Efficacy of Combination of Solifenacin and Tadalafil Versus Solifenacin Alone in Treatment of Overactive Bladder in Females
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in total Overactive Bladder Symptom Score (OABSS) at 1 month
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 18 to 60 years.
- •Symptoms of overactive bladder for more than 6 months.
- •Not receiving current medical treatment for overactive bladder.
- •Normal liver function tests.
- •Normal kidney function.
Exclusion Criteria
- •Congestive heart failure or history of recent cardiovascular events.
- •Currently on medical treatment for overactive bladder.
- •Urinary tract infection (eligible only after treatment and resolution).
- •Urinary bladder stones.
- •Post-void residual urine > 100 cubic centimeter (cm³).
- •Closed-angle glaucoma or recent ocular problems.
- •Postural hypotension.
- •History of neurological disorders (e.g., parkinsonism).
- •History of intestinal obstruction.
- •Pregnancy or planning pregnancy.
- •Myasthenia gravis.
- •Severe hepatic impairment.
- •History of hypersensitivity to solifenacin or tadalafil.
Arms & Interventions
Solifenacin 5 mg Alone
Solifenacin (oral tablet) 5 mg once daily for 3 months.
Intervention: Solifenacin (Drug)
Solifenacin 5 mg + Tadalafil 5 mg
Solifenacin (oral tablet) 5 mg once daily plus tadalafil (oral tablet) 5 mg once daily for 3 months.
Intervention: Tadalafil (Drug)
Outcomes
Primary Outcomes
Change in total Overactive Bladder Symptom Score (OABSS) at 1 month
Time Frame: Baseline and 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.
Secondary Outcomes
- Change in total Overactive Bladder Symptom Score (OABSS) at 3 months(Baseline and 3 months)
- Incidence of adverse effects (tolerability)(Up to 3 months)
Investigators
Ahmed Sabbah
Resident of Urology
Ain Shams University