Effect of Extracorporeal Magnetic Stimulation Added to Pelvic Floor Muscle Training on Post-Prostatectomy Urine Incontinence: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to Recovery of Urinary Continence
研究概览
简要总结
This study looks at whether adding a non-invasive magnetic stimulation treatment to standard pelvic floor exercises helps men regain bladder control faster after prostate surgery (HoLEP or bipolar enucleation). Some men experience temporary urine leakage after this type of surgery. Participants will be randomly assigned to receive either pelvic floor muscle exercises alone, or pelvic floor muscle exercises combined with magnetic stimulation sessions using a specialized chair. Researchers will measure how long it takes for bladder control to return, how much urine leakage occurs, and how each treatment affects participants' quality of life over 6 months of follow-up.
详细描述
This is a prospective, randomized controlled trial conducted at the outpatient urology clinic of Tanta University Hospital evaluating the effect of extracorporeal magnetic stimulation (ExMI) added to pelvic floor muscle training (PFMT) versus biofeedback-assisted PFMT alone on recovery of urinary continence following Holmium Laser Enucleation of the Prostate (HoLEP) or Bipolar Enucleation of the Prostate (BipoLEP) for benign prostatic hyperplasia.
A total of 100 male patients aged 50 years or older who develop postoperative stress-predominant urinary incontinence after catheter removal will be randomized in a 1:1 ratio to Group 1 (electromagnetic pelvic floor stimulation, n=50) or Group 2 (biofeedback-assisted pelvic floor muscle training, n=50).
All participants will receive supervised PFMT consisting of three daily sessions (10 slow contractions of 5-10 seconds and 10 rapid contractions per session) for 12 weeks postoperatively. Group 1 will additionally receive extracorporeal magnetic stimulation using a magnetic chair device, twice weekly for 20-30 minutes per session over 6-8 weeks, at an intensity adjusted to patient tolerance, aiming to induce repetitive pelvic floor muscle contraction and pudendal nerve stimulation.
Continence status will be assessed after catheter removal and at follow-up visits at 2 weeks, 1 month, 3 months, and 6 months postoperatively, using pad count, 24-hour pad weight testing, the ICIQ-UI SF questionnaire, and quality-of-life scoring. Continence will be defined as no pad use, or use of one security pad with no significant leakage.
The primary outcome is time to recovery of urinary continence. Secondary outcomes include reduction in pad usage, improvement in 24-hour pad test results, improvement in ICIQ-UI SF score, quality-of-life improvement, and treatment-related adverse events.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged ≥50 years
- •Diagnosed with symptomatic benign prostatic hyperplasia (BPH) requiring surgical intervention
- •Scheduled for Holmium Laser Enucleation of the Prostate (HoLEP) or Bipolar Enucleation of the Prostate (BipoLEP)
- •Development of postoperative stress-predominant urinary incontinence after catheter removal
- •Presence of postoperative urinary leakage requiring at least one safety pad/day
- •Ability to understand and perform pelvic floor muscle training instructions
- •Ability and willingness to attend extracorporeal magnetic stimulation sessions and follow-up visits
排除标准
- •Preoperative urinary incontinence or neurogenic bladder dysfunction
- •Previous prostate surgery or prior anti-incontinence surgery
- •Urethral stricture disease or bladder neck contracture
- •Active urinary tract infection at the time of enrollment
- •Severe cognitive impairment preventing compliance with PFMT instructions
- •Neurological disorders affecting lower urinary tract function, including Parkinson disease, multiple sclerosis, spinal cord injury, or cerebrovascular stroke with residual deficits
- •Implanted electronic or metallic devices contraindicating magnetic stimulation, including cardiac pacemaker, implantable cardioverter-defibrillator, neurostimulators, or cochlear implants
- •Uncontrolled diabetes mellitus with severe neuropathy
- •Receiving concurrent therapies for urinary incontinence during the study period
- •Persistent postoperative complications requiring reintervention (e.g., severe hematuria, clot retention)
- •Inability or refusal to complete follow-up evaluations
研究组 & 干预措施
Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)
Patients receive standard pelvic floor muscle training (three daily sessions, each with 10 slow contractions of 5-10 seconds and 10 rapid contractions, continued for 12 weeks postoperatively) plus extracorporeal magnetic stimulation using a magnetic chair device, administered twice weekly for 20-30 minutes per session over 6-8 weeks, at an intensity adjusted to patient tolerance.
干预措施: Extracorporeal Magnetic Stimulation (ExMI) (Device)
Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)
Patients receive standard pelvic floor muscle training (three daily sessions, each with 10 slow contractions of 5-10 seconds and 10 rapid contractions, continued for 12 weeks postoperatively) plus extracorporeal magnetic stimulation using a magnetic chair device, administered twice weekly for 20-30 minutes per session over 6-8 weeks, at an intensity adjusted to patient tolerance.
干预措施: Pelvic Floor Muscle Training (PFMT) (Behavioral)
Biofeedback-Assisted Pelvic Floor Muscle Training
Patients receive standard pelvic floor muscle training (three daily sessions, each with 10 slow contractions of 5-10 seconds and 10 rapid contractions, continued for 12 weeks postoperatively) with biofeedback assistance, without extracorporeal magnetic stimulation.
干预措施: Pelvic Floor Muscle Training (PFMT) (Behavioral)
结局指标
主要结局
Time to Recovery of Urinary Continence
时间窗: Up to 6 months postoperatively
Continence is defined as no pad use or use of one security pad with no significant leakage. Time from catheter removal to achievement of continence will be recorded for each participant.
次要结局
- Change in Pad Usage(Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively)
- Change in 24-Hour Pad Test Result(Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively)
- Change in ICIQ-UI SF Score(Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively)
- Change in Quality of Life (QoL) Score(Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively)
- Incidence of Treatment-Related Adverse Events(Up to 6 months postoperatively)
研究者
Abdullah Salah Al Debeiky
Lecturer of Urology
Tanta University