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Article of the week: Modifiable lifestyle behaviours impact the health‐related quality of life of bladder cancer survivors

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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 prepared by the authors. Please use the comment buttons below if you would like to join the conversation.

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

Modifiable lifestyle behaviours impact the health‐related quality of life of bladder cancer survivors

Jiil Chung*, Girish S. Kulkarni†, Jackie Bender*, Rodney H. Breau‡, David Guttman§, Manjula Maganti*, Andrew Matthew, Robin Morash**, Janet Papadakos†† and Jennifer M. Jones*

*Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, †Division of Urology, Departments of Surgery and Surgical Oncology, University Health Network and University of Toronto, Toronto, ON, ‡Division of Urology, The Ottawa Hospital and University of Ottawa, Ottawa, §Bladder Cancer Canada, Toronto, ON, Psychosocial Oncology Program, Princess Margaret Cancer Centre, **Wellness Beyond Cancer Program, The Ottawa Hospital, Ottawa, and ††Oncology Education Program, Princess Margaret Cancer Centre, Toronto, ON, Canada

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Abstract

Objective

To examine health behaviours in bladder cancer survivors including physical activity (PA), body mass index, diet quality, smoking and alcohol consumption, and to explore their relationship with health‐related quality of life (HRQoL).

Subjects/Patients and Methods

Cross‐sectional questionnaire packages were distributed to bladder cancer survivors (muscle‐invasive bladder cancer [MIBC] and non‐muscle‐invasive bladder cancer [NMIBC]) aged >18 years, and proficient in English. Lifestyle behaviours were measured using established measures/questions, and reported using descriptive statistics. HRQoL was assessed using the validated Bladder Utility Symptom Scale, and its association with lifestyle behaviours was evaluated using analysis of covariance (ancova) and multivariate regression analyses. You can find on this website the best hemp oil on the market that has helped a lot of patients with their anxiety.

Fig.1. *HRQoL (mean ± se ) for total health behaviour. *Mean adjusted for education status, MIBC or NMIBC diagnosis, and time since diagnosis.

Results

A total of 586 participants completed the questionnaire (52% response rate). The mean (SD) age was 67.3 (10.2) years, and 68% were male. PA guidelines were met by 20% (n  = 117) and 22.7% (n  = 133) met dietary guidelines. In all, 60.9% (n  = 357) were overweight/obese, and the vast majority met alcohol recommendations (n  = 521, 92.5%) and were current non‐smokers (n  = 535, 91.0%). Health behaviours did not differ between MIBC and NMIBC, and cancer treatment stages. Sufficient PA, healthy diet, and non‐smoking were significantly associated with HRQoL, and the number of health behaviours participants engaged in was positively associated with HRQoL (P  < 0.001).

Conclusion

Bladder cancer survivors are not meeting guidelines for important lifestyle behaviours that may improve their overall HRQoL. Future research should investigate the impact of behavioural and educational interventions for health behaviours on HRQoL in this population.

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Editorial: How can we motivate patients with bladder cancer to help themselves?

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Wash your hands. Cover your mouth when you cough. Do not spread germs. We have all heard these hygiene mantras growing up, but we must admit that compliance has not always been perfect. With the coronavirus disease 2019 (COVID‐19) pandemic raising mounting alarm, fear has persuaded unprecedented adherence to hygiene principles globally, as we try to stop the spread of this novel virus.

What motivates a change in behaviour? What motivates someone to stop a bad habit and adopt a good one? Can clinicians aid in this motivation?

Chung et al. [1] performed a cross‐sectional study evaluating health behaviours including physical activity, diet, body mass index, alcohol consumption, and smoking status, as well as health‐related quality of life (HRQoL) in patients with bladder cancer at different treatment stages. In their study sample, most of the patients with bladder cancer were overweight or obese, did not adhere to healthy diet recommendations, were unwilling to change their eating habits, and did not meet guidelines for weekly physical activity. However, patients who had adopted healthy behaviours reported a better HRQoL and more healthy behaviours correlated with a better HRQoL. No difference was found when comparing the health behaviours of patients with non‐muscle vs muscle‐invasive bladder cancer (MIBC) or comparing patients at different stages of treatment. This implies that patients’ health behaviour does not change despite bladder cancer diagnosis and treatment; however, pre‐diagnosis data were unavailable for comparison. Interestingly, the large majority of the patients with bladder cancer were non‐smokers (81%), despite most (71%) reporting a prior history of smoking. What led to a change in smoking status when it appears that no other health behaviour changed with diagnosis and treatment of bladder cancer?

