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
Qualifiers
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
Treatments tested in this trial
- Sacral Neuromodulation System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov