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

Surgery Clinical Trial

— VeSpAR  

Official title:

VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572348
• Other study ID #: BC-03662
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: December 14, 2023

Study information

• Verified date: January 2024
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 14, 2023
• Est. primary completion date: December 14, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Active treatment to enhance erectile function (such as PDE5-inhibitors and intracavernous injections) at the moment of prescreening for inclusion in this trial

• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Surgery
• Urethral Stricture
• Urologic Diseases

Intervention

Procedure:
• Transecting anastomotic repair (tAR)
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
• Vessel-sparing anastomotic repair (vsAR)
Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.

Locations

Country	Name	City	State
Argentina	Department of Urology, Centro de Educación Médica e Investigaciones Clínicas	Buenos Aires
Argentina	Department of Urology, Hospital Italiano de Buenos Aires	Buenos Aires
Belgium	Dept. of Urology, Ghent University Hospital	Ghent
Belgium	Dept. of Urology, University Hospital Leuven	Leuven
China	Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai
Mexico	Centro de Uretra Las Alamedas	Ciudad de mexico
Mexico	Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey	Monterrey
Portugal	Department of Urology, Hospital de Santa María, Universidad de Lisboa	Lisboa
Spain	Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe	Madrid
Spain	Dept. of Urology, Hospital Univ. de Valdecilla	Santander
United Kingdom	Department of Urology, University College London Hospital	London
United States	Department of Urology, Eastern Virginia Medical School	Norfolk	Virginia
United States	Department of Urology, SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  China,  Mexico,  Portugal,  Spain,  United Kingdom, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Erectile function	Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire	3, 12, and 24 months
Secondary	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
Secondary	Voiding function	Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.	3, 12, and 24 months
Secondary	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
Secondary	Urinary incontinence	Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)	3, 12, and 24 months
Secondary	Maximum flow rate	Qmax assessed using uroflowmetry	3, 12, and 24 months
Secondary	Residual urinary volumes	Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding	3, 12, and 24 months
Secondary	Quality of life (EQ-5D-3L)	QoL scored by the EQ-5D-3L questionnaire	3, 12, and 24 months
Secondary	Quality of life (EQ-VAS)	QoL scored by the EQ visual analogue scale (EQ-VAS)	3, 12, and 24 months