Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical ProstatectomyNCT04644614
Pelvic Floor Magnetic Stimulation in Men With Radical Prostatectomy
A study testing Magnetic Stimulation - Armchair type in people with Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy
- What is being tested?
- Magnetic Stimulation - Armchair type
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Necmettin Yildiz
Denizli, 20100
Necmettin Yildiz, 05334147399, necmi74tr@hotmail.com
Burak Ünal, MD
About this study
Official title: Effectiveness of Magnetic Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: a Prospective Randomized Sham Controlled Clinical Study
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).
Read more
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.
Read the detailed description
This study is a prospective randomized sham-controlled study. The research will be carried out between January 2021 and June 2022 in XXX Physical Medicine and Rehabilitation (PMR) Department Urogynecological Rehabilitation Unit.
After the approval of XXX Faculty of Medicine Ethics Committee, 40 patients who admitted to XXX PMR Polyclinic with RP complaints after UI and who accepted the inclusion criteria directed to the Urogynecological Rehabilitation Unit, will be included in the study.
Patients will be informed about the content, purpose and application of the study and their written consent will be obtained.
Treatment Protocol 40 men with UI after RP who meet the exclusion and inclusion criteria will be divided into 2 groups using a table of random numbers. MS will be applied to the first group and sham MS will be applied to the second group.
Group 1: Magnetic stimulation (Active MS) Group 2: Sham MS
Group 1: Magnetic stimulation (Active MS)
Patients 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. MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.
Group 2: Sham MS
The 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.
Patients who did not attend even one of the 16 sessions (MS and sham MS sessions) during the study period will be excluded from the study. Until the study is completed, patients will not be informed of what treatment they received. At the end of the treatment, patients in the sham group will be allowed to receive active MS treatment.
- Conditions
- Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy
- Being tested
- Magnetic Stimulation - Armchair type
- Keywords
- urinary incontinence, radical prostatectomy, magnetic stimulation
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Stimulation - Armchair typeDevice
Also called NovaMag NT-60
MS and Sham MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Magnetic Stimulation | Active comparator | Patients 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. Receives: Device: Magnetic Stimulation - Armchair type |
| Group 2: Sham Magnetic Stimulation | Sham comparator | The 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. Receives: Device: Magnetic Stimulation - Armchair type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
Measured: 6 weeks
Secondary outcomes (8)
Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
Measured: 6 weeks
Three-day Bladder Diary
It was used "frequency of voiding", "incontinence episodes", "nocturia", "number of pads" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem
Measured: 6 weeks
Level of sexual function - International Index of Erectile Function (IIEF)
Sexual functions
Measured: 6 weeks
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
Anxiety and Depression
Measured: 6 weeks
Treatment satisfaction - Likert scale (1-5 )
The patients evaluated the change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 4, satisfied; 3, equally satisfied and unsatisfied; 2, unsatisfied; 1, very unsatisfied)
Measured: 6 weeks
Treatment Success (Continence rate)
Patients with ≤8 gr in 24-hour pad test measurement will be considered "continent"
Measured: 6 weeks
Cure (Dry) and Improvement Rate
the absence of will be evaluated as "dryness".
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jan 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644614
- Sponsor's protocol ID
- 60116787-020/38072
- Status last verified
- Oct 2022
- First submitted
- 20 Nov 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40223765
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Magnetic Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: a Prospective Randomized Sham Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04644614
- Acronym / sponsor ID
- 60116787-020/38072
- Conditions
- Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy
- Keywords
- urinary incontinence, radical prostatectomy, magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective randomized sham-controlled study. The research will be carried out between January 2021 and June 2022 in XXX Physical Medicine and Rehabilitation (PMR) Department Urogynecological Rehabilitation Unit.
After the approval of XXX Faculty of Medicine Ethics Committee, 40 patients who admitted to XXX PMR Polyclinic with RP complaints after UI and who accepted the inclusion criteria directed to the Urogynecological Rehabilitation Unit, will be included in the study.
Patients will be informed about the content, purpose and application of the study and their written consent will be obtained.
Treatment Protocol 40 men with UI after RP who meet the exclusion and inclusion criteria will be divided into 2 groups using a table of random numbers. MS will be applied to the first group and sham MS will be applied to the second group.
Group 1: Magnetic stimulation (Active MS) Group 2: Sham MS
Group 1: Magnetic stimulation (Active MS)
Patients 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. MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.
Group 2: Sham MS
The 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.
Patients who did not attend even one of the 16 sessions (MS and sham MS sessions) during the study period will be excluded from the study. Until the study is completed, patients will not be informed of what treatment they received. At the end of the treatment, patients in the sham group will be allowed to receive active MS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Magnetic Stimulation | Active comparator | Device: Magnetic Stimulation - Armchair typePatients 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 comparator | Device: Magnetic Stimulation - Armchair typeThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Stimulation - Armchair typeAlso: NovaMag NT-60MS and Sham MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions. | Device | Group 1: Magnetic Stimulation, Group 2: Sham Magnetic Stimulation |
Primary outcome
Incontinence episodes
Time frame: 6 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
8 secondary outcomes
Severity of incontinence
Time frame: 6 weeks
Three-day Bladder Diary
Time frame: 6 weeks
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
Time frame: 6 weeks
Level of sexual function - International Index of Erectile Function (IIEF)
Time frame: 6 weeks
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
Time frame: 6 weeks
Treatment satisfaction - Likert scale (1-5 )
Time frame: 6 weeks
Treatment Success (Continence rate)
Time frame: 6 weeks
Cure (Dry) and Improvement Rate
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 40223765Unal 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Stimulation - Armchair type in people with Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence episodes (time frame: 6 weeks). 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 NCT04644614, which also lists 1 linked publication.
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 1 Nov 2022.