Benign Prostatic Hyperplasia, Post-Prostatectomy Urinary Incontinence
Conditions
Keywords
extracorporeal magnetic stimulation, pelvic floor muscle training, urinary incontinence, HoLEP, bipolar enucleation of the prostate, biofeedback, pudendal nerve stimulation
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.
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.
Interventions
DEVICEExtracorporeal 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.
BEHAVIORALPelvic 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
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery of Urinary Continence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pad Usage | 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. |
| Change in 24-Hour Pad Test Result | 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. |
| Change in ICIQ-UI SF Score | 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. |
| Change in Quality of Life (QoL) Score | Baseline (after catheter removal), 2 weeks, 1 month, 3 months, and 6 months postoperatively | Quality of life score assessed at each follow-up visit. |
| Incidence of Treatment-Related Adverse Events | Up to 6 months postoperatively | Number and type of complications or adverse events related to pelvic floor muscle training or extracorporeal magnetic stimulation. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATOREsraa Abdelhamid Elshintenawy, MD
Tanta University Faculty of Medicine
PRINCIPAL_INVESTIGATORMona Helal Omara, MD
Tanta University Faculty of Medicine
Outcome results
None listed