CClinicalTrials.gg
CompletedNCT02423486Updated Dec 2, 2019

The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback

An interventional study of Electromagnetic stimulation therapy (BIOCON-2000) and Electromagnetic stimulation therapy with biofeedback in Urinary Stress Incontinence, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-12-02.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study summary

The aim of this study is to compare the efficacy between Electromagnetic Stimulation therapy and Electromagnetic Stimulation therapy with Extracorporeal Biofeedback in Stress Urinary Incontinence patient.

02

Conditions studied

  • Urinary Stress Incontinence
03

In context

Urinary Incontinence, Stress

658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female patient with Stress Urinary Incontinence, over 20
  2. Leakage over 2g in stress pad test
  3. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion criteria

Exclusion Criteria:

  1. Mixed Urinary Incontinence which is dominant in urge urinary incontinence.
  2. True incontinence
  3. Overflow incontinence
  4. Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline.
  5. Urinary tract infection found In urine test.
  6. Patient who had pelvic organ prolapse.
  7. Patient who had inserted pacemaker.
  8. Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period.
  9. Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease .
  10. Patient who will participate in other clinical trial during this study.
  11. Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Electromagnetic stimulation therapy

    Electromagnetic stimulation therapy group

    Device: Electromagnetic stimulation therapy (BIOCON-2000)

  • Experimental
    Electromagnetic stimulation therapy with biofeedback

    Electromagnetic stimulation therapy with biofeedback group

    Device: Electromagnetic stimulation therapy with biofeedback

Interventions

  • DeviceElectromagnetic stimulation therapy (BIOCON-2000)
  • DeviceElectromagnetic stimulation therapy with biofeedback
06

What researchers measure

Primary outcomes

  1. Rate comparison of complete recovery in stress pad test after 12 weeks of treatment

    Complete recovery is defined as urinary leakage below than 2 gram in stress pad test.

    Time frame: 12 weeks

Secondary outcomes

  1. Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment

    Time frame: 12 weeks

  2. Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment

    Time frame: 12 weeks

  3. Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment

    Time frame: 12 weeks

  4. Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment

    Time frame: 12 weeks

  5. Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment

    Intravaginal pressure, Extracorporeal pelvic floor muscular strength, Oxford Scale at baseline,4weeks,8weeks,12weeks after treatment

    Time frame: 12 weeks

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02423486
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Apr 22, 2015
Start date
Nov 2013
Primary completion
Sep 6, 2019
Completion
Nov 28, 2019
Last update
Dec 2, 2019

Study contacts

Kyu-Sung Lee, Ph.D
principal investigator · Samsung Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion