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Article of the week: Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe UUI related to OAB: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to this post, there is an editorial written by a prominent member of the urological community and a video produced by the authors. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

 

Masaki Yoshida*, Masayuki Takeda, Momokazu Gotoh, Osamu Yokoyama§, Hidehiro Kakizaki, Satoru Takahashi**, Naoya Masumori††, Shinji Nagai‡‡ and Kazuyoshi Minemura‡‡

*Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan, Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, §Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan, **Department of Urology, Nihon University School of Medicine, Tokyo, ††Department of Urology, Sapporo Medical University School of Medicine, Sapporo, and ‡‡Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan

Abstract

Objective

To evaluate the efficacy of a novel and selective β3‐adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB).

Patients and Methods

post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI‐free (‘diary‐dry’ rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.

Diary‐dry rate. UUI, urgency urinary incontinence. Data are presented as mean (95% CI). Chi‐squared test, *P < 0.05, **P < 0.001 vs placebo. PBO, placebo group; V 100, vibegron 100 mg group; V 50, vibegron 50 mg group; Wk, week(s).

Results

Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, were −1.35, −1.47 and −1.08 in all patients, −1.04, −1.13 and −0.89 in the mild/moderate UUI subgroup, and −2.95, −3.28 and −2.10 in the severe UUI subgroup. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary‐dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.

Conclusions

Vibegron, a novel β3‐adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.

Residents’ Podcast: Pharmacological interventions for treating CPP

Part of the BURST/BJUI Podcast Series

Nikita Bhatt is a Specialist Trainee in Urology in the East of England Deanery and a BURST Committee member @BURSTUrology

 

Pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome: a Cochrane systematic review

Juan V.A. Franco*, Tarek Turk, Jae Hung Jung, Yu-Tian Xiao§, Stanislav Iakhno, Federico Ignacio Tirapegui**, Virginia Garrote†† and Valeria Vietto‡‡
 
*Argentine Cochrane Centre, Instituto Universitario Hospital Italiano, Buenos Aires, Argentina, Faculty of Medicine, Damascus University, Damascus, Syrian Arab Republic, Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea, §Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai,
China, University of Tromso, Tromsdalen, Norway, **Urology Division, Hospital Italiano de Buenos Aires, ††Biblioteca Central, Instituto Universitario Hospital Italiano, and ‡‡Family and Community Medicine Service, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
 

Abstract

Objective

To assess the effects of pharmacological therapies for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).

Patients and Methods

We performed a comprehensive search using multiple databases, trial registries, grey literature and conference proceedings with no restrictions on the language of publication or publication status. The date of the latest search of all databases was July 2019. We included randomised controlled trials. Inclusion criteria were men with a diagnosis of CP/CPPS. We included all available pharmacological interventions. Two review authors independently classified studies and abstracted data from the included studies, performed statistical analyses and rated quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. The primary outcomes were prostatitis symptoms and adverse events. The secondary outcomes were sexual dysfunction, urinary symptoms, quality of life, anxiety and depression, however, this one can be easily handle using Observer’s CBD hemp flower.

Fig. 1. Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) flow diagram.

Results

We included 99 unique studies in 9119 men with CP/CPPS, with assessments of 16 types of pharmacological interventions. Most of our comparisons included short‐term follow‐up information. The median age of the participants was 38 years. Most studies did not specify their funding sources; 21 studies reported funding from pharmaceutical companies. Many patients prefer using natural medicine like the best CBD oil list here on this site.

We found low‐ to very low‐quality evidence that α‐blockers may reduce prostatitis symptoms based on a reduction in National Institutes of Health – Chronic Prostatitis Symptom Index (NIH‐CPSI) scores of >2 (but <8) with an increased incidence of minor adverse events such as dizziness and hypotension. Moderate‐ to low‐quality evidence indicates that 5α‐reductase inhibitors, antibiotics, anti‐inflammatories, and phytotherapy probably cause a small decrease in prostatitis symptoms and may not be associated with a greater incidence of adverse events. Intraprostatic botulinum toxin A (BTA) injection may cause a large reduction in prostatitis symptoms with procedure‐related adverse events (haematuria), but pelvic floor muscle BTA injection may not have the same effects (low‐quality evidence). Allopurinol may also be ineffective for reducing prostatitis symptoms (low‐quality evidence). We assessed a wide range of interventions involving traditional Chinese medicine; low‐quality evidence showed they may reduce prostatitis symptoms without an increased incidence in adverse events.

