Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)

BackgroundUrethral stricture affects 0.9% of men. Initial treatment is urethrotomy. Approximately, half of the strictures recur within 4 yr. Options for further treatment are repeat urethrotomy or open urethroplasty.ObjectiveTo compare the effectiveness and cost-effectiveness of urethrotomy with open urethroplasty in adult men with recurrent bulbar urethral stricture.Design, setting, and participantsThis was an open label, two-arm, patient-randomised controlled trial. UK National Health Service hospitals were recruited and 222 men were randomised to receive urethroplasty or urethrotomy.InterventionUrethrotomy is a minimally invasive technique whereby the narrowed area is progressively widened by cutting the scar tissue with a steel blade mounted on a urethroscope. Urethroplasty is a more invasive surgery to reconstruct the narrowed area.Outcome measurements and statistical analysisThe primary outcome was the profile over 24 mo of a patient-reported outcome measure, the voiding symptom score. The main clinical outcome was time until reintervention.Results and limitationsThe primary analysis included 69 (63%) and 90 (81%) of those allocated to urethroplasty and urethrotomy, respectively. The mean difference between the urethroplasty and urethrotomy groups was –0.36 (95% confidence interval [CI] –1.74 to 1.02). Fifteen men allocated to urethroplasty needed a reintervention compared with 29 allocated to urethrotomy (hazard ratio [95% CI] 0.52 [0.31–0.89]).ConclusionsIn men with recurrent bulbar urethral stricture, both urethroplasty and urethrotomy improved voiding symptoms. The benefit lasted longer for urethroplasty.Patient summaryThere was uncertainty about the best treatment for men with recurrent bulbar urethral stricture. We randomised men to receive one of the following two treatment options: urethrotomy and urethroplasty. At the end of the study, both treatments resulted in similar and better symptom scores. However, the urethroplasty group had fewer reinterventions

Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men:the OPEN RCT

Background Men who suffer recurrence of bulbar urethral stricture have to decide between endoscopic urethrotomy and open urethroplasty to manage their urinary symptoms. Evidence of relative clinical effectiveness and cost-effectiveness is lacking. Objectives To assess benefit, harms and cost-effectiveness of open urethroplasty compared with endoscopic urethrotomy as treatment for recurrent urethral stricture in men. Design Parallel-group, open-label, patient-randomised trial of allocated intervention with 6-monthly follow-ups over 24 months. Target sample size was 210 participants providing outcome data. Participants, clinicians and local research staff could not be blinded to allocation. Central trial staff were blinded when needed. Setting UK NHS with recruitment from 38 hospital sites. Participants A total of 222 men requiring operative treatment for recurrence of bulbar urethral stricture who had received at least one previous intervention for stricture. Interventions A centralised randomisation system using random blocks allocated participants 1 : 1 to open urethroplasty (experimental group) or endoscopic urethrotomy (control group). Main outcome measures The primary clinical outcome was control of urinary symptoms. Cost-effectiveness was assessed by cost per quality-adjusted life-year (QALY) gained over 24 months. The main secondary outcome was the need for reintervention for stricture recurrence. Results The mean difference in the area under the curve of repeated measurement of voiding symptoms scored from 0 (no symptoms) to 24 (severe symptoms) between the two groups was –0.36 [95% confidence interval (CI) –1.78 to 1.02; p = 0.6]. Mean voiding symptom scores improved between baseline and 24 months after randomisation from 13.4 [standard deviation (SD) 4.5] to 6 (SD 5.5) for urethroplasty group and from 13.2 (SD 4.7) to 6.4 (SD 5.3) for urethrotomy. Reintervention was less frequent and occurred earlier in the urethroplasty group (hazard ratio 0.52, 95% CI 0.31 to 0.89; p = 0.02). There were two postoperative complications requiring reinterventions in the group that received urethroplasty and five, including one death from pulmonary embolism, in the group that received urethrotomy. Over 24 months, urethroplasty cost on average more than urethrotomy (cost difference £2148, 95% CI £689 to £3606) and resulted in a similar number of QALYs (QALY difference –0.01, 95% CI –0.17 to 0.14). Therefore, based on current evidence, urethrotomy is considered to be cost-effective. Limitations We were able to include only 69 (63%) of the 109 men allocated to urethroplasty and 90 (80%) of the 113 men allocated to urethrotomy in the primary complete-case intention-to-treat analysis. Conclusions The similar magnitude of symptom improvement seen for the two procedures over 24 months of follow-up shows that both provide effective symptom control. The lower likelihood of further intervention favours urethroplasty, but this had a higher cost over the 24 months of follow-up and was unlikely to be considered cost-effective. Future work Formulate methods to incorporate short-term disutility data into cost-effectiveness analysis. Survey pathways of care for men with urethral stricture, including the use of enhanced recovery after urethroplasty. Establish a pragmatic follow-up schedule to allow national audit of outcomes following urethral surgery with linkage to NHS Hospital Episode Statistics. Trial registration Current Controlled Trials ISRCTN98009168. Funding This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 61. See the NIHR Journals Library website for further project information

