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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

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE March 19, 2014
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
Symptom scoring on Urge-Urinary Distress Inventory questionnaire [ Time Frame: up to 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)
Cystometry and stress urethral pressure profile as measures of objective incontinence improvement [ Time Frame: up to 5 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
Official Title  ICMJE Efficacy of Functional Magnetic Stimulation in Urinary Incontinence
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Incontinence
Intervention  ICMJE Device: FMS (Magstim rapid2)
5 Hz FMS, over bilateral sacral roots.
Study Arms  ICMJE
  • Experimental: experimental group
    Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays.
    Intervention: Device: FMS (Magstim rapid2)
  • Sham Comparator: sham group
    sham FMS, 5 Hz, 20 min per day, for 10 weekdays.
    Intervention: Device: FMS (Magstim rapid2)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 17, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Urine incontinence refractory to traditional treatment

Exclusion Criteria:

  • Arrhythmia, pacemaker implantation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02091947
Other Study ID Numbers  ICMJE 201010015OB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party vghtpe user, Taipei Veterans General Hospital, Taiwan
Original Responsible Party Same as current
Current Study Sponsor  ICMJE vghtpe user
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Po-Yi Tsai, MD Dep of PMR, Taipei VGH
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP