Study
Recruiting Not a phased study
This trial at a glance
Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| St George Private Hospital | Kogarah | NSW | Recruiting |
| St George Urology | Kogarah | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 18 May 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.