Urology News Feeds

More Than 15 Years of Experience with Intradetrusor OnabotulinumtoxinA Injections for Treating Refractory Neurogenic Detrusor Overactivity: Lessons to Be Learned

Abstract Background

Intradetrusor onabotulinumtoxinA (BoNT-ONA) injections have become a well-established therapy for refractory neurogenic detrusor overactivity (NDO). However, little is known about long-term outcome and patients’ adherence to this treatment.

Objective

To assess long-term outcomes of intradetrusor BoNT-ONA injections and patients’ adherence to treatment.

Design, setting, and participants

A consecutive series of 52 patients who underwent first intradetrusor BoNT-ONA injections for refractory NDO >10 yr ago were evaluated retrospectively and prospectively at a single university spinal cord injury (SCI) centre.

Outcome measurements and statistical analysis

Primary outcome was current neuro-urologic treatment. Secondary outcomes were urodynamic parameters. For data comparison, the paired/unpaired t test, chi-square test, and McNemar test were used.

Results and limitations

Mean duration since first intradetrusor BoNT-ONA injections was 12 ± 2 yr. Most patients (61% [32 of 52]) suffered from SCI, 15% (8 of 52) from spina bifida, 14% (7 of 52) from multiple sclerosis (MS), and the remaining (10% [5 of 52]) from other neurologic disorders. Almost 60% (31 of 52) of all patients are continuing with intradetrusor BoNT-ONA injections but only 14% (1 of 7) of the patients with MS. Lack of clinical and/or urodynamic response (21% [11 of 52]) and switching to another treatment (antimuscarinics and/or neuromodulation) despite appropriate BoNT-ONA efficacy (19% [10 of 52]) were the reasons for discontinuation. In patients continuing BoNT-ONA treatment, the positive effect was sustained after repeat injections (p < 0.05).

Conclusions

Although intradetrusor BoNT-ONA injections are a highly effective therapy for refractory NDO, approximately 40% of the patients discontinue treatment over time. All prospective neurologic patients should be given this information, and it needs to be considered in the treatment decision-making process.

Patient summary

Approximately 60% of the patients treated with intradetrusor onabotulinumtoxinA injections for refractory neurogenic detrusor overactivity continue this therapy long term with good therapeutic effects.

Study registration number

NCT01293110.

Take Home Message

Although intradetrusor onabotulinumtoxinA injections are a highly effective therapy for refractory neurogenic detrusor overactivity, approximately 40% of the patients discontinue treatment over time. All prospective neurologic patients should be given this information, and it needs to be considered in the treatment decision-making process.

Keywords: Neuro-urology, Neurogenic lower urinary tract dysfunction, Neurogenic detrusor overactivity, Intradetrusor onabotulinumtoxinA injections, Urodynamic investigation, Long-term follow-up.

Footnotes

a Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital, Zürich, Switzerland

b Department of Urology, University Hospital Basel, Basel, Switzerland

c Brain Research Institute, University of Zürich and Department of Health Sciences and Technology, Swiss Federal Institute of Technology Zürich, Zürich, Switzerland

Corresponding author. Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital, Forchstrasse 340, Zürich 8008, Switzerland. Tel. +41 44 386 38 45; Fax: +41 44 386 39 09.

These authors contributed equally to this work.

Article information

PII: S0302-2838(16)30030-6
DOI: 10.1016/j.eururo.2016.03.052
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Radiopharmaceuticals: A Path Forward

Refers to article:

Radiopharmaceuticals for Palliation of Bone Pain in Patients with Castration-resistant Prostate Cancer Metastatic to Bone: A Systematic Review

Joyce M. van Dodewaard-de Jong, Daniela E. Oprea-Lager, Lotty Hooft, John M.H. de Klerk, Haiko J. Bloemendal, Henk M.W. Verheul, Otto S. Hoekstra and Alfons J.M. van den Eertwegh

Accepted 4 September 2015

Footnotes

Departments of Medicine and Urology, Tulane University School of Medicine, New Orleans, LA, USA

Departments of Medicine and Urology, Tulane University School of Medicine, Cancer Center, SL-42, 1430 Tulane Ave., New Orleans, LA 70112, USA. Tel. +1 504 988 7869.

Article information

PII: S0302-2838(16)30034-3
DOI: 10.1016/j.eururo.2016.03.056
© 2016 Published by Elsevier B.V.

Categories: Urology News Feeds

Renal Mass Biopsy: Always, Sometimes, or Never?

Take Home Message

Renal mass biopsy is a useful clinical tool; nevertheless, in a majority of patients, renal mass biopsy in its current form does not alter clinical management. Its routine use in all-comers is not indicated outside of clinical protocols.

