Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT07149103
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to give informed consent for participation in the investigation
2. Is aged 18 years or older
3. Has been diagnosed with idiopathic overactive bladder (OAB) by a qualified urologist (FRACS) or gynaecologist (FRANZCOG)
4. Eligibility is based on meeting the criteria for an OAB, defined by the International Continence Society as an average urinary frequency: ≥8 voids and ≥1 urgency episode (with or without incontinence) per 24 hours
5. Clinically acceptable laboratory results within 30 days of enrolment Urinalysis: Dipstick (Leukocytes \& Nitrites)
6. In the Investigator's opinion, participant is able and willing to comply with all trial requirements
7. Willing to allow their general practitioner and/or other specialists to be aware of their participation in the trial.
Exclusion Criteria:
1. Presence of urinary tract infection based on a positive dipstick AND positive mid-stream urine (MSU) test within 4 weeks prior to therapy commencement.
2. Female participant who is pregnant, lactating or planning pregnancy during the trial.
3. History of bladder augmentation/cystoplasty
4. Morbid obesity (BMI greater than 35)
5. Poorly controlled diabetes mellitus (HbA1c \> 7.5% (based on diabetic study)
6. Intravesical injection of botulinum toxin within 12 months of study enrolment.
7. Patients who have failed intravesical Botox therapy.
8. Patients with neurogenic lower urinary tract dysfunction or relevant neurological disease
9. A treatment within the previous year of neuromodulation (TNS or sacral neuromodulation) for OAB.
10. Participant with pacemakers or implantable defibrillators, or other active implantable devices (e.g., spinal cord stimulators, bladder neurostimulators)
11. Participant who have participated in another research trial involving an investigational product in the past 12 weeks.
12. Participant on medication therapy for OAB who have not gone through a two-week washout period during which time medications were discontinued.
13. Participant is in the investigators opinion, unable to comply with trial requirements.
14. Participant has inflamed, infected or otherwise compromised skin in the treatment area.
15. Participant with a bleeding disorder e.g., haemophilia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07149103
Study Brief:
Protocol Section:
NCT07149103