Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Ove… (NCT07416968) | Clinical Trial Compass
RecruitingPhase 4
Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study
Egypt480 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.