Footnotes

a Division of Urologic Oncology, Department of Surgical Oncology, Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA, USA

b Department of Urology, SUNY Upstate Medical University, Syracuse, NY, USA

c Department of Urology, Mayo Clinic, Rochester, MN, USA

Corresponding author. Division of Urologic Oncology, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA. Tel. +1 215 728 5342; Fax: +1 215 214 1734.

Article information

PII: S0302-2838(16)30024-0
DOI: 10.1016/j.eururo.2016.04.001
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Concurrent Androgen Deprivation with Radiotherapy: A Cautionary Tale of “Do As I Say, Not As I Do”?

Refers to article:

Assessment of the Rate of Adherence to International Guidelines for Androgen Deprivation Therapy with External-beam Radiation Therapy: A Population-based Study

Paolo Dell’Oglio, Hiba Abou-Haidar, Sami-Ramzi Leyh-Bannurah, Zhe Tian, Alessandro Larcher, Giorgio Gandaglia, Nicola Fossati, Shahrokh F. Shariat, Umberto Capitanio, Alberto Briganti, Francesco Montorsi, Markus Graefen, Fred Saad and Pierre I. Karakiewicz

Accepted 19 February 2016

Footnotes

a Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA

b Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

Corresponding author. Department of Urology, The James Buchanan Brady Urological Institute, 600 North Wolfe Street, Baltimore 21287, MD, USA. Tel. +1 443 2877225; Fax: +1 410 6148096.

Article information

PII: S0302-2838(16)30005-7
DOI: 10.1016/j.eururo.2016.03.033
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Reply to Stephen B. Williams and John F. Ward's Letter to the Editor re: Jan P. Radtke, Constantin Schwab, Maya B. Wolf, et al. Multiparametric Magnetic Resonance Imaging (MRI) and MRI–Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection:...

Refers to article:

Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial

Panu P. Tonttila, Juha Lantto, Eija Pääkkö, Ulla Piippo, Saila Kauppila, Eveliina Lammentausta, Pasi Ohtonen and Markku H. Vaarala

Accepted 14 May 2015

March 2016 (Vol. 69, Issue 3, pages 419 - 425)

Refers to article:

Re: Jan P. Radtke, Constantin Schwab, Maya B. Wolf, et al. Multiparametric Magnetic Resonance Imaging (MRI) and MRI–Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection: Correlation with Radical Prostatectomy Specimen. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2015.12.052

Stephen B. Williams and John F. Ward

Accepted 26 February 2016

Footnotes

a Department of Urology, Heidelberg University Hospital, Heidelberg, Germany

b Department of Radiology, German Cancer Research Center, Heidelberg, Germany

Corresponding author: Department of Urology, University Hospital Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Tel. +49 62215636321; Fax: +49 6221565622.

Article information

PII: S0302-2838(16)00251-7
DOI: 10.1016/j.eururo.2016.02.061
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Reply to Valerian Ciprian Lucan, Salvatore Butticè, Rosa Pappalardo, Carlo Magno's Letter to the Editor re: Mark W. Ball, Nathaniel Readal, Phillip M. Pierorazio, Mohamad E. Allaf. Splitting One Kidney into Two: Robotic Partial Kidney Transplant in a...

Refers to article:

Splitting One Kidney into Two: Robotic Partial Kidney Transplant in a Porcine Model

Mark W. Ball, Nathaniel Readal, Phillip M. Pierorazio and Mohamad E. Allaf

Accepted 11 December 2015

Refers to article:

Re: Mark W. Ball, Nathaniel Readal, Phillip M. Pierorazio, Mohamad E. Allaf. Splitting One Kidney into Two: Robotic Partial Kidney Transplant in a Porcine Model. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2015.12.014

Valerian Ciprian Lucan, Salvatore Butticè, Rosa Pappalardo and Carlo Magno

Accepted 2 March 2016

Footnotes

James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA

Corresponding author. James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, 600 North Wolfe Street, Marburg 134, Baltimore, MD 21287, USA. Tel. +1 6065242354; Fax: +1 8882775726.

Article information

PII: S0302-2838(16)00266-9
DOI: 10.1016/j.eururo.2016.03.009
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Prednisone Use in Conjunction with Abiraterone Acetate: Is Patient Safety a Concern with Long-term Steroid Exposure?

Refers to article:

Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer

Karim Fizazi, Kim N. Chi, Johann S. de Bono, Leonard G. Gomella, Kurt Miller, Dana E. Rathkopf, Charles J. Ryan, Howard I. Scher, Neal D. Shore, Peter De Porre, Anil Londhe, Tracy McGowan, Nonko Pelhivanov, Robert Charnas, Mary B. Todd and Bruce Montgomery

Accepted 10 February 2016

Footnotes

University of California San Francisco, San Francisco, CA, USA

Helen Diller Family Comprehensive Cancer Center, Department of Medicine, Division of Hematology/Oncology, 1600 Divisadero Street, Box 1711, San Francisco, CA 94143, USA. Tel. +1 (415) 353-9278; Fax: +1 (415) 353-7779.

