NCT02980328

Brief 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)

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

December 7, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 21, 2016

Last Update Submit

December 5, 2016

Conditions

Overactive BladderUrinary Incontinence

Keywords

Overactive bladderUrinary incontinenceLow-level light therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    within 12 weeks after treatment

Secondary Outcomes (1)

  • Changes in Quality of life

    within 12 weeks after treatment

Study Arms (2)

LLLT group

EXPERIMENTAL

Low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each

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.

Device: Placebo

Interventions

Low-level light therapyDEVICE

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.

Also known as: Color DNA-WSF
LLLT group
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.

Placebo-controlled group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of overactive bladder or urinary incontinence

You may not qualify if:

  • History of taking medication for urgency urinary incontinence,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National Univesity Bundang Hospital

Seongnam-si, Kyeonggi-do, 13620, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, Seoul, 07985, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination Disorders

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Yong Beom Kim, Professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Beom Kim, Professor

CONTACT

+82 31 787Ybkimlh@snubh.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

December 2, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Last Updated

December 7, 2016

Record last verified: 2016-10

Locations

KR(2)