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

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

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

Sponsors & Collaborators

• Cairo University

  collaborator OTHER

• Ain Shams University

  collaborator OTHER

• Alexandria University

  collaborator OTHER

• Zagazig University

  collaborator OTHER_GOV

• Tanta University

  collaborator OTHER

• Menoufia University

  collaborator OTHER

• Assiut University

  collaborator OTHER

• Sohag University

  collaborator OTHER

• South Valley University

  collaborator OTHER

• Beni-Suef University

  collaborator OTHER

• Minia University

  collaborator OTHER

• Aswan University

  collaborator OTHER

• Mansoura University

  lead OTHER

Principal Investigators

• Ahmed A Shokeir, professor of urology · Urology & Nephrology Center, Masnoura university, Egypt

• Sherif Mourad, Professor of Urology · Ain Shams University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2026-09-30

Completion

2026-12-31

Countries

• Egypt

Study Locations