ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence
7 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Aktiv, inte rekryterande
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Tanta, Egypten, 31111
- Tanta University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
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.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to Recovery of Urinary Continence
Tidsram: 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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Pad Usage
Tidsram: 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.
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Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
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Change in 24-Hour Pad Test Result
Tidsram: 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.
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Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
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Change in ICIQ-UI SF Score
Tidsram: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
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International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score, assessing severity and impact of urinary incontinence.
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Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
|
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Change in Quality of Life (QoL) Score
Tidsram: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
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Quality of life score assessed at each follow-up visit.
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Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively
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Incidence of Treatment-Related Adverse Events
Tidsram: Up to 6 months postoperatively
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Number and type of complications or adverse events related to pelvic floor muscle training or extracorporeal magnetic stimulation.
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Up to 6 months postoperatively
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Esraa Abdelhamid Elshintenawy, MD, Tanta University Faculty of Medicine
- Huvudutredare: Mona Helal Omara, MD, Tanta University Faculty of Medicine
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juli 2026
Primärt slutförande (Beräknad)
1 juni 2027
Avslutad studie (Beräknad)
1 juni 2027
Studieregistreringsdatum
Först inskickad
7 juli 2026
Först inskickad som uppfyllde QC-kriterierna
7 juli 2026
Första postat (Faktisk)
13 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urineringsstörningar
- Symtom i de nedre urinvägarna
- Urologiska manifestationer
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Urininkontinens
- Prostatahyperplasi
Andra studie-ID-nummer
- 36265PR74/5/26
Plan för individuella deltagardata (IPD)
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