VeSpAR: Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Strictures.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Transecting anastomotic repair (tAR) Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply. |
Procedure: Transecting anastomotic repair (tAR)
Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
|
| Active Comparator: 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. |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- FFS at 24 months [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.
Secondary Outcome Measures
- FFS at 3 and 12 months [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.
- Erectile function [3, 12, and 24 months]
Erectile function score assessed by the International Index of Erectile Function (IIEF-5) questionnaire
- Ejaculatory function [3, 12, and 24 months]
Ejaculatory function score assessed by the Male Sexual Health Questionnaire - Ejaculatory Dysfunction short form (MSHQ-EjD short form)
- Voiding function [3, 12, and 24 months]
Lower Urinary Tract symptoms assessed by the Peeling's voiding picture.
- Lower Urinary Tract symptoms [3, 12, and 24 months]
Lower Urinary Tract symptoms assessed by the International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms module (ICIQ-MLUTS)
- Urinary incontinence [3, 12, and 24 months]
Urinary incontinence assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence short form (ICIQ-UI)
- Maximum flow rate [3, 12, and 24 months]
Qmax assessed using uroflowmetry
- Residual urinary volumes [3, 12, and 24 months]
Residual urinary volumes examined by suprapubic ultrasonic measurement after voiding
- Quality of life (EQ-5D-3L) [3, 12, and 24 months]
QoL scored by the EQ-5D-3L questionnaire
- Quality of life (EQ-VAS) [3, 12, and 24 months]
QoL scored by the EQ visual analogue scale (EQ-VAS)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
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Male
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Age >= 18 years
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Fit for operation, based on the surgeon's expert opinion
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Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations
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Unique urethral stricture
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Urethral stricture =< 3 cm
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Urethral stricture at the bulbar segment
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Patient declares that it will be possible for him to attend the follow-up consultation
Exclusion Criteria:
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Absence of signed written informed consent
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Age <18 years
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Female patients
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Transgender patients
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Patients unfit for operation
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Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
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Urethral strictures exceeding 3 cm
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A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
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Lichen Sclerosus related strictures
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Strictures after failed hypospadias repair
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Patients with neurogenic bladder
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Shift of technique to augmented urethroplasty due to any circumstance
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History of pelvic radiation therapy
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Active treatment to enhance erectile function (such as PDE5-inhibitors and intracavernous injections) at the moment of prescreening for inclusion in this trial
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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
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Patient declares that it will be impossible for him to attend the follow-up consultations
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Urology, SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 2 | Department of Urology, Eastern Virginia Medical School | Norfolk | Virginia | United States | 23507-1912 |
| 3 | Department of Urology, Centro de Educación Médica e Investigaciones Clínicas | Buenos Aires | Argentina | ||
| 4 | Department of Urology, Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | ||
| 5 | Dept. of Urology, Ghent University Hospital | Ghent | Belgium | 9000 | |
| 6 | Dept. of Urology, University Hospital Leuven | Leuven | Belgium | ||
| 7 | Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Shanghai | China | ||
| 8 | Centro de Uretra Las Alamedas | Ciudad de mexico | Mexico | ||
| 9 | Department of Urology, Hospital San José Tecnológico de Monterrey, Universidad de Monterrey | Monterrey | Mexico | ||
| 10 | Department of Urology, Hospital de Santa María, Universidad de Lisboa | Lisboa | Portugal | ||
| 11 | Department of Urology, Departamento Clínico, Facultad de Ciencias Biomédicas, Universidad Europea de Madrid, Hospital Universitario de Getafe | Madrid | Spain | ||
| 12 | Dept. of Urology, Hospital Univ. de Valdecilla | Santander | Spain | ||
| 13 | Department of Urology, University College London Hospital | London | United Kingdom |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
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- 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. Review.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- UZG-U2018/01