AzTrials
AzTrials

Post-Prostatectomy Urinary IncontinenceNCT07698028

ExMI vs. Biofeedback PFMT for Post-Prostatectomy Incontinence

A study testing Extracorporeal Magnetic Stimulation (ExMI) and Pelvic Floor Muscle Training (PFMT) in people with Post-Prostatectomy Urinary Incontinence and Benign Prostatic Hyperplasia, run by Tanta University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Extracorporeal Magnetic Stimulation (ExMI) and Pelvic Floor Muscle Training (PFMT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jul 2026to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University Hospital

    Tanta, 31111

Other trials in Egypt

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Extracorporeal Magnetic Stimulation (ExMI), Pelvic Floor Muscle Training (PFMT)
Keywords
extracorporeal magnetic stimulation, pelvic floor muscle training, urinary incontinence, HoLEP, bipolar enucleation of the prostate, biofeedback, pudendal nerve stimulation
Medical subject headings
Prostatic Hyperplasia, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Pelvic Floor Muscle Training (PFMT)Behavioural

    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.

Study groups in NCT07698028
Study groupRoleWhat they receive
Electromagnetic Pelvic Floor Stimulation (ExMI + PFMT)ExperimentalPatients 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.
Receives: Device: Extracorporeal Magnetic Stimulation (ExMI); Behavioral: Pelvic Floor Muscle Training (PFMT)
Biofeedback-Assisted Pelvic Floor Muscle TrainingActive comparatorPatients 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.
Receives: Behavioral: Pelvic Floor Muscle Training (PFMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 6 months postoperatively

Secondary outcomes (5)
  1. Change in Pad Usage

    Number of pads used per day, assessed at each follow-up visit.

    Measured: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively

  2. Change in 24-Hour Pad Test Result

    Objective urine leakage measured in grams over a 24-hour period.

    Measured: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively

  3. Change in ICIQ-UI SF Score

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score, assessing severity and impact of urinary incontinence.

    Measured: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively

  4. Change in Quality of Life (QoL) Score

    Quality of life score assessed at each follow-up visit.

    Measured: Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively

  5. Incidence of Treatment-Related Adverse Events

    Number and type of complications or adverse events related to pelvic floor muscle training or extracorporeal magnetic stimulation.

    Measured: Up to 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Jul 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07698028
Sponsor's protocol ID
36265PR74/5/26
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20850831
  • 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.

    PubMed 10367836
  • 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.

    PubMed 24972732
  • 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.

    PubMed 10675166
  • 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.

    PubMed 25602133
  • 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.

    PubMed 22285403
  • 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.

    PubMed 23234620
  • 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.

    PubMed 21944127

Questions about this trial

What is this clinical trial studying?

A study testing Extracorporeal Magnetic Stimulation (ExMI) and Pelvic Floor Muscle Training (PFMT) in people with Post-Prostatectomy Urinary Incontinence and Benign Prostatic Hyperplasia, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Recovery of Urinary Continence (time frame: Up to 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07698028, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in