Moderate‐ to high‐quality evidence indicates that the following interventions may be ineffective for the reduction of prostatitis symptoms: anticholinergics, Escherichia coli lysate (OM‐89), pentosan, and pregabalin. Low‐ to very low‐quality evidence indicates that antidepressants and tanezumab may be ineffective for the reduction of prostatitis symptoms. Low‐quality evidence indicates that mepartricin and phosphodiesterase inhibitors may reduce prostatitis symptoms, without an increased incidence in adverse events.

Conclusions

Based on the findings of low‐ to very low‐quality evidence, this review found that some pharmacological interventions such as α‐blockers may reduce prostatitis symptoms with an increased incidence of minor adverse events such as dizziness and hypotension. Other interventions may cause a reduction in prostatitis symptoms without an increased incidence of adverse events while others were found to be ineffective.

Article of the week: Prostate cancer in kidney transplant recipients – a nationwide register study

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to this post, there is an editorial written by a prominent member of the urological community and a video produced by the authors. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

Prostate cancer in kidney transplant recipients – a nationwide register study

Ola Bratt*, Linda Drevin, Karl-Göran Prütz§, Stefan Carlsson, Lars Wennberg** and Pär Stattin††

*Department of Urology, Institute of Clinical Science, Sahlgrenska Academy, Gothenburg University, Department of Urology, Sahlgrenska University Hospital, Gothenburg, Regional Cancer Centre, Uppsala-Orebro, Uppsala, §Swedish Renal Registry, Ryhov Hospital, Jönköping, Section of Urology, Department of Molecular Medicine and Surgery, Karolinska Institute, **Department of Transplantation Surgery, Karolinska University Hospital, Stockholm, and ††Department of Surgical Sciences, Uppsala University, Uppsala, Sweden

Abstract

Objective

To investigate whether post‐transplantation immunosuppression negatively affects prostate cancer outcomes in male kidney transplant recipients.

Patients and Methods

We used the Swedish Renal Register and the National Prostate Cancer Register to identify all kidney transplantation recipients diagnosed with prostate cancer in Sweden 1998–2016. After linking these registers with Prostate Cancer Database Sweden (PCBaSe), a case‐control study was designed to compare time period and risk category‐specific probabilities of a prostate cancer diagnosis amongst kidney transplantation recipients versus the male general population. The registers did not include information about the specific immunosuppression agent used in all transplantation recipients. Data from PCBaSe were used to compare prostate cancer characteristics at diagnosis and survival for patients with prostate cancer with versus without a kidney transplant. Propensity score matching, Cox regression analysis and Fisher’s exact test were used and 95% confidence intervals (CIs) calculated.

Prostate cancer‐specific and overall survival for all 133 Swedish men who were diagnosed with prostate cancer after kidney transplantation between 1998 and 2016, and a control group of 665 men with prostate cancer without a kidney transplant, matched for age, year of prostate cancer diagnosis, educational duration, and county of residence. The curves were constructed with the Kaplan–Meier method. There was no evidence for a difference in cancer‐specific survival (log‐rank test: P = 0.37), but overall survival was shorter (log‐rank test: P = 0.003). KT, kidney transplantation; PC, prostate cancer.

Results

Almost half of the 133 kidney transplantation recipients were transplanted before the mid‐1990s, when PSA testing became common. The transplant recipients were not more likely than age‐matched control men to be diagnosed with any (odds ratio [OR] 0.84, 95% CI 0.70–0.99) or high‐risk or metastatic prostate cancer (OR 0.84, 95% CI 0.62–1.13). None of the ORs for the different categories of prostate cancer increased with time since transplantation. Cancer characteristics at the time of diagnosis and cancer‐specific survival were similar amongst transplant recipients and the control group of 665 men diagnosed with prostate cancer without a kidney transplant.

Conclusions

This Swedish nationwide, register‐based study gave no indication that immunosuppression after kidney transplantation increases the risk of prostate cancer or adversely affects prostate cancer outcomes. The study suggests that men with untreated low‐grade prostate cancer can be accepted for transplantation.

Editorial: Prostate cancer and kidney transplantation – exclusion or co‐existence?

