VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.

NCT03572348 | Completed

• 1 other identifier: BC-03662
• Study Type: interventional
• Target: 100
• Locations: 8 countries
• Sites: 13

Brief Summary

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.

Conditions

Urethral Stricture; Surgery; Urologic Diseases

Keywords

urethral stricture; urethroplasty; bulbar urethra; reconstructive surgery; lower urinary tract symptoms; erectile function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• FFS at 3 and 12 months

  3 and 12 months

• Erectile function

  3, 12, and 24 months

• Ejaculatory function

  3, 12, and 24 months

• Voiding function

  3, 12, and 24 months

• Lower Urinary Tract symptoms

  3, 12, and 24 months

Study Arms (2)

Transecting anastomotic repair (tAR)

ACTIVE COMPARATOR

Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.

Procedure: Transecting anastomotic repair (tAR)

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.

Procedure: Vessel-sparing anastomotic repair (vsAR)

Interventions

Transecting anastomotic repair (tAR) PROCEDURE

Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.

Transecting anastomotic repair (tAR)

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.

Vessel-sparing anastomotic repair (vsAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
• Male
• Age \>= 18 years
• Fit for operation, based on the surgeon's expert opinion
• Isolated short (=\< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations
• Unique urethral stricture
• Urethral stricture =\< 3 cm
• Urethral stricture at the bulbar segment
• Patient declares that it will be possible for him to attend the follow-up consultation

You may not qualify if:

• Absence of signed written informed consent
• Age \<18 years
• Female patients
• Transgender patients
• Patients unfit for operation
• Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
• Urethral strictures exceeding 3 cm
• A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
• Lichen Sclerosus related strictures
• Strictures after failed hypospadias repair
• Patients with neurogenic bladder
• Shift of technique to augmented urethroplasty due to any circumstance
• History of pelvic radiation therapy
• Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
• Patient declares that it will be impossible for him to attend the follow-up consultations

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (13)

Department of Urology, SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Department of Urology, Eastern Virginia Medical School

Norfolk, Virginia, 23507-1912, United States

Location

Department of Urology, Centro de Educación Médica e Investigaciones Clínicas

Buenos Aires, Argentina

Location

Department of Urology, Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Location

Dept. of Urology, Ghent University Hospital

Ghent, 9000, Belgium

Location

Dept. of Urology, University Hospital Leuven

Leuven, Belgium

Location

Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, China

Location

Centro de Uretra Las Alamedas

Mexico City, Mexico

Location

Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey

Monterrey, Mexico

Location

Department of Urology, Hospital de Santa María, Universidad de Lisboa

Lisbon, Portugal

Location

Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe

Madrid, Spain

Location

Dept. of Urology, Hospital Univ. de Valdecilla

Santander, Spain

Location

Department of Urology, University College London Hospital

London, United Kingdom

Location

Related Publications (21)

• 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.

  PMID: 24210733 BACKGROUND

• 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.

  PMID: 23153951 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.

  PMID: 24373726 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.

  PMID: 17437823 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.

  PMID: 18399836 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.

  PMID: 27307398 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.

  PMID: 21933325 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.

  PMID: 25690318 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.

  PMID: 26816808 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.

  PMID: 27844407 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.

  PMID: 28432540 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.

  PMID: 12796652 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.

  PMID: 15227649 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.

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• 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.

  PMID: 19638912 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.

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  PMID: 26453539 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.

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• Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2):150-4.

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  PMID: 16192604 BACKGROUND

• 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.

  PMID: 32917251 DERIVED

MeSH Terms

Conditions

Urethral Stricture; Urologic Diseases; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, multicentric, single-blinded, randomized, controlled, non-inferiority, phase II trial

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 28, 2018
• Study Start: September 26, 2018
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

GB (1); ES (2); BE (2); CN (1); ME (2); US (2); PT (1); AR (2)