelines differ from the European ones by having more restrictive recommendations about genetic testing of and high-dose zoledronic acid or denosumab treatment for men with metastatic prostate cancer, and by recommending considering bicalutamide monotherapy for selected patients with low-volume metastatic disease. Conclusions The 2022 Swedish prostate cancer guidelines include several new recommendations and some that differ from the European guidelines.
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| 15. |
- CARLSSON, STEFAN, 1987, et al.
(författare)
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Age at surgery, educational level and long-term urinary incontinence after radical prostatectomy
- 2011
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Ingår i: BJU International. - 1464-4096 .- 1464-410X. ; 108:10, s. 1572-1577
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE To identify predictors for long-term urinary leakage after radical prostatectomy. PATIENTS AND METHODS A consecutive series of 1411 patients who underwent radical prostatectomy (open surgery or robot-assisted laparoscopic surgery) at Karolinska University Hospital between 2002 and 2006 were invited to complete a study-specific questionnaire. Urinary leakage was defined as use of two or more pads per day. RESULTS Questionnaires were received from 1288 (91%) patients with a median follow-up of 2.2 years. Age at surgery predicts in an exponential manner long-term urinary incontinence at follow-up with an estimated relative increase of 6% per year. Among the oldest patients, 19% had urinary incontinence compared with 6% in the youngest age group, translating to a prevalence ratio of 2.4 (95% confidence interval [CI], 1.5-8.1). Low educational level, as compared with high, yielded an increased age-adjusted prevalence ratio of 2.5 (95% CI, 1.7-3.9). Patients who had undergone salvage radiation therapy had an increased prevalence of urinary incontinence (2.5; 95% CI, 1.6-3.8), as did those with respiratory disease (2.4; 95% CI, 1.3-4.4). Body mass index, prostate weight, presence of diabetes or previous transurethral resection did not appear to influence the prevalence of urinary incontinence. CONCLUSIONS In this series, a patient's age at radical prostatectomy influenced, in an exponential manner, his risk of long-term urinary incontinence. Other predictors are low educational level, salvage radiation therapy and respiratory disease. Intervention studies are needed to understand if these data are relevant to the prevalence of urinary leakage if a radical prostatectomy is postponed in an active monitoring programme.
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| 16. |
- Carlsson, Sigrid, 1982, et al.
(författare)
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Effects of surgeon variability on oncologic and functional outcomes in a population-based setting.
- 2014
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Ingår i: BMC urology. - : Springer Science and Business Media LLC. - 1471-2490. ; 14
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Tidskriftsartikel (refereegranskat)abstract
- Oncologic and functional outcomes after radical prostatectomy (RP) can vary between surgeons to a greater extent than is expected by chance. We sought to examine the effects of surgeon variation on functional and oncologic outcomes for patients undergoing RP for prostate cancer in a European center.
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| 17. |
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| 18. |
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| 19. |
- Carlsson, Sigrid, 1982, et al.
(författare)
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The excess burden of side-effects from treatment in men allocated to screening for prostate cancer. The Göteborg randomised population-based prostate cancer screening trial.