Article information

PII: S0302-2838(16)00275-X
DOI: 10.1016/j.eururo.2016.03.018
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Re: Mark W. Ball, Nathaniel Readal, Phillip M. Pierorazio, Mohamad E. Allaf. Splitting One Kidney into Two: Robotic Partial Kidney Transplant in a Porcine Model. Eur Urol. In press. http://dx.doi.org/10.1016/j.eururo.2015.12.014

Refers to article:

Splitting One Kidney into Two: Robotic Partial Kidney Transplant in a Porcine Model

Mark W. Ball, Nathaniel Readal, Phillip M. Pierorazio and Mohamad E. Allaf

Accepted 11 December 2015

Footnotes

a Clinical Institute of Urology and Renal Transplant, Cluj-Napoca, Romania

b Department of Human Pathology, Unit of Urology, University of Messina, Messina, Italy

Corresponding author. Department of Human Pathology, Unit of Urology, University of Messina, Via C. Valeria n.1, Messina, 98124, Italy. Tel. +39 3200666348; Fax: +39 0902213564.

Article information

PII: S0302-2838(16)00265-7
DOI: 10.1016/j.eururo.2016.03.008
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Re: Jan P. Radtke, Constantin Schwab, Maya B. Wolf, et al. Multiparametric Magnetic Resonance Imaging (MRI) and MRI–Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection: Correlation with Radical Prostatectomy Specimen. Eur Urol. In press....

Refers to article:

Multiparametric Magnetic Resonance Imaging (MRI) and MRI–Transrectal Ultrasound Fusion Biopsy for Index Tumor Detection: Correlation with Radical Prostatectomy Specimen

Jan P. Radtke, Constantin Schwab, Maya B. Wolf, Martin T. Freitag, Celine D. Alt, Claudia Kesch, Ionel V. Popeneciu, Clemens Huettenbrink, Claudia Gasch, Tilman Klein, David Bonekamp, Stefan Duensing, Wilfried Roth, Svenja Schueler, Christian Stock, Heinz-Peter Schlemmer, Matthias Roethke, Markus Hohenfellner and Boris A. Hadaschik

Accepted 29 December 2015

Footnotes

Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Corresponding author. 1515 Holcombe Blvd., Unit 1373, Houston, TX 77030 USA. Tel. +1 713 792 3250.

Article information

PII: S0302-2838(16)00250-5
DOI: 10.1016/j.eururo.2016.02.060
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer

Abstract Background

Abiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs the survival of patients with metastatic castration-resistant prostate cancer (mCRPC). AA plus prednisone (P) (AA + P) is approved for the treatment of patients with mCRPC.

Objective

To investigate whether long-term use of low-dose P with or without AA leads to corticosteroid-associated adverse events (CA-AEs) in mCRPC patients.

Design, setting, and participants

The study included 2267 patients in COU-AA-301 and COU-AA-302. We used an inclusive Standardized MedDRA Queries–oriented approach to identify 112 preferred terms for known CA-AEs, and assessed the incidence of CA-AEs during 3-mo exposure intervals and across all P exposure levels.

Intervention

All 2267 patients received 5 mg of P twice daily, and 1333/2267 received AA (1 g) plus P.

Results and limitations

The CA-AE incidence after any P exposure was 25%, 26%, and 23% for any grade, and 5%, 5%, and 4% for grade ≥3 CA-AEs for all patients and the AA + P and P alone groups, respectively. The most common any-grade CA-AEs were hyperglycemia (7.4%, 7.8%, and 6.9% for all patients, AA + P, and P alone, respectively) and weight increase (4.3%, 3.9%, and 4.8%, respectively). When assessed by duration of exposure (3-mo intervals up to ≥30 mo), no discernable trend was observed for CA-AEs, including hyperglycemia and weight increase. The investigator-reported study discontinuation rate due to CA-AEs was 11/2267 (0.5%), and one patient had a CA-AE resulting in death.

Conclusions

Low-dose P given with or without AA is associated with low overall incidence of CA-AEs. The frequency of CA-AEs remained low with increased duration of exposure to P.

Patient summary

We assessed adverse events in patients with metastatic castration-resistant prostate cancer during long-term treatment with a low dose of a corticosteroid. We found that long-term treatment with this low-dose corticosteroid is safe and tolerable.

Take Home Message

Long-term treatment with abiraterone acetate plus low-dose prednisone is well tolerated. These results further show that the incidence of corticosteroid-associated adverse events in patients with metastatic castration-resistant prostate cancer after long-term administration of low-dose prednisone is low and manageable.

Keywords: Abiraterone acetate, Adverse events, Corticosteroids, Glucocorticoid, Long term, Metastatic castration-resistant prostate cancer, Tolerability.

