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Excision and Primary Anastomosis for Bulbar Urethral Strictures Improves Functional Outcomes and Quality of Life: A Prospective Analysis from a Single Centre.

ABSTRACT: Background:Excision and primary anastomotic (EPA) urethroplasty remains the gold standard definitive treatment for short urethral stricture disease. For patients, postoperative erectile function and quality of life are the main goals of the surgery. Patient-reported outcome measures (PROMs) are therefore of major importance. Objective:The objective of this study was to prospectively analyse functional outcomes and patient satisfaction. Design Settings and Participants:We prospectively evaluated 47 patients before and after EPA from August 2009 until February 2017. The first follow-up visit occurred after a median of 2.2 months (n = 47/47), with the second and third follow-ups occurring at a median of 8.5 months (n = 38/47) and 20.2 months (n = 31/47). Before surgery and at each follow-up visit, the patients received five questionnaires: the International Prostate Symptom Score (IPSS), the International Prostate Symptom Score with the Quality of Life (IPSS-QOL) score, the Urogenital Distress Inventory Short Form (UDI-6) score, the International Index of Erectile Function-5 (IIEF-5) score, and the ICIQ-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTS-QOL) score. Surgical Procedure:Surgery was performed in all cases using the same standardized EPA technique. Outcome Measurements and Statistical Analysis:Voiding symptoms, erectile dysfunction, and quality of life were analysed using paired sample t-tests, with a multiple-testing Bonferroni correction. Any requirement for instrumentation after surgery was considered treatment failure. Results and Limitations:Patients with mild or no baseline erectile dysfunction showed significant decline in erectile function at first follow-up (mean IIEF-5 of 23.27 [standard deviation; SD: 2.60] vs. 13.91 [SD: 7.50]; p=0.002), but this had recovered completely at the third follow-up (IIEF-5: 23.25 [SD: 1.91]; p=0.659). Clinically significant improvements were noted in IPSS, IPSS-QOL-score, UDI-6-score, and ICIQ-LUTS-QOL-score at the first follow-up (p<0.0001). These improvements remained significant at the second and third follow-ups (p<0.0001) for all PROMs. Three of the patients experienced stricture recurrence. The main limitations of this study were incomplete questionnaires, loss to follow-up, and low number of patients. Conclusions:EPA results in an initial decline in erectile function, but full recovery occurred at a median of 20 months. Voiding improved significantly, and a major improvement in quality of life was noted, which persisted for up to 20 months after surgery. Patient Summary:This study showed the importance of patient-reported outcome measures in indicating the actual outcome of urethral stricture disease surgery.

SUBMITTER: D'hulst P

PROVIDER: S-EPMC6364126 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Excision and Primary Anastomosis for Bulbar Urethral Strictures Improves Functional Outcomes and Quality of Life: A Prospective Analysis from a Single Centre.

D'hulst Pieter P Floyd Michael S MS Castiglione Fabio F Vander Eeckt Kathy K Joniau Steven S Van der Aa Frank F

BioMed research international 20190123

<h4>Background</h4>Excision and primary anastomotic (EPA) urethroplasty remains the gold standard definitive treatment for short urethral stricture disease. For patients, postoperative erectile function and quality of life are the main goals of the surgery. Patient-reported outcome measures (PROMs) are therefore of major importance.<h4>Objective</h4>The objective of this study was to prospectively analyse functional outcomes and patient satisfaction.<h4>Design settings and participants</h4>We pr ...[more]

PMID: 30809546

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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.

Dataset Information

Excision and Primary Anastomosis for Bulbar Urethral Strictures Improves Functional Outcomes and Quality of Life: A Prospective Analysis from a Single Centre.

Publications

Excision and Primary Anastomosis for Bulbar Urethral Strictures Improves Functional Outcomes and Quality of Life: A Prospective Analysis from a Single Centre.

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