Low-level Light Therapy for Overactive Bladder and Urinary Incontinence

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Device: Low-level light therapy; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02980328

E-1601/330-002

Details and patient eligibility

About

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)

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of overactive bladder or urinary incontinence

Exclusion criteria

• History of taking medication for urgency urinary incontinence,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

LLLT group

Experimental group

Description:

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

Treatment:

Device: Low-level light therapy

Placebo-controlled group

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo