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WoMEN'S: Low Dose Tadalafil vs Solifenacin for OAB in Women
NCT07416968Phase 4
Key facts
- Status
- Recruiting
- Start
- Sep 2025
- Primary completion
- Sep 2026
- Countries
- 1
- Sponsor
- Mansoura University
- Modality
- Small Molecules
- Drugs
- tadalafil
- Conditions
- overactive bladder (OAB)
01
Overview
Phase 4, randomised trial of tadalafil in overactive bladder (OAB) (2 arms), sponsored by Mansoura University. Primary endpoint: Overactive Bladder Symptom Score percentage reduction at 12 weeks. Started Sep 2025; status: recruiting.
02
Design
2 arms- Study design
- Randomized
Group 1, Low dose Tadalafil group
Group 2: Solifenacin Group
03
Who it enrols
Women aged 18-75 with OAB symptoms for >=3 months, OABSS > 5, and urgency sub-score >= 2. Excludes those with active UTI, stress urinary incontinence, pelvic organ prolapse >= stage II, uncontrolled diabetes, or history of pelvic radiation/surgery.
04
Endpoints
Primary
Overactive Bladder Symptom Score percentage reduction
Secondary
Changes in frequency episodes in three-day voiding diary
International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form score
Overactive bladder quality of life questionnaire
Changes in number of nocturia episodes on three-day urinary diary
Changes in number of urgency episodes on three-day urinary diary
Changes in number of incontinence episodes on three-day voiding diary
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