To Investigate the Outcomes of Rectus Abdominis Flap Detrusor Myoplasty for Urinary Retention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Bladder Compliance
研究概览
简要总结
This investigates the outcomes of a surgical technique using the patient's own abdominal wall muscles to help contract the bladder in patients with urinary retention
详细描述
This study is about a surgery called Rectus Abdominis Detrusor Myoplasty (RADM). In this surgery, a small piece of the belly muscle is moved and wrapped around your bladder to help it squeeze and empty urine. Doctors are studying this surgery because current treatments, like catheters or nerve implants, don't always work for people whose bladders don't contract on their own. This study monitors the patients' progress for a year following this surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypo- or acontractility of the bladder documented on urodynamic testing
- •Injury >1 year ago for spinal cord injury patients, no improvement in contractility with time
- •Failed sacral nerve stimulation implant for urinary retention treatment (If previously implanted)
- •Irreversible non-neurogenic bladder acontractility/hypocontractility (i.e myogenic failure after chronic obstruction, aging, frailty, idiopathic)
- •Undergoing RADM
排除标准
- •Documented bladder outlet obstruction
- •Spinal cord lesion above T12
- •Upper motor neuron lesion (i.e. multiple sclerosis, stroke)
- •Rectus diastasis, significant abdominal wall hernia, or other anatomic barrier to rectus flap harvest
- •Life expectancy <10 years
- •Pregnant at time of surgery
研究组 & 干预措施
Individiuals receiving Rectus Abdominis Detrusor Myoplasty (RADM)
Individuals diagnosed with refractory urinary retention that have failed conventional approaches to treat urinary retention such as catheterization and neurostimulation.
干预措施: Rectus Abdominal Detrusor Myoplasty (Procedure)
结局指标
主要结局
Change in Bladder Compliance
时间窗: 6 Months and 1 Year Post-Op
Bladder compliance will be calculated as the change in bladder volume divided by the change in detrusor pressure during the filling phase and reported in milliliters per centimeter of water (mL/cm H₂O).
Change in Detrusor Pressure
时间窗: 6 Months and 1 Year Post-Op
Detrusor pressure during filling and voiding, including detrusor pressure at maximum flow, will be reported in centimeters of water (cm H₂O).
Change in presence of Detrusor Overactivity
时间窗: 6 Months and 1 Year Post-Op
Detrusor overactivity will be recorded as a binary variable (present or absent) based on the occurrence of involuntary detrusor contractions during filling.
Change in Urinary Flow Rate
时间窗: 6 Months and 1 Year Post-Op
Maximum urinary flow rate will be reported in milliliters per second (mL/s).
Change In Post-Void Residual Urine Volume in Urine
时间窗: 6 Months and 1 Year Post-Op
Post-void residual volume will be measured immediately following voiding and reported in milliliters (mL).
次要结局
- Change in quality of life as measured by the Short-Form 36 (SF-36)(Month 6 and Year 1 Post-Op)
研究者
Shubham Gupta
Professor
University Hospitals Cleveland Medical Center