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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT06546735
Eligibility Criteria:
Inclusion Criteria:
* Ability to confirm voluntary participation and agree to all purposes of the trial by signing and dating the Informed Consent Form in two copies.
* Men ≥40 years of age.
* History of overactive bladder symptoms (urinary frequency and urgency with or without urinary incontinence) and LUTS for at least 3 months due to BPH.
* History of urinary symptoms (≥1 urgency/24-hour episode and ≥8 urination/24-hour) for at least 3 months prior to screening.
Exclusion Criteria:
* Participant who has received mirabegrone or antimuscarinics for the treatment of LUTS within the last 30 days prior to the Screening Visit.
* Participant with evidence of lower urinary tract infection (UTI), confirmed by a culture \>100,000 CFU/mL. Should a participant present with a UTI at screening, they may be screened again after successful UTI treatment (confirmed by negative urine culture).
* Participant with symptomatic UTI, prostatitis, or chronic inflammation (such as interstitial cystitis, bladder stones, prior pelvic radiation therapy, or previous or current malignancy within the boundaries of the pelvis, including bladder, prostate, and rectum).
* History of recurrent UTI (2 episodes in the last 6 months or 3 episodes in the last year).
* Participant who has neurogenic bladder (spinal cord injury, multiple sclerosis, Parkinson's, etc.).
* Participant with a previous diagnosis of diabetic neuropathy.
* History of previous open, robotic, or minimally invasive prostate surgery (including transurethral procedures), or reconstructive bladder surgery.
* Participant with planned pelvic or prostate surgery during the trial period.
* Participant with planned cataract or glaucoma surgery during the trial period.
* Participant with significant stress incontinence or post-surgical prostate incontinence as determined by the Investigator.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Study:
NCT06546735
Study Brief:
Protocol Section:
NCT06546735