INOPASE - Performance and Safety Study of a Personalised SNM System
ConditionOveractive Bladder (OAB)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorINOPASE Pty Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult female participants 18 years of age or older
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sacral Neuromodulation System
DeviceINOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: INOPASE Sacral Neuromodulation System 01 (INO-SNM-01)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From device implantation to the end of treatment 2 daysSecondary outcomes
1
Evaluation of whether timely stimulation by the INO-SNM-01 device correlates with 'Loss of desire to urinate' as measured by the Feeling Indicator
The Feeling Indicator device 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.
Time frame
From device implantation to the end of treatment 2 days2
Evaluation of whether timely stimulation by the INO-SNM-01 device shows a reduction in bladder afferent nerve activity response when providing stimulation compared to no stimulation
Time frame
From device implantation to the end of treatment 2 days3
Evaluation of whether timely stimulation by the INO-SNM-01 shows a reduction in bladder pressure (cm H2O) measured by a urodynamics monitor
Time frame
From device implantation to the end of treatment 2 days4
Evaluation of whether timely stimulation by the INO-SNM-01 device shows an increase in urinary volume (mL) during each urination cycle as measure by a urodynamics monitor.
Time frame
From device implantation to the end of treatment 2 daysSponsors and contacts
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Source ClinicalTrials.gov