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.