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Residents’ Podcast: Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe UUI related to OAB

Part of the BURST/BJUI Podcast Series

Nikita Bhatt is a Specialist Trainee in Urology in the East of England Deanery and a BURST Committee member @BURSTUrology

Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

Masaki Yoshida*, Masayuki Takeda, Momokazu Gotoh, Osamu Yokoyama§, Hidehiro Kakizaki, Satoru Takahashi**, Naoya Masumori††, Shinji Nagai‡‡ and Kazuyoshi Minemura‡‡

*Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan, Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, §Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan, **Department of Urology, Nihon University School of Medicine, Tokyo, ††Department of Urology, Sapporo Medical University School of Medicine, Sapporo, and ‡‡Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan

Abstract

Objective

To evaluate the efficacy of a novel and selective β3‐adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB).

Patients and Methods

post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI‐free (‘diary‐dry’ rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.

Results

Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, were −1.35, −1.47 and −1.08 in all patients, −1.04, −1.13 and −0.89 in the mild/moderate UUI subgroup, and −2.95, −3.28 and −2.10 in the severe UUI subgroup. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary‐dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.

Conclusions

Vibegron, a novel β3‐adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.

Residents’ podcast: the ProtecT trial

Mr Joseph Norris is a Specialty Registrar in Urology in the London Deanery. He is currently undertaking an MRC Doctoral Fellowship at UCL, under the supervision of Professor Mark Emberton. His research interest is prostate cancer that is inconspicuous on mpMRI. Joseph sits on the committee of the BURST Research Collaborative as the Treasurer and BSoT Representative.

The ProtecT trial: analysis of the patient cohort, baseline risk stratification and disease progression

Abstract

Objective

To test the hypothesis that the baseline clinico‐pathological features of the men with localized prostate cancer (PCa) included in the ProtecT (Prostate Testing for Cancer and Treatment) trial who progressed (n = 198) at a 10‐year median follow‐up were different from those of men with stable disease (n = 1409).

Patients and Methods

We stratified the study participants at baseline according to risk of progression using clinical disease stage, pathological grade and PSA level, using Cox proportional hazard models.

Results

The findings showed that 34% of participants (n = 505) had intermediate‐ or high‐risk PCa, and 66% (n = 973) had low‐risk PCa. Of 198 participants who progressed, 101 (51%) had baseline International Society of Urological Pathology Grade Group 1, 59 (30%) Grade Group 2, and 38 (19%) Grade Group 3 PCa, compared with 79%, 17% and 5%, respectively, for 1409 participants without progression (P < 0.001). In participants with progression, 38% and 62% had baseline low‐ and intermediate‐/high‐risk disease, compared with 69% and 31% of participants with stable disease (P < 0.001). Treatment received, age (65–69 vs 50–64 years), PSA level, Grade Group, clinical stage, risk group, number of positive cores, tumour length and perineural invasion were associated with time to progression (P ≤ 0.005). Men progressing after surgery (n = 19) were more likely to have a higher Grade Group and pathological stage at surgery, larger tumours, lymph node involvement and positive margins.

Conclusions

We demonstrate that one‐third of the ProtecT cohort consists of people with intermediate‐/high‐risk disease, and the outcomes data at an average of 10 years’ follow‐up are generalizable beyond men with low‐risk PCa.

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Resident’s podcast: Retzius‐sparing robot‐assisted radical prostatectomy

Maria Uloko is a Urology Resident at the University of Minnesota Hospital. In this podcast she discusses the following BJUI Article of the Week:

Retzius‐sparing robot‐assisted radical prostatectomy (RS‐RARP) vs standard RARP: it’s time for critical appraisal

Thomas Stonier*, Nick Simson*, John Davisand Ben Challacombe

 

*Department of Urology, Princess Alexandra Hospital, Harlow, Urology Centre, Guy s Hospital, London, UK and Department of Urology, MD Anderson Cancer Center, Houston, TX, USA

 

Abstract

Since robot‐assisted radical prostatectomy (RARP) started to be regularly performed in 2001, the procedure has typically followed the original retropubic approach, with incremental technical improvements in an attempt to improve outcomes. These include the running Van‐Velthoven anastomosis, posterior reconstruction or ‘Rocco stitch’, and cold ligation of the Santorini plexus/dorsal vein to maximise urethral length. In 2010, Bocciardi’s team in Milan proposed a novel posterior or ‘Retzius‐sparing’ RARP (RS‐RARP), mirroring the classic open perineal approach. This allows avoidance of supporting structures, such as the puboprostatic ligaments, endopelvic fascia, and Santorini plexus, preserving the normal anatomy as much as possible and limiting damage that may contribute to improved postoperative continence and erectile function. There has been much heralding of the excellent functional outcomes in both the medical and the lay press, but as yet no focus or real mention of any potential downsides of this new technique.

