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NCT07698028Active, not recruiting

ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence

Effect of Extracorporeal Magnetic Stimulation Added to Pelvic Floor Muscle Training on Post-Prostatectomy Urine Incontinence: A Prospective Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
7 Jul 2026
Start date
1 Jul 2026
Primary completion date
30 Jun 2027
Lead sponsor
Tanta University
NCT number
NCT07698028

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Jul 2026 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous prostate surgery or prior anti-incontinence surgery
  • Receiving concurrent therapies for urinary incontinence during the study period

Other illness

  • 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

Other

  • Preoperative urinary incontinence or neurogenic bladder dysfunction
  • Persistent postoperative complications requiring reintervention (e.g., severe hematuria, clot retention)
  • Inability or refusal to complete follow-up evaluations

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tanta University Hospital
Coordinator of this site? Confirm its status
TantaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.