Overactive Bladder (OAB)Phase 4WoMEN'SNCT07416968
Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study
A Phase 4 study testing Tadalafil 5 mg and Solifenacin 5mg in people with Overactive Bladder (OAB) and Overactive Bladder Syndrome, run by Mansoura University at 14 sites in Egypt.
Trial summary
Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Overactive Bladder (OAB), Overactive Bladder Syndrome
- What is being tested?
- Tadalafil 5 mg and Solifenacin 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 14 sitesEgypt
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OAB symptoms persisting for ≥3 months
- OAB Symptom Score (OABSS) > 5 and urgency sub-score of OABSS ≥ 2
- Ability and willingness to provide informed consent.
Who cannot join
- Active urinary tract infection.
- Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI
- Pelvic organ prolapse stage ≥II according to POP-Q system.
- History of pelvic radiation.
- History of neurosurgical interventions.
- Pregnancy or breastfeeding.
Show all 16Show fewer
- Neuropathic diseases affecting the lower urinary tract.
- History of genitourinary malignancy.
- Post-void residual urine (PVR) > 150 ml.
- Vesical or lower ureteric stones.
- Uncontrolled diabetes mellitus (HbA1c > 7).
- Any psychological or psychiatric disorders.
- Contraindications or allergy to the used medications.
- History of surgeries in the urinary bladder.
- History of pelvic surgeries within 6 months.
- Voiding dysfunctions.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Egypt14 sites, 14 recruiting
- Recruiting
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Mohammed Hegazy, MD of urology
Yahya H Elmorsy, MSc of Urology
- Recruiting
Faculty of medicine, minia university
Al Minyā
Mohammed Hussein Qassem, 00201033131812, uromohamedhussein1987@gmail.com
- Recruiting
Faculty of medicine, Alexandria University
Alexandria
Wally Mahfouz, 00201119671666, wallymahfouz77@gmail.com
Wally Mahfouz
- Recruiting
Faculty of medicine, Aswan university
Aswān
Ahmed Salaheldein, 00201100299002, ahmed.salaheldien@aswan.edu.eg
- Recruiting
Faculty of Medicine - Assiut University
Asyut
Hassan A Aboullela, Professor of Urology, 00201063010777, h_a_aboulella@yahoo.com
- Recruiting
Faculty of Medicine - Banī Suwayf University
Banī Suwayf
AlMoatasem Adel Albadawy, 00201148019617, mo3tasemadel@gmail.com
- Recruiting
Faculty of medicine, Ain Shams University
Cairo, 1181
Sheirf Mourad, Professor of Urology, 00201005355353, msmourad@icloud.com
Sherif Mourad, professor of urology
- Recruiting
Cairo University, faculty of medicine
Cairo, 1211
Hussein Aly Hussein, Professor of Urology, 00201001422396, Husseinaly@kasralainy.edu.eg
- Recruiting
Faculty of Medicine, South Valley University
Qina
Mostafa Abdelrazek
- Recruiting
Faculty of medicine, Menofia Univeristy
Shibīn al Kawm, Al-Minūfiyyah
Ahmed Barsim, 00201096024446, ahmed.barsim@med.menofia.edu.eg
- Recruiting
Faculty of medicine, Sohag Univeristy
Sohag
Ahmed Mamdouh Abdelhamed, 00201068056074, sharkawiahmed@yahoo.com
- Recruiting
Faculty of medicine, Tanta University
Tanta, Gharbia Governorate
Mohamed Elkhashab, 01093131911, Dr_m_elkhashab@yahoo.com
Mohammed Elkhashab
- Recruiting
faulty of medicine, Tanta Univeristy
Tanta, Gharbia Governorate
Mohammed Medhat Elkhashab, 00201093131911, Dr_m_Elkhashab@yahoo.com
- Recruiting
Faculty of medicine, Zagazig University
Zagazig, Al-Sharqia
Kareem M Taha, 00201220565349, K_m_t83@yahoo.com
Kareem M Taha
About this study
Official title: Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)
Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage.
Women who join the study will be randomly placed into one of two groups:
Read more
One group will take tadalafil (5 mg), a medicine taken once a day.
The other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day.
The study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits.
The main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects.
Women aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.
