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Pelvic Floor Magnetic Stimulation in Men With Radical Prostatectomy

Primary Purpose

Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Magnetic Stimulation - Armchair type
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy focused on measuring urinary incontinence, radical prostatectomy, magnetic stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-80 years old
  2. Men with RP with incontinence over ≥50 g / 24 hours
  3. Patients within 1 month to 1 year after catheter removal
  4. Willingness to complete and do the quality of life scale
  5. Understanding procedures, benefits, and possible side effects
  6. Being able to give written, informed consent

Exclusion Criteria:

  1. History of conservative treatment after RP including MS
  2. Previous urological surgery history
  3. UI history before RP
  4. Transurethral resection of the prostate due to benign prostatic hyperplasia
  5. Patients receiving radiotherapy
  6. Presence of urinary tract infection
  7. Heart failure, presence of a pacemaker, implanted defibrillator
  8. Continuing treatment for arrhythmias
  9. Undiagnosed lower abdominal pain
  10. Electronic device or metallic implant applied to the areas between the lumbar region and lower extremities
  11. Use of drugs that may affect bladder function (antimuscarinic, duloxetine, tricyclic antidepressant, etc.)
  12. History of neurogenic bladder, peripheral or central neurological pathology

Sites / Locations

  • Necmettin YildizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1: Magnetic Stimulation

Group 2: Sham Magnetic Stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider improvement

Secondary Outcome Measures

Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
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.
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
Level of sexual function - International Index of Erectile Function (IIEF)
Sexual functions
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
Anxiety and Depression
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)
Treatment Success (Continence rate)
Patients with ≤8 gr in 24-hour pad test measurement will be considered "continent"
Cure (Dry) and Improvement Rate
the absence of will be evaluated as "dryness".

Full Information

First Posted
November 20, 2020
Last Updated
October 31, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04644614
Brief Title
Pelvic Floor Magnetic Stimulation in Men With Radical Prostatectomy
Official Title
Effectiveness of Magnetic Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: a Prospective Randomized Sham Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy
Keywords
urinary incontinence, radical prostatectomy, magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2: Sham Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic Stimulation - Armchair type
Other Intervention Name(s)
NovaMag NT-60
Intervention Description
MS and Sham MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.
Primary Outcome Measure Information:
Title
Incontinence episodes
Description
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Severity of incontinence
Description
The 24-hour pad test was carried out to evaluate urinary loss.
Time Frame
6 weeks
Title
Three-day Bladder Diary
Description
It was used "frequency of voiding", "incontinence episodes", "nocturia", "number of pads" from data collected with a 3-day bladder diary.
Time Frame
6 weeks
Title
Quality of Life - Incontinence Impact Questionnaire (IIQ-7)
Description
The IIQ-7 scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem
Time Frame
6 weeks
Title
Level of sexual function - International Index of Erectile Function (IIEF)
Description
Sexual functions
Time Frame
6 weeks
Title
Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)
Description
Anxiety and Depression
Time Frame
6 weeks
Title
Treatment satisfaction - Likert scale (1-5 )
Description
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)
Time Frame
6 weeks
Title
Treatment Success (Continence rate)
Description
Patients with ≤8 gr in 24-hour pad test measurement will be considered "continent"
Time Frame
6 weeks
Title
Cure (Dry) and Improvement Rate
Description
the absence of will be evaluated as "dryness".
Time Frame
6 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Men with urinary incontinence after radical prostatectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Necmettin Yildiz
City
Denizli
ZIP/Postal Code
20100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Necmettin Yildiz
Phone
05334147399
Email
necmi74tr@hotmail.com
First Name & Middle Initial & Last Name & Degree
Burak Ünal, MD
First Name & Middle Initial & Last Name & Degree
Ayse Sarsan, MD
First Name & Middle Initial & Last Name & Degree
Hakan Alkan, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://doi.org/10.1016/j.urols.2015.06.286

Learn more about this trial

Pelvic Floor Magnetic Stimulation in Men With Radical Prostatectomy

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