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Efficacy of Functional Magnetic Stimulation in Urinary Incontinence (FMS)

Primary Purpose

Incontinence

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
FMS (Magstim rapid2)
Sponsored by
vghtpe user
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence focused on measuring FMS, Urine incontinence

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Urine incontinence refractory to traditional treatment

Exclusion Criteria:

  • Arrhythmia, pacemaker implantation

Sites / Locations

  • Taipei Veteran General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

experimental group

sham group

Arm Description

Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays.

sham FMS, 5 Hz, 20 min per day, for 10 weekdays.

Outcomes

Primary Outcome Measures

Symptom scoring on Urge-Urinary Distress Inventory questionnaire

Secondary Outcome Measures

Cystometry and stress urethral pressure profile as measures of objective incontinence improvement

Full Information

First Posted
March 11, 2014
Last Updated
March 17, 2014
Sponsor
vghtpe user
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1. Study Identification

Unique Protocol Identification Number
NCT02091947
Brief Title
Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
Acronym
FMS
Official Title
Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
vghtpe user

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Functional Magnetic Stimulation (FMS) appears to modulate autonomic and somatic nervous systems that innervate the lower urinary tract. Stimulation of the pudendal afferent nerve near the third sacral root induces relaxation of the detrusor muscles and reinforcement of urethral sphincter. Some preliminary studies had indicated the positive effect of FMS on stress urinary incontinence. Investigators aimed to evaluate the immediate and long-term effect of this method on stress urinary incontinent patients.
Detailed Description
5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence
Keywords
FMS, Urine incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays.
Arm Title
sham group
Arm Type
Sham Comparator
Arm Description
sham FMS, 5 Hz, 20 min per day, for 10 weekdays.
Intervention Type
Device
Intervention Name(s)
FMS (Magstim rapid2)
Intervention Description
5 Hz FMS, over bilateral sacral roots.
Primary Outcome Measure Information:
Title
Symptom scoring on Urge-Urinary Distress Inventory questionnaire
Time Frame
up to 5 months
Secondary Outcome Measure Information:
Title
Cystometry and stress urethral pressure profile as measures of objective incontinence improvement
Time Frame
up to 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urine incontinence refractory to traditional treatment Exclusion Criteria: Arrhythmia, pacemaker implantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Yi Tsai, MD
Phone
886-28757293
Email
pytsai@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Organizational Affiliation
Dep of PMR, Taipei VGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veteran General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25073008
Citation
Tsai PY, Wang CP, Hsieh CY, Tsai YA, Yeh SC, Chuang TY. Long-term sacral magnetic stimulation for refractory stress urinary incontinence. Arch Phys Med Rehabil. 2014 Dec;95(12):2231-8. doi: 10.1016/j.apmr.2014.07.010. Epub 2014 Jul 27.
Results Reference
derived

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Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

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