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The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.
A randomized controlled trial comparing vessel-sparing anastomotic repair (vsAR) and transecting anastomotic repair (tAR) in isolated short bulbar urethral strictures (maximum 3 centimeter) for both surgical and functional outcome, to demonstrate that vsAR is not inferior to tAR regarding the surgical outcome, and to demonstrate a benefit for vsAR over tAR regarding postoperative erectile function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transecting anastomotic repair (tAR) | Active Comparator | Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. |
|
| Vessel-sparing anastomotic repair (vsAR) | Active Comparator | Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transecting anastomotic repair (tAR) | Procedure | Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FFS at 24 months | Failure-free survival at 24 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| FFS at 3 and 12 months | Failure-free survival at 3 and 12 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not. | 3 and 12 months |
| Erectile function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, SUNY Upstate Medical University | Syracuse | New York | 13210 | United States | ||
| Department of Urology, Eastern Virginia Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24210733 | Background | Latini JM, McAninch JW, Brandes SB, Chung JY, Rosenstein D. SIU/ICUD Consultation On Urethral Strictures: Epidemiology, etiology, anatomy, and nomenclature of urethral stenoses, strictures, and pelvic fracture urethral disruption injuries. Urology. 2014 Mar;83(3 Suppl):S1-7. doi: 10.1016/j.urology.2013.09.009. Epub 2013 Nov 8. | |
| 23153951 |
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Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial
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Patients will be randomized using software in a 1:1 ratio in either the vessel-sparing group or the transecting group. Randomisation will be stratified per participating center and single blinded; double blindation is impossible as the surgeon has to know which technique to perform.
| Vessel-sparing anastomotic repair (vsAR) | Procedure | Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis. |
|
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire |
| 3, 12, and 24 months |
| Ejaculatory function | Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form) | 3, 12, and 24 months |
| Voiding function | Lower Urinary Tract symptoms assessed by the Peeling's voiding picture. | 3, 12, and 24 months |
| Lower Urinary Tract symptoms | Lower Urinary Tract symptoms assessed by the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS) | 3, 12, and 24 months |
| Urinary incontinence | Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI) | 3, 12, and 24 months |
| Maximum flow rate | Qmax assessed using uroflowmetry | 3, 12, and 24 months |
| Residual urinary volumes | Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding | 3, 12, and 24 months |
| Quality of life (EQ-5D-3L) | QoL scored by the EQ-5D-3L questionnaire | 3, 12, and 24 months |
| Quality of life (EQ-VAS) | QoL scored by the EQ visual analogue scale (EQ-VAS) | 3, 12, and 24 months |
| Norfolk |
| Virginia |
| 23507-1912 |
| United States |
| Department of Urology, Centro de Educación Médica e Investigaciones ClÃnicas | Buenos Aires | Argentina |
| Department of Urology, Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
| Dept. of Urology, Ghent University Hospital | Ghent | 9000 | Belgium |
| Dept. of Urology, University Hospital Leuven | Leuven | Belgium |
| Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | China |
| Centro de Uretra Las Alamedas | Mexico City | Mexico |
| Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey | Monterrey | Mexico |
| Department of Urology, Hospital de Santa MarÃa, Universidad de Lisboa | Lisbon | Portugal |
| Department of Urology, Departamento ClÃnico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe | Madrid | Spain |
| Dept. of Urology, Hospital Univ. de Valdecilla | Santander | Spain |
| Department of Urology, University College London Hospital | London | United Kingdom |