Untreated prostate cancer is generally a contraindication to kidney transplantation. At our institution in Boston, we are often referred individuals with low‐volume low‐risk prostate cancer for treatment. For a cancer that would otherwise be managed with active surveillance, these kidney transplantation candidates will often be forced into some form of definitive therapy, generally radical prostatectomy, a procedure with a well‐known long‐term side‐effect profile, and then have to wait for a period of time, generally 2 years, before being considered for transplantation. The basis for this approach stems from the theoretical higher risk of disease progression and ultimately mortality on immunosuppression. In this issue of the BJU International, Bratt et al. [1] challenge these assumptions and report on the outcomes of kidney transplant recipients diagnosed with prostate cancer. First, they found no difference in prostate cancer incidence, suggesting that transplant recipients, despite being immunosuppressed, are not at higher risk of prostate cancer. Second, they found that the prostate cancer characteristics at diagnosis, overall and prostate cancer‐specific survival of kidney transplant recipients do not differ significantly from non‐transplant patients. Furthermore, the probability of developing advanced prostate cancer over time was not higher among transplant recipients on immunosuppression. Taken together, these findings show that transplant patients are not at a higher risk of poor prostate cancer outcomes.

Hypothesising that many of the transplant recipients in this study already had prostate cancer when they underwent transplantation (based on assumptions about cancer screening practices in Sweden and the time periods included), the authors aim to refute current transplantation guidelines contraindicating solid organ transplantation in those with a history of prostate cancer and requiring a minimum recurrence‐free period before placing these patients on the organ waiting list [23]. The findings of Bratt et al. [1] corroborate previous case series including the largest study of cancer incidence among transplant recipients and a meta‐analysis of six studies. Given the available data, is it still justifiable to deny patients with low‐risk prostate cancer life‐saving kidney transplantation? If the answer is ‘no’, what would be fair cutoffs in Gleason score, number of positive biopsy cores, PSA level, time from diagnosis, etc.? While this study does not definitely answer the question, it would seem reasonable that candidates for active surveillance, especially those with very low‐risk prostate cancer, should be eligible for kidney transplantation without prior definitive therapy. Denying immediate placement on the waiting list represents not only a significant reduction of quality of life, but also leads to reduced survival due to longer dialysis time.

Another concern often heard from those in favour of definitive therapy before transplantation is the added risks of prostatectomy in immunosuppressed individuals; this is understandable given that the incidence of definitive therapy on active surveillance is ~50% at 10 years after diagnosis [4]. However, the available data suggest that prostatectomy after transplantation is safe. For example, in a recent systematic review, only one of 35 patients had a Clavien ≥ 3 complication and graft function was maintained in all patients [5]

To summarise, this study [1], and others before that, suggests that immunosuppression after kidney transplantation is unlikely to adversely affect prostate cancer initiation or progression. Men with low‐risk prostate cancer should be considered for transplantation without first undergoing definitive therapy. There is evidence around the world, and at our institution, that transplant specialists are finally starting to accept this pathway. This study will further reinforce this concept.

by Lorine Haeuser, David‐Dan Nguyen Quoc‐Dien Trinh

References

  1. Bratt O, Drevin L, Prütz K‐G, Carlsson S, Wennberg L, Stattin P. Prostate cancer in kidney transplant recipients – a nationwide register study. BJU Int 2020; 125: 679– 85
  2. Murray KF, Carithers RL. AASLD practice guidelines: evaluation of the patient for liver transplantation. Hepatology 2005; 41: 1407– 32
  3. Oechslin E, Kiowski W, Schneider J, Follath F, Turina M, Gallino A. Pretransplant malignancy in candidates and posttransplant malignancy in recipients of cardiac transplantation. Ann Oncol 1996; 7: 1059– 63
  4. Tosoian JJ, Mamawala M, Epstein JI et al. Intermediate and longer‐term outcomes from a prospective active‐surveillance program for favorable‐risk prostate cancer. J Clin Oncol 2015; 33: 3379– 85
  5. Zeng J, Christiansen A, Pooli A, Qiu F, LaGrange CA. Safety and clinical outcomes of robot‐assisted radical prostatectomy in kidney transplant patients: a systematic review. J Endourol 2018; 32: 935– 43

Article of the week: Using data from an online health community to examine the impact of prostate cancer on sleep

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to this post, there is an editorial written by a prominent member of the urological community. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

Using data from an online health community to examine the impact of prostate cancer on sleep

Rebecca Robbins*, Girardin Jean‐Louis, Nicholas Chanko, Penelope Combs, Nataliya Byrne†‡, Stacy Loeb†‡

