NCT07416968

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage. Women who join the study will be randomly placed into one of two groups: One group will take tadalafil (5 mg), a medicine taken once a day. The other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day. The study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits. The main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects. Women aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.

Conditions

• Overactive Bladder (OAB)
• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DRUG	Tadalafil 5 mg	Tadalafil 5 mg orally once daily for the duration of 12 weeks
DRUG	Solifenacin 5mg	solifenacin succinate 5 mg orally once daily for the duration of 12 weeks

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

14 sites across 1 country: Egypt