Low-level Light Therapy for Overactive Bladder and Urinary Incontinence

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02980328
• Other study ID #: E-1601/330-002
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 21, 2016
• Last updated: December 5, 2016
• Start date: December 2016

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: Yong Beom Kim, Professor
• Phone: +82 31 787
• Email: Ybkimlh[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of overactive bladder or urinary incontinence

Exclusion Criteria:

• History of taking medication for urgency urinary incontinence,

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univesity Bundang Hospital	Seongnam-si	Kyeonggi-do
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	within 12 weeks after treatment	No