Endoscopic urethrotomy versus open urethroplasty for men with bulbar urethral stricture: the OPEN randomised trial cost-effectiveness analysis

Background Bulbar urethral stricture is a common cause for urinary symptoms in men and its two main treatment options both have drawbacks with little evidence on their relative cost-effectiveness. Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus. Objective To assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men. Methods Set in the UK National Health Service with recruitment from 38 hospital sites, a randomised controlled trial of open urethroplasty and endoscopic urethrotomy with 6-monthly follow-up over 24 months was conducted. Two hundred and twenty-two men requiring operative treatment for recurrence of bulbar urethral stricture and having had at least one previous intervention for stricture were recruited. Effectiveness was measured by quality- adjusted life years (QALYs) derived from EQ-5D 5L. Cost-effectiveness was measured by the incremental cost per QALY gained over 24 months using a within trial analysis and a Markov model with a 10-year time horizon. Results In the within trial, urethroplasty cost on average more than urethrotomy (cost difference: £2148 [95% CI 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: − 0.01 [95% CI − 0.17, 0.14)] over 24 months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that the results were robust, despite observed missing data. Conclusions Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty. Keypoints Urethrotomy and urethroplasty both led to symptom improvement for men with bulbar urethral stricture—a common cause for urinary symptoms in men; Urethroplasty appeared unlikely to offer good value for money compared to urethrotomy based on current evidence. Trial registration: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507). Trial protocol: The latest version (1.8) of the full protocol is available at: www.journalslibrary.nihr.ac.uk/programmes/hta/105723/#/ and a published version is also available: Stephenson R, Carnell S, Johnson N, Brown R, Wilkinson J, Mundy A, et al. Open urethroplasty versus endoscopic urethrotomy—clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial. Trials 2015;16:600. https://doi.org/10.1186/s13063-015-1120-4. Trial main clinical results publication: Goulao B, Carnell S, Shen J, MacLennan G, Norrie J, Cook J, et al. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial), European Urology, Volume 78, Issue 4, 2020, Pages 572–580.

Urethroplasty in the management of urethral strictures: a literature review

Urethral stricture is defined as pathological urethral narrowing caused by corpus spongiosum fibrosis. The etiology of this condition is mostly idiopathic, which can also result from iatrogenic (like previous urethral surgeries, catheterization, or resection), inflammatory and traumatic causes. The evidence discussing the management of urethral strictures is scarce. The management starts with an appropriate evaluation of the condition through a comprehensive history taking (obstructive symptoms) and physical examination. Diagnostic investigations include cystoscopy (the most specific), urethrography, patient reported scales, like American urological association symptom index, uroflowmetry, and retrograde urethrography. Previous literature shows urethroplasty is cost effective, whether when it is used as the primary treatment or following a non-successful dilation and direct visualization internal urethrotomy. Moreover, open urethroplasty and endoscopic urethrotomy were comparable among both procedures in terms of voiding improvement; however, urethroplasty benefit was more durable. Akin to that, urethroplasty was found to be a successful procedure in up to 95% of the cases with the appropriate experience level. Although excision and primary anastomosis and augmentation/substitution urethroplasties have considerable long-term success rates, the EPA procedures have a controversial influence on sexual function, which may be unacceptable to some reconstructive urologists. In general, there are a few large scales, multi center studies that can produce high-quality evidence. There is an urge to develop more high-grade research in terms of ideal management of urethral strictures.

Endoscopic Urethrotomy Vs Open Urethroplasty for Men With Bulbar Urethral Stricture: The Open Randomised Trial Cost-Effectiveness Analysis

Background: Bulbar urethral stricture is a common cause for urinary symptoms in men and its two main treatment options both have drawbacks with little evidence on their relative cost-effectiveness. Current guidelines on the management of recurrent bulbar urethral stricture have been predominantly based on expert opinion and panel consensus.Objective: To assess the relative cost-effectiveness of open urethroplasty and endoscopic urethrotomy as treatment for recurrent urethral stricture in men.Methods: Set in the UK National Health Service with recruitment from 38 hospital sites, a randomised controlled trial of open urethroplasty and endoscopic urethrotomy with 6-monthly follow-up over 24 months was conducted. Two hundred and twenty-two men requiring operative treatment for recurrence of bulbar urethral stricture and having had at least one previous intervention for stricture were recruited. Effectiveness was measured by quality- adjusted life years (QALYs) derived from EQ-5D 5L. Cost-effectiveness was measured by the incremental cost per QALY gained over 24 months using a within trial analysis and a Markov model with a 10-year time horizon. Results: In the within trial, urethroplasty cost on average more than urethrotomy (cost difference: £2148 [95% CI: 689, 3606]) and resulted in a similar number of QALYs on average (QALY difference: -0.01 [95% CI: -0.17, 0.14)] over 24 months. The Markov model produced similar results. Sensitivity analyses using multiple imputation, suggested that the results were robust, despite observed missing data.Conclusions: Based on current practice and evidence, urethrotomy is a cost-effective treatment compared with urethroplasty. Trial registration: ISRCTN: 98009168 (date: 29 November 2012) and it is also in the UK NIHR Portfolio (reference 13507).

INTERNAL ENDOSCOPIC URETHROTOMY FOR URETHRAL STRICTURES : EVALUATION OF RESULTS AND INFLUENZATING FACTORS

Objective: To describe the clinical aspects of urethral strictures managed internal endoscopic urethrotomy (IEU) and to evaluate the outcomes and factors on success rate. Patients and methods:This is a retrospective, descriptive, analytical and monocentric 2-year study of patient records with an IEU indicated for urethral stricture. The parameters studied were: age, history of endo-urethral maneuvers, clinical symptomatology,etiologies, strictures characteristics and outcomes. The outcomes were appreciated by the quality of the voiding jet and the outcomes of the control rétrograde urethrocystography.. Results:Sixty patients were included. The mean age was 50±19.3 years old. An history endo-urethral was found in 38.3% of patients. The mean of consultation time was 20.7±30.7 months. Dysuria was the most common reason for consultation. The most common etiologies were those of infectious and iatrogenic. The bulbar seat was predominant. The mean of length was 0.9±0.5cm. After the mean delay of 14.5 ± 6.9 months, the overall success rate was 60%. Per and postoperative complications were dominated by retention of urine. The outcomes showed that there was no significant correlation between age, previous treatment, etiology, seat, length, number of strictures, and outcome. Conclusion:The IEU gives a good results if the indication is well posed. Seat, length, single or multiple character, etiology and history of endo-urethral maneuvers do not affect the outcomes.

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.

Infectious etiologies of genital elephantiasis outside of filariasis endemic regions: a case report

Background Isolated genital elephantiasis outside filariasis endemic tropical and subtropical regions is rare and presents a diagnostic and therapeutic challenge. Serologic and radiographic investigation must be undertaken to exclude reversible causes of genital elephantiasis. Case presentation Authors report herein the case of a 58-year-old patient with chronic penile and scrotal elephantiasis. He had a history of untreated urethritis and an endoscopic urethrotomy for urethra stricture three years ago. Serological test for chlamydiosis was positive. Retrograde urethrocystography demonstrated a bulbar urethra stricture. The patient spectacularly and completely improved after endoscopic urethrotomy and long-term doxycycline. Conclusions Early treatment of sexual transmitted infections such as chlamydiosis is important to prevent the evolution of penoscrotal elephantiasis and to avoid surgical procedures.