Tag Archive for: Article of the Week

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Video: The Metabolic Syndrome & the Prostate

Association between metabolic syndrome and intravesical prostatic protrusion in patients with benign prostatic enlargement and lower urinary tract symptoms (MIPS Study)

Abstract

Objective

To investigate the association between metabolic syndrome (MetS) and morphological features of benign prostatic enlargement (BPE), including total prostate volume (TPV), transitional zone volume (TZV) and intravesical prostatic protrusion (IPP).

Patients and Methods

Between January 2015 and January 2017, 224 consecutive men aged >50 years presenting with lower urinary tract symptoms (LUTS) suggestive of BPE were recruited to this multicentre cross‐sectional study. MetS was defined according to International Diabetes Federation criteria. Multivariate linear and logistic regression models were performed to verify factors associated with IPP, TZV and TPV.

Results

Patients with MetS were observed to have a significant increase in IPP (P < 0.01), TPV (P < 0.01) and TZV (P = 0.02). On linear regression analysis, adjusted for age and metabolic factors of MetS, we found that high‐density lipoprotein (HDL) cholesterol was negatively associated with IPP (r = −0.17), TPV (r = −0.19) and TZV (r = −0.17), while hypertension was positively associated with IPP (r = 0.16), TPV (r = 0.19) and TZV (r = 0.16). On multivariate logistic regression analysis adjusted for age and factors of MetS, hypertension (categorical; odds ratio [OR] 2.95), HDL cholesterol (OR 0.94) and triglycerides (OR 1.01) were independent predictors of TPV ≥ 40 mL. We also found that HDL cholesterol (OR 0.86), hypertension (OR 2.0) and waist circumference (OR 1.09) were significantly associated with TZV ≥ 20 mL. On age‐adjusted logistic regression analysis, MetS was significantly associated with IPP ≥ 10 mm (OR 34.0; P < 0.01), TZV ≥ 20 mL (OR 4.40; P < 0.01) and TPV ≥ 40 mL (OR 5.89; P = 0.03).

Conclusion

We found an association between MetS and BPE, demonstrating a relationship with IPP.

Article of the Week: Impact of bladder cancer on health‐related quality of life

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 the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video discussing the paper.

If you only have time to read one article this week, it should be this one.

Impact of bladder cancer on health‐related quality of life

Angela B. Smith*, Byron Jaeger, Laura C. Pinheiro§, Lloyd J. EdwardsHung-Jui Tan*, Matthew E. Nielsen*¶ and Bryce B. Reeve§

 

*Department of Urology Lineberger Comprehensive Cancer Center, Multidisciplinary Genitourinary OncologyDepartment of Biostatistics, Gillings School of Global Public Health§Department of Health Policy and Management, Gillings School of Global Public Health , and Department of Epidemiology, Gillings School of Global Public Health, UNC, Chapel Hill, NC, USA

 

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Abstract

Objectives

To identify changes in health‐related quality of life (HRQoL) after diagnosis of bladder cancer in older adults in comparison with a group of adults without bladder cancer (controls).

Patients and Methods

Data from the Surveillance, Epidemiology and End Results registries were linked with Medicare Health Outcomes Survey (MHOS) data. Medicare beneficiaries aged ≥65 years in the period 1998–2013, who were diagnosed with bladder cancer between baseline and follow‐up through the MHOS, were matched with control subjects without cancer using propensity scores. Linear mixed models were used to estimate predictors of HRQoL changes.

Results

After matching, 535 patients with bladder cancer (458 non‐muscle‐invasive bladder cancer [NMIBC] and 77 with muscle‐invasive bladder cancer [MIBC]) and 2 770 control subjects without cancer were identified. Both patients with NMIBC and those with MIBC reported significant declines in HRQoL scores over time vs controls: physical component summary −2 and −5.3 vs −0.4, respectively; bodily pain −1.9 and −3.6 vs −0.7; role physical −2.7 and −4.7 vs −0.7; general health −2.4 and −6.1 vs 0; vitality −1.2 and −3.5 vs −0.1; and social functioning −2.1 and −5.7 vs −0.8. All scores ranged from 0 to 100. When stratified by time since diagnosis, HRQoL improved over 1 year for some domains (role physical), but remained lower across most domains.

