Female Stress Urinary IncontinenceNCT00910338
Efficacy and Safety of Extracorporeal Biofeedback
A study testing PFMT with Extracorporeal Biofeedback in people with Female Stress Urinary Incontinence, run by KYU-SUNG LEE at 2 sites in South Korea.
Trial summary
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Stress Urinary Incontinence
- What is being tested?
- PFMT with Extracorporeal Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jul 2007to Dec 2009
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with stress urinary incontinence
- Standard pad test > 2gram
Who cannot join
- Women with:
- Mixed urinary incontinence of which urgency incontinence is dominant
- True incontinence
- Overflow incontinence
- Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
- Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
Show all 11Show fewer
- Pelvic organ prolapse which the stage is at least 2
- Proven urinary tract infection during screening period
- Pacemaker
- Pregnant women
- Neurogenic voiding dysfunction
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Irwon-dong, 135-710
Asan Medical Center, Ulsan College of Medicine
Seoul
About this study
Official title: Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.
- Conditions
- Female Stress Urinary Incontinence
- Being tested
- PFMT with Extracorporeal Biofeedback
- Keywords
- Pelvic Floor Muscle Training, Extracorporeal Biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMT with Extracorporeal BiofeedbackDevice
Also called HnJ-5300
Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks
- Twice a week for the first 4 weeks
- Once a week for the next 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| PFMT with Extracorporeal Biobeedback | Experimental | Not described Receives: Device: PFMT with Extracorporeal Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.
Measured: After 12 weeks of treatment
Secondary outcomes (2)
Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.
Measured: After 12 weeks of treatment
Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KYU-SUNG LEE
- Sponsor type
- University, hospital or other
- Collaborators
- Furun Medical
- Responsible party
- Sponsor-investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910338
- Sponsor's protocol ID
- 2007-06-075
- Status last verified
- Apr 2011
- First submitted
- 28 May 2009
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- 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
- Efficacy and Safety of Extracorporeal Biofeedback Pelvic Floor Muscle Training to Treat Urodynamic Stress Incontinence
- ClinicalTrials.gov ID
- NCT00910338
- Acronym / sponsor ID
- 2007-06-075
- Conditions
- Female Stress Urinary Incontinence
- Keywords
- Pelvic Floor Muscle Training, Extracorporeal Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KYU-SUNG LEEUniversity, hospital or other
- Collaborators
- Furun Medical
- Study start
- Jul 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 May 2009 (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.
Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFMT with Extracorporeal Biobeedback | Experimental | Device: PFMT with Extracorporeal Biofeedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with stress urinary incontinence
- Standard pad test > 2gram
Key exclusion criteria (11 listed)
- Mixed urinary incontinence of which urgency incontinence is dominant
- True incontinence
- Overflow incontinence
- Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
- Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
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 |
|---|---|---|
| PFMT with Extracorporeal BiofeedbackAlso: HnJ-5300Pelvic Floor Muscle Training with Extracorporeal Biofeedback Device for 12 weeks * Twice a week for the first 4 weeks * Once a week for the next 8 weeks | Device | PFMT with Extracorporeal Biobeedback |
Primary outcome
Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test.
Time frame: After 12 weeks of treatment
2 secondary outcomes
Change in Incontinence severity VAS (I-VAS), Sandvik questionnaire, Incontinence Quality of Life (I-QoL), and Pelvic Floor Muscle Strength.
Time frame: After 12 weeks of treatment
Patient perception of Treatment Benefit, Satisfaction, Willingness to Retreatment/Recommendation (BSW).
Time frame: After 12 weeks of treatment
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.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT with Extracorporeal Biofeedback in people with Female Stress Urinary Incontinence, run by KYU-SUNG LEE at 2 sites 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 2 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 2 sites 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?
Cure rate according to standard pad test ; Cure is defined as less than 2g on the standard pad test. (time frame: After 12 weeks of treatment). 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.