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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 1.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000547145
Acronym
The ROSE Study Part 1
Enrollment
10
Registered
2019-04-08
Start date
2019-02-12
Completion date
2019-02-21
Last updated
2026-02-04

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 first 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 810 device, will be delivered to participants through a diode placed in their nasal cavity for the duration of their second cystometric fill (up to 25 minutes). Cystometry is a test used to look for problems with the filling and emptying of the bladder. During the filling phase of the test (cystometric fill), the bladder is filled with saline solution, bladder pressures measured and the patient asked about their urge to void. This process will occur d

Near infrared light (NIRL), using a Vielight 810 device, will be delivered to participants through a diode placed in their nasal cavity for the duration of their second cystometric fill (up to 25 minutes). Cystometry is a test used to look for problems with the filling and emptying of the bladder. During the filling phase of the test (cystometric fill), the bladder is filled with saline solution, bladder pressures measured and the patient asked about their urge to void. This process will occur during participants' Urology outpatient clinic appointments and will only occur once.

Sponsors

Melbourne Health
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

• Greater than or equal to 20 years of age • Attending a urodynamic investigation for symptoms that include OAB • Able to provide informed consent • Able and willing to participate in the study tasks

Exclusion criteria

• Demonstrate bladder outlet obstruction on first fill UD • Have high / untreated blood pressure i.e. systolic >150mmHg or diastolic >100mmHg at baseline measure • Have cognitive impairment that requires care by another person • Are unable to communicate in English without the service of an interpreter • Have moderate to severe voiding dysfunction on first UD void • Are unable to wear the study nasal prong • Have serious medical conditions including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant’s ability to cooperate • Are participating in any other therapeutic trial

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026