Conclusions

After diagnosis, patients with bladder cancer experienced significant declines in physical, mental and social HRQoL relative to controls. Decrements were most pronounced among individuals with MIBC. Methods to better understand and address HRQoL decrements among patients with bladder cancer are needed.

Editorial: Well‐being beyond the bladder. How do we improve the overall health of patients with bladder cancer?

Declines in quality of life and physical function are commonly associated with all cancers 1, and in this month’s issue of BJUI, Smith et al. 2 describe the changes in quality of life that occur specifically in patients with bladder cancer. The authors examine 535 individuals with bladder cancer (of whom 77 [14%] had invasive disease) and matched them to 2770 non‐cancer controls using propensity scores. The Surveillance, Epidemiology and End Results (SEER) registry was linked with the Medicare Health Outcomes Survey. This dataset represents linkages of population‐based SEER data with survey data for Medicare‐managed enrollees. In this study, patients were surveyed at different times with respect to their diagnosis and the authors identified all patients who were surveyed some time before and after their diagnosis. By harnessing this dataset, the authors describe changes that occur in mental and physical function. The authors should be commended for conducting an analysis that seeks to quantify the impact of a bladder cancer diagnosis on multiple dimensions affecting quality of life.

A few findings are worth highlighting. First, the quality of life of a patient with bladder cancer declines more between a pre‐diagnosis and post‐diagnosis assessment as compared with matched, non‐cancer controls. As any urological oncologist can attest, a bladder cancer diagnosis causes permanent changes to a patient’s life. Second, people with bladder cancer have deficits in multiple domains of well‐being and not just in physical function. Third, people with bladder cancer have impairments in well‐being whether they have non‐invasive or invasive disease. Fourth, decrements were more pronounced in those with invasive disease. In fact, patients who underwent cystectomy had statistically significant declines in nearly all physical domains and similar declines in mental health‐related quality of life across several domains, including emotional, vitality and social functioning. Lastly, a predictor of a significant decrease in both the physical component and mental component score included a diagnosis of recent depression. This insightful study shows the potential impact of a bladder cancer diagnosis on mental and physical health‐related quality of life.

So, with these detriments in mind, can urologists do anything to address these declines in quality of life for patients with bladder cancer?

In clinical practice, urologists may be able to play an active role in mitigating the negative consequences of therapy, be it for invasive or non‐invasive disease. If a urologist is following a patient with non‐muscle‐invasive bladder cancer, then there are clinical visits for cystoscopy, intravesical instillation and follow‐up, during which a provider can regularly check in with a patient and offer recommendations. If a patient has muscle‐invasive bladder cancer, they are typically seen a few times before surgery and there is an incentive to address potentially modifiable sources of morbidity before a major operation plagued by complications.

While encouraging healthy behaviours is common sense and may help some patients, understanding the difference between motivating self‐care (e.g. coaching our patients) and recommending programmes that are scientifically established and effective (e.g. recommending a programme proven in a randomized controlled trial) are different. One major challenge in promoting healthy behaviours in our patients is understanding their mindset, i.e. their motivation to make meaningful change. The Transtheoretical Model is a biopsychosocial model that conceptualizes intent for changing behaviour: pre‐contemplation, contemplation, preparation, action, maintenance and termination 3. Based on a continuum of patient activation and knowledge of these stages, interventions can be designed more effectively and focused on individuals. Conversation content, clinician effort and clinical resources can be judiciously allotted instead of offering all options to all patients.

The presence of validated interventions that have been determined to consistently improve quality of life is evolving. A new area of preoperative care known as prehabilitation, is being studied in patients with cancer and seeks to optimize preoperative factors, such as increasing fitness, improving nutritional status, encouraging smoking cessation and decreasing anxiety 4. Although studies vary in quality, content and outcomes measured 5, there is still an opportunity to exercise common sense and make practical suggestions.

For busy urologists who manage patients with bladder cancer, any patient can benefit from:

  1. Mindful conversations: having open and regular communication about quality of life.
  2. Measurements: tracking patient‐reported outcome measures longitudinally to follow well‐being systematically and identify detrimental changes early.
  3. Multidisciplinary resources: offer support (Fig. 1) based on conversations (#1) and scores (#2).

Conversations only require a little provider time, monitoring patient‐reported outcomes can be facilitated by the use of technology such as the electronic health record, and most institutions have previously established resources that patients can use during their care. Strategies may be low‐cost, quick and capable of helping patients or caregivers. Also, data show that routine assessment of patient‐reported outcome measures in patients with advanced cancers may be associated with improved overall survival 6.

Potential targets to improve patient well‐being during bladder cancer care.

Acknowledging that other dimensions of health are affected after a bladder cancer diagnosis may allow us to track, address and ultimately improve the health of our patients. When we care for patients with bladder cancer, focusing cancer treatment is paramount; however, we can also extend this treatment by being cognisant of quality of life. Complementing oncological care with efforts to promote health in other ways allows us to promote well‐being and treat these patients beyond the bladder.

 

Matthew Mossanen*, Justin C. Brown† and Deborah Schrag
*Division of Urology, Brigham and Womens Hospital, Harvard Medical School, Boston, MA, USA and Dana Farber Cancer Institute, Boston, MA, USA

 

Read the full article
References

 

  • Petrick JL, Reeve BB, Kucharska‐Newton AM et alFunctional status declines among cancer survivors: trajectory and contributing factorsJournal of Geriatric Oncology 20145: 359–67

 

  • Smith AB, Jaeger B, Pinheiro LC et alImpact of bladder cancer on health‐related quality of lifeBJU Int 2018121: 549–57

 

 

  • Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment‐related morbidity, increase cancer treatment options, and improve physical and psychological health outcomesAm J Phys Med Rehabil 201392: 715–27

 

 

  • Basch E, Deal AM, Dueck AC et alOverall survival results of a trial assessing patient‐reported outcomes for symptom monitoring during routine cancer treatmentJAMA 2017318: 197–8

 

Video: Impact of bladder cancer on health‐related quality of life

Impact of bladder cancer on health‐related quality of life

 

Read the full article

Abstract

Objectives

To identify changes in health‐related quality of life (HRQoL) after diagnosis of bladder cancer in older adults in comparison with a group of adults without bladder cancer (controls).

Patients and Methods

Data from the Surveillance, Epidemiology and End Results registries were linked with Medicare Health Outcomes Survey (MHOS) data. Medicare beneficiaries aged ≥65 years in the period 1998–2013, who were diagnosed with bladder cancer between baseline and follow‐up through the MHOS, were matched with control subjects without cancer using propensity scores. Linear mixed models were used to estimate predictors of HRQoL changes.

Results

After matching, 535 patients with bladder cancer (458 non‐muscle‐invasive bladder cancer [NMIBC] and 77 with muscle‐invasive bladder cancer [MIBC]) and 2 770 control subjects without cancer were identified. Both patients with NMIBC and those with MIBC reported significant declines in HRQoL scores over time vs controls: physical component summary −2 and −5.3 vs −0.4, respectively; bodily pain −1.9 and −3.6 vs −0.7; role physical −2.7 and −4.7 vs −0.7; general health −2.4 and −6.1 vs 0; vitality −1.2 and −3.5 vs −0.1; and social functioning −2.1 and −5.7 vs −0.8. All scores ranged from 0 to 100. When stratified by time since diagnosis, HRQoL improved over 1 year for some domains (role physical), but remained lower across most domains.

Conclusions

After diagnosis, patients with bladder cancer experienced significant declines in physical, mental and social HRQoL relative to controls. Decrements were most pronounced among individuals with MIBC. Methods to better understand and address HRQoL decrements among patients with bladder cancer are needed.

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Article of the Week: The implications of baseline bone‐health assessment at initiation of androgen‐deprivation therapy for prostate cancer

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 the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this month, it should be this one.

The implications of baseline bone‐health assessment at initiation of androgen‐deprivation therapy for prostate cancer

 

Peter S. Kirk* , Tudor Borza*, Vah akn B. Shahinian, Megan E.V. Caram§Danil V. Makarov**, Jeremy B. Shelton††, John T. Leppert‡‡§§, Ryan M. Blake*, Jennifer A. Davis§, Brent K. Hollenbeck*, Anne Sales§¶¶ and Ted A. Skolarus *§

 

*Dow Division of Health Services Research, Department of Urology, Division of Nephrology, Department of Internal Medicine, Division of Hematology and Oncology, Department of Internal Medicine, University of Michigan Health System, §Veterans Affairs (VA) Health Services Research and Development, Center for Clinical Management Research, VA Ann Arbor Healthcare System, University of Michigan Medical School, Ann Arbor, MI, USA, Departments of Urology and Population Health, NYU Langone Medical Center, New York City, NY, USA, **VA New York Healthcare System, New York City, NY, USA, ††VA Greater Los Angeles Healthcare System, Los Angeles City, LA, USA, ‡‡Department of Urology, Stanford University School of Medicine, Stanford, CA, USA, §§VA Palo Alto Healthcare System, Palo Alto, CA, USA, and ¶¶Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, MI, USA

 

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Abstract

Objectives

To assess bone‐density testing (BDT) use amongst prostate cancer survivors receiving androgen‐deprivation therapy (ADT), and downstream implications for osteoporosis and fracture diagnoses, as well as pharmacological osteoporosis treatment in a national integrated delivery system.

Patients and methods

We identified 17 017 men with prostate cancer who received any ADT between 2005 and 2014 using the Veterans Health Administration cancer registry and administrative data. We identified claims for BDT within a 3‐year period of ADT initiation. We then used multivariable regression to examine the association between BDT use and incident osteoporosis, fracture, and use of pharmacological treatment.

Results

We found that a minority of patients received BDT (n = 2 502, 15%); however, the rate of testing increased to >20% by the end of the study period. Men receiving BDT were older at diagnosis and had higher‐risk prostate cancer (both P < 0.001). Osteoporosis and fracture diagnoses, use of vitamin D ± calcium, and bisphosphonates were all more common in men who received BDT. After adjustment, BDT, and to a lesser degree ≥2 years of ADT, were both independently associated with incident osteoporosis, fracture, and osteoporosis treatment.

Conclusions

BDT is rare amongst patients with prostate cancer treated with ADT in this integrated delivery system. However, BDT was associated with substantially increased treatment of osteoporosis indicating an underappreciated burden of osteoporosis amongst prostate cancer survivors initiating ADT. Optimising BDT use and osteoporosis management in this at‐risk population appears warranted.

 

Editorial: Low rates of bone density testing in prostate cancer survivors on androgen‐deprivation therapy: where do we go from here?

In this month’s issue of the BJU International, Kirk et al. 1 describe their findings regarding an important issue in the care of prostate cancer survivors on androgen‐deprivation therapy (ADT): the underuse of bone density testing (BDT) to screen for osteoporosis. ADT is the commonest systemic therapy in patients with prostate cancer, used in both metastatic and localised settings. Whilst it has clear survival benefits, ADT is also associated with harms including cardiovascular, cognitive, and metabolic side‐effects, as well as an increased risk of osteoporosis and fractures. These bone‐related complications are costly from a quality‐of‐life and financial perspective, especially given the critical importance of mobility in maintaining performance status and cardiovascular health during cancer treatment 23. Consequently, most clinical practice guidelines include osteoporosis screening as a recommendation for men undergoing ADT.

In their study, ‘The implications of baseline bone health assessment at initiation of androgen‐deprivation therapy for prostate cancer’, the authors describe patterns of use of BDT and diagnosis of osteoporosis amongst men treated for prostate cancer in the USA Veterans Affairs (VA) system within a 3‐year period following ADT initiation. There was a statistically significant increase in the BDT rate throughout the study period; however, overall BDT remains uncommon amongst patients with prostate cancer on ADT, used in only 15% of men in their cohort. Unsurprisingly, patients who received BDT were more likely to be diagnosed with osteoporosis, be diagnosed with a fracture, and receive treatment with vitamin D, calcium and bisphosphonates. The authors acknowledge an important limitation about the applicability of their VA study to the civilian health population. However, given that the VA and military health systems perform as well, if not better, on several important metrics in prostate cancer care 45, these results should not be ignored simply because they were obtained in the military health system.

The increase in BDT screening throughout the study may be attributable to increased awareness of guidelines published during the study period. However, the overall BDT rate remains low. This may be explained by insufficient access, lack of information technology, as well as more nebulous aspects of care such as physician culture, beliefs, and habits 6.

