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ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence

NCT07698028 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-13

No results posted yet for this 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.

Conditions

  • Post-Prostatectomy Urinary Incontinence
  • Benign Prostatic Hyperplasia

Interventions

DEVICE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Esraa Abdelhamid Elshintenawy, MD · Tanta University Faculty of Medicine

  • Mona Helal Omara, MD · Tanta University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698028 on ClinicalTrials.gov