Tag Archive for: Article of the Week

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

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

Video: Fesoterodine vs tolterodine in men and women with OAB

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.

Article of the week: Remote ischaemic preconditioning reduces injury during partial nephrectomy

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. Huang and colleagues to accompany their article.

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

Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a ‘blinded’ randomised controlled trial

Jiwei Huang, YongHui Chen, Baijun Dong, Wen Kong, Jin Zhang, Wei Xue, DongMing Liu and Yiran Huang

Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China

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OBJECTIVE

• To evaluate whether remote ischaemic preconditioning (RIPC) reduces renal injury in patients undergoing laparoscopic partial nephrectomy (LPN).

PATIENTS AND METHODS

• In all, 82 patients undergoing LPN were randomly assigned to either the RIPC or control group, with 40 and 38 patients, respectively completing 6-months follow-up.

•  RIPC was conducted after induction of anaesthesia, which consisted of three 5-min cycles of right lower limb ischaemia and 5 min of reperfusion during each cycle.

•  The primary outcome was the absolute change in glomerular filtration rate (GFR) of the affected kidney by renal scintigraphy from baseline to 6 months.

•  The secondary outcomes included urinary retinol-binding protein (RBP) levels measured at 24 and 48 h, serum creatinine, and estimated GFR (eGFR) at 1 and 6 months, and changes in GFR by renal scintigraphy.

RESULTS

•  There were no differences in the change of GFR of the affected kidney at 6 months, while it was significantly decreased by 15.0% in the control group vs 8.8% in the RIPC group at 1 month (P = 0.034).

•  The urinary RBP levels increased 8.4-fold at 24 h in the control group compared with a lower increase of 3.9-fold in the RIPC group (P < 0.001).

•  There were no differences in the serum creatinine level or eGFR at 1 and 6 months between the two groups.

CONCLUSIONS

•  In patients undergoing LPN, RIPC using transient lower limb ischaemia may reduce renal impairment in the short term, but failed in the longer term despite a non-significant trend in favour of RIPC.

•  These novel data support the need for a larger study of RIPC during LPN surgery.

 

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Article of the week: No difference in sexual function seen between monopolar and bipolar TURP

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.

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

Bipolar vs monopolar transurethral resection of the prostate: evaluation of the impact on overall sexual function in an international randomized controlled trial setting

Charalampos Mamoulakis1,2, Andreas Skolarikos3, Michael Schulze4, Cesare M. Scoffone5, Jens J. Rassweiler4, Gerasimos Alivizatos3, Roberto M. Scarpa5 and Jean J.M.C.H. de la Rosette1

1Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands, 2Department of Urology, University Hospital of Heraklion, University of Crete Medical School, Heraklion, Crete, Greece, 3Second Department of Urology, Sismanoglio Hospital, University of Athens Medical School, Athens, Greece, 4Department of Urology, SLK Kliniken Heilbronn, University of Heidelberg, Heilbronn, Germany, and 5Department of Urology, San Luigi Hospital, University of Turin, Orbassano, Turin, Italy

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OBJECTIVE

• To compare monopolar and bipolar transurethral resection of the prostate (M-TURP and B-TURP, respectively) using a true bipolar system, for the first time in an international multicentre double-blind randomized controlled trial focusing on the overall sexual function quantified with the International Index of Erectile Function Questionnaire (IIEF-15). Other baseline/perioperative parameters potentially influencing erectile function (EF) after TURP were secondarily investigated.

MATERIALS AND METHODS

• From July 2006 to June 2009, consecutive TURP candidates with benign prostatic obstruction were prospectively recruited in four academic urological centres, randomized 1:1 into M-TURP/B-TURP arms and followed up at 6 weeks, 6 and 12 months after surgery. In all, 295 eligible patients were enrolled.

• Overall sexual function was quantified using self-administered IIEF-15 at baseline and at each subsequent visit.

•  Total IIEF/domain scores were calculated and EF score classified erectile dysfunction severity. Differences in erectile dysfunction severity at each visit compared with baseline (EF evolution), classified patients into ‘improved’, ‘stable’ or ‘deteriorated’.

•  Pre-postoperative IIEF/domain scores and differences in the distribution of EF evolution were compared between arms throughout follow-up.

RESULTS

• In all, 279 patients received the allocated intervention; 218/279 patients (78.1%) provided complete IIEF-15 data at baseline and were considered in sexual function analysis. Complete IIEF-15 data were available from 193/218 (88.5%), 186/218 (85.3%) and 179/218 (82.1%) patients at 6 weeks, 6 months and 12 months, respectively.

