VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures

Abstract

Background Vessel-sparing anastomotic repair (vsAR) has been developed as a less traumatic alternative to transecting anastomotic repair (tAR) to treat isolated short bulbar urethral strictures. This vessel-sparing technique could result in improved functional outcomes without jeopardizing the excellent surgical outcome after (transecting) anastomotic repair. The purpose of this study is to directly compare vsAR and tAR for both surgical and functional outcomes. Methods This trial is a prospective, interventional, multi-center, single-blinded, 1:1 randomized, controlled, non-inferiority, phase II trial. Sample size calculation resulted in a required sample size of 100 patients (50 patients per arm). Trial participants will be randomized by an independent third party using a computer-based random sequence generator with permuted blocks of variable size. The primary objective of this trial is to show that vsAR is non-inferior to tAR in terms of failure-free survival after 24 months of follow-up, considering a non-inferiority limit of 10%. Failure is defined as the inability to pass a 16-Fr flexible cystoscope through the reconstructed area without damaging the urethral mucosa. Secondary end-points mainly include differences in postoperative complications and changes in functional outcome parameters, which will be assessed with validated questionnaires. All participants are scheduled for follow-up at 3, 12, and 24 months postoperatively. Discussion This trial will provide level Ib evidence about the differences in both surgical and functional outcome between vsAR and tAR, which may importantly scape the future of bulbar urethral reconstruction. Depending on the trial results, this phase II trial may generate a larger phase III trial with more statistical power and a lower alpha value. Trial registration This trial is registered at clinicaltrials.gov (NCT03572348) and in the Belgian Clinical Trial Registry (B670201837335). The trial was registered prospectively. Registered on 28 June 2018.

Non-Transecting Urethroplasty for Bulbar Urethral Strictures—Narrative Review and Treatment Algorithm

“…Other groups have also found no significant difference in long-term stricture-free recurrence rates between the transecting and non-transecting bulbar urethroplasty [ 19 ]. Important randomized control data awaits publication of the VeSpAR trial, a prospective, interventional, multi-center study with 1:1 randomization of patients to vessel-sparing to transecting anastomotic repair in short bulbar urethral strictures, although this will still leave unanswered questions regarding augmented techniques [ 35 ].…”

Mucomucosal anastomotic non‐transecting augmentation (MANTA) urethroplasty: a ventral modification for obliterative strictures

“…The six-item LUTS score, as derived from the USS PROM, significantly improved from a baseline median (IQR) score of 13 (8)(9)(10)(11)(12)(13)(14) to postoperative median (IQR) score of 3.5 (1-8) (P < 0.001). In sexually active patients, there were no differences in the median baseline vs postoperative IIEF-EF scores (median [IQR] 27 [17][18][19][20][21][22][23][24][25][26][27][28][29][30] vs 24 [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30]; P = 0.4). Similarly, no differences were found in the median ICIQ-UI sum scores (median [IQR] 0 [0-8] vs 0 [0-7]; P = 0.5).…”

“…In a first step, EPA was refined using a non-transecting approach (ntEPA) [11] and the need of urethral mobilisation could be reduced by establishing a ventral access [12,13]. Results from the VeSpAR trial (ClinicalTrials.gov identifier: NCT03572348) are eagerly awaited to assess the noninferiority of ntEPA compared to conventional transecting EPA in terms of failure-free survival and functional outcome parameters [14]. The non-transecting strategy was eventually transferred to AAU in the context of simultaneous graft augmentation [15][16][17].…”

Sexual function after anterior urethroplasty: a systematic review

“…Non-transecting techniques seem to diminish vascular damage secondary to EPA repairs, but their clinical benefit over EF is yet to be consistently proven (see Table 1 for details). There is an ongoing prospective, multi-center, randomized, non-inferiority trial, comparing transecting and non-transecting techniques (46). This study will provide evidence on both surgical and functional results after these techniques, including erectile function, and will try to shed light on the value of bulbar artery preservation.…”