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Tests treatment safety and results for Overactive Bladder (OAB)
Official title INOPASE - Performance and Safety Study of a Personalised SNM System
ClinicalTrials.gov ID: NCT07193407
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Kogarah, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kogarah, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.