Low-dose tadalafil versus solifenacin for treating overactive bladder in women

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

This trial will test whether taking daily low-dose tadalafil or daily solifenacin reduces overactive bladder symptoms in women aged 18–75.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Mansoura University (Academic / other)
• Drugs / interventions: radiation
• Locations: 14 sites (Shibīn al Kawm, Al-Minūfiyyah and 13 other locations)
• Trial ID: NCT07416968 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter Egyptian trial compares once-daily tadalafil 5 mg with once-daily solifenacin 5 mg over 12 weeks in women with overactive bladder. Participants are randomly assigned to one of the two medication arms and will keep bladder diaries, complete symptom and quality-of-life questionnaires, and undergo uroflowmetry and post-void residual measurements at scheduled visits. The primary outcome is change in OAB symptoms such as urgency and frequency, with secondary outcomes including quality of life, objective bladder function measures, and treatment side effects. Key exclusions include predominant stress incontinence, significant pelvic organ prolapse, active infection, certain neurologic disorders, recent pelvic surgery, and contraindications to the study drugs.

Who should consider this trial

Good fit: Women aged 18–75 with at least three months of OAB symptoms, an OAB Symptom Score >5 with urgency subscore ≥2, and who meet safety criteria may be eligible.

Not a fit: Women whose urinary symptoms are primarily stress incontinence, who have significant pelvic organ prolapse, active urinary tract infection, uncontrolled diabetes, certain neurologic conditions, recent pelvic surgery, or contraindications to the study drugs are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could offer an alternative daily medication that reduces urgency and frequency with a different side-effect profile than current antimuscarinic treatments.

How similar studies have performed: Some smaller studies and data on PDE5 inhibitors for lower urinary tract symptoms suggest potential benefit, but large randomized comparisons with antimuscarinics in women are limited.

Eligibility criteria

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.

Where this trial is running

Shibīn al Kawm, Al-Minūfiyyah and 13 other locations

• Faculty of medicine, Menofia Univeristy — Shibīn al Kawm, Al-Minūfiyyah, Egypt (Recruiting)
• Faculty of medicine, Zagazig University — Zagazig, Al-Sharqia, Egypt (Recruiting)
• Urology and Nephrology Center, Mansoura University — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
• Faculty of medicine, Tanta University — Tanta, Gharbia Governorate, Egypt (Recruiting)
• faulty of medicine, Tanta Univeristy — Tanta, Gharbia Governorate, Egypt (Recruiting)
• Faculty of medicine, minia university — Al Minyā, Egypt (Recruiting)
• Faculty of medicine, Alexandria University — Alexandria, Egypt (Recruiting)
• Faculty of medicine, Aswan university — Aswān, Egypt (Recruiting)
• Faculty of Medicine - Assiut University — Asyut, Egypt (Recruiting)
• Faculty of Medicine - Banī Suwayf University — Banī Suwayf, Egypt (Recruiting)
• Faculty of medicine, Ain Shams University — Cairo, Egypt (Recruiting)
• Cairo University, faculty of medicine — Cairo, Egypt (Recruiting)
• Faculty of Medicine, South Valley University — Qina, Egypt (Recruiting)
• Faculty of medicine, Sohag Univeristy — Sohag, Egypt (Recruiting)

Study contacts

• Study coordinator: Mohammed Hegazy, M.D of Urology

Conditions Overactive Bladder; Overactive Bladder Syndrome; OAB; Tadalafil; Solifenacin; Low dose tadalafil; Urgency; frequency