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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorMansoura University

About this trial

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.

Eligibility criteria

Qualifiers

OAB symptoms persisting for ≥3 months

OAB Symptom Score (OABSS) > 5 and urgency sub-score of OABSS ≥ 2

Ability and willingness to provide informed consent.

Disqualifiers

Active urinary tract infection.

Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI

Pelvic organ prolapse stage ≥II according to POP-Q system.

History of pelvic radiation.

Trial design

Treatments tested in this trial

  • Tadalafil 5 mg
  • Solifenacin 5mg

Treatment groups

480 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mansoura University

Lead sponsor

Cairo University

Collaborator

Ain Shams University

Collaborator

Alexandria University

Collaborator

Zagazig University

Collaborator

Tanta University

Collaborator

Menoufia University

Collaborator

Assiut University

Collaborator

Sohag University

Collaborator

South Valley University

Collaborator

Beni-Suef University

Collaborator

Minia University

Collaborator

Aswan University

Collaborator