An interventional study of Flush Advanced+ Dietary Drink Mix and Placebo Dietary Drink Mix in Urinary Tract, sponsored by Bonafide Health. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Bonafide Health · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to evaluate the efficacy of the Flush Advanced+ dietary drink mix to reduce bothersome urinary tract symptoms compared to a placebo. The main questions it aims to answer are:
Participants will:
Urologic health problems can significantly impact quality of life in women and can affect overall well-being, social relationships, sexual relationships, and physical activity. While prescription antibiotics are commonly used to treat problems related to urologic health, many women seek alternatives to prescription medications and are interested in supporting their urinary tract health using dietary supplements.
Non-antibiotic approaches, such as D-mannose, cranberry, vitamins, and hydration support have demonstrated potential in mitigating bothersome urinary tract symptoms. D-mannose may prevent E. coli from adhering to the urinary tract, while Pacran® whole cranberry fruit powder has shown to significantly reduce the incidence of urologic health problems, such as urinary tract infections (UTIs), as well as and the incidence of UTIs with urinary frequency and urgency symptoms. Adequate hydration and the balance of key electrolytes, including potassium, calcium, and magnesium, may promote the flushing of bacteria from the urinary tract.
This clinical trial aims to evaluate the efficacy of Flush Advanced+, a dietary supplement drink mix containing D-mannose, Pacran® whole cranberry fruit powder, vitamins, and electrolytes, in improving urinary health outcomes. By targeting the mechanisms involved in UTI pathogenesis - such as bacterial adhesion and urinary pH regulation - this trial seeks to provide support for bothersome urinary tract symptom episodes that can significantly impact women's health and quality of life.
The purpose of this double-blind, placebo-controlled study is to evaluate the efficacy and safety of Flush Advanced+ in supporting urinary tract health for women aged 18-75. Flush Advanced+ is a commercially available product.
Bonafide Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Have a history of recurrent, bothersome urinary tract symptom episodes.
a. * >5 bothersome urinary tract symptom episodes in the past 6 months OR >7 in the past 12 months will be excluded
Exclusion Criteria:
1. Individuals who are lactating, pregnant, or planning to become pregnant during the study.
2. Seeking enrollment in another clinical trial or active participation in a clinical trial.
3. >5 bothersome urinary tract symptom episodes in the past 6 months OR >7 in the past 12 months.
4. Use of anticoagulants (e.g., warfarin) in the past 30 days. 5. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
6. History of hyperkalemia (high potassium). 7. History of Chronic Kidney Disease, kidney infections, or nephrolithiasis (kidney stones).
8. History of hospitalization for urologic or urinary tract symptoms. 9. History of recurrent bothersome urinary tract symptom episodes accompanied by symptoms indicative of more complications, such as recurrent fever, vomiting, chills, flank pain, visible blood in urine, and pain radiating down the legs 10. Introduction of antibiotics unrelated to a urological occurrence during the study period.
11. Current use of D-mannose. 12. Current use of cranberry supplements or cranberry juice or use of cranberry supplements of juice in 4 weeks prior to enrollment.
13. Has previously used the Flush Advanced+ product. 14. Current use of antibiotic-based prophylaxis or use of antibiotics within 2 weeks of enrollment.
15. History of Diabetes mellitus (Type 1 and/or 2). 16. Individuals who are immunocompromised, including those with known immunodeficiency disorders or receiving chronic immunosuppressive therapy (e.g., corticosteroids, chemotherapy, biologic agents).
17. History of cancer within two years prior to enrollment. 18. Use of vaginal and/or local estrogen therapy (permitted if stable dose longer than 90 days).
19. Active or suspected vaginitis. 20. Started a new nonantibiotic-based prophylaxis within the last 90 days. 21. Use of probiotics (permitted if orally administered with stable dose longer than 90 days).
22. Use of indwelling or intermittent urinary catheterization. 23. Diagnosis of overactive bladder (OAB) or interstitial cystitis / bladder pain syndrome (IC/BPS).
24. Urologic procedure within 6 months prior to trial enrollment or with a planned urological procedure in the 6 months following enrollment.
25. Any urologic or gynecologic surgical history that could cause or exacerbate urinary tract symptoms.
26. History of structural urinary tract disease or abnormalities. 27. History of Lichen sclerosis. 28. Use of potassium-sparing medications.
a. E.g., Spironolactone (used for PCOS) (potassium-sparing diuretic); ACE inhibitors and ARBs; systemic calcineurin inhibitors.
39. Use of statins. 30. Use of Vitamin C if the total daily amount consumed (including the amount in Flush Advanced+) meets or surpasses the tolerable upper intake level (UL) for adult females of 2,000 mg, per NIH guidelines 31. Use of Vitamin B6 if the total daily amount consumed (including the amount in Flush Advanced+) meets or surpasses the tolerable upper intake level (UL) for adult females of 100 mg, per NIH guidelines 32. Use of methenamine (permitted if stable dose longer than 90 days).
Flush Advanced+ dietary drink mix
Dietary Supplement: Flush Advanced+ Dietary Drink Mix
Placebo dietary drink mix containing no active ingredients
Dietary Supplement: Placebo Dietary Drink Mix
Flush Advanced+ dietary drink mix containing Pacran cranberry whole fruit powder, D-mannose, vitamins, and electrolytes
Drink mix with identical or similar appearance and taste as Flush Advanced+ but contains no active ingredients
Urinary Tract Symptom Episode Incidence
Total number of participant-reported episodes of bothersome urinary tract symptoms
Time frame: From enrollment to the end of intervention at 6 months
Impression of Improvement in Urinary Tract Health
Overall impression of improvement in urinary tract health, as measured by the Patient Global Impression of Change (PGIC) at Month 2, Month 4, and Month 6. The PGIC is a 1-item, 7-point Likert scale ranging from 1 (Very Much Improved) to 7 (Very Much Worse), where a higher score indicates worse outcomes.
Time frame: From enrollment to the end of intervention at 6 months
Sex-Triggered Urinary Tract Symptom Episode Incidence
Total number of participant-reported urinary tract symptom episodes that participants report were triggered by sexual activity
Time frame: From enrollment to the end of intervention at 6 months
Antibiotic Use for Urinary Tract Symptom Episodes
Total number of courses of antibiotics taken for bothersome urinary tract symptom episodes
Time frame: From enrollment to the end of intervention at 6 months
Good versus Bad Urinary Health Days
Ratio of self-reported 'good' vs. 'bad' vs. 'neither good nor bad' urinary health days assessed via daily diaries. The diary contained a 1-item, 3-point Likert scale ranging from 1 (Bad) to 3 (Good), where a higher score indicates better outcomes.
Time frame: From enrollment to the end of intervention at 6 months
Urinary Health-Related Quality of Life
Change in quality of life as it relates to urinary tract health, as measured by an approved, modified version of the Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ) every other week. The RUTIIQ is an 18-item questionnaire measured on a 11-point Likert scale ranging from 0 (Strongly Disagree) to 10 (Strongly Agree), where a higher score indicates better outcomes.
Time frame: From enrollment to the end of intervention at 6 months
Product Experience
Assess women's experience using the product, as measured by an internally-developed Product Experience Questionnaire (PEQ) monthly. The PEQ is 20-item questionnaire measured on a 4-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree), where a higher score indicates a more favorable experience.
Time frame: From enrollment to the end of intervention at 6 months
Symptom severity at the time of an acute bothersome urinary tract symptom episode
Bothersome urinary tract symptom episode, as measured by the Urinary Tract Infection - Symptom Impairment Questionnaire (UTI-SIQ-8) and Recurrent Urinary Tract Infection Symptom Scale, section C (RUTISS-C.) The UTI-SIQ-8 is an 8-item questionnaire measured on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very strong), where a higher score indicates worse outcomes.. The RUTISS-C is an 11-item questionnaire measured on an 11-point Likert scale ranging from 0 (Not Present) to 10 (Extremely Severe), where a higher score indicates worse outcomes.
Time frame: Daily for 7 days starting at the onset of bothersome urinary tract symptoms
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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