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Pelvic Floor Magnetic Stimulation in Men With Radical Prostatectomy

NCT04644614 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-01

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Magnetic Stimulation - Armchair type

MS and Sham MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.

Sponsors & Collaborators

  • Pamukkale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-02-01
Completion
2023-04-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644614 on ClinicalTrials.gov