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ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence

7. juli 2026 opdateret af: Abdullah Salah Al Debeiky, Tanta University

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

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Tanta, Egypten, 31111
        • Tanta University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Recovery of Urinary Continence
Tidsramme: 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.
Up to 6 months postoperatively

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pad Usage
Tidsramme: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Number of pads used per day, assessed at each follow-up visit.
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Change in 24-Hour Pad Test Result
Tidsramme: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Objective urine leakage measured in grams over a 24-hour period.
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Change in ICIQ-UI SF Score
Tidsramme: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score, assessing severity and impact of urinary incontinence.
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Change in Quality of Life (QoL) Score
Tidsramme: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Quality of life score assessed at each follow-up visit.
Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
Incidence of Treatment-Related Adverse Events
Tidsramme: Up to 6 months postoperatively
Number and type of complications or adverse events related to pelvic floor muscle training or extracorporeal magnetic stimulation.
Up to 6 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tanta University

Efterforskere

  • Ledende efterforsker: Esraa Abdelhamid Elshintenawy, MD, Tanta University Faculty of Medicine
  • Ledende efterforsker: Mona Helal Omara, MD, Tanta University Faculty of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 36265PR74/5/26

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