Efficacy of Functional Magnetic Stimulation in Urinary Incontinence (FMS)

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Status and phase: Unknown; Phase 2

Conditions: Incontinence

Treatments: Device: FMS (Magstim rapid2)

Study type: Interventional

Funder types: Other

Identifiers

NCT02091947

201010015OB

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urine incontinence refractory to traditional treatment

Exclusion criteria

• Arrhythmia, pacemaker implantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

experimental group

Experimental group

Description:

Real FMS, 5 Hz, 20 minutes per day, for 10 weekdays.

Treatment:

Device: FMS (Magstim rapid2)

sham group

Sham Comparator group

Description:

sham FMS, 5 Hz, 20 min per day, for 10 weekdays.

Treatment:

Device: FMS (Magstim rapid2)