Personalised sacral neuromodulation (INO-SNM-01) for overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, non-randomised interventional study enrolling up to 10 adult women with refractory overactive bladder to test the sensing and stimulation capabilities of the INO-SNM-01 system. Participants will have a temporary trial lead implanted near the sacral nerve and remain in hospital for monitoring and testing for up to two days to record bladder nerve activity and patient-reported urgency. The study will look for correlations between nerve signals and urgency sensations and will deliver stimulation based on sensed activity to see if symptoms are reduced. Safety and device performance will be monitored throughout, with no comparison group used in this initial feasibility work.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult female participants 18 years of age or older
2. Diagnosed with refractory overactive bladder that is resistant to behavioural therapy and/or pharmacotherapy, for at least 12 weeks
3. Experience at least 3 urgency episodes within a 24-hour period from the past 3 consecutive days (reported in a bladder diary)
4. Baseline of greater than 7 on the Overactive Bladder Symptom Score (OABSS)
5. Baseline score of greater than 12 on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
6. Willing to receive SNM therapy
7. Willing to provide free and Informed consent to participate in the clinical investigation
8. Able to understand all study instructions, willing to attend all study visits, and likely to comply with all study procedures

Exclusion Criteria:

1. Participants who are diagnosed with stress urinary incontinence
2. Received tibial nerve stimulation therapy within the past 3 months
3. Received treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
4. Have neurological conditions such as dementia, multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
5. Participants who presently have, or are at high risk of urinary tract infection
6. Have uncontrolled systemic disease or comorbidities which may affect bladder function (for example diabetes, hypertension, cancer)
7. Implanted with a neurostimulator, pacemaker, or defibrillator
8. Participation in another interventional drug or device clinical trial concurrently or concluding within 30 days of screening
9. Women who are pregnant
10. Participants with known history of allergies to materials in contact with tissue for this study (i.e. adhesive dressing patch, silicone)
11. Have implanted devices that contain metallic components within 2cm of the implanted lead location
12. 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

Where it's running

• St George Private Hospital
  Kogarah, New South Wales, Australia Recruiting
• St George Urology
  Kogarah, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Wiliam Lynch — St George Urology
• Study coordinator: Christopher Ong
• Email: chris.ong@wonderlandmedical.com
• Phone: +61411256603

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.