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RECRUITING
NCT07416968
PHASE4

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

Sponsor: Mansoura University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2025-09-01

Completion Date

2026-12

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

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

Locations (14)

Faculty of medicine, Menofia Univeristy

Shibīn al Kawm, Al-Minūfiyyah, Egypt

Faculty of medicine, Zagazig University

Zagazig, Al-Sharqia, Egypt

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Faculty of medicine, Tanta University

Tanta, Gharbia Governorate, Egypt

faulty of medicine, Tanta Univeristy

Tanta, Gharbia Governorate, Egypt

Faculty of medicine, minia university

Al Minyā, Egypt

Faculty of medicine, Alexandria University

Alexandria, Egypt

Faculty of medicine, Aswan university

Aswān, Egypt

Faculty of Medicine - Assiut University

Asyut, Egypt

Faculty of Medicine - Banī Suwayf University

Banī Suwayf, Egypt

Faculty of medicine, Ain Shams University

Cairo, Egypt

Cairo University, faculty of medicine

Cairo, Egypt

Faculty of Medicine, South Valley University

Qina, Egypt

Faculty of medicine, Sohag Univeristy

Sohag, Egypt