*Division of Sleep and Circadian Disorders, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA, Department of Population Health, New York University (NYU) School of Medicine, and Department of Urology, NYU School of Medicine and Manhattan Veterans Affairs, New York, NY, USA

Previous epidemiological studies have examined the relationship between sleep disturbances and prostate cancer risk and/or survival. However, less has been published about the impact of sleep disturbance on quality of life (QoL) for prostate cancer survivors and their caregivers. Although prostate cancer presents numerous potential barriers to sleep (e.g., hot flashes, nocturia), current survivorship guidelines do not address sleep. In addition to its impact on QoL, sleep disturbances also mediate the impact of cancer status on missed days from work and healthcare expenditures.

A broader examination of contributors to poor sleep in prostate cancer, and the impact on patients and caregivers would be an important contribution to raise awareness of these issues in the medical community, improve survivorship care, reduce healthcare costs, and stimulate future research. The objective of our letter is to analyse sleep barriers reported by patients with prostate cancer and caregivers posted to a large online health community.

Editorial: The provision of comfort – addressing barriers to sleep in prostate cancer

“In whatever disease sleep is laborious, it is a deadly symptom,” is a famed aphorism by Hippocrates, because he deeply understood the role of sleep in the process of healing. One of the main goals of any comprehensive cancer management plan should be the provision of comfort. In academic literature, discussions of advances in prostate cancer treatment are often limited to novel therapeutics, such as immunotherapy. What gets often ignored in these discussions is the patient’s perspective—especially that of sleep disturbances. This is why an intriguing qualitative analysis in this BJUI issue by Robbins et al is a refreshing read [1]. The authors examined discussions on an online health community to elucidate the barriers to sleep among prostate cancer patients and caregivers.

Parsing through thousands of anonymized public comments, the authors report several interesting findings: one, majority of comments related to sleep (86%) are posted by patients—signifying high interest in this aspect of management; second, a plurality of comments discuss sleep medications (22%), with comments about advanced disease discussing these medications three times more than those discussing localized disease; third, associated side effects of fatigue and pain were largely observed in advanced disease comments, also we have noticed that many people is using this website https://observer.com/2020/05/best-cbd-hemp-flower/ to buy CBD and reduce the pain cause by the disease. Interestingly, the authors also used Linguistic Inquiry Word Count (LIWC) software—a reasonable tool to assess emotional states—and reported that advanced disease comments were significantly more negative in perspective than localized disease comments. This analysis is an especially useful contribution—and should enable contemporary Prostate Cancer Survivorship Care Guidelines to expand on the impact of sleep disturbances [1].

These findings have considerable implications. To start with, these findings need to be contextualized within the larger body of evidence we have on impact of sleep disturbances on prostate cancer. In a recent study, Markt et al prospectively followed 32,141 men (with 4261 prostate cancer cases) using the Health Professionals Follow-Up Study (HPFS), and found no association between self-reported duration of sleep and prostate cancer outcomes [2]. However, the authors of the HPFS study did emphasize that sleep disruptions were associated with increased risk of developing lethal or aggressive prostate cancer. The finding by Robbins et al that a significant proportion of patients are discussing these issues through online communities suggests that the prevalence of sleep disturbance—and its impact on quality of life—among prostate cancer patients is poorly understood and inadequately measured.

Representative quotes highlighted by Robbins et al also reveal that prostate cancer patients often suffer from severe insomnia, indicating lack of sleep-related patient education initiatives. Additionally, quotes by caregivers also underscore that there is a general lack of information on how to address sleep disruptions for patients they attend to. This is a missed opportunity, as evidence suggests that nutritional therapy (soy supplementation, for example) and combination of resistance training with aerobic exercise may improve cancer related fatigue and quality of life among prostate cancer patients [3], although less is known about effective interventions that would improve sleep. Furthermore, disturbances in sleep have expensive implications for health care spending and workplace absenteeism—with prostate cancer survivorship phase accounting for 50% of total cancer care related costs [4]. Studies that have investigated this relationship report that sleep disturbances significantly increase the utilization of health care and workplace absenteeism, with the impact constituting 2% and 8%, respectively [4]. Given the exponential rise in overall health care spending in the United States, addressing costs stemming from preventable adverse events is urgent—this present study demonstrates that more creative interventions are wanting.  

Beyond economic and survivorship care concerns, this qualitative study paints a grim picture of the conversations happening in these online patient communities, with comments revealing a negative emotional state for many. While sleep disturbances are an important contributor for this development, lack of patient education can also engender greater confusion and distress. Findings from this study should spur greater interest and support for devising and implementing patient-centered initiatives that improve sleep quality. This is required not only because these will likely improve the quality of life for prostate cancer patients, but also because we have a moral responsibility to provide comfort for these patients.

by Junaid Nabi

References

1.         Robbins R, Girardin JL, Chanko N, Combs, P, Byrne N, Loeb S Using data from an online health community to examine the impact of prostate cancer on sleep. BJU Int. 2020; 125(5).

2.         Markt SC, Flynn-Evans EE, Valdimarsdottir UA, Sigurdardottir LG, Tamimi RM, Batista JL, et al. Sleep Duration and Disruption and Prostate Cancer Risk: a 23-Year Prospective Study. Cancer Epidemiol Biomarkers Prev. 2016;25(2):302-8.

3.         Baguley BJ, Bolam KA, Wright ORL, Skinner TL. The Effect of Nutrition Therapy and Exercise on Cancer-Related Fatigue and Quality of Life in Men with Prostate Cancer: A Systematic Review. Nutrients. 2017;9(9):1003.

4.         Gonzalez BD, Grandner MA, Caminiti CB, Hui S-KA. Cancer survivors in the workplace: sleep disturbance mediates the impact of cancer on healthcare expenditures and work absenteeism. Support Care Cancer. 2018;26(12):4049-55.

Article of the week: Information on surgical treatment of benign prostatic hyperplasia on YouTube is highly biased and misleading

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to this post, there is an editorial written by a prominent member of the urological community and a visual abstract for a swift overview of the article. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

Information on surgical treatment of benign prostatic hyperplasia on YouTube is highly biased and misleading

Patrick Betschart*, Manolis Pratsinis*, Gautier Müllhaupt*, Roman Rechner*, Thomas RW Herrmann, Christian Gratzke, Hans–Peter Schmid*, Valentin Zumstein* and Dominik Abt*

*Department of Urology, Cantonal Hospital St Gallen, St Gallen, Urology Clinic, Spital Thurgau AG, Frauenfeld, Switzerland, and Department of Urology, Albert–Ludwigs–University, Freiburg, Germany

Abstract

Objectives

To assess the quality of videos on the surgical treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) available on YouTube, given that such video‐sharing platforms are frequently used as sources of patient information and the therapeutic landscape of LUTS/BPH has evolved substantially during recent years.

Materials and Methods

A systematic search for videos on YouTube addressing treatment options for LUTS/BPH was performed in May 2019. Measures assessed included basic data (e.g. number of views), grade of misinformation and reporting of conflicts of interest. The quality of content was analysed using the validated DISCERN questionnaire. Data were analysed using descriptive statistics.

Fig. 1. Degree of misinformation compared to currently available evidence on surgical BPH treatment 7 (no: green; very little: light green; moderate: light blue; high: light red; extreme: dark red), rate of commercial bias (yes: red; no: light green) and rate of declaration of conflicts of interests (COI; yes: blue; no: orange) for the analysed videos divided by topics. BipolEP, bipolar enucleation of the prostate; HoLEP, holmium laser enucleation of the prostate; iTIND, temporary implantable Nitinol device; PAE, prostatic artery embolization; ThuLEP, thulium laser enucleation of the prostate

Results

A total of 159 videos with a median (range) of 8570 (648–2 384 391) views were included in the analysis. Only 21 videos (13.2%) were rated as containing no misinformation, 26 (16.4%) were free of commercial bias, and two (1.3%) disclosed potential conflicts of interest. According to DISCERN, the median overall quality of the videos was low (2 out of 5 points for question 16). Only four of the 15 assessed categories (bipolar and holmium laser enucleation of the prostate, transurethral resection of the prostate and patient‐based search terms) were scored as having moderate median overall quality (3 points).

Conclusion

Most videos on the surgical treatment of LUTS/BPH on YouTube had a low quality of content, provided misinformation, were subject to commercial bias and did not report on conflicts of interest. These findings emphasize the importance of thorough doctor–patient communication and active recommendation of unbiased patient education materials.

