Pelvic Floor Magnetic Stimulation in Men With Radical Prostatectomy
Effectiveness of Magnetic Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: a Prospective Randomized Sham Controlled Clinical Study
1 other identifier
interventional
40
1 country
1
Brief Summary
MS is a technology developed to non-invasively stimulate the central and peripheral nervous system, is applied in the treatment of UI. The MS technique aims to directly stimulate the pelvic floor muscles and sacral roots in the treatment of UI (3,4). MS is a more acceptable, relatively painless, non-invasive and suitable electrical treatment method for patients with UI (5). Data from studies suggest that MS may be beneficial for patients with UI after RP (1,2,5,6,7). In the literature, there are only 3 randomized controlled trials evaluating MS efficacy using a magnetic chair in patients with UI after RP (1,6,8) and one of them was published in Korean (6) and two of them in English(1,8). In these studies, MS was compared with pelvic floor muscle exercises (PFME) or electrical stimulation (ES) (intra-anal).Yokoyama et al.reported that MS and ES treatments had shown to provide earlier continence compared to the control group after RP. MS and ES are recommended as options for patients who want rapid recovery of postoperative UI(1). Liu et al reported that MS was more effective than PTKE on incontinence symptoms and quality of life (8). However, as far as we know, there is no prospective randomized sham-controlled study evaluating the effectiveness of MS in patients with post-RP UI. In addition, there are no suggestions regarding MS in the guidelines on urinary incontinence management due to insufficient data (9). In this study, sham-controlled efficacy of MS will be evaluated in patients with UI after RP. Our study is the first prospective randomized controlled trial comparing MS and Sham MS efficacy in patients with UI after RP. In this study, we aimed to evaluate the effectiveness of MS on incontinence related clinical parameters, quality of life, sexual functions, depression and anxiety in patients with UI after RP.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2020
CompletedFirst Posted
Study publicly available on registry
November 25, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2023
CompletedNovember 1, 2022
October 1, 2022
2.1 years
November 20, 2020
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
6 weeks
Secondary Outcomes (8)
Severity of incontinence
6 weeks
Three-day Bladder Diary
6 weeks
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
6 weeks
Level of sexual function - International Index of Erectile Function (IIEF)
6 weeks
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
6 weeks
- +3 more secondary outcomes
Study Arms (2)
Group 1: Magnetic Stimulation
ACTIVE COMPARATORPatients will be instructed to sit in a magnetic coil chair. Magnetic flux is generated in this field. This current stimulates the nerve or muscle of the pelvic floor. To administer MS, a stimulation amplitude of 200 μs and a repetition of 10 Hz for 10 minutes, 2 minutes rest in between, 50 Hz for 10 minutes (20 minutes total), 5 seconds on / 5 seconds off, in accordance with device literature will be adjusted to produce maximum stimuli with the cycle. During each treatment session, the device will be adjusted to receive patients the current intensity gradually increasing, reaching the maximum stimulation intensity.
Group 2: Sham Magnetic Stimulation
SHAM COMPARATORThe Sham MS treatment program will be the same as active MS in terms of duration, frequency, current duration, current intensity and general patient experience. The same magnetic chair will be used for both groups. Sham therapy application will be applied by the coordinator of the study by placing a thin deflector lead / aluminum coated plate on the magnetic coil of the magnetic chair that prevents the magnetic flux from penetrating into the patient. During both applications, the patients will be exposed to the same sound, vibration sensation and lighting of the device.
Interventions
MS and Sham MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.
Eligibility Criteria
You may qualify if:
- years old
- Men with RP with incontinence over ≥50 g / 24 hours
- Patients within 1 month to 1 year after catheter removal
- Willingness to complete and do the quality of life scale
- Understanding procedures, benefits, and possible side effects
- Being able to give written, informed consent
You may not qualify if:
- History of conservative treatment after RP including MS
- Previous urological surgery history
- UI history before RP
- Transurethral resection of the prostate due to benign prostatic hyperplasia
- Patients receiving radiotherapy
- Presence of urinary tract infection
- Heart failure, presence of a pacemaker, implanted defibrillator
- Continuing treatment for arrhythmias
- Undiagnosed lower abdominal pain
- Electronic device or metallic implant applied to the areas between the lumbar region and lower extremities
- Use of drugs that may affect bladder function (antimuscarinic, duloxetine, tricyclic antidepressant, etc.)
- History of neurogenic bladder, peripheral or central neurological pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necmettin Yildiz
Denizli, 20100, Turkey (Türkiye)
Related Publications (1)
Unal B, Sarsan A, Yildiz N, Alkan H. Efficacy of Magnetic Stimulation in Men With Urinary Incontinence After Radical Prostatectomy: A Randomized, Quadruple-Blind, Sham-Controlled Clinical Trial. Neurourol Urodyn. 2025 Jun;44(5):1140-1148. doi: 10.1002/nau.70055. Epub 2025 Apr 14.
PMID: 40223765DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PAU
Study Record Dates
First Submitted
November 20, 2020
First Posted
November 25, 2020
Study Start
January 1, 2021
Primary Completion
February 1, 2023
Study Completion
April 15, 2023
Last Updated
November 1, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share