Footnotes

a Institut Gustave Roussy, University of Paris Sud, Villejuif, France

b BC Cancer Agency, Vancouver, BC, Canada

c The Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK

d Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA

e Charité-Universitätsmedizin Berlin, Berlin, Germany

f Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA

g Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA

h Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA

i Janssen Research & Development, Beerse, Belgium

j Janssen Research & Development, Horsham, PA, USA

k Janssen Scientific Affairs, Horsham, PA, USA

l Janssen Research & Development, Raritan, NJ, USA

m Janssen Research & Development, Los Angeles, CA, USA

n Janssen Global Services, Raritan, NJ, USA

o University of Washington, Seattle, WA, USA

Corresponding author. Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, 114 Rue Edouard Vaillant, 94800 Villejuif, France. Tel. +33 1 42114317; Fax: +33 1 42115211.

Article information

PII: S0302-2838(16)00213-X
DOI: 10.1016/j.eururo.2016.02.035
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Assessment of the Rate of Adherence to International Guidelines for Androgen Deprivation Therapy with External-beam Radiation Therapy: A Population-based Study

Abstract Background

The National Comprehensive Cancer Network and the European Association of Urology guidelines recommend using radiation therapy (RT) with androgen deprivation therapy (ADT) to treat high-risk and locally advanced prostate cancer patients.

Objective

To evaluate the degree of adherence to these guidelines.

Design, setting, and participants

Between 2003 and 2009, in the Surveillance Epidemiology and End Results (SEER)–Medicare database, 14 180 patients were diagnosed with high-risk (T1–T2 with World Health Organization histologic grade 3) or locally advanced (T3–T4 with any histologic grade) prostatic adenocarcinoma.

Intervention

Administration of RT-ADT versus RT alone.

Outcome measurements and statistical analysis

We assessed the rate of adherence to guidelines with respect to use of RT-ADT in the overall population and after stratification according to stage–grade groupings (T1–T2 G3 vs T3–T4 any grade), age (66–69, 70–74, 75–79, ≥80 yr), Charlson Comorbidity Index (CCI) (0, 1, ≥2), and preexisting baseline cardiovascular (CV) disease. We depicted the rate of RT-ADT administration graphically over the study period. Multivariable logistic regression analyses were performed to assess the predictors of RT-ADT use.

Results and limitations

RT-ADT rates and guideline adherence were 58–75%, with the highest rate (75%) in 2003 and the lowest (58%) in 2009. When stratified according to stage–grade groupings, age, CCI, and preexisting baseline CV disease, similar results were obtained. In multivariable analyses, year of diagnosis (p < 0.001), patient age (p < 0.001), stage–grade groupings (p < 0.001), CCI (p = 0.036), race (p < 0.001), marital status (p < 0.001), population density (p < 0.001), and US regions (p < 0.001) were independent predictors of RT-ADT use. The limitations of our study include age >65 yr and exclusive Medicare coverage.

Conclusions

The rate of guideline adherence regarding the use of RT-ADT is suboptimal and decreases with time instead of increasing.

Patient summary

This population-based study provides evidence of low adherence to international urologic guidelines regarding the combination of radiation therapy (RT) with androgen deprivation therapy (ADT) for high-risk and locally advanced prostate cancer (PCa) patients. Despite the increasing number of randomized controlled trials over time that showed a survival benefit for patients with high-risk and locally advanced PCa treated with RT-ADT compared with RT alone, the rate of adherence to guidelines decreased with time.

Take Home Message

Despite several randomized controlled trials that substantiated the urologic guidelines documenting a significant survival benefit for patients with high-risk metastatic prostate cancer treated with radiation therapy combined with androgen deprivation therapy, the rate of use of combination treatment for this subset of patients is suboptimal and decrease over time.

Keywords: High-risk prostate cancer, Locally advanced prostate cancer, RT-ADT, SEER-Medicare.

Footnotes

a Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, Canada

b Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy

c Department of Urology, University of Montreal Health Center, Montreal, Canada

d Martini-Clinic, Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

e Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Canada

f Department of Urology, Medical University of Vienna and General Hospital, Vienna, Austria

Corresponding author. Cancer Prognostics and Health Outcomes Unit, 264 Blvd. Rene-Levesque E., Room 228, Montreal, QC H2X 1P1, Canada. Tel. +1 514 890 8000, ext. 35335; Fax: +1 514 227 5103.

Contributed equally.

Article information

PII: S0302-2838(16)00247-5
DOI: 10.1016/j.eururo.2016.02.057
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Re: Daniel M. Geynisman. Anti-programmed Cell Death Protein 1 (PD-1) Antibody Nivolumab Leads to a Dramatic and Rapid Response in Papillary Renal Cell Carcinoma with Sarcomatoid and Rhabdoid Features. Eur Urol 2015;68:912–4

Refers to article:

Anti-programmed Cell Death Protein 1 (PD-1) Antibody Nivolumab Leads to a Dramatic and Rapid Response in Papillary Renal Cell Carcinoma with Sarcomatoid and Rhabdoid Features

Daniel M. Geynisman

Accepted 2 July 2015

November 2015 (Vol. 68, Issue 5, pages 912 - 914)

Footnotes

a Department of Specialistic Clinical and Odontostomatological Sciences, Polytechnic University of Marche, Ancona, Italy

b Medical Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria Ospedali Riuniti Umberto I, GM Lancisi, G Salesi, Ancona, Italy

c Section of Pathological Anatomy, Polytechnic University of the Marche Region, School of Medicine, United Hospitals, Ancona, Italy

d Unit of Urology/Division of Oncology, URI, IRCCS Ospedale San Raffaele, Milan, Italy

e Department of Surgery, Cordoba University Medical School, Cordoba, Spain

f Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN, USA

Corresponding author. Pathological Anatomy, Polytechnic University of the Marche Region, School of Medicine, United Hospitals, Via Conca 71, I−60126 Torrette, Ancona, Italy.

Article information

PII: S0302-2838(16)00239-6
DOI: 10.1016/j.eururo.2016.02.049
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Reply to Francesco Piva, Matteo Santoni, Marina Scarpelli, et al's Letter to the Editor re: Daniel M. Geynisman. Anti-programmed Cell Death Protein 1 (PD-1) Antibody Nivolumab Leads to a Dramatic and Rapid Response in Papillary Renal Cell Carcinoma...

Refers to article:

Anti-programmed Cell Death Protein 1 (PD-1) Antibody Nivolumab Leads to a Dramatic and Rapid Response in Papillary Renal Cell Carcinoma with Sarcomatoid and Rhabdoid Features

Daniel M. Geynisman

Accepted 2 July 2015

November 2015 (Vol. 68, Issue 5, pages 912 - 914)

Refers to article:

Re: Daniel M. Geynisman. Anti-programmed Cell Death Protein 1 (PD-1) Antibody Nivolumab Leads to a Dramatic and Rapid Response in Papillary Renal Cell Carcinoma with Sarcomatoid and Rhabdoid Features. Eur Urol 2015;68:912–4

Francesco Piva, Matteo Santoni, Marina Scarpelli, Alberto Briganti, Antonio Lopez-Beltran, Liang Cheng, Rossana Berardi, Francesco Montorsi and Rodolfo Montironi

Accepted 16 February 2016

Footnotes

a Program in Molecular Therapeutics, Fox Chase Cancer Center, Philadelphia, PA, USA

b Program in Molecular and Cell Biology and Genetics, Drexel University College of Medicine, Philadelphia, PA, USA

c Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA

Corresponding author. Department of Hematology/Oncology, Fox Chase Cancer Center, Temple Health, 333 Cottman Avenue, Philadelphia, PA 19111, USA. Tel. +1 215 7283889; Fax: +1 215 7283639.

Article information

PII: S0302-2838(16)00238-4
DOI: 10.1016/j.eururo.2016.02.048
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy

Abstract Background

Understanding predictors for the recovery of erectile function (EF) after nerve-sparing radical prostatectomy (nsRP) might help clinicians and patients in preoperative counseling and expectation management of EF rehabilitation strategies.

Objective

To describe the effect of potential predictors on EF recovery after nsRP by post hoc decision-tree modeling of data from A Study of Tadalafil After Radical Prostatectomy (REACTT).

Design, setting, and participants

Randomized double-blind double-dummy placebo-controlled trial in 423 men aged <68 yr with adenocarcinoma of the prostate (Gleason ≤7, normal preoperative EF) who underwent nsRP at 50 centers from nine European countries and Canada.

Intervention

Postsurgery 1:1:1 randomization to 9-mo double-blind treatment with tadalafil 5 mg once a day (OaD), tadalafil 20 mg on demand, or placebo, followed by a 6-wk drug-free-washout, and a 3-mo open-label tadalafil OaD treatment.

Outcome measurements and statistical analysis

Three decision-tree models, using the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score at the end of double-blind treatment, washout, and open-label treatment as response variable. Each model evaluated the association between potential predictors: presurgery IIEF domain and IIEF single-item scores, surgical approach, nerve-sparing score (NSS), and postsurgery randomized treatment group.

Results and limitations

The first decision-tree model (n = 422, intention-to-treat population) identified high presurgery sexual desire (IIEF item 12: ≥3.5 and <3.5) as the key predictor for IIEF-EF at the end of double-blind treatment (mean IIEF-EF: 14.9 and 11.1), followed by high confidence to get and maintain an erection (IIEF item 15: ≥3.5 and <3.5; IIEF-EF: 15.4 and 7.1). For patients meeting these criteria, additional non-IIEF–related predictors included robot-assisted laparoscopic surgery (yes or no; IIEF-EF: 19.3 and 12.6), quality of nerve sparing (NSS: <2.5 and ≥2.5; IIEF-EF: 14.3 and 10.5), and treatment with tadalafil OaD (yes and no; IIEF-EF: 17.6 and 14.3). Additional analyses after washout and open-label treatment identified high presurgery intercourse satisfaction as the key predictor.