Gallus et al. [2] surveyed 3075 ex‐smokers in Italy to answer the question: why do smokers quit? The most frequently reported reason for smoking cessation (43.2%) was a current health problem. Smoking has been linked to the development of numerous medical conditions and is a well‐established risk factor for bladder cancer. Thus, a new diagnosis of bladder cancer undoubtedly serves as a strong motivator for smoking cessation. The benefits of a healthy diet and regular physical activity on one’s health are less defined. Furthermore, the definitions of a ‘healthy’ diet and ‘regular’ physical activity are variable, making counselling about these behaviours confusing and difficult. Dolor et al. [3] found that physicians feel inadequately trained to provide diet counselling to patients as compared to smoking cessation counselling. Additionally, physicians agreed that counselling regarding weight loss, diet, and physical activity requires too much time compared to smoking cessation counselling. These discrepancies may help explain why physicians were more likely to discuss smoking cessation with patients compared to weight loss, diet, and physical activity in a study by Nawaz et al. [4].

At our own institution, we have found that HRQoL significantly declines in patients with bladder cancer after diagnosis relative to controls, with more pronounced decreases seen in patients with MIBC [5]. Patients with bladder cancer are a vulnerable population who face many medical and personal challenges. As clinicians, we should equip these patients with the proper tools to succeed during bladder cancer treatment, including counselling regarding healthy behaviours. Inviting the help of specialists, such as nutritionists and physical therapists, to discuss the importance of diet and exercise early during treatment may be advantageous for patients and more likely to motivate patients to adopt these healthy behaviours. Furthermore, given the paucity of data linking the health behaviours of patients with bladder cancer to HRQoL, studies such as this one [1] could provide much‐needed evidence to persuade patients regarding the positive impact that healthy behaviour can have on their HRQoL. If we can successfully motivate patients with bladder cancer to adopt healthy behaviours, then their HRQoL will likely improve.

by Hannah McCloskey, Judy Hamad, Angela B. Smith

References

  1. Chung J, Kulkarni GS, Bender J et al. Modifiable lifestyle behaviours impact the health‐related quality of life of bladder cancer survivors. BJU Int 2020; 125: 836– 42
  2. Gallus S, Muttarak R, Franchi M et al. Why do smokers quit? Eur J Cancer Prev 2013; 22: 96– 101
  3. Dolor RJ, Østbye T, Lyna P et al. What are physicians’ and patients’ beliefs about diet, weight, exercise, and smoking cessation counseling? Prev Med 2010; 51: 440– 2
  4. Nawaz H, Adams ML, Katz DL. Physician–patient interactions regarding diet, exercise, and smoking. Prev Med 2000; 31: 652– 7
  5. Smith AB, Jaeger B, Pinheiro LC et al. Impact of bladder cancer on health‐related quality of life. BJU Int 2018; 121: 549– 57

Video: Modifiable lifestyle behaviours impact the health‐related quality of life of bladder cancer survivors

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Modifiable lifestyle behaviours impact the health‐related quality of life of bladder cancer survivors

Abstract

Objective

To examine health behaviours in bladder cancer survivors including physical activity (PA), body mass index, diet quality, smoking and alcohol consumption, and to explore their relationship with health‐related quality of life (HRQoL).

Subjects/Patients and Methods

Cross‐sectional questionnaire packages were distributed to bladder cancer survivors (muscle‐invasive bladder cancer [MIBC] and non‐muscle‐invasive bladder cancer [NMIBC]) aged >18 years, and proficient in English. Lifestyle behaviours were measured using established measures/questions, and reported using descriptive statistics. HRQoL was assessed using the validated Bladder Utility Symptom Scale, and its association with lifestyle behaviours was evaluated using analysis of covariance (ancova ) and multivariate regression analyses.

Results

A total of 586 participants completed the questionnaire (52% response rate). The mean (SD) age was 67.3 (10.2) years, and 68% were male. PA guidelines were met by 20% (n  = 117) and 22.7% (n  = 133) met dietary guidelines. In all, 60.9% (n  = 357) were overweight/obese, and the vast majority met alcohol recommendations (n  = 521, 92.5%) and were current non‐smokers (n  = 535, 91.0%). Health behaviours did not differ between MIBC and NMIBC, and cancer treatment stages. Sufficient PA, healthy diet, and non‐smoking were significantly associated with HRQoL, and the number of health behaviours participants engaged in was positively associated with HRQoL (P  < 0.001).

