VeSpAR: A Randomized Controlled Trial Comparing Vessel-Sparing Anastomotic Repair and Transecting Anastomotic Repair in Isolated Short Bulbar Urethral Strictures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- FFS at 24 months
研究概览
简要总结
The investigators want to verify whether the surgical outcome of vessel-sparing anastomotic repair in isolated short bulbar urethral strictures is not inferior to the surgical outcome of transecting anastomotic repair. Furthermore, the investigators compare the functional outcome of both techniques verifying if there is less erectile dysfunction after vessel-sparing anastomotic repair than after transecting anastomotic repair.
详细描述
A randomized controlled trial comparing vessel-sparing anastomotic repair (vsAR) and transecting anastomotic repair (tAR) in isolated short bulbar urethral strictures (maximum 3 centimeter) for both surgical and functional outcome, to demonstrate that vsAR is not inferior to tAR regarding the surgical outcome, and to demonstrate a benefit for vsAR over tAR regarding postoperative erectile function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients will be randomized using software in a 1:1 ratio in either the vessel-sparing group or the transecting group. Randomisation will be stratified per participating center and single blinded; double blindation is impossible as the surgeon has to know which technique to perform.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Voluntary signed written informed consent (according to the rules of Good Clinical Practice and national regulations)
- •Age >= 18 years
- •Fit for operation, based on the surgeon's expert opinion
- •Isolated short (=< 3cm) bulbar urethral stricture confirmed by preoperative retrograde urethrography (RUG), voiding cysto-urethrography (VCUG), cystoscopy, ultrasonography or a combination of investigations
- •Unique urethral stricture
- •Urethral stricture =< 3 cm
- •Urethral stricture at the bulbar segment
- •Patient declares that it will be possible for him to attend the follow-up consultation
排除标准
- •Absence of signed written informed consent
- •Age <18 years
- •Female patients
- •Transgender patients
- •Patients unfit for operation
- •Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
- •Urethral strictures exceeding 3 cm
- •A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck)
- •Lichen Sclerosus related strictures
- •Strictures after failed hypospadias repair
- •Patients with neurogenic bladder
- •Shift of technique to augmented urethroplasty due to any circumstance
- •History of pelvic radiation therapy
- •Active treatment to enhance erectile function (such as PDE5-inhibitors and intracavernous injections) at the moment of prescreening for inclusion in this trial
- •Any condition or situation, which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
- •Patient declares that it will be impossible for him to attend the follow-up consultations
结局指标
主要结局
FFS at 24 months
时间窗: 24 months
Failure-free survival at 24 months. Surgical failure is defined as urethroscopic evidence of stricture recurrence, impossible to pass with a 16Fr silicone urethral catheter, independent of whether the stricture is treated or not.
次要结局
- Maximum flow rate(3, 12, and 24 months)
- Erectile function(3, 12, and 24 months)
- Quality of life (EQ-5D-3L)(3, 12, and 24 months)
- FFS at 3 and 12 months(3 and 12 months)
- Lower Urinary Tract symptoms(3, 12, and 24 months)
- Ejaculatory function(3, 12, and 24 months)
- Urinary incontinence(3, 12, and 24 months)
- Residual urinary volumes(3, 12, and 24 months)
- Quality of life (EQ-VAS)(3, 12, and 24 months)
- Voiding function(3, 12, and 24 months)