Article of the week: Salvage radical prostatectomy following focal therapy: functional and oncological outcomes

Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to this post, there is an editorial written by prominent members of the urological community. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

Salvage radical prostatectomy following focal therapy: functional and oncological outcomes

Jaime O. Herrera-Caceres*, Gregory J. Nason*, Noelia Salgado-Sanmamed, Hanan Goldberg*, Dixon T.S. Woon*, Thenappen Chandrasekar*, Khaled Ajib*, Guan Hee Tan*, Omar Alhunaidi*, Theodorus van der Kwast, Antonio Finelli*, Alexandre R. Zlotta*, Robert J. Hamilton*, Alejandro Berlin, Nathan Perlis* and Neil E. Fleshner*

*Division of Urology, Department of Surgical Oncology, Department of Radiation Oncology, and Department of Pathology and Laboratory Medicine, University Health Network, University of Toronto, Toronto, ON, Canada

Abstract

Objectives

To report the oncological and functional outcomes of salvage radical prostatectomy (sRP) after focal therapy (FT).

Patients and Methods

A retrospective review of all patients who underwent sRP after FT was performed. Clinical and pathological outcomes focussed on surgical complications, oncological, and functional outcomes.

Fig. 1. Impact of PSM on the absence of detectable disease after sRP (including PSA persistence and/or BCR).

Results

In all, 34 patients were identified. The median (interquartile range [IQR]) age was 61 (8.25) years. FT modalities included high‐intensity focussed ultrasound (19 patients), laser ablation (13), focal brachytherapy (one) and cryotherapy (one). The median (IQR) time from FT to recurrence was 10.9 (17.6) months. There were no rectal or ureteric injuries. Two (5.9%) patients had iatrogenic cystotomies and four (11.8%) developed bladder neck contractures. The mean (sd) hospital stay was 2.5 (2.1) days. The T‐stage was pT2 in 14 (41.2%) patients, pT3a in 16 (47.1%), and pT3b in four (11.8%). In all, 13 (38%) patients had positive surgical margins (PSMs). Six (17.6%) patients received adjuvant radiotherapy (RT). At a mean follow‐up of 4.3 years, seven (20.6%) patients developed biochemical recurrence (BCR), and of these, six (17.6%) patients required salvage RT. PSMs were associated with worse BCR‐free survival (hazard ratio 6.624, 95% confidence interval 2.243–19.563; P < 0.001). The median (IQR) preoperative International Prostate Symptom Score and International Index of Erectile Function score was 7 (4.5–9.5) and 23.5 (15.75–25) respectively, while in the final follow‐up the median (IQR) values were 7 (3.5–11) and 6 (5–12.25), respectively (P = 0.088 and P < 0.001). At last follow‐up, 31 (91.2%) patients were continent, two (5.9%) had moderate (>1 pad/day) incontinence, and one (2.9%) required an artificial urinary sphincter.

Conclusions

sRP should be considered as an option for patients who have persistent clinically significant prostate cancer or recurrence after FT. PSMs should be recognised as a risk for recurrent disease after sRP.

Editorial: Further evidence that surgery after focal therapy for prostate cancer is safe

In this month’s issue of BJUI, Herrera‐Caceres et al. [1] report the results of a retrospective cohort study in 34 patients who underwent salvage radical prostatectomy after focal therapy. The majority of these cases were performed using open surgery (82.4%). Overall, there were no rectal injuries reported and 91% of patients were fully continent (‘pad‐free’) at last follow‐up, while one patient required an artificial urinary sphincter. A total of 38% of patients had a positive surgical margin (PSM) and 20.6% developed biochemical recurrence (BCR), with 17.6% requiring adjuvant radiotherapy. On multivariate analysis, a PSM was found to be associated with worse overall BCR‐free survival.

There is mounting evidence that focal therapy is associated with arguably good intermediate‐term oncological outcomes, while it minimizes the toxicity of traditional whole‐gland therapies, with the majority of studies reporting erectile function rates in excess of 70% and fewer than 5% of patients reporting urinary incontinence [2]. However, disease recurrence after focal therapy remains a concern, with some studies reporting that one in three patients undergoing focal therapy require either further focal treatment or transition to whole‐gland therapy at 5 years. This has created the need to explore salvage options, of which salvage radical prostatectomy is currently the most investigated. The present study by Herrera‐Caceres et al. is now the fifth paper in the last 4 years to evaluate the toxicity of surgery after focal therapy, with data on over 150 men reported in the literature to date [3,4,5,6]. Despite small numbers across each study, the results have been encouragingly consistent.

