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Bladder catheter duration after Urethral Stricture correction surgery: a randomized trial

Duration of urethral catheterization after Urethroplasty: a randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-292qvqs
Enrollment
Unknown
Registered
2023-02-23
Start date
2022-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethra stenosis

Interventions

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 202

Sponsors

Hospital de Clínicas de Porto Alegre
Lead Sponsor
Hospital de Clínicas de Porto Alegre
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Male; 18 years of age or older; diagnosis of urethral stenosis with indication of anterior urethroplasty

Exclusion criteria

Exclusion criteria: Posterior urethral stenosis; bladder neck sclerosis; vesicourethral anastomosis stricture; neurogenic etiology for urinary symptoms or requiring intermittent bladder catheterization; previous anterior urethroplasty; staged urethroplasty; urethral fistulas

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Evaluate the rate of urinary infection and asymptomatic bacteriuria 4 weeks after the procedure with clinical examination and analysis of urine culture.;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 International Index of Erectile Function (IIEF-5) score, preoperatively, in the 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.

Countries

Brazil

Contacts

Public ContactPatric Tavares

Hospital de Clínicas de Porto Alegre

ptavares@hcpa.edu.br+55(51) 33598000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)