• Sexual function did not differ significantly between arms during follow-up (scores: IIEF, P = 0.750; EF, P = 0.636; orgasmic function, P = 0.868; sexual desire, P = 0.735; intercourse satisfaction, P = 0.917; overall satisfaction, P = 0.927).

• Resection type was not a predictor of any sexual function changes observed.

• Distribution of EF evolution did not differ between arms at any time (M-TURP vs B-TURP at 12 months: improved, 23/87 [26.4%] vs 18/92 [19.6%]; stable, 53/87 [60.9%] vs 56/92 [60.8%]; deteriorated, 11/87 [12.7%] vs 18/92 [19.6%]; P = 0.323).

CONCLUSION

• There were no differences between M-TURP/B-TURP in any aspect of sexual function.

 

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Article of the week: Dutch GPs influenced by ERSPC PSA study

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 of Miss van der Meer and Dr Blanker discussing their article.

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

Impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) on prostate-specific antigen (PSA) testing by Dutch general practitioners

Saskia Van der Meer, Boudewijn J. Kollen*, Willem H. Hirdes, Martijn G. Steffens, Josette E.H.M. Hoekstra-Weebers, Rien M. Nijman and Marco H. Blanker*

Department of Urology, Isala Clinics, Zwolle, and Departments of *General Practice, Psychosocial services and Urology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

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OBJECTIVE

• To determine the impact of the European Randomized Study of Screening for Prostate Cancer (ERSPC) publication in 2009 on prostate-specific antigen (PSA) level testing by Dutch general practitioners (GPs) in men aged ≥40 years.

MATERIALS AND METHODS

• Retrospective study with a Dutch insurance company database (containing PSA test claims) and a large district hospital-laboratory database (containing PSA-test results).

• The difference in primary PSA-testing rate as well as follow-up testing before and after the ERSPC was tested using the chi-square test with statistical significance at P < 0.05.

RESULTS

• Decline in PSA tests 4 months after ERSPC publication, especially for men aged ≥60 years.

• Primary testing as well as follow-up testing decreased, both for PSA levels of <4 ng/mL as well as for PSA levels of 4–10 ng/mL.

• Follow-up testing after a PSA level result of >10 ng/mL moderately increased (P = 0.171).

• Referral to a urologist after a PSA level result of >4 ng/mL decreased slightly after the ERSPC publication (P = 0.044).

CONCLUSIONS

• After the ERSPC publication primary PSA testing as well as follow-up testing decreased.

• Follow-up testing seemed not to be adequate after an abnormal PSA result. The reasons for this remain unclear.

 

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Article of the week: Botulinum toxins are not interchangeable for overactive bladder

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 of Miss Ravindra and colleagues discussing their article.

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

Botulinum toxin type A for the treatment of non-neurogenic overactive bladder: does using onabotulinumtoxinA (Botox®) or abobotulinumtoxinA (Dysport®) make a difference?

Pravisha Ravindra, Benjamin L. Jackson and Richard J. Parkinson

Nottingham Urology Centre, Nottingham University Hospitals, NHS Trust, Nottingham, UK

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OBJECTIVE

• To compare the clinical effects of two different commercially available botulinum toxin type A products, onabotulinumtoxinA (Botox®; Allergan Inc., Irvine, CA, USA) and abobotulinumtoxinA (Dysport®; Ipsen Ltd, Slough, UK), on non-neurogenic overactive bladder (OAB).

PATIENTS AND METHODS

• We included 207 patients, who underwent treatment with botulinum toxin type A for non-neurogenic OAB from January 2009 to June 2012 at our institution, in a prospective database that recorded details of their presentation, treatment and outcomes.

• In December 2009, our institution switched from using onabotulinumtoxinA to using abobotulinumtoxinA.

RESULTS

• Results from the onabotulinumtoxinA cohort (n = 101) and the abobotulinumtoxinA cohort (n = 106) were compared.

• Similar reductions in daytime frequency, nocturia and incontinence episodes were observed after treatment, with no difference in duration of effect.

• The abobotulinumtoxinA cohort had almost twice the rate of symptomatic urinary retention (23 vs 42%) requiring intermittent self-catheterisation (ISC).

CONCLUSIONS

• AbobotulinumtoxinA use was complicated by a significantly higher risk of requiring ISC.

• The study suggests that these two toxins are not interchangeable at the doses used.