Unlike salvage surgery after radiation therapy, the risk of intra‐operative injury appears to be very rare in men undergoing surgery after focal therapy. For instance, in the present study and that of Marconi et al. [3] no major complications after surgery are reported and, most notably, no rectal injuries occurred during salvage surgery, which has been a very significant issue reported in up to 5% of men undergoing salvage after radiation therapy techniques.

Data from the present study mainly concern patients undergoing open surgery after focal therapy, in contrast to the study by Marconi et al. [3] that reports on surgery performed using the robotic platform. The finding that the outcomes were similar between the open technique and the robotic technique mirrors that reported in recent randomized controlled trials of open and robotic surgery for primary disease, and provides evidence that it is surgical experience rather than a specified surgical technique that has most impact on outcome after prostate cancer surgery. One aspect in which the present study and that of Marconi et al. [3] differ is the rate of bladder neck contracture (BNC); in the present study, 11.8% of patients experienced BNC, whereas no patient experienced BNC after robotic surgery. The rate of BNC may have been influenced by the previous focal therapy, or it may have been the result of the open technique as BNC has been reported to be more common after open surgery because of the marked difference in how the anastomosis is performed in the two different procedures.

Urinary continence outcomes were arguably excellent in the present study, with 91.2% of patients ‘pad‐free’ at last follow‐up, a finding that is replicated in the literature on surgery after focal therapy. These outcomes are more in keeping with those seen after primary radical prostatectomy than surgery after radiation. The poor continence outcomes of salvage surgery after radiation therapy could be related to poor urethral and sphincter function caused by the initial radiation therapy.

Erectile function outcomes are hard to interpret in the present study, with 53% of patients having a ‘response to medical therapy’, but the exact definition of this is not clear. The mean International Index of Erective Function score postoperatively was 6, suggesting that erectile function after the toxicity of multiple treatments can be expected to be poor.

While functional outcomes in the present study and those of other studies reporting on surgery after focal therapy are encouraging, this study and others do demonstrate that these men have a significant risk of harbouring high‐risk, high‐stage disease (58% with T3 disease, 47% with pT3, 11% with T3b) on final pathological analysis, which is also reflected in a relatively high PSM rate (38%). This rate is clearly higher than in men undergoing surgery for primary disease; however, it is similar to that in surgery for recurrent disease in other tumour types for which surgery appears always to be associated with worse oncological outcomes. This can be explained by the fact that patients experiencing recurrent disease, by the very nature of their disease that has not been ‘cured’ by one therapeutic method, have worse outcomes.

Despite the extent of disease found on final pathological analysis in the present study, the risk of patients experiencing BCR after LASIK surgery Southlake was relatively low at 20.6%, while only 17.6% underwent salvage therapy in the form of radiation.

In summary, the present paper adds to the weight of evidence that surgery after focal therapy can be safely performed in expert hands (whether open or robot‐assisted), with minimal complications and good functional outcomes. The high‐stage disease on final pathological examination is in keeping with other published studies in this field. Overall, the study provides valuable additional data that can be used to help counsel men considering focal therapy as a primary treatment method for their prostate cancer.

by Thomas Stonier and Paul Cathcart

References

  1. Herrera‐Caceres JNason GSalgado‐Sanmamed N et al. Salvage radical prostatectomy following focal therapy: functional and oncological outcomes. BJU Int 2020125525– 30
  2. Shah TPeters MEldred‐Evans D et al. Early‐medium‐term outcomes of primary focal cryotherapy to treat nonmetastatic clinically significant prostate cancer from a prospective multi centre registry. Eur Urol 20197698– 105
  3. Marconi LStonier TTourinho‐Barbosa R et al. Robot‐assisted radical prostatectomy after focal therapy: oncological, functional outcomes and predictors of recurrence. Eur Urol 20197627– 30
  4. Linares‐Espinos ESanchez‐Salas RSivaraman A et al. Minimally invasive salvage prostatectomy after primary radiation or ablation treatment. Urology 201694111
  5. Nunes‐Silva IBarret ESrougi V et al. Effect of prior focal therapy on perioperative, oncologic and functional outcomes of salvage robotic assisted radical prostatectomy. J Urol 20171981069– 76
  6. Thompson JSridhar ATan W et al. Pathological findings and magnetic resonance imaging concordance at salvage radical prostatectomy for local recurrence following partial ablation using high intensity focused ultrasound. J Urol 20192011134– 43

 

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