Urinary Stress IncontinenceNCT02423486
The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
A study testing Electromagnetic stimulation therapy (BIOCON-2000) and Electromagnetic stimulation therapy with biofeedback in people with Urinary Stress Incontinence, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Electromagnetic stimulation therapy (BIOCON-2000) and Electromagnetic stimulation therapy with biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to 28 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient with Stress Urinary Incontinence, over 20
- Leakage over 2g in stress pad test
- 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
Who cannot join
- Mixed Urinary Incontinence which is dominant in urge urinary incontinence.
- True incontinence
- Overflow incontinence
- Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline.
- Urinary tract infection found In urine test.
- Patient who had pelvic organ prolapse.
Show all 11Show fewer
- Patient who had inserted pacemaker.
- Pregnant woman, patient who have positive result in urine pregnancy test, patient who have plan pregnancy during study period.
- Disorder in Neurosystem like stroke, multiple sclerosis, spinal injury, Parkinson's disease .
- Patient who will participate in other clinical trial during this study.
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Electromagnetic stimulation therapy (BIOCON-2000), Electromagnetic stimulation therapy with biofeedback
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic stimulation therapy (BIOCON-2000)Device
Electromagnetic stimulation therapy with biofeedbackDevice
| Study group | Role | What they receive |
|---|---|---|
| Electromagnetic stimulation therapy | Experimental | Electromagnetic stimulation therapy group Receives: Device: Electromagnetic stimulation therapy (BIOCON-2000) |
| Electromagnetic stimulation therapy with biofeedback | Experimental | Electromagnetic stimulation therapy with biofeedback group Receives: Device: Electromagnetic stimulation therapy with biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment
Measured: 12 weeks
Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment
Measured: 12 weeks
Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment
Measured: 12 weeks
Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startNov 2013
- Primary completion6 Sep 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423486
- Sponsor's protocol ID
- 2013-11-088
- Other IDs
- ksleedr
- Status last verified
- Nov 2019
- First submitted
- 24 Mar 2015
- Last updated
- 2 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback
- ClinicalTrials.gov ID
- NCT02423486
- Acronym / sponsor ID
- 2013-11-088
- Conditions
- Urinary Stress Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electromagnetic stimulation therapy | Experimental | Device: Electromagnetic stimulation therapy (BIOCON-2000)Electromagnetic stimulation therapy group |
| Electromagnetic stimulation therapy with biofeedback | Experimental | Device: Electromagnetic stimulation therapy with biofeedbackElectromagnetic stimulation therapy with biofeedback group |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patient with Stress Urinary Incontinence, over 20
- Leakage over 2g in stress pad test
- 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
Key exclusion criteria (11 listed)
- Mixed Urinary Incontinence which is dominant in urge urinary incontinence.
- True incontinence
- Overflow incontinence
- Patient who had performed electric stimulation therapy,bladder training within 2 weeks before baseline.
- Urinary tract infection found In urine test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic stimulation therapy (BIOCON-2000) | Device | Electromagnetic stimulation therapy |
| Electromagnetic stimulation therapy with biofeedback | Device | Electromagnetic stimulation therapy with biofeedback |
Primary outcome
Rate comparison of complete recovery in stress pad test after 12 weeks of treatment
Time frame: 12 weeks
Complete recovery is defined as urinary leakage below than 2 gram in stress pad test.
5 secondary outcomes
Incontinence Severity VAS at baseline,4weeks,8weeks,12weeks after treatment
Time frame: 12 weeks
Sandvik questionnaire at baseline,4weeks,8weeks,12weeks after treatment
Time frame: 12 weeks
Incontinence - Quality of Life questionnaire at baseline,8weeks,12 weeks after treatment
Time frame: 12 weeks
Benefit,Satisfaction and Willingness to Continue questionnaire at 12 weeks after treatment
Time frame: 12 weeks
Pelvic floor muscular strength at baseline,4weeks,8weeks,12weeks after treatment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
Related trials for Urinary Stress Incontinence
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic stimulation therapy (BIOCON-2000) and Electromagnetic stimulation therapy with biofeedback in people with Urinary Stress Incontinence, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate comparison of complete recovery in stress pad test after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.