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Clinical trial Recruiting at 14 sites Phase 4 Interventional Ages 18 to 75 Women only

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

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

Run by Mansoura University · NCT07416968 · Data updated 2026-11-12

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

More Overactive Bladder (OAB) trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 75 Years
SexWomen only
Enrollment480 (estimated)
SponsorMansoura University
Academic / other
Drugs / interventionsradiation
Locations14 sites (Shibīn al Kawm, Al-Minūfiyyah and 13 other locations)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedSeptember 2026
Study endsDecember 2026
Registry record updatedFebruary 18, 2026
Trial IDNCT07416968 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
Show 8 more locations
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.