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Holmium: YAG Versus Cold Knife Internal Urethrotomy in the Management of Short Urethral Strictures: A Randomized Controlled Trial

ABSTRACT: Introduction: our study aimed to assess the safety and efficacy of Holmium: YAG laser internal urethrotomy compared to the cold knife internal urethrotomy. Methods: Eighty adult male patients presented with a urethral stricture less than 1.5 cm were included in our study; they were randomly allocated into 2 groups representing Holmium and cold knife internal urethrotomy. A careful evaluation with ascending cystourethrogram and uroflowmetry were done on all patients, and they were followed up for 1 year with uroflowmetry. Results: Each group included 40 patients sharing the same demographic data. The most common cause of a urethral stricture in both groups was iatrogenic injury. The mean operative time of the cold knife urethrotomy procedure was 10.98 ± 2.40 minutes compared to 15.43 ± 2.48 minutes in the holmium laser urethrotomy group with a highly significant difference. The results showed success rates of 90% and 80% for the holmium laser and cold knife internal urethrotomy groups respectively. The perioperative complication according to the Clavien-Dindo classification, showed no statistically significant difference in grade 1 and 2 complications. A recurrence rate with the need for redo surgery representing grade 3B complication was seen in 4 cases in the Holmium group compared to 8 cases in the cold knife group with a statistically significant difference. Conclusion: Both Holmium Laser and cold knife internal urethrotomy are an effective surgical option for the treatment of a urethral stricture less than 1.5 cm with a promising outcome after 1-year follow-up with a better success rate using the Holmium laser.

SUBMITTER: Gamal M

PROVIDER: S-EPMC8558697 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

Project description:BackgroundUrethral stricture disease is a common problem amongst men in Western countries often leading to a decreased quality of life. Current endoscopic treatment procedure shows an unsatisfying stricture recurrence rate which could be improved by addition of local therapies.ObjectivesTo provide an overview of both preclinical and clinical studies in order to investigate current level of evidence on the addition of local therapy to improve urethral stricture recurrence rates after endoscopic procedures.MethodsWe performed a literature search in December 2020 and August 2021 using Cochrane, Embase, PubMed, Scopus and Web of Science and identified articles through combinations of search terms for 'urethral stricture disease', 'stricture formation' and 'local interventions'. We used the SYRCLE, RoB-2 and ROBINS-I tools to assess risk of bias across included studies. We did not perform a meta-analysis due to methodological differences between studies.ResultsWe included 32 articles in the qualitative analysis, 20 of which were preclinical studies and 12 clinical studies. Regarding preclinical articles using an animal model, nearly all interventions showed to have a positive effect on either urethral fibrosis, urethral stricture formation and/or fibrotic protein expression levels. Here, immunosuppressants and chemotherapeutics seemed most promising for possible clinical purposes. Regarding clinical studies, mitomycin-C and hyaluronic acid and carboxymethylcellulose showed positive effects on urethral stricture recurrence rates with low to intermediate risk of bias across studies. However, the positive clinical effects of mitomycin-C and steroids seemed to decrease in studies with a longer follow-up time.ConclusionAlthough local adjuvant use of mitomycin-C or hyaluronic acid and carboxymethylcellulose may carry clinical potential to improve urethral structure recurrence rates after endoscopic procedures, we believe that a large, well-designed RCT with a yearlong follow-up time is necessary to identify the true clinical value.

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Holmium: YAG Versus Cold Knife Internal Urethrotomy in the Management of Short Urethral Strictures: A Randomized Controlled Trial

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