A Randomized Triple-Blind Placebo-Controlled Study to Evaluate the Effects of a Supplement on Lower Urinary Tract Symptoms in Men.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Urinary Tract Symptoms
- Sponsor
- Optimale
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in Lower Urinary Tract Symptoms (LUTS)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study aims to evaluate the effects of the ProstaThrive™ supplement on lower urinary tract symptoms (LUTS) in men. It is a 90-day virtual, randomized, placebo-controlled trial with 80 male participants aged 40 and above. The primary endpoint is the reduction in LUTS, while secondary endpoints include changes in sexual function and performance.
Detailed Description
This is a virtual two-arm randomized placebo-controlled clinical trial lasting 90 days. Participants will take the ProstaThrive™ supplement or a placebo daily and complete questionnaires at Baseline, Day 30, Day 60, and Day 90. The study will assess the efficacy of ProstaThrive™ on LUTS such as urinary urgency, nighttime urination frequency, perceived urinary flow, and bladder emptying, as well as secondary outcomes related to sexual function.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male participants aged 40+
- •Experience symptoms such as frequent nighttime urination, incomplete bladder emptying, weak urinary stream, and frequent daytime urination
- •Difficulty in getting or maintaining an erection
- •Willing to avoid introducing any new products or medications targeting LUTS or erectile dysfunction during the study period
Exclusion Criteria
- •Recent surgeries or invasive treatments
- •History of prostate or male reproductive cancers
- •Urinary issues caused by neurological conditions
- •Previous surgery on the genitals, prostate, bladder, or urethra
- •Known allergies to product ingredients
- •Diagnosed with chronic health conditions impacting study participation
- •Current substance abuse
- •Participation in other clinical trials
- •Taking medications or supplements targeting LUTS or erectile dysfunction
Outcomes
Primary Outcomes
Change in Lower Urinary Tract Symptoms (LUTS)
Time Frame: Baseline, Day 30, Day 60, and Day 90
Measured by urinary urgency, nighttime urination frequency (nocturia), perceived urinary flow, and perceived bladder emptying at Baseline, Day 30, Day 60, and Day 90 via questionnaires, including questions adapted from the International Prostate Symptom Score (IPSS).
Secondary Outcomes
- Change in Sexual Function and Performance(Baseline, Day 30, Day 60, and Day 90)