NCT01779323已完成不适用
Prospective Study of Urethral Mobility in Male Stress Urinary Incontinence Pre- and Post- Placement of Transobturator Sling
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in urethral mobility
研究概览
简要总结
The hypothesis is men with stress urinary incontinence, including those following radical retropubic prostatectomy and other prostate surgery, have preoperative urethral mobility as measured by magnetic resonance imaging (MRI) that improves significantly following sling placement. The investigators theorize that the sling helps with primary hypermobility of this pathophysiologic cause of stress urinary incontinence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •The control group:
- •normal male subjects
- •The Intervention group:
- •with stress urinary incontinence
- •45 years or older
- •history of prior radical prostatectomy
- •complains of stress urinary incontinence
- •scheduled for a transobturator sling surgery
- •ability and willingness to provide written consent
排除标准
- •absolute or relative contraindications to MRI
- •claustrophobia
- •inability to undergo the male sling surgery
- •PI judgement
- •Absolute contraindications to MRI:
- •electronically, magnetically, and mechanically activated implants
- •ferromagnetic or electronically operated active devices
- •metallic splinters in the eye
- •ferromagnetic hemostatic clips in the central nervous system
- •Relative contraindications to MRI:
- •cochlear implants
- •other pacemakers
- •nerve stimulators
- •lead wires or similar wires
- •prosthetic heart valves
- •hemostatic clips
- •non-ferromagnetic stapedial implants
结局指标
主要结局
Change in urethral mobility
时间窗: Within 2-5 months after enrollment
Measure change in urethral mobility from baseline versus 2-5 months post-surgery versus no surgical intervention.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment MethodsLower Urinary Tract SymptomsVoiding DysfunctionBenign Prostate ObstructionDetrusor UnderactivityNCT02193451North Bristol NHS Trust820
Unknown
不适用
Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical ProstatectomyUrinary Incontinence, UrgeIncontinenceProstatectomyOveractive BladderProstate CancerNCT03061760Collegium Medicum w Bydgoszczy250
已完成
不适用
MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal BalloonUrinary IncontinenceProstate CancerErectile DysfunctionHypothermiaNCT01979848University of California, Irvine3
已完成
不适用
Transient Urinary Incontinence After Holmium Laser Enucleation of the Prostate (HoLEP)Prostatic HyperplasiaIncontinenceNCT01108367Seoul National University Hospital204
撤回
不适用
Male Stress Urinary Incontinence and Sexual HealthProstate CancerNCT01379378Stanford University