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)

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• History of neurosurgical interventions.
• Pregnancy or breastfeeding.
• Neuropathic diseases affecting the lower urinary tract.
• History of genitourinary malignancy.
• Post-void residual urine (PVR) > 150 ml.
• Vesical or lower ureteric stones.
• Uncontrolled diabetes mellitus (HbA1c > 7).
• Any psychological or psychiatric disorders.
• Contraindications or allergy to the used medications.
• History of surgeries in the urinary bladder.
• History of pelvic surgeries within 6 months.
• Voiding dysfunctions.