INOPASE - Performance and Safety Study of a Personalised SNM System

INOPASE Pty Ltd

Status

Not yet enrolling

Conditions

Overactive Bladder (OAB)

Treatments

Device: Sacral Neuromodulation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07193407

PoC-01

Details and patient eligibility

About

The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manage symptoms of refractory overactive bladder in adult women aged 18-70 who have not responded to standard treatments.

The main questions it aims to answer are:

Is there a clear relationship between bladder nerve activity and patient-reported urgency sensations?
Can targeted stimulation based on bladder nerve activity reduce overactive bladder symptoms?
Is the INO-SNM-01 System safe to use?

Researchers will not use a comparison group in this study. Instead, all participants will receive the investigational device to see if it works as intended.

Participants will undergo surgery to have a temporary trial lead implanted near the sacral nerve and spend up to 2 days in hospital for monitoring and testing to assess the device sensing and stimulation capabilities.

Up to 10 participants will take part in this first-in-human feasibility study at a single site in Australia.

Enrollment

10 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult female participants between 18 and 70 years of age
Diagnosed with refractory overactive bladder that is resistant to behavioural therapy and/or pharmacotherapy, for at least 12 weeks
Experience at least 3 urgency episodes within a 24-hour period from the past 3 consecutive days (reported in a bladder diary)
Baseline of greater than 7 on the Overactive Bladder Symptom Score (OABSS)
Baseline score of greater than 12 on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
Willing to receive SNM therapy
Willing to provide free and Informed consent to participate in the clinical investigation
Able to understand all study instructions, willing to attend all study visits, and likely to comply with all study procedures

Exclusion criteria

Participants who are diagnosed with stress urinary incontinence
Received tibial nerve stimulation therapy within the past 3 months
Received treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
Have neurological conditions such as dementia, multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
Participants who presently have, or are at high risk of urinary tract infection
Have uncontrolled systemic disease or comorbidities which may affect bladder function (for example diabetes, hypertension, cancer)
Implanted with a neurostimulator, pacemaker, or defibrillator
Participation in another interventional drug or device clinical trial concurrently or concluding within 30 days of screening
Women who are pregnant
Participants with known history of allergies to materials in contact with tissue for this study (i.e. adhesive dressing patch, silicone)
Have implanted devices that contain metallic components
Any other clinical or social reason that, in the opinion of the investigator could restrict a participant's ability to successfully meet the study objectives