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

Clarifying the management of men with recurrent urethral stricture: A pragmatic multicentre randomised superiority trial of open urethroplasty versus endoscopic urethrotomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN98009168
Enrollment
500
Registered
2012-11-29
Start date
2013-02-01
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Recurrent urethral stricture Urological and Genital Diseases Urethral stricture

Interventions

We need to randomise at least 500 men recruited from NHS hospitals to undergo either of the two options of endoscopic urethrotomy and open urethroplasty and then follow their progress over 2 years. Du

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
ICIQ-Male Short Form questionnaire repeated measurement over 24 months following intervention

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026