- 2011
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Ingår i: European journal of cancer (Oxford, England : 1990). - : Elsevier BV. - 1879-0852 .- 0959-8049. ; 47:4, s. 545-53
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The number of men needed to treat to prevent one death is rather high in prostate cancer screening. How this affects the burden of treatment-related side-effects is unclear. The aim of this study was to evaluate the treatment related morbidity following radical prostatectomy in men participating in the Göteborg randomised population-based prostate cancer screening trial. METHODS: In 1995, 20,000 men aged 50-64years were randomly allocated (1:1) to biennial PSA-screening or to a control group not invited. A subset of prostate cancer patients undergoing radical prostatectomy between 2001 and 2008 responded to questionnaires preoperatively and at 18months postoperatively. The primary endpoint was patient-reported frequencies of erectile dysfunction as measured by the validated International Index of Erectile Function-5 questionnaire and urinary incontinence as assessed by use of pads. Analyses were made according to intention to screen. FINDINGS: After 14years of follow-up, a total of 1849 men were detected with prostate cancer (1138 screened versus 711 controls, excluding 7 cancers detected at autopsy in the control group). Overall, 1047 received treatment with curative intent and radical prostatectomy was performed in 829 cases (79.2%). In this study, 294 of these men participated (205 screened and 89 controls). Of preoperatively potent men 79.1% (91/115) in the screening-group and 90.7% (49/54) in the control-group became impotent or sexually inactive 18months postoperatively, whereas 14.3% (29/203) of screened men and 20.5% (18/88) of controls were considered postoperatively incontinent (regular use of pads). Extrapolated data yields that 120/10,000 more men become impotent and 25/10,000 more men will have the need of pads among men invited to regular PSA screening. The 'cost' per life saved at the same follow-up of screening is four men impotent and less than one man incontinent. INTERPRETATION: Despite the relatively high risk of erectile dysfunction and incontinence following radical prostatectomy for prostate cancer, the excess burden of permanent side-effects after population-based screening can be regarded as relatively low, when related to the number of men saved from prostate cancer death. These data can be useful when calculating the harms and benefits of screening. However, the outcome on a population-level may differ from the benefit for the individual.
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| 20. |
- Colleen, S, et al.
(författare)
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Urogenitalt trauma.
- 2012
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Ingår i: Urologi 2ed. eds: Damber JE, Peeker R.. - Lund, Sverige : Lund: Studentlitteratur. - 9789144075921
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Bokkapitel (övrigt vetenskapligt/konstnärligt)
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| 21. |
- Cornford, Philip, et al.
(författare)
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EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent.
- 2024
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Ingår i: European urology. - 1873-7560.
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Tidskriftsartikel (refereegranskat)abstract
- The European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Society of Urogenital Radiology (ESUR)-International Society of Urological Pathology (ISUP)-International Society of Geriatric Oncology (SIOG) guidelines provide recommendations for the management of clinically localised prostate cancer (PCa). This paper aims to present a summary of the 2024 version of the EAU-EANM-ESTRO-ESUR-ISUP-SIOG guidelines on the screening, diagnosis, and treatment of clinically localised PCa.The panel performed a literature review of all new data published in English, covering the time frame between May 2020 and 2023. The guidelines were updated, and a strength rating for each recommendation was added based on a systematic review of the evidence.A risk-adapted strategy for identifying men who may develop PCa is advised, generally commencing at 50yr of age and based on individualised life expectancy. The use of multiparametric magnetic resonance imaging in order to avoid unnecessary biopsies is recommended. When a biopsy is considered, a combination of targeted and regional biopsies should be performed. Prostate-specific membrane antigen positron emission tomography imaging is the most sensitive technique for identifying metastatic spread. Active surveillance is the appropriate management for men with low-risk PCa, as well as for selected favourable intermediate-risk patients with International Society of Urological Pathology grade group 2 lesions. Local therapies are addressed, as well as the management of persistent prostate-specific antigen after surgery. A recommendation to consider hypofractionation in intermediate-risk patients is provided. Patients with cN1 PCa should be offered a local treatment combined with long-term intensified hormonal treatment.The evidence in the field of diagnosis, staging, and treatment of localised PCa is evolving rapidly. These PCa guidelines reflect the multidisciplinary nature of PCa management.This article is the summary of the guidelines for "curable" prostate cancer. Prostate cancer is "found" through a multistep risk-based screening process. The objective is to find as many men as possible with a curable cancer. Prostate cancer is curable if it resides in the prostate; it is then classified into low-, intermediary-, and high-risk localised and locally advanced prostate cancer. These risk classes are the basis of the treatments. Low-risk prostate cancer is treated with "active surveillance", a treatment with excellent prognosis. For low-intermediary-risk active surveillance should also be discussed as an option. In other cases, active treatments, surgery, or radiation treatment should be discussed along with the potential side effects to allow shared decision-making.
