📃 Paper Title: Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)
🧍 Author: Goulao
🕒 Year: 2020
📚 Journal: European Urology
🌎 Country: UK
ㅤContext to the study:
Can you tell me about a study that showed a benefit for urethroplasty recurrent bulbar stricture?
ㅤ✅ Take-home message of study:
In men with recurrent bulbar stricture, both urethroplasty and urethrotomy improve voiding symptoms, with observed benefit lasting longer in urethroplasty.
Urethroplasty reduces recurrence and reintervention rate.
ㅤ Multicentre, open-label, two-arm, patient-randomized controlled trial
ㅤ
Study participants:
Inclusion criteria
Adult men with bulbar stricture disease having previously undergone at least one treatment for the condition.
Exclusion Criteria
Current perineal sepsis and/or urethra-cutaneous fistula
Patients
222 Adult Men
Patients randomised 1:1 to urethrotomy (n=113) or urethroplasty (n=109).
53 NHS centres
ㅤ
ㅤ
Key study outcomes:
Primary Outcome
The primary outcome was the profile over 24 months of a patient-reported outcome measure (PROM) and the voiding symptom score. The main clinical outcome was time until reintervention.
PROMs by written questionnaire were collected at baseline, and 3, 12, 24 months post intervention and before and after a reintervention.
Case report forms were completed at 3,12,and 24 months after intervention to capture clinical outcomes and adverse events.
Uroflow was performed at baseline, 3 months and between 12 and 24 months.
Outcomes
Groups were well matched for baseline characteristics (age, length of stricture, duration of disease, prior intervention, time since last intervention, site of stricture or aetiology of stricture).
Voiding Score (Scoreable range 0-24)
Urethroplasty 7.4
Urethrotomy 7.8
p=0.6
The mean difference between the urethroplasty and urethrotomy groups was -0.36 (95% confidence interval [CI] -1.74 to 1.02).
Impact of Urinary Symptoms (Scoreable range 0-3)
Urethroplasty 1.1
Urethrotomy 1.0
p=0.6
Satisfaction with sexual function (Scoreable range 0-5)
Urethroplasty 2.9
Urethrotomy 2.5
p=0.09
Qmax improved at 12 or 24 months from baseline (%)
Urethroplasty 19%
Urethrotomy 13%
p=0.024
Odds ratio 2.1: urethrotomy group had twice the odds of experiencing an improvement of>10ml/s in maximum flow rate at 3 months, OR increasing to 2.6 at 12 or 24 months.
Recurrence (n)
Urethroplasty 19
Urethrotomy 39
p = 0.001
Hazard ratio 0.46
Re-intervention (n)
Urethroplasty 15
Urethrotomy 29
p=0.017
48% lower reintervention risk of urethroplasty (HR 0.52 [0.31-0.89]).
Serious Adverse Event
The percentage of SAEs was similar in both the urethroplasty and the urethrotomy groups (10.9% vs 11.3%)
ㅤ
ㅤ
Study Limitations:
Study drop out rate:
-159/222 patients included in primary analysis (63% of urethroplasty and 81% of urethrotomy)
No blinding
ㅤ