Conclusions

Exploratory decision-tree analyses identified high presurgery sexual desire, confidence, and intercourse satisfaction as key predictors for EF recovery. Patients meeting these criteria might benefit the most from conserving surgery and early postsurgery EF rehabilitation. Strategies for improving EF after surgery should be discussed preoperatively with all patients; this information may support expectation management for functional recovery on an individual patient level.

Patient summary

Understanding how patient characteristics and different treatment options affect the recovery of erectile function (EF) after radical surgery for prostate cancer might help physicians select the optimal treatment for their patients. This analysis of data from a clinical trial suggested that high presurgery sexual desire, sexual confidence, and intercourse satisfaction are key factors predicting EF recovery. Patients meeting these criteria might benefit the most from conserving surgery (robot-assisted surgery, perfect nerve sparing) and postsurgery medical rehabilitation of EF.

Trial registration

ClinicalTrials.gov, NCT01026818

Take Home Message

Exploratory decision-tree modeling suggested that high presurgery sexual desire, sexual confidence, and intercourse satisfaction are key predictors for erectile function (EF) recovery after nerve-sparing radical prostatectomy. Patients meeting these criteria might benefit most from conserving surgery (robot assisted, perfect nerve sparing) and postsurgery medical rehabilitation and preservation of erectile function. Strategies for improving EF after surgery should be discussed preoperatively with all patients; this information may support expectation management for functional recovery on an individual patient level.

Keywords: Clinical trials, Decision-tree analysis, Erectile dysfunction, Nerve-sparing radical prostatectomy, Phosphodiesterase type 5 inhibitors, Predictors, Prostate cancer, Rehabilitation, Tadalafil.

Footnotes

a Department of Urology, Vita Salute San Raffaele University, Milan, Italy

b Department of Urology and Urological Oncology, Hanover Medical School, Hanover, Germany

c Global Statistical Sciences, EU Statistics, Lilly Deutschland GmbH, Bad Homburg, Germany

d Department of Surgery, Division of Urology, University of Western Ontario, London, Ontario, Canada

e Therapeutic Area Men's Health, Eli Lilly SpA, Florence, Italy

f Memorial Sloan Kettering Cancer Center, New York, NY, USA

g Biomedicines BU, Lilly Deutschland GmbH, Bad Homburg, Germany

Corresponding author. Department of Urology, Vita Salute San Raffaele University, Via Olgettina, 60, 20132 Milan, Italy. Tel. +39 02 26437286; Fax: +39 02 26437298.

§ Contributed equally.

Article information

PII: S0302-2838(16)00214-1
DOI: 10.1016/j.eururo.2016.02.036
© 2016 Published by Elsevier B.V.

Categories: Urology News Feeds

Laparoscopic Management of Ureteroileal Anastomosis Strictures: Initial Experience

Abstract Background

A ureteroileal anastomosis stricture (UAS) is one of the most frequent complications after radical cystectomy. Open surgical repair is the treatment of choice but is associated with morbidity.

Objective

To describe the efficacy and safety of laparoscopic management for benign secondary UAS.

Design, setting, and participants

A review was performed of the 11 initial procedures performed at our academic center from December 2010 to December 2014, with mean follow-up of 38 mo (range 12–169). Patients included had benign ureteroileal strictures longer than 1 cm.

Surgical procedure

A pure laparoscopic approach was systematically used, involving a two-step procedure for left and a one-step procedure for right ureteral stenosis.

Measurements

Perioperative data were collected and complications were assessed using the Clavien-Dindo grading system. Outcomes and follow-up data were analyzed.

Results and limitations

A descriptive statistical analysis was performed for 11 surgeries in ten patients. The median stricture length was 2.4 cm. No conversion to open surgery was required. The mean blood loss was 180 ml and the mean hospital stay was 10 d. Early complications included limited lymphorrhea (n = 1), limited anastomotic leakage (n = 2), and accidental descent of a ureteral catheter (n = 1) that was replaced with radiologic intervention. The mean follow-up was 38 mo (range 12–169). No late complications were reported. After 1 yr of follow-up, six patients had good glomerular filtration rates, all patients were asymptomatic, and no stenotic relapses were detected.

Conclusions

This laparoscopic technique for the management of benign secondary UAS is feasible, with good results and without long-term complications. This minimally invasive approach reduces the morbidity associated with open surgery while retaining good success rates.

Patient summary

We describe a novel laparoscopic approach for patients with a ureteroileal anastomosis stricture after radical cystectomy to avoid the complications associated with open surgery. The surgery was found to be viable and safe with good long-term results.