Conclusion

Bladder cancer survivors are not meeting guidelines for important lifestyle behaviours that may improve their overall HRQoL. Future research should investigate the impact of behavioural and educational interventions for health behaviours on HRQoL in this population.

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Editorial: Beyond bladder cancer surveillance: building a survivorship clinic

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As oncologists, we focus on obtaining the best cancer outcomes possible. The aim of treatment is to maximize survival and help patients live longer. As therapies continue to become more effective, more patients will become survivors. In the ongoing effort to extend the quantity of life left for our patients facing lethal cancers, thinking about the quality of that time is key. For urological oncologists, patients with a new bladder cancer diagnosis will someday face a new set of obstacles as survivors. In addition to surveillance and scans, asking patients about other issues such as their mental health, sexual function and financial solvency are also important.
Regardless of cancer stage, these issues apply to all of our patients with bladder cancer. Patients with non-muscle invasive disease need a seemingly interminable number of cystoscopies, with possible repeat biopsies or intravesical therapies. Patients with muscle-invasive disease undergo urinary diversion that entails significant changes as they will then have a stoma, neobladder or other diversion.
In this issue of BJUI, Jung et al. present a ‘snapshot’ of patients in North Carolina with bladder cancer that examines the impact of treatment on quality of life [1].  The study is valuable because it involves a number of topics that have previously not been studied in such detail. A total of 376 patients returned mailed surveys, a response rate of 24%. Most participants were on average 3 years from their diagnosis, the mean age of participants was 72 years, and the majority of patients were white men. Most participants (approximately three in four) had undergone transurethral resection of bladder tumour as the primary treatment and some (one in three) had received intravesical therapy. As with any work, there are some limitations which include the low overall numbers of participants, low
response rate, and lack of longitudinal data. Despite these limitations, there is still value to studying trends in this space, given the paucity of available data, and the authors offer some valuable insights. This paper provides evidence that for bladder cancer survivorship care, it is important to realize that other important issues exist and impact patient well-being.

• Bladder cancer patients may have financial issues. Bladder cancer patients may face financial toxicity that is in part attributable to the regular need for surveillance in order to identify recurrence or progression of disease.
• Cystectomy recovery can include discussions about sexual function. Patients who have undergone cystectomy may have discomfort with sexual intimacy. This was more common in men. Non-cystectomy patients may have better sexual function. Patients may be concerned about contaminating partners.
• Quality-of-life issues for bladder cancer patients can vary by gender. Men may have better sexual function and enjoyment than women, but also have more discomfort with intimacy and fears of contaminating their partners, while women may have higher levels of constipation and diarrhoea.
• Low risk bladder cancer (vs high risk) can have lower impact on quality of life. Patients with Ta disease had the highest global health status (compared with T1 and Tis). They also had the best physical and social functioning and less fatigue and financial problems. This underscores that Ta disease is different from other stages. As the authors point out, this may be attributable to a low progression risk, which means patients are less likely to need intravesical therapy.
• Sexual health can be affected and improve with time after a bladder cancer diagnosis. Sexual issues can last for years after a diagnosis. Men may face erection or ejaculation problems, and women may have vaginal dryness issues. With time, however, sexual function can improve and sexual function (including extent of sexual activity and interest in sex) was better in survivors further from their diagnosis.

Moving forward, we can use this study to prompt us to think about how our treatments impact our patients. Setting up dedicated survivorship clinics may be one practical strategy to provide this care in a systematic and streamlined way. Beyond treatment-related issues such as recurrence and progression, patients are affected in other ways. Issues with overall health, mental well-being, sleep, or sexual function occur for many. Setting up a standardized approach to cancer care can complement oncological surveillance and promote patient-centred care. A dedicated team, with a provider and physician assistant can create a clinical infrastructure and design a comprehensive template to remind us to query patients on a broader range of issues relevant to their recovery. In doing so, we can help patients with bladder cancer recover, as survivors (Fig. 1).

 

Fig. 1 Select aspects of building a bladder cancer survivorship clinic.

