U101 oral capsules to prevent recurrent urinary tract infections in women

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated Recurrent Urinary Tract Infections (rUTIs) in Women

This trial will test whether daily U101 can prevent recurrent urinary tract infections in women aged 20–75 who have a history of rUTIs.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Ages: 20 Years to 75 Years
• Sex: Female
• Sponsor: TCM Biotech International Corp. (Industry-sponsored)
• Locations: 13 sites (Kaohsiung City and 12 other locations)
• Trial ID: NCT07184827 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 study enrolling about 348 women with a history of recurrent UTIs. After screening to confirm no active infection, participants are randomized 1:1 to receive U101 or matching placebo for 24 weeks (TID for 8 weeks then BID for 16 weeks) with site visits every 4 weeks. The trial measures UTI recurrence rates, safety outcomes, and quality of life, with an optional open-label extension available after the main study. Menopausal status and site are used for stratification at randomization.

Who should consider this trial

Good fit: Non-pregnant, non-nursing women aged 20 to 75 with a documented history of ≥2 UTIs in 6 months or ≥3 UTIs in 12 months and no active infection at randomization are ideal candidates.

Not a fit: Women who are pregnant, breastfeeding, planning pregnancy, have a current positive urine culture or ongoing UTI symptoms, or who do not meet the recurrence history or age criteria are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, U101 could lower the number of recurrent UTIs and improve quality of life for women who get frequent UTIs.

How similar studies have performed: Antibiotic and prophylactic approaches have shown success in reducing rUTI risk in past studies, but U101 is a new agent being tested in a Phase 3 setting.

Eligibility criteria

Inclusion Criteria:

1. Provide a signed informed consent form.
2. Non-pregnant, non-nursing females ≥ 20 and \< 76 years old.
3. Having a history of ≥ 2 UTI events during the preceding 6 months or ≥ 3 UTI events during the preceding 12 months (including any UTI event that occurs on the date of ICF signing). At least one of the previous UTI events must have microbiologic evidence (e.g., per the investigator's judgment based on urine culture results).
4. The last urine culture (including those conducted for suspected UTI event or retest) before the randomization has to be negative.
5. Having a negative urinalysis result and no symptoms suggestive of a UTI on the day of randomization.

Exclusion Criteria:

1. Females who are pregnant, nursing, have a desire for pregnancy or have a positive pregnancy test at screening.
2. Women of childbearing potential who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period (use of spermicide is prohibited). Women of childbearing potential are defined as premenopausal females capable of becoming pregnant.
3. Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin \> 1.5 x upper limit of normal (ULN).
4. Serum creatinine \> 1.5 x ULN.
5. Prothrombin time (PT) or INR \> 1.2 x ULN.
6. Platelet counts \< 100,000/μL.
7. Serum vitamin D level \< 11 ng/mL.
8. HbA1c \> 8.0%.
9. Positive test for hepatitis B (both HBsAg and HBeAg), hepatitis C (anti-HCV antibody) or HIV (anti-HIV antibody).
10. Symptoms suggestive of a systemic inflammatory response (fever \> 38℃ or WBC count \> 12,000) at the screening.
11. A major functional or anatomical abnormality of the urogenital tract (e.g., renal cell carcinoma, outlet obstruction, etc.).
12. Diagnosis of pelvic organ prolapse ≥ grade 2 (according to pelvic organ prolapse quantification POP-Q classification) without any treatment within 6 months of the screening visit.
13. Diagnosis of complicated UTIs within 6 months of the screening visit.
14. Residual urine volume \> 100 mL within a month of the screening visit.
15. History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.
16. Having any of the following procedures within a week of the screening: urinary catheterization (e.g., Foley catheter), ureteral stent, percutaneous nephrostomy, or cystostomy.
17. Intravesical instillation of hyaluronic acid within 6 months of the screening visit.
18. Treatment with pentosan polysulfate sodium (PPS) within 6 months of the screening visit.
19. Use of antibiotic prophylaxis for rUTI within a month of the screening visit.
20. Use of local hormone therapy (cream, gel, insert, ring, or tablets) in urogenital areas within a month of the screening.
21. Any history of thrombocytopenia, hemophilia, or bladder cancer; history of endoscopy-confirmed gastrointestinal ulcers within 3 years prior to randomization.
22. Active malignancy (under intensive cancer treatment or considered in progression) or a history of any malignancy involving the pelvic cavity within 5 years prior to randomization, with the exception of adequately treated basal cell carcinoma and cervical cancer in-situ. Subjects in stable condition will be evaluated and discussed individually with the investigator.
23. Immunocompromised or history of organ transplant.
24. History of allergies to pentosan polysulfate sodium.
25. Having planned major surgery within 24 weeks after the study.
26. Participation in any interventional clinical trial within 30 days of the screening visit.
27. Other significant medical problem(s) or intercurrent acute illness(es) that in the opinion of the Investigators, would make participation in the study unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objective.
28. Subjects who are illiterate.
29. Subjects having a family history of macular degeneration or having been diagnosed with macular degeneration (except for those with asymptomatic age-related macular degeneration) .

Where this trial is running

Kaohsiung City and 12 other locations

• Chang Gung Memorial Hospital, Kaohsiung Branch — Kaohsiung City, Taiwan (Recruiting)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Active_not_recruiting)
• Taipei Tzu Chi Hospital — New Taipei City, Taiwan (Recruiting)
• China Medical University Hospital — Taichung, Taiwan (Recruiting)
• Chung Shan Medical University Hospital — Taichung, Taiwan (Recruiting)
• Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
• National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
• Chang Gung Memorial Hospital, Taipei Branch — Taipei, Taiwan (Recruiting)
• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
• Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
• Tri-Service General Hospital (TSGH) — Taipei, Taiwan (Recruiting)
• Chang Gung Memorial Hospital, Linkuo Branch — Taoyuan, Taiwan (Recruiting)

Study contacts

• Principal investigator: En Meng, MD — Tri-Service General Hospital
• Study coordinator: Emily Ma Clinical Research Manager

Conditions Recurrent Urinary Tract Infections in Women; recurrent urinary tract infections; recurrent urinary tract infections in women; rUTI; UTI; rUTIs; UTIs; pentosan polysulfate sodium