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ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence

NCT07698028 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-07-01
Last updated
2026-07-13

Condition(s) studied

Post-Prostatectomy Urinary IncontinenceBenign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

Extracorporeal Magnetic Stimulation (ExMI)Pelvic Floor Muscle Training (PFMT)

Extracorporeal Magnetic Stimulation (ExMI): Non-invasive pelvic floor and pudendal nerve stimulation delivered via a magnetic chair device, twice weekly for 20-30 minutes per session over 6-8 weeks.

Pelvic Floor Muscle Training (PFMT): Supervised pelvic floor muscle training consisting of three daily sessions (10 slow contractions of 5-10 seconds and 10 rapid contractions per session), continued for 12 weeks postoperatively, with biofeedback assistance.

Study summary

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.

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Time to Recovery of Urinary Continence — 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.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Hospital Tanta Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07698028 on ClinicalTrials.gov ↗ ← All trials in Egypt