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Efficacy of Functional Magnetic Stimulation in Urinary Incontinence (FMS)

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ClinicalTrials.gov Identifier: NCT02091947
Recruitment Status : Unknown
Verified March 2014 by vghtpe user, Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Incontinence Device: FMS (Magstim rapid2) Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
Study Start Date : November 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Symptom scoring on Urge-Urinary Distress Inventory questionnaire [ Time Frame: up to 5 months ]

Secondary Outcome Measures :
  1. Cystometry and stress urethral pressure profile as measures of objective incontinence improvement [ Time Frame: up to 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urine incontinence refractory to traditional treatment

Exclusion Criteria:

  • Arrhythmia, pacemaker implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091947


Contacts
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Contact: Po-Yi Tsai, MD 886-28757293 pytsai@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veteran General Hospital Recruiting
Taipei, Taiwan, 11217
Contact: Po-Yi Tsai, MD         
Principal Investigator: Po-Yi Tsai, MD         
Sponsors and Collaborators
vghtpe user
Investigators
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Principal Investigator: Po-Yi Tsai, MD Dep of PMR, Taipei VGH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: vghtpe user, Po-Yi Tsai MD, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02091947    
Other Study ID Numbers: 201010015OB
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
FMS
Urine incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders