INOPASE - Performance and Safety Study of a Personalised SNM System

Official title

Feasibility and Safety Study to Evaluate the Sensing and Stimulation Performance of a Personalised Sacral Neuromodulation (SNM) System for Refractory Overactive Bladder

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.

Interventions

• Device Sacral Neuromodulation System
  INOPASE Sacral Neuromodulation System (INO-SNM-01) for treatment of overactive bladder.

Primary outcome measures

• Correlation between bladder afferent nerve activity measured by the INO-SNM-01 and patient reported urgency sensation (Feeling Indicator measure) [Time frame: From device implantation to the end of treatment 2 days]

Secondary outcome measures (6)

• Evaluation of whether timely stimulation by the INO-SNM-01 device correlates with 'Loss of desire to urinate' as measured by the Feeling Indicator [Time frame: From device implantation to the end of treatment 2 days]
• 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 days]
• 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 days]
• 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 days]
• Evaluation of whether timely stimulation using the INO-SNM-01 device shows an increase in time between urination cycles (minutes) as reported by the Feeling Indicator [Time frame: From device implantation to the end of treatment 2 days]
• Incidence of Adverse Events [Time frame: From device implantation to the end of treatment 2 days]

Eligibility criteria

Inclusion criteria

• 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)
• 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 within 2cm of the implanted lead location
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Australia · 2 centers

• St George Private Hospital — Kogarah
• St George Urology — Kogarah

Identifiers

NCT: NCT07193407 · PoC-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