Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2023
INTERVENTION: E01.370.390.820 This is a prospective randomized clinical study with blinded evaluation in randomized blocks. The sample will consist of 132 patients who will undergo anterior urethroplasty from June 2022 to June 2025. Block randomization with a computerized random number generator was used to assign sample numbers equally to each arm, with block sizes random. The allocation will be performed by one of the researchers who has not participated in the surgery, the day after the surgery. The procedures will be performed by two trained and experienced surgeons. Immediately after urethroplasty, randomization between groups 1 and 2 will be performed, in blocks according to the location of the stenosis (navicular fossa, penile, peno‐bulbar and bulbar) in a 1:1 ratio between groups: group 1 ‐ DUC of 2 weeks and group 2 ‐ 3‐week DUC. The parameters observed in the preoperative evaluation will be through the demographic characteristics (age, presence of smoking, level of education, nationality and clinical comorbidities), characteristics of urethral stenosis (etiology, location, length, presence of cystostomy, Qmax, post voiding residue and IPSS ) and characteristics of the surgical technique (Dorsal inlay, Dorsal onlay, dorsolateral, ventral, EAP). In the postoperative evaluation, the parameters observed will be Qmax, post voiding residue, Validated Questionnaire for Urethroplasty (PROM), Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ‐EJD), rate of symptomatic UTI and bacteriuria. The patient will need to consent to the Free and Informed Consent Form (ICF), complete clinical and demographic data and the IPSS, IIEF‐5 and MSHQ‐EJD questionnaires. The patient's first return for outpatient care for tube removal will be in 2 or 3 weeks, depending on randomization. The second eva CONDITION: N00 ‐ N99 Urethra stenosis PRIMARY OUTCOME: Surgical success in the groups with a duration of urethral catheterization (UCD) of 2 and 3 weeks verified by uroflowmetry, with a maximum flow equal to or greater than 15 ml/s after 12 months of treatment being considered successful. In patients with flow lower than 15 m/s, a urethral patency test with a 16 Fr urinary catheter or urethroscopy with a 17 Fr cystoscope will be performed. SECONDARY OUTCOME: Check for changes in the International Inde Xof Erectile Function (IIEF‐5) score, preoperatively, in the 3rd, 6th and 12th month after the procedure. Check for changes in the International Prostate Symptom Score (IPSS) preoperatively, in the 3rd, 6th and 12th month after the procedure. Check for changes in the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ‐EJD), preoperatively, 3rd, 6th and 12th month after the procedure. Check for changes in the score of the questionnaire for patients undergoing urethral surgery (USS‐PROM) in the preoperative period, in the 3rd, 6th and 12th month after the procedure. Evaluate the rate of urinary infection and asymptomatic bacteriuria 4 weeks after the procedure with clinical examination and analysis of urine culture. INCLUSION CRITERIA: Male; 18 years of age or older; diagnosis of urethral stenosis with indication of anterior urethroplasty
Epistemonikos ID: f5453a64ab606e2c1ab7b096178624e86d21d833
First added on: Feb 20, 2024