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| 22. |
- Demirci, Umit, et al.
(författare)
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Urovaginal fistula formation after gynaecological and obstetric surgical procedures: Clinical experiences in a Scandinavian series.
- 2013
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Ingår i: Scandinavian journal of urology and nephrology. - : Informa UK Limited. - 1651-2065 .- 2168-1805 .- 2168-1813. ; 47:2, s. 140-144
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Tidskriftsartikel (refereegranskat)abstract
- Abstract Objective. The aim of this retrospective study was to review what kinds of surgical procedures are most frequently complicated by urovaginal fistulae, to find out how they were diagnosed and managed, and to study the outcome after surgical reconstruction. Material and methods. Nineteen women who underwent fistula repair at Sahlgrenska University Hospital between 2003 and 2009 were retrospectively studied by reviewing the medical records. Results. For 17 of the 19 patients hysterectomy was the causative procedure. Fourteen patients developed vesicovaginal and five developed ureterovaginal fistula. Urethrocystoscopy was sufficient for the diagnosis in nearly 50% of the patients and when combined with methylene blue instillation 90% of all fistulae were found. Several patients sought medical advice due to vaginal leakage following gynaecological surgery without the doctor suspecting a fistula, and for these patients the diagnosis was delayed. Eighteen patients were operated on with an abdominal approach and one with a vaginal approach, in all cases a minimum of 3 months after primary surgery. The reconstruction technique included the interposition of vascularized tissue. None of the patients reported leakage or relapse at follow-up after fistula repair. Conclusions. Hysterectomy was the most common cause behind the formation of urovaginal fistulae. Misinterpretation of symptoms after gynaecological surgery was common even in cases where the symptoms were indicative of a urovaginal fistula. Delayed fistula repair after a minimum of 3 months, via the abdominal route and with the interposition of vascularized tissue, yielded an excellent final outcome.
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| 23. |
- Derogar, Maryam, et al.
(författare)
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Preparedness for side effects and bother in symptomatic men after radical prostatectomy in a prospective, non-randomized trial
- 2016
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Ingår i: Acta Oncologica. - 0284-186X .- 1651-226X. ; 55:12, s. 1467-1476
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Many clinicians believe that preparedness before surgery for possible post-surgery side effects reduces the level of bother experienced from urinary incontinence and decreased sexual health after surgery. There are no published studies evaluating this belief. Therefore, we aimed to study the level of preparedness before radical prostatectomy and the level of bother experienced from urinary incontinence and decreased sexual health after surgery. MATERIAL AND METHODS: We prospectively collected data from a non-selected group of men undergoing radical prostatectomy in 14 centers between 2008 and 2011. Before surgery, we asked about preparedness for surgery-induced urinary problems and decreased sexual health. One year after surgery, we asked about bother caused by urinary incontinence and erectile dysfunction. As a measure of the association between preparedness and bothersomeness we modeled odds ratios (ORs) by means of logistic regression. RESULTS: Altogether 1372 men had urinary incontinence one year after surgery as well as had no urinary leakage or a small urinary dribble before surgery. Among these men, low preparedness was associated with bother resulting from urinary incontinence [OR 2.84; 95% confidence interval (CI) 1.59-5.10]. In a separate analysis of 1657 men we found a strong association between preparedness for decreased sexual health and experiencing bother from erectile dysfunction (OR 5.92; 95% CI 3.32-10.55). CONCLUSION: In this large-sized prospective trial, we found that preparedness before surgery for urinary problems or sexual side effects decreases bother from urinary incontinence and erectile dysfunction one year after surgery.
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| 24. |
- Erestam, Sofia, et al.
(författare)
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Associations between intraoperative factors and surgeons' self-assessed operative satisfaction.