Studies such as this are vital to identify opportunities for improving care delivery. What are needed next are innovations to optimise the delivery of care for patients treated with ADT. Whilst improving BDT adherence may lack the cachet of next‐generation targeted therapies, this is an example of the kind of simple, measurable area where improvement in care delivery systems may yield large benefits.

There are many possible avenues for success: quality improvement collaboratives are one well‐known innovation, which may be applicable to this area: examples, such as the Michigan Urological Surgery Improvement Collaborative (MUSIC) and the AUA Quality Registry (AQUA) are success stories, but to our knowledge there are no published studies specifically attempting to improve adherence to BDT guidelines within these cohorts. Other practice‐based innovations include navigators and multidisciplinary cancer teams, either of which may yield improvements in guideline adherence. Online patient support groups can raise awareness. And although we all know how electronic reminders have frustrated countless physicians, electronic reminders about recommended tests and interventions may be an important tool. At our institution, a Prostate Cancer Foundation grant is funding the development of a mobile health app, which is targeted exclusively at men receiving ADT for prostate cancer. This app will encourage physical activity and healthy eating, which can both support bone health.

In our view, the issue of bone screening is a clear example of where innovative strategies to improve care delivery and guideline adherence may make a big difference for men living with prostate cancer. We look forward to seeing more in the years to come.

 

Sabrina S. Harmouch, Alexandra J. Berger, and Alexander P. Cole

 

Center for Surgery and Public Health, Division of Urological Surgery, Brigham and Wo mens Hospital, Harvard Medical School, Boston, MA, USA

 

References
  • Kirk PS, Borza T, Shahinian VB et al. The implications of baseline bone‐health assessment at initiation of androgen‐deprivation therapy for prostate cancerBJU Int2018121: 558–64

 

 

 

  • Cole AP, Jiang W, Lipsitz SR et al. The use of prostate specific antigen screening in purchased versus direct care settings: data from the TRICARE® military databaseJ Urol 2017198: 1295–300

 

  • Cullen J, Brassell SA, Chen Y et al. Racial/Ethnic patterns in prostate cancer outcomes in an active surveillance cohortProstate Cancer 20112011: 234519

 

 

Article of the Week: NICE Guidance. Sepsis – recognition, diagnosis and early management

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.

If you only have time to read one article this month, it should be this one.

Sepsis: recognition, diagnosis and early management

 

Overview
This guideline covers the recognition, diagnosis and early management of sepsis for all populations. The guideline
committee identied that the key issues to be included were: recognition and early assessment, diagnostic and prognostic value of blood markers for sepsis, initial treatment, escalating care, iden tifying the source of infection, early monitoring, information and support for patients and carers, and training and education.
Who is it For?
People with sepsis, their families and carers.
Healthcare professionals working in primary, secondary and tertiary care. Recommendations
People have the right to be involved in discussions and make informed decisions about their care, as described in
your care [https://www.nice.org.uk/about/nice-communities/public-involvement/your-care].Making decisions  using NICE guidelines [https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/using-NICE-guidelines-to-make-decisionsexplains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

 

More Information
You can also see this guideline in the NICE pathway on sepsis [https://pathways.nice.org.uk/pathways/sepsis].
To nd out what NICE has said on topics related to this guideline, see our web page on infections [https://www.nice.org.uk/guidance/conditions-and-diseases/infections]See also the guideline committees discussion and the evidence reviews (in the full guideline [https://www.nice.org.uk/Guidance/NG51/evidence]), and information about how the guideline was developed [https://www.nice.org.uk/Guidance/NG51/documents], including details of the committee. Recommendations for Research The guideline committee has made the following recommendations for research.

 

Read the full article

© NICE (2017) Sepsis: recognition, diagnosis and early management

 

Infographic: Impact of dutasteride/tamsulosin combination therapy on sexual function in men with LUTS secondary to BPH

Infographic: Impact of dutasteride/tamsulosin combination therapy on sexual function in men with LUTS secondary to BPH

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Article of the Week: Impact of dutasteride/tamsulosin combination therapy on sexual function in men with LUTS secondary to BPH

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 the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this month, it should be this one.

