Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
- Conditions
- Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
- Registration Number
- NCT06546735
- Lead Sponsor
- Eurofarma Laboratorios S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- 614
Inclusion Criteria:<br><br> - Ability to confirm voluntary participation and agree to all purposes of the trial by<br> signing and dating the Informed Consent Form in two copies.<br><br> - Men =40 years of age.<br><br> - History of overactive bladder symptoms (urinary frequency and urgency with or<br> without urinary incontinence) and LUTS for at least 3 months due to BPH.<br><br> - History of urinary symptoms (=1 urgency/24-hour episode and =8 urination/24-hour)<br> for at least 3 months prior to screening.<br><br>Exclusion Criteria:<br><br> - Participant who has received mirabegrone or antimuscarinics for the treatment of<br> LUTS within the last 30 days prior to the Screening Visit.<br><br> - Participant with evidence of lower urinary tract infection (UTI), confirmed by a<br> culture >100,000 CFU/mL. Should a participant present with a UTI at screening, they<br> may be screened again after successful UTI treatment (confirmed by negative urine<br> culture).<br><br> - Participant with symptomatic UTI, prostatitis, or chronic inflammation (such as<br> interstitial cystitis, bladder stones, prior pelvic radiation therapy, or previous<br> or current malignancy within the boundaries of the pelvis, including bladder,<br> prostate, and rectum).<br><br> - History of recurrent UTI (2 episodes in the last 6 months or 3 episodes in the last<br> year).<br><br> - Participant who has neurogenic bladder (spinal cord injury, multiple sclerosis,<br> Parkinson's, etc.).<br><br> - Participant with a previous diagnosis of diabetic neuropathy.<br><br> - History of previous open, robotic, or minimally invasive prostate surgery (including<br> transurethral procedures), or reconstructive bladder surgery.<br><br> - Participant with planned pelvic or prostate surgery during the trial period.<br><br> - Participant with planned cataract or glaucoma surgery during the trial period.<br><br> - Participant with significant stress incontinence or post-surgical prostate<br> incontinence as determined by the Investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mean number of urgency episodes per day
- Secondary Outcome Measures
Name Time Method The mean number of voids per day;The mean number of incontinence episodes per day