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Outpatient laser ablation of NMIBC

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Outpatient laser ablation of non-muscle-invasive bladder cancer: is it safe, tolerable and cost-effective?

Kathie A. Wong, Grace Zisengwe, Thanos Athanasiou*, Tim O’Brien and Kay Thomas

The Urology Centre, Guys and St. Thomas’ NHS Foundation Trust, and *Surgical Epidemiology Unit, Department of Surgery and Cancer, Imperial College London, London, UK

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OBJECTIVES

• To evaluate the safety, tolerability and effectiveness of outpatient (office-based) laser ablation (OLA), with local anaesthetic, for non-muscle-invasive bladder cancer (NMIBC) in an elderly population with and without photodynamic diagnosis (PDD).

• To compare the cost-effectiveness of OLA of NMIBC with that of inpatient cystodiathermy (IC).

PATIENTS AND METHODS

• We conducted a prospective cohort study of patients with NMIBC treated with OLA by one consultant surgeon between March 2008 and July 2011

• A subgroup of patients had PDD before undergoing OLA.

• Safety and effectiveness were determined by complications (In the immediate post operative period, at three days and at three months), patient tolerability (visual analogue score) and recurrence rates.

• The long-term costs and cost-effectiveness of OLA and IC of NMIBC were evaluated using Markov modeling.

RESULTS

• A total of 74 OLA procedures (44 white-light, 30 PDD) were carried out in 54 patients. The mean (range) patient age was 77 (52–95) years. More than half of the patients had more than three comorbidities. Previous tumour histology ranged from G1pTa to T3.

• One patient had haematuria for 1 week which settled spontaneously and did not require hospital admission. There were no other complications.

• The procedure was well tolerated with pain scores of 0–2/10.

• Additional lesions were found in 21% of patients using PDD that were not found using white light.

• At 3 months, the percentage of patients who had recurrence after OLA with white light and OLA with PDD were 10.6 and 4.3%, respectively. At 1 year, 65.1% and 46.9% of patients had recurrence.

• The cost of OLA was found to be much lower than that of IC (£538 vs £1474), even with the addition of PDD (£912 vs £1844).

• Over the course of a patient’s lifetime, OLA was more clinically effective, measured in quality-adjusted life-years (QALY), than IC (0.147 [sd 0.059]) and less costly (£2576.42 [sd £7293.07]).

• At a cost-effectiveness threshold of £30 000/QALY, as set by the National Institute for Health and Care Excellence, there was an 82% probability that OLA was cost-effective.

CONCLUSIONS

• This is the first study to demonstrate the long-term cost-effectiveness of OLA of NMIBC.

• The results support the use of OLA for the treatment of NMIBC, especially in the elderly.

Video: Cryoablation after failed primary radiotherapy: study finds encouraging results

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Salvage focal and salvage total cryoablation for locally recurrent prostate cancer after primary radiation therapy

Andre Luis de Castro Abreu*, Duke Bahn*†, Scott Leslie*, Sunao Shoji*, Paul Silverman†, Mihir M. Desai*, Inderbir S. Gill* and Osamu Ukimura*

*USC Institute of Urology, Hillard and Roclyn Herzog Center for Prostate Cancer Focal Therapy, Keck School of Medicine, University of Southern California, Los Angeles, and †Prostate Institute of America, Community Memorial Hospital, Ventura, CA, USA

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OBJECTIVES

• To present the oncological and functional outcomes of salvage focal (SFC) and salvage total (STC) cryoablation for recurrent prostate cancer (PCa) after failed primary radiotherapy.

PATIENTS AND METHODS

• From March 2003 to August 2010, 50 men with biopsy-proven unilateral (n = 25) or bilateral (n = 25) radio-recurrent PCa underwent SFC or STC, respectively.

• Patients were assessed after treatment by prostate-specific antigen (PSA) testing, transrectal ultrasonography, biopsy and questionnaires. Biochemical failure (BF) was defined using the Phoenix criteria (PSA nadir + 2 mg/mL).

• Data were prospectively collected and retrospectively analysed.

RESULTS

• The median pre-cryoablation PSA level and Gleason score were, respectively, 2.8 ng/mL and 7 for SFC, and 3.9 ng/mL and 7 for STC. The median follow-up was 31 and 53 months (P = 0.004) for SFC and STC, respectively.

• Oncological outcomes were as follows: no patient died; one patient who underwent STC developed bone metastases; eight patients who underwent SFC and three who underwent STC had BF and the 5-year BF-free survival rates were 54 and 86%, respectively. In those patients without BF, the mean PSA decreased by 86% for SFC and 90% for STC within the first year and remained stable.

• Functional outcomes were as follows: new onset urinary incontinence occurred in three (13%) patients in the STC group, whereas no patient in the SFC group developed incontinence (P = 0.10); Two of seven patients in the SFC group retained postoperative potency, but none of the four potent patients in the STC group recovered potency postoperatively (P = 0.48); one (4%) patient in the STC group developed a recto-urethral fistula, but none occurred in the SFC group (P = 0.48).

CONCLUSIONS

• SFC and STC are feasible and safe with acceptable mid-term oncological outcomes. For carefully selected patients, SFC is an option that could be associated with lower treatment-related morbidity compared with STC.

• Although longer follow-up and more patient numbers are needed, our initial oncological and functional outcomes of SFC and STC are encouraging.

Video: Small renal calculi can be effectively managed with microperc

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Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial

Ravindra B. Sabnis, Raguram Ganesamoni, Amit Doshi, Arvind P. Ganpule, Jitendra Jagtap and Mahesh R. Desai

Department of Urology, Muljibhai Patel Urological Hospital, Nadiad, Gujarat, India

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OBJECTIVE

• To compare micropercutaneous nephrolithotomy (microperc) and retrograde intrarenal surgery (RIRS) for the management of renal calculi <1.5 cm with regard to stone clearance rates and surgical characteristics, complications and postoperative recovery.

PATIENTS AND METHODS

• Seventy patients presenting with renal calculi <1.5 cm were equally randomized to a microperc or a RIRS group between February 2011 and August 2012 in this randomized controlled trial. Randomization was based on centralized computer-generated numbers. Patients and authors assessing the outcomes were not blinded to the procedure.

• Microperc was performed using a 4.85-F (16-gauge) needle with a 272-μm laser fibre. RIRS was performed using a uretero-renoscope.

• Variables studied were stone clearance rates, operating time, need for JJ stenting, intra-operative and postoperative complications (according to the Clavien–Dindo classification system), surgeon discomfort score, postoperative pain score, analgesic requirement and hospital stay.

• Stone clearance was assessed using ultrasonography and X-ray plain abdominal film of kidney, ureter and bladder at 3 months.

RESULTS

• There were 35 patients in each group. All the patients were included in the final analysis.

• The stone clearance rates in the microperc and RIRS groups were similar (97.1 vs 94.1%, P = 1.0).

• The mean [sd] operating time was similar between the groups (51.6 [18.5] vs 47.1 [17.5], P = 0.295). JJ stenting was required in a lower proportion of patients in the microperc group (20 vs 62.8%, P < 0.001). Intra-operative complications were a minor pelvic perforation in one patient and transient haematuria in two patients, all in the microperc group. One patient in each group required conversion to miniperc.

• One patient in the microperc group needed RIRS for small residual calculi 1 day after surgery. The decrease in haemoglobin was greater in the microperc group (0.96 vs 0.56 g/dL, P < 0.001). The incidence of postoperative fever (Clavien I) was similar in the two groups (8.6 vs 11.4%, P = 1.0). None of the patients in the study required blood transfusion.

• The mean [sd] postoperative pain score at 24 h was slightly higher in the microperc group (1.9 [1.2] vs 1.6 [0.8], P = 0.045). The mean [sd] analgesic requirement was higher in the microperc group (90 [72] vs 40 [41] mg tramadol, P < 0.001). The mean [sd] hospital stay was similar in the two groups (57 [22] vs 48 [18] h, P = 0.08).

CONCLUSIONS

• Microperc is a safe and effective alternative to RIRS for the management of small renal calculi and has similar stone clearance and complication rates when compared to RIRS.

• Microperc is associated with higher haemoglobin loss, increased pain and higher analgesic requirements, while RIRS is associated with a higher requirement for JJ stenting.

Step-by-Step: Percutaneous suprapubic tube bladder drainage in RARP

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Percutaneous suprapubic tube bladder drainage after robot-assisted radical prostatectomy: a step-by-step guide

Khurshid R. Ghani, Quoc-Dien Trinh, Jesse D. Sammon, Wooju Jeong, Andrea Simone, Ali Dabaja, Stacey Dusik, James O. Peabody and Mani Menon

Vattikuti Urology Institute, Henry Ford Health System, Detroit, MI, USA

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OBJECTIVE

• To describe our technique of maintaining bladder drainage after robot-assisted radical prostatectomy (RARP) using a percutaneous suprapubic tube (PST) in place of a urethral catheter.

METHODS

• A watertight anastomosis permits placement of the PST. Contraindications include morbid obesity, concomitant inguinal hernia mesh repair, anticoagulation therapy, limited hand dexterity in the patient, bladder neck reconstruction and extensive adhesiolysis at RARP.

• The necessary equipment includes a 14-F PST balloon catheter set, a three-way connector, a connecting tube, a suture passer, 1/0 polypropylene sutures on a CT1 needle, a sterile plastic button, adhesive and steri-strips.

RESULTS

• The important steps for PST placement are: Step 1: robot-assisted placement of a bladder wall anchor suture; Step 2: transferring the bladder wall suture to anterior abdominal skin; Step 3: guided placement of the PST under robotic vision; Step 4: securing the PST within the bladder and abdominal wall; Step 5. postoperative care: clamping the PST on postoperative day 5, recording each void and post-void residual urine volumes in a patient diary, removal of the PST on postoperative day 7 after 48 h of voiding with residual urine <100 mL per void.

CONCLUSION

• We provide a concise step-by-step guide for placement of a PST during RARP as well as important management aspects for the successful adoption of this technique.

Changing paradigms in the investigation of an elevated PSA level

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Changing paradigms in the investigation of an elevated PSA level

Roger Kirby, Uday Patel, Ben Challacombe and Prokar Dasgupta
The Prostate Centre, London, UK

Published as a comment article in BJU International 2013; 112: 283–285. doi: 10.1111/j.1464-410X.2012.11779.x.

Video Commentary by Roger Kirby, BJUI Associate Editor.

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Video: Fesoterodine vs tolterodine in men and women with OAB

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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.

Video: Remote ischaemic preconditioning: good for the short term

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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.

Video: PSA testing decreased in the Netherlands after ERSPC study

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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.

 

Video: botox course the preferred choice for non-neurogenic OAB

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

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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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