 

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Article of the week: Plasma vaporization: the new standard for PCNL tract creation?

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 procedure by Dr Chiang and colleagues showing tract creation using plasma vaporization.

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

 

Randomized and prospective trial comparing tract creation using plasma vaporization with balloon dilatation in percutaneous nephrolithotomy

Po Hui Chiang and Hsin Hao Su

Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan

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OBJECTIVE

• To evaluate the efficacy and safety of plasma vaporization for tract creation in percutaneous nephrolithotomy (PCNL).

PATIENTS AND METHODS

• In this randomized prospective trial we enrolled 65 patients and assigned each to one of two groups: 33 patients were randomly scheduled to undergo plasma vaporization and 32 were scheduled to undergo balloon dilatation for tract creation.

• A bipolar resectoscope mounted with a plasma vaporization button electrode or a traditional balloon dilator were used to create the nephrostomy tract.

RESULTS

• The mean blood loss, mean length of hospital stay and mean operating time, stone-free rates and postoperative complications in the two groups were compared using the t-test or chi-squared test (Fisher’s exact test).

• The plasma vaporization group had a significantly lower mean (SD) decrease in haematocrit level (3.5 [2.8]% vs 6.6 [3.3]%; P = 0.02) and a shorter mean (SD) hospital stay (2.6 [1.2] days vs 5.3 [3.4] days; P = 0.0).

• There were no significant differences in the operating time, stone-free rate or cases of postoperative fever between the two groups.

CONCLUSION

• The plasma vaporization technique is safe, leads to less blood loss than the other techniques, and is a simple solution for creating the nephrostomy tract for PCNL.

 

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Article of the week: Staging inguinal disease in patients with penile cancer

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.

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

 

Phase 1 prospective evaluation of the oncological adequacy of robotic assisted video-endoscopic inguinal lymphadenectomy in patients with penile carcinoma

Surena F. Matin, Janice N. Cormier*, John F. Ward, Louis L. Pisters, Christopher G. Wood, Colin P.N. Dinney, Richard E. Royal*, Xuelin Huang and Curtis A. Pettaway

Departments of Urology, *Surgical Oncology and Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA

Read the full article
OBJECTIVE

• To prospectively determine the oncological adequacy of robotic assisted video-endoscopic inguinal lymphadenectomy (RAVEIL).

PATIENTS AND METHODS

• Patients with T1-3N0 penile cancer were enrolled into a prospective phase I trial at a tertiary care institution from March 2010 to January 2012. All patients underwent an initial RAVEIL approach.

• Verification of adequacy of dissection was performed by an independent surgeon via a separate open incision at the conclusion of the RAVEIL procedure.

• Out of 10 patients, if more than two superficial inguinal fields with ≥2 nodes or more than four with ≥1 node remained within the superficial dissection field, the study would not proceed to phase II.

RESULTS

• Of 10 enrolled patients two had inguinal metastases and all positive nodes were detected by RAVEIL. The remaining eight patients had no metastases, with a mean of nine (range 5–21) left and nine (range 6–17) right nodes removed. One inguinal field RAVEIL was converted to an open dissection.

• The verifying surgeon confirmed that 18 of 19 inguinal fields (94.7% in nine patients) had an adequate dissection. Two benign nodes were found just beneath Scarpa’s fascia above the inguinal dissection field.

• Limitations of the study include an inability to determine decisively what specific wound complications were related to RAVEIL because of the protocol-specified creation of a small inguinal incision for verification of adequate dissection.

CONCLUSION

• RAVEIL allowed adequate staging of disease in the inguinal region among patients with penile cancer at risk for inguinal metastases.

 

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Article of the week: Implanting periurethral myofibres to treat incontinence

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 of Prof. René Yiou discussing his article.

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

 

Periurethral skeletal myofibre implantation in patients with urinary incontinence and intrinsic sphincter deficiency: a phase I clinical trial

René Yiou1, Jean-Yves Hogrel8, Catherine-Marie Loche2, François-Jerome Authier3, Philippe Lecorvoisier7, Pauline Jouany4, Françoise Roudot-Thoraval5 and Jean-Pascal Lefaucheur6

