Auriculotherapy on Lower Urinary Tract Symptoms in Elderly Men

NCT02330107 | Completed

• 1 other identifier: 1-ZVD4
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Lower urinary tract symptoms (LUTS) represent a widespread health problem that negatively affects the quality of life (QoL) of majority of the male aging population. Although LUTS are not life threatening, these symptoms include urinary retention, voiding difficulty, frequent feeling of urinary urgency, and nocturia, all of which negatively affect the daily functions, sleep quality, and sexual activities of patients. Despite the proven effectiveness of conventional pharmacological therapies, most men are reluctant to try these treatments because of perceived side effects and potential complications. Other non-invasive complementary treatments for LUTS should be explored because of the limitations of pharmacological therapy. Auriculotherapy (AT), one of the approaches in traditional Chinese medicine, is a therapeutic method in which specific points in the auricle are stimulated to treat various physical disorders. AT is a specialized form of acupuncture in which the ear is viewed as a microsystem of the body. A minimally invasive measure of AT, instead of using needles, is adopted in this study to avoid pain induction. This randomized controlled trial (RCT) aims to determine the effectiveness of AT in improving the conditions of the elderly with LUTS in terms of symptom relief, enhancing QoL, and improving sleep conditions. Male subjects, who are 60 years old or above and with moderate to severe LUTS, will be recruited. Subjects in 'Treatment arm 1' will receive MAT and placebo LA on specific auricular points on one side of the ear during each treatment session. Subjects in 'Treatment arm 2' will receive LA and placebo MAT using low-energy laser applied to selected acupoints of the ear, and a plaster centred with a portion of Junci Medulla that mimics MAT treatment will also be given. Subjects in 'Treatment arm 3' will receive a combined approach (both MAT and LA). Subjects in the 'placebo arm' will serve as placebo controls. Six auricular acupoints that are considered to affect LUTS will be selected. Only one ear at a time will receive treatment. Thus, the ears will be treated alternately. The total treatment period will be four weeks. The experimental objects will be replaced every other day. Therefore, treatment will be performed thrice a week. Subjects will be assessed at baseline up to 3 months after the therapy. This study can advance our knowledge of complementary approaches to improve the LUTS conditions of the elderly population and the feasibility of AT among clients with LUTS in a future large-scale study.

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 1. International Prostate Symptom Score (IPSS - Hong Kong Chinese Version 2)

  This instrument will be used to collect information regarding the LUTS condition of the subjects. The instrument consists of seven Likert-scale questions \[scores from 0 (not at all) to 5 (almost always)\] that will address two aspects of LUTS. Three questions involve filling problems (daytime frequency and nocturnal urgency), and four questions assess voiding problems (emptying, intermittency, weak stream, and straining). The total IPSS score from the seven questions ranges from 0 to 35. The IPSS (Hong Kong Chinese version 2) has been recently validated and found to be a valid, reliable, and sensitive measure for assessing Chinese populations with LUTS (Cronbach's alpha coefficient = 0.71, ICC of the symptom questions = 0.80, ICC of the QoL = 0.70) (Choi et al., 2014). This tool will be set as the primary variable to indicate the actual effect size and continuously monitor the effectiveness of the treatments throughout the study.

  collected at baseline up to 3 months after therapy

Secondary Outcomes (6)

• Maximum urinary flow rate (Qmax)

  collected at baseline up to 3 months after therapy

• 2. Post-void residual urine test

  collected at baseline up to 3 months after therapy

• Pittsburgh sleep quality index

  collected at baseline up to 3 months after therapy

• Subjects' expectations towards therapy

  collected at baseline up to 3 months after therapy

• Patient satisfaction towards therapy

  collected at baseline up to 3 months after therapy

Study Arms (3)

Treatment arm 1

EXPERIMENTAL

Subjects will receive MAT and placebo LA. The magnetic pellets will be applied to the six selected acupoints as detected by an acupoint finder. To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of MAT. Subjects will be asked to wear a pair of laser protective goggles to "blind" them during treatment.

Other: MAT & LAT

Treatment arm 2

EXPERIMENTAL

Subjects will receive a combined approach that includes the use of MAT and LA. A laser device (Pointer Pulse™) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz, which is a common acceptable dosage for clinical use (King et al., 1990; Round et al., 2013). This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the reactive region of each of the six selected acupoints on the ear. Laser protective goggles will be provided to the subjects and the researchers for eye protection.

Other: MAT & LAT

Treatment arm 3

PLACEBO COMPARATOR

Subjects will serve as a placebo control and will receive LA at "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of plasters centred with a small portion of Junci Medulla (mimicking the MAT treatment).

Other: MAT & LAT

Interventions

MAT & LAT OTHER

For MAT, the magnetic pellets will have \~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm, to be put on the 6 selected acupoints of the ear. For LAT, a laser device (Pointer Pulse™) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz. A 1-minute treatment using the continuous mode of the device will be directly applied to the reactive region of each of the six selected acupoints on the ear.

Treatment arm 1; Treatment arm 2; Treatment arm 3

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Neighbourhood Advice-Action Council

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lorna KP Suen, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 25, 2014
• First Posted: January 1, 2015
• Study Start: September 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

HK (1)