The OPEN Trial: Open Urethroplasty versus Endoscopic Urethrotomy: Clarifying the management of men with recurrent urethral stricture

Not Applicable

Completed

• Conditions: Recurrent urethral stricture; Urological and Genital Diseases; Urethral stricture

• Registration Number: ISRCTN98009168
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26718754 2017 results in http://www.ncbi.nlm.nih.gov/pubmed/28347354 2020 results in https://pubmed.ncbi.nlm.nih.gov/33228846/ (added 25/11/2020) 2021 cost effectiveness analysis in https://pubmed.ncbi.nlm.nih.gov/33941140/ (added 05/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-29
• Study Completion: 2017-02-01
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 222

Inclusion Criteria

1. Adult men aged 16 years or older
2. Stricture located predominantly in bulbar urethra
3. Undergone at least one previous intervention (urethrotomy, dilatation, or urethroplasty) for bulbar stricture
4. Clinician and patient agreement that intervention is required
5. Suitable for general or regional anaesthesia of up to 3 hours duration
6. Willingness to have 2 week period of catheterisation
7. Provided written informed consent for participation in the study prior to any study specific procedures

Exclusion Criteria

1. Age less than 16 years
2. Stricture extending into membranous urethra or predominantly sited in penile urethra
3. Presence of perineal sepsis and/or fistula
4. No previous intervention for bulbar stricture
5. High anaesthetic risk or inability to adhere to protocol due to comorbidity
6. Inability or unwillingness to provide informed consent to randomisation
7. Previous participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified