Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women

NCT07184827 | Recruiting Phase 3 DMC

• 1 other identifier: TCMU101-001
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 13

Brief Summary

The goal of this clinical trial is to learn if drug U101 works to prevent recurrent urinary tract infection (rUTI) in women (≥ 20 and \< 76 years old) with a medical history. It will also investigate the safety and the impact on the Quality of Life improvement of drug U101. The main questions it aims to answer are:

• Does the drug prevent or decrease the recurrence of urinary tract infection (UTI) during the 24-week treatment?
• Will the Quality of Life be improved during the 24-week treatment?
• What medical problems do participants have when taking drug U101? Researchers will compare drug U101 to a placebo (a look-alike substance that contains no drug) to see if drug U101 works to prevent rUTI. Participants will:
• Orally take drug U101 or placebo every day for 24 weeks in the main study, three times per day (TID) for 8 weeks and twice per day (BID) for 16 weeks.
• Visit the site once every 4 weeks for checkups and tests during the main study.
• be asked to enroll in extensional study (the open-label extension (OLE) with drug U101 treatment or the Safety Follow-Up Visits with no investigational product treatment) for 24 weeks after they complete the 24-week main study.
• Visit the site when the suspected UTI occurred during the main study or the extension study.

Conditions

Recurrent Urinary Tract Infections in Women

Keywords

recurrent urinary tract infections; recurrent urinary tract infections in women; rUTI; UTI; rUTIs; UTIs; pentosan polysulfate sodium; PPS; Glycosaminoglycan; Glycosaminoglycans; GAG; GAGs

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects without UTI recurrence during the 24-week main study period

  To demonstrate the efficacy of U101 in preventing recurrent urinary tract infections (rUTIs) in women

  The primary analysis will be performed at the end of the 24-week main study

Secondary Outcomes (33)

• Time to the first UTI episode during the main study period

  This analysis will be performed at the end of the 24-week main study

• Percentage of subjects with ≤ 1 UTI episode during the main study period

  This analysis will be performed at the end of the 24-week main study

• Average number of time-normalized UTI episodes per 4 weeks during the main study period

  This analysis will be performed at the end of the 24-week main study

• Quality of Life assessment: Daily Activities Interference during the main study period

  This analysis will be performed at the end of the 24-week main study

• Quality of Life assessment: Pain Intensity during the main study period

  This analysis will be performed at the end of the 24-week main study

Study Arms (2)

Placebo

PLACEBO COMPARATOR

One capsule of Placebo will be administered orally three times per day (TID) for 8 weeks followed by one capsule of placebo twice per day (BID) for 16 weeks.

Other: Placebo

U101

EXPERIMENTAL

One capsule (100 mg) of U101 will be administered orally three times per day (TID) for 8 weeks followed by one capsule of U101 twice per day (BID) for 16 weeks.

Drug: U101

Interventions

U101 DRUG

One capsule (100 mg) of U101 will be administered orally three times per day (TID) for 8 weeks followed by one capsule of U101 twice per day (BID) for 16 weeks.

Also known as: pentosan polysulfate sodium (PPS)

U101

Placebo OTHER

One capsule of Placebo will be administered orally three times per day (TID) for 8 weeks followed by one capsule of placebo twice per day (BID) for 16 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide a signed informed consent form.
• Non-pregnant, non-nursing females ≥ 20 and \< 76 years old.
• 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).
• The last urine culture (including those conducted for suspected UTI event or retest) before the randomization has to be negative.
• Having a negative urinalysis result and no symptoms suggestive of a UTI on the day of randomization.

You may not qualify if:

• Females who are pregnant, nursing, have a desire for pregnancy or have a positive pregnancy test at screening.
• 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.
• Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin \> 1.5 x upper limit of normal (ULN).
• Serum creatinine \> 1.5 x ULN.
• Prothrombin time (PT) or INR \> 1.2 x ULN.
• Platelet counts \< 100,000/μL.
• Serum vitamin D level \< 11 ng/mL.
• HbA1c \> 8.0%.
• Positive test for hepatitis B (both HBsAg and HBeAg), hepatitis C (anti-HCV antibody) or HIV (anti-HIV antibody).
• Symptoms suggestive of a systemic inflammatory response (fever \> 38℃ or WBC count \> 12,000) at the screening.
• A major functional or anatomical abnormality of the urogenital tract (e.g., renal cell carcinoma, outlet obstruction, etc.).
• 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.
• Diagnosis of complicated UTIs within 6 months of the screening visit.
• Residual urine volume \> 100 mL within a month of the screening visit.
• History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.

Sponsors & Collaborators

• TCM Biotech International Corp.: lead

Study Sites (13)

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 District, Taiwan

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Pentosan Sulfuric Polyester

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Organic Chemicals; Polysaccharides; Carbohydrates

Study Officials

• En Meng, MD

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Ma Clinical Research Manager

CONTACT

+886-2-2697-2628; emilyma@tcmbio.com

Principal Investigator

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: September 22, 2025
• Study Start: October 14, 2020
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (13)