Overactive BladderNCT07312955
Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females
A study testing Solifenacin and Tadalafil in people with Overactive Bladder, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin and Tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Hospital (Urology Department)
Cairo, Cairo Governorate, 11511
About this study
Official title: 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).
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin, Tadalafil
- Keywords
- Overactive bladder, Urinary urgency, Urinary frequency, Nocturia, Urge urinary incontinence, Solifenacin, Tadalafil, Antimuscarinic agents, Phosphodiesterase 5 inhibitors, Overactive Bladder Symptom Score, Women, Females
- Medical subject headings
- Urinary Bladder, Overactive, Nocturia, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolifenacinDrug
Solifenacin 5 mg oral tablet, once daily for 3 months.
TadalafilDrug
Tadalafil 5 mg oral tablet, once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin 5 mg Alone | Active comparator | Solifenacin (oral tablet) 5 mg once daily for 3 months. Receives: 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. Receives: Drug: Tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1 month
Secondary outcomes (2)
Change in total Overactive Bladder Symptom Score (OABSS) at 3 months
Difference in total OABSS from baseline to 3 months.
Measured: Baseline and 3 months
Incidence of adverse effects (tolerability)
Number and percentage of participants reporting adverse effects during the treatment period.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 May 2025
- Primary completion15 Nov 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to receive solifenacin 5 mg alone or solifenacin 5 mg plus tadalafil 5 mg for 3 months.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sabbah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312955
- Sponsor's protocol ID
- FMASU MS 386/2025
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combination of Solifenacin and Tadalafil Versus Solifenacin Alone in Treatment of Overactive Bladder in Females
- ClinicalTrials.gov ID
- NCT07312955
- Acronym / sponsor ID
- FMASU MS 386/2025
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Urinary urgency, Urinary frequency, Nocturia, Urge urinary incontinence, Solifenacin, Tadalafil, Antimuscarinic agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to receive solifenacin 5 mg alone or solifenacin 5 mg plus tadalafil 5 mg for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Solifenacin 5 mg Alone | Active comparator | Drug: SolifenacinSolifenacin (oral tablet) 5 mg once daily for 3 months. |
| Solifenacin 5 mg + Tadalafil 5 mg | Experimental | Drug: TadalafilSolifenacin (oral tablet) 5 mg once daily plus tadalafil (oral tablet) 5 mg once daily for 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SolifenacinSolifenacin 5 mg oral tablet, once daily for 3 months. | Drug | Solifenacin 5 mg Alone |
| TadalafilTadalafil 5 mg oral tablet, once daily for 3 months. | Drug | Solifenacin 5 mg + Tadalafil 5 mg |
Primary outcome
Change in total Overactive Bladder Symptom Score (OABSS) at 1 month
Time frame: 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.
2 secondary outcomes
Change in total Overactive Bladder Symptom Score (OABSS) at 3 months
Time frame: Baseline and 3 months
Incidence of adverse effects (tolerability)
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solifenacin and Tadalafil in people with Overactive Bladder, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total Overactive Bladder Symptom Score (OABSS) at 1 month (time frame: Baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.