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Clinical Trials in Egypt / NCT07416968
Recruiting Phase 4

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

NCT07416968 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mansoura University
Phase
Phase 4
Started
2025-09-01
Last updated
2026-02-18

Condition(s) studied

Overactive Bladder (OAB)Overactive Bladder Syndrome

Investigational drug(s) / intervention(s)

Tadalafil 5 mg →Solifenacin 5mg →

Tadalafil 5 mg: Tadalafil 5 mg orally once daily for the duration of 12 weeks

Solifenacin 5mg: solifenacin succinate 5 mg orally once daily for the duration of 12 weeks

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Faculty of medicine, Menofia Univeristy Shibīn al Kawm Al-Minūfiyyah Recruiting
Faculty of medicine, Zagazig University Zagazig Al-Sharqia Recruiting
Urology and Nephrology Center, Mansoura University Al Mansurah Dakahlia Governorate Recruiting
Faculty of medicine, Tanta University Tanta Gharbia Governorate Recruiting
faulty of medicine, Tanta Univeristy Tanta Gharbia Governorate 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

More Mansoura University trials in Egypt

Evaluation of Dentoalveolar Changes of Clear Aligners Versus Fixed Orthodontic Appliances on Skeletal Class I Non-extraction Patients With Dental Crowding Active, not recruiting
Effect of AV Distraction and Acuapoint Stimulation in Pediatric Extraction on Pain and Anxiety Enrolling by invitation
Stone Heterogeneity Index and Shock Wave Lithotripsy Outcomes in Pediatrics Active, not recruiting
Impact of a Mobile Application-Based Medication Reminder on Treatment Adherence Among Patients With Chronic Diseases and Memory Impairment: A Nursing Leadership Perspective Recruiting
Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women Recruiting

Other trials for the same condition

Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women Recruiting
Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07416968 on ClinicalTrials.gov ↗ ← All trials in Egypt