- 2020
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Ingår i: Surgical endoscopy. - : Springer Science and Business Media LLC. - 1432-2218 .- 0930-2794. ; 34:1, s. 61-68
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Tidskriftsartikel (refereegranskat)abstract
- Little is known concerning what may influence surgeon satisfaction with a surgical procedure and its associations with intraoperative factors. The objective was to explore the relationships between surgeons' self-assessed satisfaction with performed radical prostatectomies and intraoperative factors such as technical difficulties and intraoperative complications as reported by the surgeon subsequent to the operation.We utilized prospectively collected data from the controlled LAPPRO trial where 4003 patients with prostate cancer underwent open (ORP) or robot-assisted laparoscopic (RALP) radical prostatectomy. Patients were included from fourteen centers in Sweden during 2008-2011. Surgeon satisfaction was assessed by questionnaires at the end of each operation. Intraoperative factors included time for the surgical procedure as well as difficulties and complications in various steps of the operation. To model surgeon satisfaction, a mixed effect logistic regression was used. Results were presented as odds ratios (OR) with 95% confidence intervals (CI).The surgeons were satisfied in 2905 (81%) and dissatisfied in 702 (19%) of the surgical procedures. Surgeon satisfaction was not statistically associated with type of surgical technique (ORP vs. RALP) (OR 1.36, CI 0.76; 2.43). Intraoperative factors such as technical difficulties or complications, for example, suturing of the anastomosis was negatively associated with surgeon satisfaction (OR 0.24, CI 0.19; 0.30).Our data indicate that technical difficulties and/or intraoperative complications were associated with a surgeon's level of satisfaction with an operation.
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| 25. |
- Forsmark, A., et al.
(författare)
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Health Economic Analysis of Open and Robot-assisted Laparoscopic Surgery for Prostate Cancer Within the Prospective Multicentre LAPPRO Trial
- 2018
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Ingår i: European Urology. - : Elsevier BV. - 0302-2838 .- 1873-7560. ; 74:6, s. 816-824
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Tidskriftsartikel (refereegranskat)abstract
- Background: The rapid adoption of robot-assisted laparoscopy in radical prostatectomy has preceded data regarding associated costs. Qualitative evidence regarding cost outcomes is lacking. Objective: This study assessed how costs were affected by robot-assisted laparoscopic prostatectomy (RALP) compared with open surgery. Design, setting, and participants: Cost analysis was based on the dataset of the LAPPRO (Laparoscopic Prostatectomy Robot Open) clinical trial, which is a prospective controlled, nonrandomised trial of patients who underwent prostatectomy at 14 centres in Sweden between September 2008 and November 2011. Currently, data are available from a follow-up period of 24 mo. Intervention: In the LAPPRO trial, RALP was compared with radical retropubic prostatectomy (RRP). Outcome measurements and statistical analysis: Costs per surgical technique were assessed based on resource variable data from the LAPPRO database. The calculation of average costs was based on mean values; Swedish currency was converted to purchasing power parity US dollar (PPP$). All tests were two-tailed and conducted at alpha = 0.05 significance level. Results and limitations: The cost analysis comprised 2638 men. Based on the LAPPRO trial data, RALP was associated with an increased cost/procedure of PPP$ 3837 (95% confidence interval: 2747-4928) compared with RRP. The result was sensitive to variations in caseload. Main drivers of overall cost were robotic system cost, operation time, length of stay, and sick leave. Limitations of the study include the uneven distribution between RALP and RRP regarding procedures in public/for-profit hospitals and surgeon/centre procedural volume. Conclusions: Based on the LAPPRO trial data, this study showed that RALP was associated with an increased cost compared with RRP in Swedish health care. There are many factors influencing the costs, making the absolute result dependent on the specific setting. However, by identifying the main cost drivers and/or most influential parameters, the study provides support for informed decisions and predictions. Patient summary: In this study, we looked at the cost outcome when performing prostatectomies by robot-assisted laparoscopic technique compared with open surgery in Sweden. We found that the robot-assisted procedure was associated with a higher mean cost. (C) 2018 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology.
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