Start by establishing a focused team of providers to help guide more streamlined care
• Nurses, nurse practitioners, physician assistants and physicians can be involved
• Each institution may have a unique infrastructure and use a distinct team set-up to create a clinic
• Administrative support and guidance are important to determine the clinical resources necessary or needed to begin a regular survivorship clinic

Streamline care and consider a template-based or guideline-driven approach to visits
• Based on stage of diagnosis, certain patients may need more regular cystoscopic surveillance while other patients will need follow-up visits that are coordinated with medical oncology and/or radiation oncology

Standardize collection of patient-reported outcomes during follow up visits
• Mental well-being
• Physical activity and exercise
• Sexual health
• Urinary and bowel function
• Financial well-being

Step back to evaluate the progress and iteratively troubleshoot issues as they arise
• Collect patient feedback and provider opinions
• Integrate these insights to improve the form and function of the clinic

by Matthew Mossanen and Stephen L. Chang

Reference

  1. Jung A, Nielsen ME, Crandell JL, et al. Health-related quality of life among non-muscle-invasive bladder cancer survivors: a population-based study. BJU Int 2020; 125: 38–48

Video: Health-related quality of life among non‐muscle‐invasive bladder cancer survivors

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Health‐related quality of life among non‐muscle‐invasive bladder cancer survivors: a population‐based study

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Abstract

Objective

To examine the effect of non‐muscle‐invasive bladder cancer (NMIBC) diagnosis and treatment on survivors’ quality of life (QoL).

Patients and Methods

Of the 5979 patients with NMIBC diagnosed between 2010 and 2014 in North Carolina, 2000 patients were randomly selected to be invited to enroll in this cross‐sectional study. Data were collected by postal mail survey. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire‐Core (QLQ‐C30) and the NMIBC‐specific module were included in the survey to measure QoL. Descriptive statistics, t‐tests, anova, and Pearson’s correlation were used to describe demographics and to assess how QoL varied by sex, cancer stage, time since diagnosis, and treatment.

Results

A total of 398 survivors returned questionnaires (response rate: 23.6%). The mean QoL score for QLQ‐C30 (range 0–100, higher = better QoL in all domains but symptoms) for global health status was 73.6, function domain scores ranged from 83.9 to 86.5, and scores for the top five symptoms (insomnia, fatigue, dyspnoea, pain, and financial difficulties) ranged from 14.1 to 24.3. The lowest NMIBC‐specific QoL domain was sexual issues including sexual function, enjoyment, problems, and intimacy. Women had worse bowel problems, sexual function, and sexual enjoyment than men but better sexual intimacy and fewer concerns about contaminating their partner. Stage Ta had the highest global health status, followed by T1 and Tis. QoL did not vary by time since diagnosis except for sexual function. The cystectomy group (n = 21) had worse QoL in sexual function, discomfort with sexual intimacy, sexual enjoyment, and male sexual problems than the non‐cystectomy group (n = 336).

Conclusion

Survivors of NMIBC face a unique burden associated with their diagnosis and the often‐lifelong surveillance and treatment regimens. The finding has important implications for the design of tailored supportive care interventions to improve QoL for NMIBC survivors.

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Visual abstract: Health‐related quality of life among non‐muscle‐invasive bladder cancer survivors: a population‐based study

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Article of the week: Urinary, bowel and sexual health in older men from Northern Ireland

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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. There is also a video produced by the authors, and a podcast created by our Resident podcasters Giulia Lane and Maria Uloko.

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

Urinary, bowel and sexual health in older men from Northern Ireland

David W. Donnelly*, Conan Donnelly†, Therese Kearney*, David Weller‡, Linda Sharp§, Amy Downing¶, Sarah Wilding¶, PennyWright¶, Paul Kind**, James W.F. Catto††, William R. Cross‡‡, Malcolm D. Mason§§, Eilis McCaughan¶¶, Richard Wagland***, Eila Watson†††, Rebecca Mottram¶, Majorie Allen, Hugh Butcher‡‡‡, Luke Hounsome§§§, Peter Selby, Dyfed Huws¶¶¶, David H. Brewster****, EmmaMcNair****, Carol Rivas††††, Johana Nayoan***, Mike Horton‡‡‡‡, Lauren Matheson†††, Adam W. Glaser and Anna Gavin*