Take Home Message

Laparoscopic management for benign secondary ureteroileal anastomosis strictures is feasible and safe with good results and without long-term complications. This minimally invasive approach reduced the morbidity associated with open surgery while maintaining good success rates.

Keywords: Ureteroileal anastomosis stricture, Laparoscopy, Ureteral reimplantation, Ureteroenteric stricture.

Footnotes

Department of Urology, Fundació Puigvert, Universitat Autonoma de Barcelona, Barcelona, Spain

Corresponding author. Department of Urology, Fundació Puigvert, Universitat Autonoma de Barcelona, Calle Cartagena 340-350, Barcelona 08025, Spain. Tel. +34 695342419.

Article information

PII: S0302-2838(16)00223-2
DOI: 10.1016/j.eururo.2016.02.045
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

The Aetiology, Treatment, and Outcome of Urogenital Fistulae Managed in Well-and Low-resourced Countries: A Systematic Review

Abstract Context

Urogenital fistula is a global healthcare problem, predominantly associated with obstetric complications in low-resourced countries and iatrogenic injury in well-resourced countries. Currently, the published evidence is of relatively low quality, mainly consisting retrospective case series.

Objective

We evaluated the available evidence for aetiology, intervention, and outcomes of urogenital fistulae worldwide.

Evidence acquisition

We performed a systematic review of the PubMed and Scopus databases, classifying the evidence for fistula aetiology, repair techniques, and outcomes of surgery. Comparisons were made between fistulae treated in well-resourced countries and those in low-resourced countries.

Evidence synthesis

Over a 35-yr period, 49 articles were identified using our search criteria, which were included in the qualitative analysis. In well-resourced countries, 1710/2055 (83.2%) of fistulae occurred following surgery, whereas in low-resourced countries, 9902/10 398 (95.2%) were associated with childbirth. Spontaneous closure can occur in up to 15% of cases using catheter drainage and conservative approaches are more likely to be successful for nonradiotherapy fistulae. Of patients undergoing repairs in well-resourced countries, the median overall closure rate was 94.6%, while in low-resourced countries, this was 87.0%. Closure was significantly more likely to be achieved using a transvaginal approach then a transabdominal technique (90.8% success vs 83.9%, Fisher's exact test; p = 0.0176).

Conclusions

It is difficult to conclude whether any specific route of surgery has advantage over any other, given the selection of patients to a particular procedure is based upon individual fistula characteristics. However, surgical repair should be carried out by experienced fistula surgeons, well versed in all techniques as the primary attempt at repair is likely to be the most successful.

Patient summary

Urogenital fistulae are a common problem worldwide; however, the available evidence on fistula management is poor in quality. We searched the current literature and identified that 95% of fistulae occur following childbirth in low-resourced countries, whereas 80% of fistulae are associated with surgery in well-resourced countries, where successful repair is also more likely to be achieved. The first attempt at repair is often the most successful and therefore fistula surgery should be centralised to hospitals with the most experience.

Take Home Message

Demonstrating a benefit of a particular fistula repair technique is difficult, as patients are selected for treatment based on specific criteria. However, as the primary repair attempt is likely to be the most successful, an argument exists for centralised management.

Keywords: Fistula, Interposition graft, Obstetric fistula, Obstructed labour, Radiation fistula, Vesico-vaginal fistula.

Footnotes

a Academic Urology Unit, Royal Hallamshire Hospital, Sheffield, UK

b Department of Urogynaecology, Newcastle University, Newcastle, UK

Corresponding author. Room H26, H-Floor, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK. Tel. +44 (0)114 271 3048; Fax: +44 (0)114 279 7841.

Article information

PII: S0302-2838(16)00190-1
DOI: 10.1016/j.eururo.2016.02.015
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Complete Responses with Targeted Therapy in Metastatic Renal Cell Carcinoma: Balancing Efficacy and Toxicity

Refers to article:

Outcomes for Patients with Metastatic Renal Cell Carcinoma Achieving a Complete Response on Targeted Therapy: A Registry-based Analysis

Tomas Buchler, Zbynek Bortlicek, Alexandr Poprach, Tomas Pavlik, Veronika Veskrnova, Michaela Honzirkova, Milada Zemanova, Ondrej Fiala, Katerina Kubackova, Ondrej Slaby, Marek Svoboda, Rostislav Vyzula, Ladislav Dusek and Bohuslav Melichar on behalf of the Czech Renal Cancer Cooperative Group.

Accepted 16 December 2015

Footnotes

a Tom Baker Cancer Center, Calgary, Alberta, Canada

b Princess Margaret Cancer Center, Toronto, Ontario, Canada

Corresponding author. Department of Medical Oncology, Princess Margaret Cancer Centre, Suite 5-222, 610 University Avenue, Toronto, Ontario M5G 2M9, Canada. Tel. +1 416-946-4501; Fax: +1 416-946-6546.

