Efficacy of Functional Magnetic Stimulation in Urinary Incontinence (FMS)

March 17, 2014 updated by: vghtpe user
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

5 Hz repetitive magnetic stimulation was applied over bilateral sacral roots for 20 minutes.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veteran General Hospital
        • Contact:
          • Po-Yi Tsai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Urine incontinence refractory to traditional treatment

Exclusion Criteria:

  • Arrhythmia, pacemaker implantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental group
Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays.
Device: FMS (Magstim rapid2)
5 Hz FMS, over bilateral sacral roots.
SHAM_COMPARATOR: sham group
sham FMS, 5 Hz, 20 min per day, for 10 weekdays.
Device: FMS (Magstim rapid2)
5 Hz FMS, over bilateral sacral roots.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom scoring on Urge-Urinary Distress Inventory questionnaire
Time Frame: up to 5 months
up to 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cystometry and stress urethral pressure profile as measures of objective incontinence improvement
Time Frame: up to 5 months
up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

vghtpe user

Investigators

  • Principal Investigator: Po-Yi Tsai, MD, Dep of PMR, Taipei VGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (ESTIMATE)

March 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201010015OB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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