| Palminteri E, Berdondini E, Verze P, De Nunzio C, Vitarelli A, Carmignani L. Contemporary urethral stricture characteristics in the developed world. Urology. 2013 Jan;81(1):191-6. doi: 10.1016/j.urology.2012.08.062. Epub 2012 Nov 13. |
| 24373726 | Background | Morey AF, Watkin N, Shenfeld O, Eltahawy E, Giudice C. SIU/ICUD Consultation on Urethral Strictures: Anterior urethra--primary anastomosis. Urology. 2014 Mar;83(3 Suppl):S23-6. doi: 10.1016/j.urology.2013.11.007. Epub 2013 Dec 27. |
| 17437823 | Background | Jordan GH, Eltahawy EA, Virasoro R. The technique of vessel sparing excision and primary anastomosis for proximal bulbous urethral reconstruction. J Urol. 2007 May;177(5):1799-802. doi: 10.1016/j.juro.2007.01.036. |
| 18399836 | Background | Gur U, Jordan GH. Vessel-sparing excision and primary anastomosis (for proximal bulbar urethral strictures). BJU Int. 2008 May;101(9):1183-95. doi: 10.1111/j.1464-410X.2008.07619.x. No abstract available. |
| 27307398 | Background | Lumen N, Poelaert F, Oosterlinck W, Lambert E, Decaestecker K, Tailly T, Hoebeke P, Spinoit AF. Nontransecting Anastomotic Repair in Urethral Reconstruction: Surgical and Functional Outcomes. J Urol. 2016 Dec;196(6):1679-1684. doi: 10.1016/j.juro.2016.06.016. Epub 2016 Jun 12. |
| 21933325 | Background | Andrich DE, Mundy AR. Non-transecting anastomotic bulbar urethroplasty: a preliminary report. BJU Int. 2012 Apr;109(7):1090-4. doi: 10.1111/j.1464-410X.2011.10508.x. Epub 2011 Sep 20. |
| 25690318 | Background | Virasoro R, Zuckerman JM, McCammon KA, DeLong JM, Tonkin JB, Capiel L, Rovegno AR, Favre G, Giudice CR, Eltahawy EA, Gur U, Jordan GH. International multi-institutional experience with the vessel-sparing technique to reconstruct the proximal bulbar urethra: mid-term results. World J Urol. 2015 Dec;33(12):2153-7. doi: 10.1007/s00345-015-1512-9. Epub 2015 Feb 18. |
| 26816808 | Background | Bugeja S, Andrich DE, Mundy AR. Non-transecting bulbar urethroplasty. Transl Androl Urol. 2015 Feb;4(1):41-50. doi: 10.3978/j.issn.2223-4683.2015.01.07. |
| 27844407 | Background | Anderson KM, Blakely SA, O'Donnell CI, Nikolavsky D, Flynn BJ. Primary non-transecting bulbar urethroplasty long-term success rates are similar to transecting urethroplasty. Int Urol Nephrol. 2017 Jan;49(1):83-88. doi: 10.1007/s11255-016-1454-1. Epub 2016 Nov 14. |
| 28432540 | Background | Le W, Li C, Zhang J, Wu D, Liu B. Preliminary clinical study on non-transecting anastomotic bulbomembranous urethroplasty. Front Med. 2017 Jun;11(2):277-283. doi: 10.1007/s11684-017-0515-x. Epub 2017 Apr 22. |
| 12796652 | Background | Andrich DE, Dunglison N, Greenwell TJ, Mundy AR. The long-term results of urethroplasty. J Urol. 2003 Jul;170(1):90-2. doi: 10.1097/01.ju.0000069820.81726.00. |
| 15227649 | Background | Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 19638912 | Background | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. |
| 9187685 | Background | Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0. |
| 26453539 | Background | Utomo E, Blok BF, Pastoor H, Bangma CH, Korfage IJ. The measurement properties of the five-item International Index of Erectile Function (IIEF-5): a Dutch validation study. Andrology. 2015 Nov;3(6):1154-9. doi: 10.1111/andr.12112. Epub 2015 Oct 9. |
| 28850951 | Background | Verla W, Waterloos M, Lumen N. Urethroplasty and Quality of Life: Psychometric Validation of a Dutch Version of the Urethral Stricture Surgery Patient Reported Outcome Measures. Urol Int. 2017;99(4):460-466. doi: 10.1159/000479189. Epub 2017 Aug 30. |
| 18537788 | Background | Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4. |
| 16192604 | Background | Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, Smith MA. Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol. 2005 Oct 1;23(28):7199-206. doi: 10.1200/JCO.2005.01.149. |
| 32917251 | Derived | Verla W, Waterloos M, Waterschoot M, Van Parys B, Spinoit AF, Lumen N. VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures. Trials. 2020 Sep 11;21(1):782. doi: 10.1186/s13063-020-04712-5. |
| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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