A prospective randomised placebo‐controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)

 

Claus G. Roehrborn*, Michael J. Manyak, Juan Manuel Palacios-MorenoTimothy H. Wilson§, Erik P.M. Roos, Javier Cambronero Santos**, Dimitrios Karanastasis††Janet Plastino‡‡, Francois Giuliano§§ and Raymond C. Rosen¶¶

 

*Department of Urology, University of Texas (UT) Southwestern Medical Center, Dallas, TX, USA, GlaxoSmithKline (GSK), Washington, DC, USA, GSK, Madrid, Spain, §PAREXEL International, Durham, NC, USA, Antonius Ziekenhuis Sneek, Sneek, The Netherlands, **Hospital Universitario Infanta Leonor, Madrid, Spain, ††Urologic Clinic, General Hospital of Athens Elpis, Athens, Greece, ‡‡GSK, Collegeville, PA,USA, §§Neuro-Urology R. Poincare Hospital AP-HP, Garches, UMR1179 Inserm-UVSQ-Paris Saclay University, Paris, France, France, and ¶¶New England Research Institutes,nWatertown, MA, USA

 

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Abstract

Objective

To prospectively assess the impact of the fixed‐dose combination (FDC) of the 5α‐reductase inhibitor (5ARI), dutasteride 0.5 mg and the α1‐adrenoceptor antagonist, tamsulosin 0.4 mg (DUT‐TAM FDC) therapy on sexual function domain scores in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), using the Men’s Sexual Health Questionnaire (MSHQ).

Patients and Methods

This European and Australian double‐blind, placebo‐controlled, parallel‐group study was conducted at 51 centres. Inclusion criteria: age ≥50 years, International Prostate Symptom Score ≥12, prostate volume ≥30 cc, prostate‐specific antigen 1.5–10 ng/mL. Patients were randomised 1:1 to DUT‐TAM FDC therapy or placebo for 12 months. The change from baseline to Month 12 on the total MSHQ (primary endpoint) and MSHQ erection, ejaculation and satisfaction domains (secondary outcome) was assessed, using a mixed model repeated measures analysis. Safety was evaluated.

Results

The intention‐to‐treat population included 489 patients (243 DUT‐TAM FDC therapy; 246 placebo). A significant decrease (worsening) was observed with DUT‐TAM FDC therapy versus placebo on the total MSHQ score (−8.7 vs −0.7; standard error [se]: 0.81, 0.78; P < 0.001), and the ejaculation (−7.5 vs −0.6; se: 0.56, 0.55; P < 0.001) and satisfaction (−0.6 vs +0.3; se: 0.3, 0.29, P = 0.047) domains, but not the erection domain (−1.0 vs −0.5; se: 0.19, 0.19, P = 0.091).

Conclusion

This is the first domain‐specific quantitative evaluation of DUT‐TAM FDC therapy on sexual function in men with LUTS secondary to BPH. The observed changes in the MSHQ with DUT‐TAM FDC therapy were mainly driven by changes in the ejaculation domain. These findings will help give context to erectile and ejaculatory dysfunction AEs reported spontaneously in earlier 5ARI studies.

Editorial: Sexual function in patients undergoing combination treatment with α1‐adrenoceptor antagonists and 5α‐reductase inhibitors – a step forward in a still‐open debate

Combination treatment with α1‐adrenoceptor antagonists and 5α‐reductase inhibitors (5ARIs) is recommended in men with moderate‐to‐severe LUTS and risk of disease progression 12. These drugs can improve symptoms as well as urodynamic markers of BOO 34. Despite the clinical benefits, the potential negative impact of these drugs on sexual function is of major concern, and may be cause for treatment discontinuation. Additionally, in everyday clinical practice, the incidence of sexually‐related adverse events is often perceived to be higher than that reported in clinical trials, and clinicians may consequently be reluctant to prescribe these drugs in younger, sexually active patients 5. Evidence from the literature in this area, however, is low‐level, controversial and inconclusive. Notably, in most clinical studies on combination treatment, assessment of sexual function is based only on the reported incidence of sexually‐related adverse events; a non‐quantitative method that can be biased by the subjective burden of suffering, by a patient’s misinterpretation of symptoms and his propensity to mention them during follow‐up visits.

