Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

Phase 2

• Conditions: Incontinence

• Registration Number: NCT02091947
• Lead Sponsor: vghtpe user

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 Timeline

• Study Start: 2010-11
• Status Verified: 2014-03
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-17
• Last Update Submitted: 2014-03-17
• Study First Posted: 2014-03-19
• Last Update Posted: 2014-03-19
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Urine incontinence refractory to traditional treatment

Exclusion Criteria

• Arrhythmia, pacemaker implantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symptom scoring on Urge-Urinary Distress Inventory questionnaire	up to 5 months

Secondary Outcome Measures

Name	Time	Method
Cystometry and stress urethral pressure profile as measures of objective incontinence improvement	up to 5 months

Trial Locations

Locations (1)

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan