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Clinical Trials/NCT02091947
NCT02091947
Unknown
Phase 2

Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

vghtpe user1 site in 1 country40 target enrollmentNovember 2010
ConditionsIncontinence

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Incontinence
Sponsor
vghtpe user
Enrollment
40
Locations
1
Primary Endpoint
Symptom scoring on Urge-Urinary Distress Inventory questionnaire
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
June 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
vghtpe user
Responsible Party
Sponsor Investigator
Principal Investigator

vghtpe user

Po-Yi Tsai MD

Taipei Veterans General Hospital, Taiwan

Eligibility Criteria

Inclusion Criteria

  • Urine incontinence refractory to traditional treatment

Exclusion Criteria

  • Arrhythmia, pacemaker implantation

Outcomes

Primary Outcomes

Symptom scoring on Urge-Urinary Distress Inventory questionnaire

Time Frame: up to 5 months

Secondary Outcomes

  • Cystometry and stress urethral pressure profile as measures of objective incontinence improvement(up to 5 months)

Study Sites (1)

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