Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

NCT07312955 | Completed

• 1 other identifier: FMASU MS 386/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Overactive Bladder

Keywords

Overactive bladder; Urinary urgency; Urinary frequency; Nocturia; Urge urinary incontinence; Solifenacin; Tadalafil; Antimuscarinic agents; Phosphodiesterase 5 inhibitors; Overactive Bladder Symptom Score; Women; Females

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in total Overactive Bladder Symptom Score (OABSS) at 3 months

  Baseline and 3 months

• Incidence of adverse effects (tolerability)

  Up to 3 months

Study Arms (2)

Solifenacin 5 mg Alone

ACTIVE COMPARATOR

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

Drug: Solifenacin

Solifenacin 5 mg + Tadalafil 5 mg

EXPERIMENTAL

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

Drug: Tadalafil

Interventions

Solifenacin DRUG

Solifenacin 5 mg oral tablet, once daily for 3 months.

Solifenacin 5 mg Alone

Tadalafil DRUG

Tadalafil 5 mg oral tablet, once daily for 3 months.

Solifenacin 5 mg + Tadalafil 5 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital (Urology Department)

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Nocturia; Urinary Incontinence, Urge

Interventions

Solifenacin Succinate; Tadalafil

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Indole Alkaloids; Indoles; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Participants are randomized 1:1 to receive solifenacin 5 mg alone or solifenacin 5 mg plus tadalafil 5 mg for 3 months.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: May 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning after publication of the primary results (or thesis acceptance) and available for (e.g., 5 years).
• 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.

Locations

EG (1)