Article information

PII: S0302-2838(16)00169-X
DOI: 10.1016/j.eururo.2016.01.050
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

Postoperative Lymphocele Formation after Pelvic Lymph Node Dissection at the Time of Radical Prostatectomy Should Not Be Considered an Inevitable Consequence of the Approach

Refers to article:

Prospective Randomized Trial Comparing Titanium Clips to Bipolar Coagulation in Sealing Lymphatic Vessels During Pelvic Lymph Node Dissection at the Time of Robot-assisted Radical Prostatectomy

Pietro Grande, Giovanni Battista Di Pierro, Livio Mordasini, Matteo Ferrari, Christoph Würnschimmel, Hansjörg Danuser and Agostino Mattei

Accepted 3 August 2016

Footnotes

a Department of Urology, University of Leipzig, Leipzig, Germany

b Department of Urology, University of Patras, Patras, Greece

Corresponding author. Department of Urology, University of Patras, Aristotelous 1, Athens 15562, Greece.

Article information

PII: S0302-2838(16)30519-X
DOI: 10.1016/j.eururo.2016.08.046
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds

New and Established Technology in Focal Ablation of the Prostate: A Systematic Review

Abstract Context

Focal therapy of prostate cancer has been proposed as an alternative to whole-gland treatments.

Objective

To summarize the evidence regarding sources of energy employed in focal therapy.

Evidence acquisition

Embase and Medline (PubMed) were searched from 1996 to October 31, 2015 following the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Ongoing trials were selected from electronic registries. The stage of assessment of each source of energy was determined using the Idea, Development, Exploration, Assessment, Long-term study recommendations.

Evidence synthesis

Thirty-seven articles reporting on 3230 patients undergoing focal therapy were selected. Thirteen reported on high-intensity focused ultrasound, 11 on cryotherapy, three on photodynamic therapy, four on laser interstitial thermotherapy, two on brachytherapy, three on irreversible electroporation, and one on radiofrequency. High-intensity focused ultrasound, cryotherapy, photodynamic therapy, and brachytherapy have been assessed in up to Stage 2b studies. Laser interstitial thermotherapy and irreversible electroporation have been evaluated in up to Stage 2a studies. Radiofrequency has been evaluated in one Stage 1 study. Median follow-up varied between 4 mo and 61 mo, and the median rate of serious adverse events ranged between 0% and 10.6%. Pad-free leak-free continence and potency were obtained in 83.3–100% and 81.5–100%, respectively. In series with intention to treat, the median rate of significant and insignificant disease at control biopsy varied between 0% and 13.4% and 5.1% and 45.9%, respectively. The main limitations were the length of follow-up, the absence of a comparator arm, and study heterogeneity.

Conclusions

Focal therapy has been evaluated using seven sources of energy in single-arm retrospective and prospective development studies up to Stage 2b. Focal therapy seems to have a minor impact on quality of life and genito-urinary function. Oncological effectiveness is yet to be defined against standard of care.

Patient summary

Seven sources of energy have been employed to selectively ablate discrete areas of prostate cancer. There is high evidence that focal therapy is safe and has low detrimental impact on continence and potency. The oncological outcome has yet to be evaluated against standard of care.

Take Home Message

Seven different sources of energy have been employed to treat prostate cancer in a focal manner. Across 37 retrospective to prospective development studies, focal therapy seems to be safe and provides good preservation of genito-urinary function.

Keywords: Focal therapy, Partial ablation, Prostate cancer.

Footnotes

a Division of Surgery and Interventional Science, University College London, London, UK

b Department of Urology, University College London Hospitals NHS Foundation Trust, London, UK

c Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

d Section of Urology, University of Chicago, Chicago, IL, USA

e Department of Urology, New York University School of Medicine, New York, NY, USA

f Division of Urology, Duke University Medical Center, Durham, NC, USA

g Department of Urology, Lille University Medical Center, Lille University, France

Corresponding author. Division of Surgery and Interventional Science, University College London, 74 Huntley Street, London W1P 7NN, UK. Tel. +44 (0)20 3447 9194; Fax: +44 (0)20 3447 9303.

These authors are joint first authors.

Article information

PII: S0302-2838(16)30512-7
DOI: 10.1016/j.eururo.2016.08.044
© 2016 Published by Elsevier B.V.

Categories: Urology News Feeds

Re: Role of Human Papillomavirus in Penile Carcinomas Worldwide

Footnotes

Urology Department, University of Rostock, Rostock, Germany

Corresponding author. Urology Department, University of Rostock, E. Heydemann Strasse 6, Rostock 18057, Germany.

Article information

PII: S0302-2838(16)30502-4
DOI: 10.1016/j.eururo.2016.08.035
© 2016 European Association of Urology, Published by Elsevier B.V.

Categories: Urology News Feeds