Urinary Incontinence Episodes After the Magnetic Stimulation in Men With Radical Prostatectomy Clinical Trial
Official title:
Effectiveness of Magnetic Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: a Prospective Randomized Sham Controlled Clinical Study
| Verified date | October 2022 |
| Source | Pamukkale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | April 15, 2023 |
| Est. primary completion date | February 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Necmettin Yildiz | Denizli |
| Lead Sponsor | Collaborator |
|---|---|
| Pamukkale University |
Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incontinence episodes | Patients with a 50% or greater reduction in incontinence episodes were consider improvement | 6 weeks | |
| Secondary | Severity of incontinence | The 24-hour pad test was carried out to evaluate urinary loss. | 6 weeks | |
| Secondary | 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. | 6 weeks | |
| Secondary | 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 | 6 weeks | |
| Secondary | Level of sexual function - International Index of Erectile Function (IIEF) | Sexual functions | 6 weeks | |
| Secondary | Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD) | Anxiety and Depression | 6 weeks | |
| Secondary | 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) | 6 weeks | |
| Secondary | Treatment Success (Continence rate) | Patients with =8 gr in 24-hour pad test measurement will be considered "continent" | 6 weeks | |
| Secondary | Cure (Dry) and Improvement Rate | the absence of will be evaluated as "dryness". | 6 weeks |