Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

Efficacy of Combination of Solifenacin and Tadalafil Versus Solifenacin Alone in Treatment of Overactive Bladder in Females

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 Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Solifenacin; Drug: Tadalafil

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11511
      • Ain Shams University Hospital (Urology Department)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Solifenacin 5 mg Alone; Solifenacin (oral tablet) 5 mg once daily for 3 months.	Drug: Solifenacin; Solifenacin 5 mg oral tablet, once daily for 3 months.
Experimental: Solifenacin 5 mg + Tadalafil 5 mg; Solifenacin (oral tablet) 5 mg once daily plus tadalafil (oral tablet) 5 mg once daily for 3 months.	Drug: Tadalafil; Tadalafil 5 mg oral tablet, once daily for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total Overactive Bladder Symptom Score (OABSS) at 3 months	Difference in total OABSS from baseline to 3 months.	Baseline and 3 months
Incidence of adverse effects (tolerability)	Number and percentage of participants reporting adverse effects during the treatment period.	Up to 3 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): November 15, 2025
• Study Completion (Actual): November 15, 2025

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Women; Urge urinary incontinence; Tadalafil; Overactive bladder; Nocturia; Females; Overactive Bladder Symptom Score; Urinary urgency; Urinary frequency; Solifenacin; Phosphodiesterase 5 inhibitors; Antimuscarinic agents
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Nocturia; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indole Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 3-Ring; Carbolines; Tetrahydroisoquinolines; Isoquinolines; Quinuclidines; Tadalafil; Solifenacin Succinate
• Other Study ID Numbers: FMASU MS 386/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning after publication of the primary results (or thesis acceptance) and available for (e.g., 5 years).
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No