Overactive Bladder
Conditions
Keywords
Overactive bladder, Urinary urgency, Urinary frequency, Nocturia, Urge urinary incontinence, Solifenacin, Tadalafil, Antimuscarinic agents, Phosphodiesterase 5 inhibitors, Overactive Bladder Symptom Score, Women, Females
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).
Interventions
DRUGSolifenacin
Solifenacin 5 mg oral tablet, once daily for 3 months.
DRUGTadalafil
Tadalafil 5 mg oral tablet, once daily for 3 months.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized 1:1 to receive solifenacin 5 mg alone or solifenacin 5 mg plus tadalafil 5 mg for 3 months.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total Overactive Bladder Symptom Score (OABSS) at 1 month | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in total Overactive Bladder Symptom Score (OABSS) at 3 months | Baseline and 3 months | Difference in total OABSS from baseline to 3 months. |
| Incidence of adverse effects (tolerability) | Up to 3 months | Number and percentage of participants reporting adverse effects during the treatment period. |
Countries
Egypt
Outcome results
None listed