1Hôpital Henri Mondor, Service d’Urologie and CRCDC, 2Hôpital Albert Chenevier, Service de Médecine Physique et de Réadaptation, 3Hôpital Henri Mondor, Département de Pathologie, 4Hôpital Henri Mondor, Unité de Recherche Clinique (URC), Pôle Recherche Clinique et Santé Publique, 5Hôpital Henri Mondor, Département de Santé Publique, Pôle Recherche Clinique et Santé Publique, UPEC, 6Hôpital Henri Mondor, Service de Physiologie – Explorations Fonctionnelles, Université Paris-Est, Faculté de Médecine, APHP, 7Hôpital Henri Mondor, INSERM, Créteil, and 8Université Paris 6, UMR S974, INSERM U974, CNRS UMR 7215, GH Pitié-Salpêtrière, Institut de Myologie, Paris, France

This open-label nonrandomized phase I clinical trial was registered on clinicalTrials.gov (#NCT00472069)

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OBJECTIVES

• To assess the safety of periurethral myofibre implantation in patients with urinary incontinence due to intrinsic sphincter deficiency (ISD).

• To assess the resulting myogenic process and effects on urinary continence.

PATIENTS AND METHODS

• An open-label non-randomised phase I clinical trial was conducted in five men and five women with ISD (mean age, 62.5 years).

• A free muscle strip from the patient’s gracilis muscle was implanted around the urethra as a means to deliver locally myofibres and muscle precursor cells (MPCs).

• Patients were assessed for collection formation and incomplete bladder emptying.

• The maximum urethral closure pressure (MUCP) and concomitant periurethral electromyographic (EMG) activity were recorded before surgery and 1 and 3 months after surgery. Continence was assessed using the 24-h pad test and self-completed questionnaires, for 12 months.

RESULTS

• There were no serious side-effects.

• Continence improved significantly during the 12-month follow-up in four of the five women, including two who recovered normal continence. In the women, MUCP increased two-fold and de novo EMG periurethral activity was recorded. In the men, MUCP and EMG recordings showed similar improvements but the effect on continence was moderate.

• The few patients enrolled could affect these results.

CONCLUSIONS

• This is the first report of a one-step procedure for transferring autologous MPCs via myofibre implantation in patients with ISD.

• EMG and urodynamic assessments showed improvement of periurethral muscle activity.

• Further work is needed to confirm and improve the therapeutic efficiency of this procedure.

 

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Article of the week: Using MRI to select and monitor active surveillance CaP patients

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.

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

 

Multiparametric magnetic resonance imaging findings in men with low-risk prostate cancer followed using active surveillance

Jeffrey K. Mullins*, David Bonekamp, Patricia Landis*, Hosne Begum, Alan W. Partin*, Jonathan I. Epstein*, H. Ballentine Carter* and Katarzyna J. Macura*

*James Buchanan Brady Urological Institute, Russell H. Morgan Department of Radiology, and Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD, USA

Read the full article
OBJECTIVE

• To assess the performance of multiparametric magnetic resonance imaging (MRI) in identifying pathological-index (path-index) lesions, defined as cancer present in the same prostate sextant in two separate surveillance biopsies, in men followed within an active surveillance (AS) programme for low-risk prostate cancer (CaP) with extended follow-up.

MATERIALS AND METHODS

• A total of 50 men, representing >215 person-years of follow-up in an AS programme, who were referred for prostate MRI were randomly chosen to have their images reviewed by a radiologist with expertise in prostate MRI, who was blinded to biopsy results.

• Index lesions on MRI were defined as a single suspicious lesion ≥10 mm or >2 lesions in a given prostate sextant. Lesions on MRI were considered suspicious if ≥2 abnormal parameters co-registered anatomically. Path-index lesions were defined as cancer present in a given prostate sextant on two separate biopsy sessions.

• Sensitivity and specificity were calculated to test the performance of MRI for identifying path-index lesions.

• Clinical and pathological features were compared between men with and without a MRI-index lesion.

RESULTS

• A total of 31 path-index and 13 MRI-index lesions were detected in 22 and 10 patients, respectively.

• Multiparametric MRI demonstrated excellent specificity and negative predictive value (0.974 and 0.897, respectively) for the detection of path-index lesions. Sensitivity (0.19) and positive predictive value (0.46) were considerably lower.

• Patients with an index lesion on MRI were younger and less likely to have met the ‘Epstein’ criteria for very low-risk CaP.

• Compared with men without an MRI lesion, a significant increase in biopsy reclassification was noted for men with a MRI lesion (40 vs 12.5%, P = 0.04).

CONCLUSIONS

• A non-suspicious MRI was highly correlated with a lack of path-index lesions in an AS population.

• Multiparametric MRI may be useful in both the selection and monitoring of patients undergoing AS.

 

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