MedDataX Logo

Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

NCT ID: NCT07312955

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized 1:1 to receive solifenacin 5 mg alone or solifenacin 5 mg plus tadalafil 5 mg for 3 months.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Solifenacin 5 mg Alone

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

Group Type ACTIVE_COMPARATOR

Solifenacin

Intervention Type DRUG

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

Solifenacin 5 mg + Tadalafil 5 mg

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

Group Type EXPERIMENTAL

Tadalafil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Solifenacin

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

Intervention Type DRUG

Tadalafil

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Sabbah

Resident of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University Hospital (Urology Department)

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU MS 386/2025

Identifier Type: -

Identifier Source: org_study_id