Overactive BladderPhase 3NCT02980328
Low-level Light Therapy for Overactive Bladder and Urinary Incontinence
A Phase 3 study testing Low-level light therapy in people with Overactive Bladder and Urinary Incontinence, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary Incontinence (UI) Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence
- What is being tested?
- Low-level light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2016to Dec 2017
- Phase
- Phase 3
- 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
- Clinical diagnosis of overactive bladder or urinary incontinence
Who cannot join
- History of taking medication for urgency urinary incontinence,
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National Univesity Bundang Hospital
Seongnam-si, Kyeonggi-do, 13620
Dong Hun Suh, PhD, +82 31 787 ext. 7263, sdhwcj@naver.com
Ewha Womans University Mokdong Hospital
Seoul, Seoul, 07985
Sarah Lee, PhD, +82 2 2650 ext. 6011, sarahmd@ewha.ac.kr
About this study
Official title: Double-blind, Randomized, Shame-controlled Multicenter Clinical Study to Evaluate Efficacy and Safety of Low-level Light Therapy Device(Color DNA-WSF) for the Treatment of Overactive Bladder and Urinary Incontinence in Women
This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary Incontinence (UI)
Read the detailed description
Study design: This was a prospective, randomized, double-blind, placebo-controlled, multi-centered trial carried out at two university hospitals. This clinical trial was approved by the Korea Food and Drug Administration and the Institutional Review Boards of the two hospitals.
Study process:
All patients gave informed written consent after being informed of the details of the study. Participants were randomized into either the LLLT or placebo control groups at the third visit. All participants underwent demographic and history taking, a physical examination, bladder examination and laboratory tests. All participants were educated on how to use the device by demonstration and a picture-guided user manual.
During the second visit, the participants conducted a self-evaluation of frequency of urgency urinary incontinence episode using the OABSS scale and underwent urine examination (pre-treatment measurement). The third visit occurred 7 days from the date of the second visit, and a clinical primary nurse described how to use the medical equipment and devices when they were at home. All subjects filled out self-reported diary and filled out UDI-6 and IIQ-7 questionnaires in each visit. Subjects carried out the self-treatment in the same way at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo examination and filled out OABSS, UDI-6 and IIQ-7 questionnaires (post-treatment measurement).
Statistical analysis:
All data are summarized as means ± standard deviation or as numbers with proportions. A p < 0.05 was considered to indicate significance. The investigator decided that the therapeutic effect would be a > 20% reduction in the frequency of urgency urinary incontinence episodes after treatment. The statistical analysis was conducted using the self-reported micturition diary after the 12 week visit as the primary endpoint. The investigator used an independent t-test or Wilcoxon rank sum test depending on the normality of the data to evaluate differences in each group between frequency of urgency urinary incontinence episodes measured after the 12 week visit and baseline values. To test for normality, the investigator performed Shapiro-Wilk's test. The examination of the ratio difference in nominal variable was carried out using chi-square test or Fisher's exact test. A per-protocol (PP) and intent to treat (ITT) analyses were used in our clinical trial to assess efficacy and safety. A Last observation carried forward (LOCF) method was used for ITT analysis missing data.
- Conditions
- Overactive Bladder, Urinary Incontinence
- Being tested
- Low-level light therapy, Placebo
- Keywords
- Overactive bladder, Urinary incontinence, Low-level light therapy
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level light therapyDevice
Also called Color DNA-WSF
we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
PlaceboDevice
we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
| Study group | Role | What they receive |
|---|---|---|
| LLLT group | Experimental | Low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each Receives: Device: Low-level light therapy |
| Placebo-controlled group | Placebo comparator | Placebo low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of urinary incontinence episode
The primary outcome was frequency of urgency urinary incontinence episode based on the self-evaluated micturition diary measuring the difference between urgency urinary incontinence episode count pre and post-treatment. Urgency urinary incontinence episode was measured by the mean of 3 days report prior to the visit (week 0, 4 and 12). The higher values represent a worse outcome. All data collected by self-reported sheet. The participants conducted a self-evaluation of frequency of urgency urinary incontinence episode from 3 days prior to the visits and submitted to the investigator.
