INOPASE - Performance and Safety Study of a Personalised SNM System

N/ARecruitingNCT07193407

INOPASE Pty Ltd10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Overactive Bladder (OAB)

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure)

Success is defined as the ability of the INO-SNM-01 device to detect an increase in nerve activity (mV) as measured by the INO-SNM-01 when the participant reports 'Urgency' on the wireless input Feeling Indicator device. The Feeling Indicator allows patients to record their urgency sensations as 'Desire to urinate', 'Loss of desire to urinate', 'Urgency' or 'Urination' in real-time throughout the test period.