Efficacy of Functional Magnetic Stimulation in Urinary Incontinence

NCT ID: NCT02091947

Last Updated: 2014-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-06-30

Brief Summary

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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

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

Conditions

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Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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experimental group

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

Group Type EXPERIMENTAL

FMS (Magstim rapid2)

Intervention Type DEVICE

5 Hz FMS, over bilateral sacral roots.

sham group

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

Group Type SHAM_COMPARATOR

FMS (Magstim rapid2)

Intervention Type DEVICE

5 Hz FMS, over bilateral sacral roots.

Interventions

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FMS (Magstim rapid2)

5 Hz FMS, over bilateral sacral roots.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Urine incontinence refractory to traditional treatment

Exclusion Criteria

* Arrhythmia, pacemaker implantation
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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vghtpe user

OTHER_GOV

Sponsor Role lead

Responsible Party

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vghtpe user

Po-Yi Tsai MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Po-Yi Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Dep of PMR, Taipei VGH

Locations

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Taipei Veteran General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Po-Yi Tsai, MD

Role: CONTACT

886-28757293

Facility Contacts

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Po-Yi Tsai, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25073008 (View on PubMed)

Other Identifiers

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201010015OB

Identifier Type: -

Identifier Source: org_study_id

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