Landslides caused by the M_w7.8 Kaikōura earthquake and the immediate response

Tens of thousands of landslides were generated over 10, 000 km2 of North Canterbury and Marlborough as a consequence of the 14 November 2016, MW7.8 Kaikōura Earthquake. The most intense landslide damage was concentrated in 3500 km2 around the areas of fault rupture. Given the sparsely populated area affected by landslides, only a few homes were impacted and there were no recorded deaths due to landslides. Landslides caused major disruption with all road and rail links with Kaikōura being severed. The landslides affecting State Highway 1 (the main road link in the South Island of New Zealand) and the South Island main trunk railway extended from Ward in Marlborough all the way to the south of Oaro in North Canterbury. The majority of landslides occurred in two geological and geotechnically distinct materials reflective of the dominant rock types in the affected area. In the Neogene sedimentary rocks (sandstones, limestones and siltstones) of the Hurunui District, North Canterbury and around Cape Campbell in Marlborough, first-time and reactivated rock-slides and rock-block slides were the dominant landslide type. These rocks also tend to have rock material strength values in the range of 5-20 MPa. In the Torlesse 'basement' rocks (greywacke sandstones and argillite) of the Kaikōura Ranges, first-time rock and debris avalanches were the dominant landslide type. These rocks tend to have material strength values in the range of 20-50 MPa. A feature of this earthquake is the large number (more than 200) of valley blocking landslides it generated. This was partly due to the steep and confined slopes in the area and the widely distributed strong ground shaking. The largest landslide dam has an approximate volume of 12(±2) M m3 and the debris from this travelled about 2.7 km2 downslope where it formed a dam blocking the Hapuku River. The long-term stability of cracked slopes and landslide dams from future strong earthquakes and large rainstorms are an ongoing concern to central and local government agencies responsible for rebuilding homes and infrastructure. A particular concern is the potential for debris floods to affect downstream assets and infrastructure should some of the landslide dams breach catastrophically. At least twenty-one faults ruptured to the ground surface or sea floor, with these surface ruptures extending from the Emu Plain in North Canterbury to offshore of Cape Campbell in Marlborough. The mapped landslide distribution reflects the complexity of the earthquake rupture. Landslides are distributed across a broad area of intense ground shaking reflective of the elongate area affected by fault rupture, and are not clustered around the earthquake epicentre. The largest landslides triggered by the earthquake are located either on or adjacent to faults that ruptured to the ground surface. Surface faults may provide a plane of weakness or hydrological discontinuity and adversely oriented surface faults may be indicative of the location of future large landslides. Their location appears to have a strong structural geological control. Initial results from our landslide investigations suggest predictive models relying only on ground-shaking estimates underestimate the number and size of the largest landslides that occurred.</p

The Mw7.8 2016 Kaikoura earthquake: surface fault rupture and seismic hazard context

We provide a summary of the surface fault ruptures produced by the Mw7.8 14 November 2016 Kaikōura earthquake, including examples of damage to engineered structures, transportation networks and farming infrastructure produced by direct fault surface rupture displacement. We also provide an overview of the earthquake in the context of the earthquake source model and estimated ground motions from the current (2010) version of the National Seismic Hazard Model (NSHM) for New Zealand. A total of 21 faults ruptured along a c.180 km long zone during the earthquake, including some that were unknown prior to the event. The 2010 version of the NSHM had considered multi-fault ruptures in the Kaikōura area, but not to the degree observed in the earthquake. The number of faults involved a combination of known and unknown faults, a mix of complete and partial ruptures of the known faults, and the non-involvement of a major fault within the rupture zone (i.e. the Hope Fault) makes this rupture an unusually complex event by world standards. However, the strong ground motions of the earthquake are consistent with the high hazard of the Kaikōura area shown in maps produced from the NSHM

Students' participation in collaborative research should be recognised

Letter to the editor