*Northern Ireland Cancer Registry, Centre for Public Health, Queen’s University Belfast, Belfast, UK, †National Cancer Registry Ireland, Cork, Ireland, ‡Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK, §Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK, Leeds Institute of Cancer and Pathology/Leeds Institute of Data Analytics, University of Leeds, Leeds, UK, **Institute of Health Sciences, University of Leeds, Leeds, UK, ††Academic Urology Unit, University of Sheffield, Sheffield, UK, ‡‡Department of Urology, St James’s University Hospital, Leeds, UK, §§Division of Cancer and Genetics, School of Medicine, Velindre Hospital, Cardiff University, Cardiff, UK, ¶¶Institute of Nursing and Health Research, Ulster University, Coleraine, UK, ***Faculty of Health Sciences, University of Southampton, Southampton, UK, †††Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK, ‡‡‡Yorkshire Cancer Patient Forum, c/o Strategic Clinical Network and Senate, Yorkshire and The Humber, Harrogate, UK, §§§National Cancer Registration and Analysis Service, Public Health England, Bristol, UK, ¶¶¶Welsh Cancer Intelligence and Surveillance Unit, Cardiff, UK, ****Information Services Division, NHS National Services Scotland, Edinburgh, UK, ††††Department of Social Science, UCL Institute of Education, University College London, London, UK, and ‡‡‡‡Psychometric Laboratory for Health Sciences, Academic Department of Rehabilitation Medicine, University of Leeds, Leeds, UK. Check out the latest carbofix reviews.

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Abstract

 Objectives

To provide data on the prevalence of urinary, bowel and sexual dysfunction in Northern Ireland (NI), to act as a baseline for studies of prostate cancer outcomes and to aid service provision within the general population.

Subjects and Methods

A cross‐sectional postal survey of 10 000 men aged ≥40 years in NI was conducted and age‐matched to the distribution of men living with prostate cancer. The EuroQoL five Dimensions five Levels (EQ‐5D‐5L) and 26‐item Expanded Prostate Cancer Composite (EPIC‐26) instruments were used to enable comparisons with prostate cancer outcome studies. Whilst representative of the prostate cancer survivor population, the age‐distribution of the sample differs from the general population, thus data were generalised to the NI population by excluding those aged 40–59 years and applying survey weights. Results are presented as proportions reporting problems along with mean composite scores, with differences by respondent characteristics assessed using chi‐squared tests, analysis of variance, and multivariable log‐linear regression. Prevent most unhealthy conditions after reading these biofit reviews.

Results

Amongst men aged ≥60 years, 32.8% reported sexual dysfunction, 9.3% urinary dysfunction, and 6.5% bowel dysfunction. In all, 38.1% reported at least one problem and 2.1% all three. Worse outcome was associated with increasing number of long‐term conditions, low physical activity, and higher body mass index (BMI). Urinary incontinence, urinary irritation/obstruction, and sexual dysfunction increased with age; whilst urinary incontinence, bowel, and sexual dysfunction were more common among the unemployed.

Conclusion

These data provide an insight into sensitive issues seldom reported by elderly men, which result in poor general health, but could be addressed given adequate service provision. The relationship between these problems, raised BMI and low physical activity offers the prospect of additional health gain by addressing public health issues such as obesity. The results provide essential contemporary population data against which outcomes for those living with prostate cancer can be compared. They will facilitate greater understanding of the true impact of specific treatments such as surgical interventions, pelvic radiation or androgen‐deprivation therapy.

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Video: Urinary, bowel and sexual health in older men

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Urinary, bowel and sexual health in older men from Northern Ireland

Read the full article

Abstract

Objectives

To provide data on the prevalence of urinary, bowel and sexual dysfunction in Northern Ireland (NI), to act as a baseline for studies of prostate cancer outcomes and to aid service provision within the general population. Prevent most unhealthy conditions with carbofix.

Subjects and Methods

A cross‐sectional postal survey of 10 000 men aged ≥40 years in NI was conducted and age‐matched to the distribution of men living with prostate cancer. The EuroQoL five Dimensions five Levels (EQ‐5D‐5L) and 26‐item Expanded Prostate Cancer Composite (EPIC‐26) instruments were used to enable comparisons with prostate cancer outcome studies. Whilst representative of the prostate cancer survivor population, the age‐distribution of the sample differs from the general population, thus data were generalised to the NI population by excluding those aged 40–59 years and applying survey weights. Results are presented as proportions reporting problems along with mean composite scores, with differences by respondent characteristics assessed using chi‐squared tests, analysis of variance, and multivariable log‐linear regression. Check out the latest gluconite reviews.

