An interventional study of Solifenacin and Tadalafil in Overactive Bladder, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Overactive bladder (OAB) is characterized by urinary urgency with or without urge urinary incontinence, usually with frequency and nocturia, in the absence of urinary tract infection or other obvious pathology. Antimuscarinic agents such as solifenacin are commonly used but may provide incomplete symptom control. Tadalafil (a Phosphodiesterase type 5 inhibitorsinhibitor) has been reported to improve lower urinary tract symptoms and may offer additional benefit in overactive bladder. This randomized controlled trial evaluates the efficacy and tolerability of solifenacin 5 mg plus tadalafil 5 mg versus solifenacin 5 mg alone in females with overactive bladder using the Overactive Bladder Symptom Score (OABSS).
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Solifenacin (oral tablet) 5 mg once daily for 3 months.
Drug: Solifenacin
Solifenacin (oral tablet) 5 mg once daily plus tadalafil (oral tablet) 5 mg once daily for 3 months.
Drug: Tadalafil
Solifenacin 5 mg oral tablet, once daily for 3 months.
Tadalafil 5 mg oral tablet, once daily for 3 months.
Change in total Overactive Bladder Symptom Score (OABSS) at 1 month
Difference in total OABSS (sum of frequency, nocturia, urgency, and urge incontinence domain scores; higher scores indicate worse symptoms) from baseline to 1 month.
Time frame: Baseline and 1 month
Change in total Overactive Bladder Symptom Score (OABSS) at 3 months
Difference in total OABSS from baseline to 3 months.
Time frame: Baseline and 3 months
Incidence of adverse effects (tolerability)
Number and percentage of participants reporting adverse effects during the treatment period.
Time frame: Up to 3 months
Plan to share: Yes — De-identified individual participant data (IPD) underlying the reported results (including OABSS total and domain scores and adverse event data) and a data dictionary will be made available to qualified researchers upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Beginning after publication of the primary results (or thesis acceptance) and available for (e.g., 5 years).
Access criteria: Requests should include a brief proposal and analysis plan. Access will be provided after review and approval by the study investigators/department and execution of a data use agreement. Data will be shared in a secure format.
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Nov 2025, 6 months.
Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 6 months is below that.
Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tadalafil