- Being tested
- Tadalafil 5 mg, Solifenacin 5mg
- Keywords
- Overactive Bladder, OAB, Tadalafil, Solifenacin, Low dose tadalafil, Urgency, frequency, Urge Urinary Incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5 mgDrug
Tadalafil 5 mg orally once daily for the duration of 12 weeks
Solifenacin 5mgDrug
solifenacin succinate 5 mg orally once daily for the duration of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1, Low dose Tadalafil group | Experimental | Participants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks Receives: Drug: Tadalafil 5 mg |
| Group 2: Solifenacin Group | Active comparator | Participants will receive solifenacin succinate 5 mg orally once daily for the duration of 12 weeks Receives: Drug: Solifenacin 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Symptom Score percentage reduction
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms. Three points reduction in the total OABSS is determined as the minimal threshold for a meaningful change
Measured: from enrollment to 12 weeks
Secondary outcomes (6)
Changes in frequnecy episodes in three-day voiding diary
Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary diary
Measured: from enrollment to follow up visits at 4,8 and 12 weeks
changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score
self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms
Measured: from enrollment to follow up visits at 4,8 and 12 weeks
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)
elf administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life
Measured: All follow up visits at 4, 8, and 12 weeks
Changes in number of nocturia episodes on three-day urinary diary
changes in the mean number of nocturia episodes per night(waking up in the middle of the night to void) as measured by a self-administered three-day voiding diary
Measured: from enrollment to follow up visits at 4,8 and 12 weeks
Changes in number of urgency episodes on three-day urinary diary
Changes in the mean number of urgency episodes per day (strong desire to void that cannot be postponed or withheld) as measured by a self administered three-day voiding diary
Measured: from enrollment to follow up visits at 4,8 and 12 weeks
Changes in number of incontinence episodes on three-day voiding diary
Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary
Measured: from enrollment to follow up visits at 4,8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Ain Shams University, Alexandria University, Zagazig University, Tanta University, Menoufia University, Assiut University, Sohag University, South Valley University, Beni-Suef University, Minia University, Aswan University
- Responsible party
- Sponsor
- Investigators
- Ahmed A Shokeir, professor of urology, Study director, Urology & Nephrology Center, Masnoura university, EgyptSherif Mourad, Professor of Urology, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416968
- Sponsor's protocol ID
- R.25.08.3317
- Acronym
- WoMEN'S
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)
- ClinicalTrials.gov ID
- NCT07416968
- Acronym / sponsor ID
- WoMEN'S / R.25.08.3317
- Keywords
- Overactive Bladder, OAB, Tadalafil, Solifenacin, Low dose tadalafil, Urgency, frequency, Urge Urinary Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Ain Shams University, Alexandria University, Zagazig University, Tanta University, Menoufia University, Assiut University, Sohag University, South Valley University, Beni-Suef University, Minia University, Aswan University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (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.
Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage.
Women who join the study will be randomly placed into one of two groups:
One group will take tadalafil (5 mg), a medicine taken once a day.
The other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day.
The study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits.
The main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects.
Women aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, Low dose Tadalafil group | Experimental | Drug: Tadalafil 5 mgParticipants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks |
| Group 2: Solifenacin Group | Active comparator | Drug: Solifenacin 5mgParticipants will receive solifenacin succinate 5 mg orally once daily for the duration of 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OAB symptoms persisting for ≥3 months
- OAB Symptom Score (OABSS) > 5 and urgency sub-score of OABSS ≥ 2
- Ability and willingness to provide informed consent.
Key exclusion criteria (16 listed)
- Active urinary tract infection.
- Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI
- Pelvic organ prolapse stage ≥II according to POP-Q system.
- History of pelvic radiation.
- History of neurosurgical interventions.
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 |
|---|---|---|
| Tadalafil 5 mgTadalafil 5 mg orally once daily for the duration of 12 weeks | Drug | Group 1, Low dose Tadalafil group |
| Solifenacin 5mgsolifenacin succinate 5 mg orally once daily for the duration of 12 weeks | Drug | Group 2: Solifenacin Group |
Primary outcome
Overactive Bladder Symptom Score percentage reduction
Time frame: from enrollment to 12 weeks
self administered questionnaire with minimum score of 0 and maximum score of 15, higher score means worse symptoms. Three points reduction in the total OABSS is determined as the minimal threshold for a meaningful change
6 secondary outcomes
Changes in frequnecy episodes in three-day voiding diary
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
changes in International Consultation on Incontinence Questionnaire- Urinary Incontinence-Short Form (ICIQ-UI-SF) score
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)
Time frame: All follow up visits at 4, 8, and 12 weeks
Changes in number of nocturia episodes on three-day urinary diary
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
Changes in number of urgency episodes on three-day urinary diary
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
Changes in number of incontinence episodes on three-day voiding diary
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Overactive Bladder (OAB)
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
RecruitingPhase 2
RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder
Overactive Bladder (OAB)
Recruiting
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
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
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
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.
Ahmed A Shokeir, professor of urology study director
Urology & Nephrology Center, Masnoura university, Egypt
Sherif Mourad, Professor of Urology study chair
Ain Shams University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil 5 mg and Solifenacin 5mg in people with Overactive Bladder (OAB) and Overactive Bladder Syndrome, run by Mansoura University at 14 sites 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hegazy, M.D of Urology (+201028299216, mhalem88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overactive Bladder Symptom Score percentage reduction (time frame: from enrollment to 12 weeks). 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 18 Feb 2026.