Results

Amongst men aged ≥60 years, 32.8% reported sexual dysfunction, 9.3% urinary dysfunction, and 6.5% bowel dysfunction. In all, 38.1% reported at least one problem and 2.1% all three. Worse outcome was associated with increasing number of long‐term conditions, low physical activity, and higher body mass index (BMI). Urinary incontinence, urinary irritation/obstruction, and sexual dysfunction increased with age; whilst urinary incontinence, bowel, and sexual dysfunction were more common among the unemployed.

Conclusion

These data provide an insight into sensitive issues seldom reported by elderly men, which result in poor general health, but could be addressed given adequate service provision. The relationship between these problems, raised BMI and low physical activity offers the prospect of additional health gain by addressing public health issues such as obesity. The results provide essential contemporary population data against which outcomes for those living with prostate cancer can be compared. They will facilitate greater understanding of the true impact of specific treatments such as surgical interventions, pelvic radiation or androgen‐deprivation therapy.

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Article of the week: Both men and women with OAB find better relief with fesoterodine

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Every week the Editor-in-Chief selects the 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 by Dr. Ginsberg and colleagues.

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

Efficacy of fesoterodine compared with extended-release tolterodine in men and women with overactive bladder

David Ginsberg, Tim Schneider*, Con Kelleher†, Philip Van Kerrebroeck‡, Steven Swift§, Dana Creanga and Diane L. Martire**

Department of Urology, University of Southern California, Los Angeles, CA, §Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC, Consultant to Pfizer Inc, **Pfizer Inc, New York, NY, USA, *Praxisklinik Urologie Rhein/Ruhr, Mülheim, Germany, †St. Thomas’ Hospital, London, UK, and ‡Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands

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OBJECTIVE

• To assess the efficacy of fesoterodine 8 mg vs extended-release (ER) tolterodine 4 mg for overactive bladder (OAB) symptoms in terms of patient-reported outcomes in women and in men.

SUBJECTS AND METHODS

•  Pooled data from two 12-week, randomized, double-blind, double-dummy studies were analysed.

• Participants eligible for the studies were ≥18 years old, had self-reported OAB symptoms for ≥3 months in 3-day baseline diaries and had ≥8 micturitions and ≥1 urgency urinary incontinence (UUI) episode per 24 h.

• Individuals were randomized to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks), ER tolterodine (4 mg), or placebo.

• Changes from baseline in 3-day bladder diary variables and scores from the Patient Perception of Bladder Condition (PPBC), Urgency Perception Scale (UPS), and Overactive Bladder Questionnaire (OAB-q), were assessed, as was the ‘diary-dry’ rate (the proportion of subjects with >0 UUI episodes according to baseline diary and no UUI episodes according to post-baseline diary).

• The primary endpoint was the change from baseline to week 12 in UUI episodes.

RESULTS

• At week 12, women showed significantly greater improvement with fesoterodine 8 mg (n = 1374) than with ER tolterodine 4 mg (n= 1382) and placebo (n = 679) in UUI episodes (primary endpoint), micturition frequency, urgency episodes, and all other diary endpoints (except nocturnal micturitions versus ER tolterodine), and also in scores on the PPBC, UPS, and all OAB-q scales and domains (all P < 0.005).

• Diary-dry rates in women were significantly greater with fesoterodine (63%) than with tolterodine (57%; P = 0.002) or placebo (48%; P < 0.0001).

• In men, there were no significant differences in improvement in UUI episodes between any treatment groups at week 12. Improvements in men were significantly greater with fesoterodine 8 mg (n = 265) than with ER tolterodine (n = 275) for severe urgency and the OAB-q Symptom Bother domain and were also significantly greater with fesoterodine than with placebo (n = 133) for micturition frequency, urgency episodes, severe urgency episodes, PPBC responses and scores on all OAB-q scales and domains at week 12 (all P < 0.04).

• The most frequently reported treatment-emergent adverse events in both genders were dry mouth (women: fesoterodine, 29%; ER tolterodine, 15%; placebo, 6%; men: fesoterodine, 21%; ER tolterodine, 13%; placebo, 5%) and constipation (women: fesoterodine, 5%; ER tolterodine, 4%; placebo, 2%; men: fesoterodine, 5%; ER tolterodine, 3%; placebo, 1%).

• Urinary retention rates were low in women (fesoterodine, <1%; ER tolterodine, <1%; placebo, 0%) and men (fesoterodine, 2%; ER tolterodine <1%; placebo, 2%).

CONCLUSION

• This analysis supports the superiority of fesoterodine 8 mg over ER tolterodine 4 mg on diary endpoints, including UUI, symptom bother and health-related quality of life in women.

