The effect of Masport Botulinum toxin injection in reducing the recurrence of bulbar urethral stricture

Phase 3

• Conditions: Bulbar Urethral Stricture.; Other specified disorders of male genital organs; N50.8

• Registration Number: IRCT20191222045852N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Men over 18 years
Diagnosed with urethral stricture
Who were candidates for surgery for bulbar stricture

Exclusion Criteria

Patients with stenosis length of more than 1.5 cm
Spongiofibrosis
Acute retention
Multiple stenosis
Stenosis due to lichen sclerosis
Active urinary tract infections,
Neurogenic bladder,
Stenosis in the penile urethra or membranous
History of benign prostatic hyperplasia
Prostate cancer
Pelvic radiotherapy
Urethroplasty
More than one internal urethrotomy
Hypersensitivity reaction to any of the components of Botulinum Toxin Type A

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: recurrence rate of urethral stricture. Timepoint: 3-6-9 months after the operation. Method of measurement: Questionnaire, examination, uroflowmetry.

Secondary Outcome Measures

Name	Time	Method
Investigation of prostate symptoms. Timepoint: 3-6-9 months after the intervention. Method of measurement: Questionnaire, examination, uroflowmetry.;Investigation of surgical outcome. Timepoint: 3-6-9 months after the intervention. Method of measurement: Questionnaire, examination, uroflowmetry.