Roehrborn et al. 1 investigated the impact of a fixed‐dose combination of the 5ARI dutasteride 0.5 mg and the α1‐adrenoceptor antagonist tamsulosin 0.4 mg therapy on sexual function in sexually active men with LUTS, secondary to BPH 1. The authors designed a prospective, randomized, placebo‐controlled study and adopted, for the first time in this setting, the Men’s Sexual Health Questionnaire (MSHQ). Overall, 489 patients, with a mean age of 65.5 years, an IPSS ≥12 and a prostate volume ≥30 mL were randomized to receive combination therapy (= 243) or placebo (= 246) for 12 months. Change in sexual function from baseline to month 12, as measured by a change in total MSHQ score, was the primary endpoint of the study. Change from baseline in the MSHQ erection, ejaculation and satisfaction domain scores were among the secondary endpoints. The authors found a statistically significant decrease in the total MSHQ score in the active treatment group compared with placebo at all post‐treatment visits (months 1,3, 6, 9 and 12), indicating a worsening of sexual function 1. The magnitude of the total MSHQ reduction was greater at month 6 and remained substantially unchanged beyond this time point. This change was driven largely by the change in the score for the ejaculatory domain, which showed a similar temporal trend. Changes in terms of the overall satisfaction domain, although statistically significant, were judged to be numerically small and therefore unlikely to be clinically relevant. Changes in terms of erectile domain score were not statistically significant.

The major methodological strength of this study was the adoption of the MSHQ, a clinically validated questionnaire designed to assess quantitatively multiple domains of sexual function, namely erectile function, ejaculatory function and sexual satisfaction. Findings are relevant from both a pathophysiological and clinical viewpoint. Indeed, the temporal trend that characterizes the deterioration of ejaculatory function and therefore the total MSHQ score implies the involvement of both drugs in this process. From a clinical point of view the study provides additional data to counsel patients requiring combination therapy about the deleterious effects on sexual function and particularly on ejaculatory function. The main limitations of the study, as acknowledged by the authors, is the lack of long‐term follow‐up. Indeed, a recent meta‐analysis showed a positive correlation between duration of therapy with 5ARIs and incidence of sexual dysfunction, with long‐term exposure (≥1 year) being associated with a significantly higher risk 6. Consequently, conclusive data about erectile function cannot be drawn based on the results from the present 1‐year‐long study. Additionally, the authors do not report on possible changes in sexual desire. This aspect deserves future investigation as the risk of decreased libido has been reported to be statistically significant in patients assuming therapy with 5ARIs 6. Finally, results from clinical trials do not always correspond to everyday clinical practice, as patient selection for therapies in the real world is often different with respect to inclusion criteria adopted in clinical trials. Specifically, patients who receive therapy with 5ARIs (alone or in combination) in everyday clinical practice are often older than the patients who were enrolled in the present study and in other clinical trials and therefore may have comorbidities that could contribute to the development of sexual side effects during treatment 5.

Ferdinando Fusco and Massimiliano Creta
Department of Neurosciences, Human Reproduction and Odontostomatology, University of Naples Federico II, Naples, Italy

 

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References

 

  • Roehrborn CG, Manyak MJ, Palacios‐Moreno JM et al. A prospective randomised placebo‐controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)BJU Int 2018121: 647–58

 

  • Gratzke C, Bachmann A, Descazeaud A et al. EAU guidelines on the assessment of non‐neurogenic male lower urinary tract symptoms including benign prostatic obstructionEur Urol201567: 1099–109

 

  • Fusco F, Creta M, Imperatore V et al. Benign prostatic obstruction relief in patients with lower urinary tract symptoms suggestive of benign prostatic enlargement undergoing endoscopic surgical procedures or therapy with alpha‐blockers: a review of urodynamic studiesAdv Ther201734: 773–83

 

  • Matsukawa Y, Takai S, Funahashi Y et al. Effects of withdrawing α1‐blocker from combination therapy with α1‐blocker and 5α‐reductase inhibitor in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective and comparative trial using urodynamicsJ Urol 2017198: 905–12

 

  • Fusco F, Arcaniolo D, Creta M et al. Demographic and comorbidity profile of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia in a real‐life clinical setting: Are 5‐alpha‐reductase inhibitor consumers different? World J Urol 201533: 685–9

 

  • Liu L, Zhao S, Li F et al. Effect of 5α‐reductase inhibitors on sexual function: a meta‐analysis and systematic review of randomized controlled trialsJ Sex Med 201613: 1297–310

 

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