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NCT02091947 Clinical Trial

Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

Incontinence Clinical Trial

— FMS  

Official title:
Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02091947
Other study ID # 201010015OB
Secondary ID
Status Recruiting
Phase Phase 2
First received March 11, 2014
Last updated March 17, 2014
Start date November 2010
Est. completion date June 2014

Study information
Verified date March 2014
Source Taipei Veterans General Hospital, Taiwan
Contact Po-Yi Tsai, MD
Phone 886-28757293
Email pytsai@vghtpe.gov.tw
Is FDA regulated No
Health authority Taiwan : Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Urine incontinence refractory to traditional treatment

Exclusion Criteria:

- Arrhythmia, pacemaker implantation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• FMS (Magstim rapid2)
5 Hz FMS, over bilateral sacral roots.

Locations
Country Name City State
Taiwan Taipei Veteran General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
vghtpe user

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom scoring on Urge-Urinary Distress Inventory questionnaire up to 5 months No
Secondary Cystometry and stress urethral pressure profile as measures of objective incontinence improvement up to 5 months No
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