Skip to content

A research study to see if infrared light applied via the nostril is safe and will help reduce symptoms for people with overactive bladder.

An evaluation of the safety and efficacy of photobiomodulation on symptoms of an overactive bladder. Part 2..

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001012167
Acronym
The ROSE Study Part 2
Enrollment
6
Registered
2019-07-15
Start date
2019-08-05
Completion date
2020-01-31
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Overactive bladder is a term describing the clinical problem of urinary urgency +/-urgency incontinence. It is a bothersome condition that occurs equally in men and women. OAB places a burden on both the individual and the healthcare system. It is associated with reduced quality of life, increased risk of falls, high healthcare utilisation, personal cost and lower work productivity. This research study is the second part of a two-part study that aims to establish whether intervention with Near Infrared Red Light therapy delivered via a nasal prong can help to reduce the symptoms of overactive bladder. It is hoped that this research will lead to a more effective and standardised treatment plan for people with overactive bladder. The research intervention (Near Infrared Light) has successfully been used for other conditions where people are in pain.

Interventions

Near infrared light (NIRL), using a Vielight 810nm device, will be delivered to participants through a diode placed in their nasal cavity for 25 minutes, 5 times per week for 4 weeks; i.e. 20 sessions in total. The first session will be undertaken in the Urology Outpatient Clinic; thereafter 1 session per week will be delivered by the Study Research Assistant in the participant's home and the other 4 sessions per week self-administered by the participant. Monitoring of adherence to the intervent

Near infrared light (NIRL), using a Vielight 810nm device, will be delivered to participants through a diode placed in their nasal cavity for 25 minutes, 5 times per week for 4 weeks; i.e. 20 sessions in total. The first session will be undertaken in the Urology Outpatient Clinic; thereafter 1 session per week will be delivered by the Study Research Assistant in the participant's home and the other 4 sessions per week self-administered by the participant. Monitoring of adherence to the intervention will be by way of a daily participant diary, weekly research assistant visit and weekly phone call to the participant.

Sponsors

Melbourne Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• >=20 years of age • Attending the outpatient continence service for help to manage urinary urgency ± urgency incontinence; not necessarily treatment naive • Able to provide informed consent • Able and willing to participate in the study tasks

Exclusion criteria

• Known bladder outlet obstruction, moderate to severe voiding dysfunction or significant cystocele • High or untreated blood pressure i.e. systolic >150mmHg or diastolic >100mmHg at baseline measure • Cognitive impairment that requires care by another person • Are unable to communicate in English without the service of an interpreter • Serious medical conditions which are likely to influence their ability to cooperate • Participating in any other therapeutic trial • Are starting a new intervention for OAB at the time of the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026