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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Solifenacin 5 mg oral tablet, once daily for 3 months.
Tadalafil 5 mg oral tablet, once daily for 3 months.
Ain Shams University Hospital (Urology Department)
Cairo, Cairo Governorate, Egypt
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
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