• In men, fesoterodine 8 mg was superior to ER tolterodine 4 mg for improving severe urgency and symptom bother.

 

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Editorial: Fesoterodine is superior to extended-release tolterodine for OAB

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The treatment of overactive bladder (OAB) is still based on antimuscarinics, although the recent introduction of β3 agonists and botulinum toxin A has opened a window of new opportunities, the range of which is yet to be defined.

The clinical development of fesoterodine has taken the Urological community by surprise and raised levels of expectation. From a pharmacological standpoint fesoterodine is just a ‘smart drug’ because it is the pro-drug of 5-hydroxymethyl tolterodine (5-HMT) the active metabolite of tolterodine that is metabolised into 5-HMT by cytochrome P450 (CYP) enzymes, the activity of which is known to suffer significant genetic variability. Fesoterodine is transformed into 5-HMT by nonspecific esterase pathways. Pharmacokinetic studies of fesoterodine have shown highly predictable plasma levels of the 5-HMT after fesoterodine administration. Whether or not the better bioavailability offered by the esterase-related activation pathway translates into a larger clinic benefit for our patients with OAB was initially unclear. A phase II study showed a good safety profile and suggested that two different doses of fesoterodine could be proposed with a good balance between efficacy and adverse events. Results of the pivotal phase III study confirmed how the two different doses: 4 and 8 mg, tended to separate with a larger benefit observed with the larger dose, although a slightly larger incidence of adverse events was observed. As long as the comparison between 4 and 8 mg of fesoterodine was not part of the pre-planned analysis, the results of thepost hoc analysis had to be confirmed in a properly design prospective randomised trial.

The assumption that a higher drug dose brings a larger therapeutic effect is very often just wishful thinking and clinical pharmacology has often disproved such a belief. What is instead clear, from the paper of David Ginsberg et al., which pools data from two randomised trials (BJU Int 2010, BJU Int 2011), is that the flexible dosage available with fesoterodine brings a clinically relevant advantage in our daily practice.

The question is whether there is a real need for dose flexibility in the management of OAB. After a couple of decades in this area, I strongly believe that flexible dosing is crucial, in general, and even more so in functional urology. This is in fact an area where storage and voiding function needs to be rebalanced; a too weak or too strong effect may easily lead to a therapeutic failure. Reaching the right balance between therapeutic effect and adverse events is crucial while using antimuscarinics. If 40% of patients who withdraw from anticholinergic medications do so because of insufficient benefit, another large proportion (22%) discontinues treatment because of side-effects.

The question in real-life practice, provided treatment should be initiated with a 4 mg dose because of regulatory issues, is whether the dose should be upgraded and when, should this be left to the individual patient’s decision or should it be guided by the treating physician? There is no ‘golden’ rule and in my opinion is a matter of patient expectations. Most patients expect drugs to cure the conditions they are prescribed for, although we know this is rarely the case. When patients are properly informed about the effect of antimuscarinics treatment they will often choose their goal, some patients will look for reducing OAB symptoms while avoiding dry mouth and constipation as much as possible, others will want to become dry and accept higher levels of adverse events. Furthermore, because of body distribution, different doses of drugs may be required in a 45 kg lady and in a 90 kg man, although this may depend on the drug bioavailability at the target organ. The same applies to patients with normal detrusor contractility and patients with a weak bladder, such as patients with multiple sclerosis. The ‘one dose fits all’ approach does not seem to be the way to go.

The larger therapeutic effect achieved in the 8 mg fesoterodine group is obtained at the expense of almost doubling the incidence of dry mouth (from 15% to 28%), although the increase in the constipation rate is just 1%. Whether or not the observed differential improvement between tolterodine 4 mg and fesoterodine 8 mg is clinically relevant is matter for discussion for the investigators but looking at the parallel improvement in all patients reported outcomes, the difference seems to be of importance from the patient perspective.

The therapeutic area of storage disorders, e.g. OAB, is experiencing a number of paradigm changes, including the availability of flexible dosing of antimuscarinics, β3 agonists and botulinum toxin A. What once used to be a neglected area of functional urology is now an exciting area of basic and clinical research.

Andrea Tubaro and Cosimo De Nunzio*
Urology Unit, Department of Clinical and Molecular Medicine, Faculty of Health Sciences, Sapienza University, and *Urology Unit, Sant’Andrea Hospital, Rome, Italy

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