NCT07416968 Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study
| NCT ID | NCT07416968 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mansoura University |
| Condition | Overactive Bladder (OAB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 480 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Ahmed A Shokeir, professor of urology
STUDY DIRECTOR
Urology & Nephrology Center, Masnoura university, Egypt
Frequently Asked Questions
Who can join the NCT07416968 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Overactive Bladder (OAB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07416968 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07416968 currently recruiting?
Yes, NCT07416968 is actively recruiting participants. Contact the research team at mhalem88@yahoo.com for enrollment information.
Where is the NCT07416968 trial being conducted?
This trial is being conducted at Shibīn al Kawm, Egypt, Zagazig, Egypt, Al Mansurah, Egypt, Tanta, Egypt and 10 additional locations.
Who is sponsoring the NCT07416968 clinical trial?
NCT07416968 is sponsored by Mansoura University. The principal investigator is Ahmed A Shokeir, professor of urology at Urology & Nephrology Center, Masnoura university, Egypt. The trial plans to enroll 480 participants.