 

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Residents’ podcast: Cluster analysis of multiple chronic conditions associated with urinary incontinence among women in the USA

Giulia Lane M.D. and Iryna Crescenze M.D. are Fellows in Neuro-urology and Pelvic Reconstruction in the Department of Urology at the University of Michigan.

In this podcast they discuss the following BJUI Article of the Week:

Cluster analysis of multiple chronic conditions associated with urinary incontinence among women in the USA

Abstract

Objective

To identify patterns of prevalent chronic medical conditions among women with urinary incontinence (UI).

Materials and Methods

We combined cross‐sectional data from the 2005–2006 to 2011–2012 US National Health and Nutrition Examination Surveys, and identified 3 800 women with UI and data on 12 chronic conditions. Types of UI included stress UI (SUI), urgency UI (UUI), and mixed stress and urgency UI (MUI). We categorized UI as mild, moderate or severe using validated measures. We performed a two‐step cluster analysis to identify patterns between clusters for UI type and severity. We explored associations between clusters by UI subtype and severity, controlling for age, education, race/ethnicity, parity, hysterectomy status and adiposity in weighted regression analyses.

Results

Eleven percent of women with UI had no chronic conditions. Among women with UI who had at least one additional condition, four distinct clusters were identified: (i) cardiovascular disease (CVD) risk‐younger; (ii) asthma‐predominant; (iii) CVD risk‐older; and (iv) multiple chronic conditions (MCC). In comparison to women with UI and no chronic diseases, women in the CVD risk‐younger (age 46.7 ± 15.8 years) cluster reported the highest rate of SUI and mild UI severity. In the asthma‐predominant cluster (age 51.5 ± 10.2 years), women had more SUI and MUI and more moderate UI severity. Women in the CVD risk‐older cluster (age 57.9 ± 13.4 years) had the highest rate of UUI, along with more severe UI. Women in the MCC cluster (age 61.0 ± 14.8 years) had the highest rates of MUI and the highest rate of moderate/severe UI.

Conclusions

Women with UI rarely have no additional chronic conditions. Four patterns of chronic conditions emerged with differences by UI type and severity. Identification of women with mild UI and modifiable conditions may inform future prevention efforts.

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Residents’ podcast: Urinary continence recovery after radical prostatectomy

Maria Uloko is a Urology Resident at the University of Minnesota Hospital and Giulia Lane is a Female Pelvic Medicine and Reconstructive Surgery Fellow at the University of Michigan.

In this podcast they discuss the BJUI Article of the Week ‘Investigating the mechanism underlying urinary continence recovery after radical prostatectomy: effectiveness of a longer urethral stump to prevent urinary incontinence‘.

 

Investigating the mechanism underlying urinary continence recovery after radical prostatectomy: effectiveness of a longer urethral stump to prevent urinary incontinence

 

Yoshifumi Kadono*, Takahiro Nohara*, Shohei Kawaguchi*, Renato Naito*, Satoko Urata*, Kazufumi Nakashima*, Masashi Iijima*, Kazuyoshi Shigehara*, Kouji Izumi*, Toshifumi Gabata† and Atsushi Mizokami*

*Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan; †Department of Radiology, Kanazawa University School of Medicine, 13‐1 Takara‐machi, Kanazawa, Ishikawa 920‐8640, Japan

Abstract

Objective

To assess the chronological changes in urinary incontinence and urethral function before and after radical prostatectomy (RP), and to compare the findings of pelvic magnetic resonance imaging (MRI) before and after RP to evaluate the anatomical changes.

Patients and Methods

In total, 185 patients were evaluated with regard to the position of the distal end of the membranous urethra (DMU) on a mid‐sagittal MRI slice and urethral sphincter function using the urethral pressure profilometry. The patients also underwent an abdominal leak point pressure test before RP and at 10 days and 12 months after RP. The results were then compared with the chronological changes in urinary incontinence.

Fig. 1 Intraoperative view of the apex of the prostate transection line between the urethra and prostate at the normal (straight line) and long urethral stump (dashed line) positions.

Results

The MRI results showed that the DMU shifted proximally to an average distance of 4 mm at 10 days after RP and returned to the preoperative position at 12 months after RP. Urethral sphincter function also worsened 10 days after RP, with recovery after 12 months. The residual length of the urethral stump and urinary incontinence were significantly associated with the migration length of the DMU at 10 days after RP. The residual length of the urethral stump was a significant predictor of urinary incontinence after RP.

Conclusion

This is the first study to elucidate that the slight vertical repositioning of the membranous urethra after RP causes chronological changes in urinary incontinence. A long urethral residual stump reduces urinary incontinence after RP.

 

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Resident’s Podcast: NICE Guidance – ceftolozane & tazobactam for complicated UTIs

Eleanor Zimmermann is due to start her Urology registrar training in the Southwest this October, and is a BURST Core Surgical Trainee Representative. @BURSTUrology

In this Residents’ Podcast, Eleanor discusses the NICE Guidance on complicated urinary tract infections: ceftolozane/tazobactam

 

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Residents’ Podcast: UK‐ROPE Study

Maria Uloko is a Urology Resident at the University of Minnesota Hospital and Giulia Lane is a Female Pelvic Medicine and Reconstructive Surgery Fellow at the University of Michigan

In this podcast they discuss the BJUI Article of the Month ‘Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)’

 

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity‐matched comparison with transurethral resection of the prostate (the UK‐ROPE study)

 

Alistair F. Ray*, John Powell†‡, Mark J. Speakman§, Nicholas T. LongfordRanan DasGupta**, Timothy Bryant††, Sachin Modi††, Jonathan Dyer‡‡, Mark Harris‡‡Grace Carolan-Rees* and Nigel Hacking††

 

*Cedar, Cardiff University/Cardiff and Vale University Health Board, Cardiff, Centre for Health Technology Evaluation, National Institute for Health and Care Excellence, London, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, §Department of Urology, Taunton and Somerset NHS Trust, Taunton, SNTL Statistics Research and Consulting, Department of Medicine, Imperial College London, **Department of Urology, St. MaryHospital, Imperial College Healthcare NHS Trust, London, ††Department of Interventional Radiology, and ‡‡Department of Urology, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK

 

Abstract

Objectives

To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP).

Patients and Methods

As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK‐ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post‐procedure, and complication data post‐PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non‐inferiority analysis on propensity‐score‐matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire‐based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK‐ROPE study database.

Results

The results showed that PAE was clinically effective, producing a median 10‐point IPSS improvement from baseline at 12 months post‐procedure. PAE did not appear to be as effective as TURP, which produced a median 15‐point IPSS score improvement at 12 months post‐procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality‐of‐life (QoL) improvement, there was no evidence of PAE being non‐inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post‐procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non‐target embolization that presented as self‐limiting penile ulcers. Additional patient‐reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy‐one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights.

Conclusion

Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone‐beam computed tomography is encouraged to improve operator confidence and minimize non‐target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients’ symptoms, requirements and anatomical variation.

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Residents’ Podcast: Follow‐up of TIND implantation for the treatment of benign prostatic obstruction

 

Maria Uloko and Guilia Lane are Urology Residents at the University of Minnesota Hospital.

In this podcast they discuss the BJUI Article of the Week, 3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction
Special Guest: Mike Borofsky

 

3‐Year follow‐up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction

 

Francesco Porpiglia , Cristian Fiori, Riccardo Bertolo, Andrea GiordanoEnrico Checcucci, Diletta Garrou, Giovanni Cattaneo, Stefano De Luca and Daniele Amparore

 

Division of Urology, Department of Oncology School of Medicine, San Luigi Hospital, University of Turin, Orbassano (Turin), Italy

 

Abstract

Objectives

To report 3‐year follow‐up results of the first implantations with a temporary implantable nitinol device (TIND®; Medi‐Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Patients and Methods

In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Qmax) <12 mL/s, and prostate volume <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to Clavien–Dindo classification), functional results, and quality of life (QoL) were evaluated. Follow‐up assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student’s t‐test, one‐way analysis of variance and Kruskal–Wallis tests were used for statistical analyses.

Results

At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14–23) and the QoL score was 3 (3–4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Qmax was significant at every follow‐up time point. After 36 months of follow‐up, a 41% rise in Qmax was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6–24) and the IPSS QoL was 2 (1–4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36‐month follow‐up.

Conclusions

The extended follow‐up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well‐tolerated, for at least 36 months after treatment.

 

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