Low-level Light Therapy for Overactive Bladder and Urinary Incontinence
NCT ID: NCT02980328
Last Updated: 2016-12-07
Study Results
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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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2016-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LLLT group
Low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each
Low-level light therapy
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.
Placebo-controlled group
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.
Placebo
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.
Interventions
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Low-level light therapy
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.
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yong Beom Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National Univesity Bundang Hospital
Seongnam-si, Kyeonggi-do, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Dong Hun Suh, PhD
Role: primary
Sarah Lee, PhD
Role: primary
Other Identifiers
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E-1601/330-002
Identifier Type: -
Identifier Source: org_study_id