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临床试验/NCT05680168
NCT05680168招募中不适用

Efficacy of Extracorporeal Magnetic Stimulation, Pelvic Floor Muscle Exercise, and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence: A Randomized Controlled Trial

Hamad General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
One hour pad test

研究概览

简要总结

Urinary incontinence is one of the most common complications of radical prostatectomy. Multiple prevention and treatment modalities have been proposed in the management of post prostatectomy urinary incontinence. This is a randomized controlled comparative study to evaluate the efficacy of extracorporeal magnetic stimulation alone and combined with pelvic floor muscle exercise versus pelvic floor muscle exercise alone in the management of post radical prostatectomy urinary incontinence. This study is expected to be performed over 7 years. The study population will be all male patients who are prepared for radical prostatectomy under urology department in HMC and were referred to voiding dysfunction for preoperative counselling and postoperative rehabilitation. Patients will be randomized into one of three treatment groups. The first group will receive sessions of extracorporeal magnetic field stimulation only. The second group will receive extracorporeal magnetic stimulation in addition to pelvic floor muscle exercise. The third group will receive pelvic floor muscle exercise only. The recruitment phase will take 3 years. Patients will be followed for 18 months for the course of urinary incontinence symptoms, severity of urinary incontinence on 1-hour pad test, urodynamic leak point pressure and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and the ICIQ quality of life (QOL) score. This study is proposed to reveal strong evidence on the efficacy of extracorporeal magnetic stimulation on the management of post radical prostatectomy urinary incontinence.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • The study population will include all adult male patients 18 years of age and above, with localized prostate cancer of low or intermediate risk disease who chose definitive treatment with radical prostatectomy either through open radical retropubic prostatectomy (RRP) or through robotic assissted laparoscopic radical prostatectomy (RALP) as first line for treatment and had the surgery under Hamad General Hospital urology department care.

排除标准

  • Patients with high risk , locally advanced or metastatic prostate cancer at time of diagnosis
  • Patients with low to intermediate risk prostate cancer who received chemo or radiotherapy then had salvage surgery
  • Patients with urinary incontinence or diagnosed overactive bladder before radical prostatectomy.
  • Patients with complicated surgery resulting in anastomotic leak, prolonged catheterisation more than 3 weeks, reinsertion of catheter due to retention of urine.
  • Patients who refuse to participate in the clinical trial.

结局指标

主要结局

One hour pad test

时间窗: 18 months from the start of intervention

Measuring the weight of an incontinence pad used for one hour to detect the volume of urinary leakage in one hour assessed at 6 points of follow up

the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

时间窗: 18 months from the start of intervention

Questionnaire administered at 6 points of follow up

Urodynamic leak point pressure.

时间窗: 1 day (Once) after 6 weeks of the start of rehabilitation process

Urodynamic study to evaluate the bladder dynamics and its response to radical prostatectomy and its response to rehabilitation

次要结局

  • International Consultation on Incontinence Questionnaire quality of life score(18 months from the start of intervention)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ahmed Albakr

Principal Investigator

Hamad General Hospital

研究点 (1)

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