Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

Ain Shams University

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: Solifenacin; Drug: Tadalafil

Study type: Interventional

Funder types: Other

Identifiers

NCT07312955

FMASU MS 386/2025

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Solifenacin 5 mg Alone

Active Comparator group

Description:

Solifenacin (oral tablet) 5 mg once daily for 3 months.

Treatment:

Drug: Solifenacin

Solifenacin 5 mg + Tadalafil 5 mg

Experimental group

Description:

Solifenacin (oral tablet) 5 mg once daily plus tadalafil (oral tablet) 5 mg once daily for 3 months.

Treatment:

Drug: Tadalafil