ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence

NCT07698028 | Active Not Recruiting

• 1 other identifier: 36265PR74/5/26
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

extracorporeal magnetic stimulation; pelvic floor muscle training; urinary incontinence; HoLEP; bipolar enucleation of the prostate; biofeedback; pudendal nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Time to Recovery of Urinary Continence

  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.

  Up to 6 months postoperatively

Secondary Outcomes (5)

• 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

Study Arms (2)

Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)

EXPERIMENTAL

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.

Device: Extracorporeal Magnetic Stimulation (ExMI); Behavioral: Pelvic Floor Muscle Training (PFMT)

Biofeedback-Assisted Pelvic Floor Muscle Training

ACTIVE COMPARATOR

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.

Behavioral: Pelvic Floor Muscle Training (PFMT)

Interventions

Extracorporeal Magnetic Stimulation (ExMI) DEVICE

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.

Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)

Pelvic Floor Muscle Training (PFMT) BEHAVIORAL

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.

Biofeedback-Assisted Pelvic Floor Muscle Training; Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, 31111, Egypt

Location

Related Publications (8)

• Yamanishi T, Mizuno T, Watanabe M, Honda M, Yoshida K. Randomized, placebo controlled study of electrical stimulation with pelvic floor muscle training for severe urinary incontinence after radical prostatectomy. J Urol. 2010 Nov;184(5):2007-12. doi: 10.1016/j.juro.2010.06.103. Epub 2010 Sep 20.

  PMID: 20850831 RESULT

• Galloway NT, El-Galley RE, Sand PK, Appell RA, Russell HW, Carlan SJ. Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology. 1999 Jun;53(6):1108-11. doi: 10.1016/s0090-4295(99)00037-0.

  PMID: 10367836 RESULT

• Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.

  PMID: 24972732 RESULT

• Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet. 2000 Jan 8;355(9198):98-102. doi: 10.1016/S0140-6736(99)03473-X.

  PMID: 10675166 RESULT

• Anderson CA, Omar MI, Campbell SE, Hunter KF, Cody JD, Glazener CM. Conservative management for postprostatectomy urinary incontinence. Cochrane Database Syst Rev. 2015 Jan 20;1(1):CD001843. doi: 10.1002/14651858.CD001843.pub5.

  PMID: 25602133 RESULT

• Herrmann TR, Liatsikos EN, Nagele U, Traxer O, Merseburger AS; EAU Guidelines Panel on Lasers, Technologies. EAU guidelines on laser technologies. Eur Urol. 2012 Apr;61(4):783-95. doi: 10.1016/j.eururo.2012.01.010. Epub 2012 Jan 17.

  PMID: 22285403 RESULT

• Krambeck AE, Handa SE, Lingeman JE. Experience with more than 1,000 holmium laser prostate enucleations for benign prostatic hyperplasia. J Urol. 2013 Jan;189(1 Suppl):S141-5. doi: 10.1016/j.juro.2012.11.027.

  PMID: 23234620 RESULT

• Elmansy HM, Kotb A, Elhilali MM. Holmium laser enucleation of the prostate: long-term durability of clinical outcomes and complication rates during 10 years of followup. J Urol. 2011 Nov;186(5):1972-6. doi: 10.1016/j.juro.2011.06.065. Epub 2011 Sep 23.

  PMID: 21944127 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Esraa Abdelhamid Elshintenawy, MD

  Tanta University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Mona Helal Omara, MD

  Tanta University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

EG (1)