Measured: within 12 weeks after treatment
Secondary outcomes (1)
Changes in Quality of life
The secondary outcome measures was quality of life, assessed by UDI-6 and IIQ-7. The UDI-6 descriptive system comprises the following 6 dimensions: bladder stimulation (2), stress-related urinary incontinence (2), obstructive disorder and pain. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to UDI-6 equation formula. The higher values represent a worse outcome. The IIQ-7 descriptive system comprises the following 7 dimensions: physical activity (2), travelling (2), social activity and psychological effect (2). Each dimension has 3 levels: no problems, some problems, extreme problems, and the score was calculated by multiplying 33 to the score (maximum 100). The subscales combined to compute a total score according to IIQ-7 equation formula.
Measured: within 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Beom Kim, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980328
- Sponsor's protocol ID
- E-1601/330-002
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Shame-controlled Multicenter Clinical Study to Evaluate Efficacy and Safety of Low-level Light Therapy Device(Color DNA-WSF) for the Treatment of Overactive Bladder and Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT02980328
- Acronym / sponsor ID
- E-1601/330-002
- Conditions
- Overactive Bladder, Urinary Incontinence
- Keywords
- Overactive bladder, Urinary incontinence, Low-level light therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 2 Dec 2016 (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.
This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary Incontinence (UI)
Detailed description
Study design: This was a prospective, randomized, double-blind, placebo-controlled, multi-centered trial carried out at two university hospitals. This clinical trial was approved by the Korea Food and Drug Administration and the Institutional Review Boards of the two hospitals.
Study process:
All patients gave informed written consent after being informed of the details of the study. Participants were randomized into either the LLLT or placebo control groups at the third visit. All participants underwent demographic and history taking, a physical examination, bladder examination and laboratory tests. All participants were educated on how to use the device by demonstration and a picture-guided user manual.
During the second visit, the participants conducted a self-evaluation of frequency of urgency urinary incontinence episode using the OABSS scale and underwent urine examination (pre-treatment measurement). The third visit occurred 7 days from the date of the second visit, and a clinical primary nurse described how to use the medical equipment and devices when they were at home. All subjects filled out self-reported diary and filled out UDI-6 and IIQ-7 questionnaires in each visit. Subjects carried out the self-treatment in the same way at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo examination and filled out OABSS, UDI-6 and IIQ-7 questionnaires (post-treatment measurement).
Statistical analysis:
All data are summarized as means ± standard deviation or as numbers with proportions. A p < 0.05 was considered to indicate significance. The investigator decided that the therapeutic effect would be a > 20% reduction in the frequency of urgency urinary incontinence episodes after treatment. The statistical analysis was conducted using the self-reported micturition diary after the 12 week visit as the primary endpoint. The investigator used an independent t-test or Wilcoxon rank sum test depending on the normality of the data to evaluate differences in each group between frequency of urgency urinary incontinence episodes measured after the 12 week visit and baseline values. To test for normality, the investigator performed Shapiro-Wilk's test. The examination of the ratio difference in nominal variable was carried out using chi-square test or Fisher's exact test. A per-protocol (PP) and intent to treat (ITT) analyses were used in our clinical trial to assess efficacy and safety. A Last observation carried forward (LOCF) method was used for ITT analysis missing data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLT group | Experimental | Device: Low-level light therapyLow-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each |
| Placebo-controlled group | Placebo comparator | Device: PlaceboPlacebo low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of overactive bladder or urinary incontinence
Key exclusion criteria (1 listed)
- History of taking medication for urgency urinary incontinence,
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 |
|---|---|---|
| Low-level light therapyAlso: Color DNA-WSFwe used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule. | Device | LLLT group |
| Placebowe used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule. | Device | Placebo-controlled group |
Primary outcome
Frequency of urinary incontinence episode
Time frame: within 12 weeks after treatment
The primary outcome was frequency of urgency urinary incontinence episode based on the self-evaluated micturition diary measuring the difference between urgency urinary incontinence episode count pre and post-treatment. Urgency urinary incontinence episode was measured by the mean of 3 days report prior to the visit (week 0, 4 and 12). The higher values represent a worse outcome. All data collected by self-reported sheet. The participants conducted a self-evaluation of frequency of urgency urinary incontinence episode from 3 days prior to the visits and submitted to the investigator.
1 secondary outcome
Changes in Quality of life
Time frame: within 12 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
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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.
Yong Beom Kim, Professor principal investigator
Seoul National University Bundang Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-level light therapy in people with Overactive Bladder and Urinary Incontinence, run by Seoul National University Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Dec 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Beom Kim, Professor (+82 31 787 ext. 7253, Ybkimlh@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of urinary incontinence episode (time frame: within 12 weeks after 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 7 Dec 2016; AzTrials last refreshed its copy on 29 Oct 2026.