Clinical Trial Radar

Name: Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)
Creator: Mansoura University
Published: 2026-02-18
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07416968 (WoMEN'S) for Overactive Bladder (OAB), Overactive Bladder Syndrome is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S) Phase 4 480 Randomized

Recruiting

Clinical Trial NCT07416968 (WoMEN'S) is designed to study Treatment for Overactive Bladder (OAB), Overactive Bladder Syndrome. It is a Phase 4 interventional study that is recruiting, having started on September 1, 2025, with plans to enroll 480 participants. Led by Mansoura University, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on February 18, 2026.

Brief 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.

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 on...

Official Title

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)

Conditions

Overactive Bladder (OAB)Overactive Bladder Syndrome

Other Study IDs

WoMEN'S
R.25.08.3317

NCT ID Number

NCT07416968

Start Date (Actual)

2025-09-01

Last Update Posted

2026-02-18

Completion Date (Estimated)

2026-12

Enrollment (Estimated)

480

Study Type

Interventional

PHASE

Phase 4

Status

Recruiting

Keywords

Overactive Bladder
OAB
Tadalafil
Solifenacin
Low dose tadalafil
Urgency
frequency
Urge Urinary Incontinence

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

Quadruple

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalGroup 1, Low dose Tadalafil group Participants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks	Tadalafil 5 mg Tadalafil 5 mg orally once daily for the duration of 12 weeks
Active ComparatorGroup 2: Solifenacin Group Participants will receive solifenacin succinate 5 mg orally once daily for the duration of 12 weeks	Solifenacin 5mg solifenacin succinate 5 mg orally once daily for the duration of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	from enrollment to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	from enrollment to follow up visits at 4,8 and 12 weeks

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

Female

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.

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.
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.

Mansoura University

Study Central Contact

Contact: Mohammed Hegazy, M.D of Urology, +201028299216, [email protected]

Contact: Yahya H ElMorsy, MSc of Urology, +201100311999, [email protected]

14 Study Locations in 1 Countries

EGYPT

Al-Minūfiyyah

Faculty of medicine, Menofia Univeristy, Shibīn al Kawm, Al-Minūfiyyah, Egypt

Ahmed Barsim, Contact, 00201096024446, [email protected]

Recruiting

Al-Sharqia

Faculty of medicine, Zagazig University, Zagazig, Al-Sharqia, Egypt

Kareem M Taha, Contact, 00201220565349, [email protected]

Kareem M Taha, Principal Investigator

Recruiting

Dakahlia Governorate

Urology and Nephrology Center, Mansoura University, Al Mansurah, Dakahlia Governorate, 35516, Egypt

Mohammed Hegazy, MD of urology, Principal Investigator

Yahya H Elmorsy, MSc of Urology, Sub-Investigator

Recruiting

Gharbia Governorate

Faculty of medicine, Tanta University, Tanta, Gharbia Governorate, Egypt

Mohamed Elkhashab, Contact, 01093131911, [email protected]

Mohammed Elkhashab, Principal Investigator

Recruiting

faulty of medicine, Tanta Univeristy, Tanta, Gharbia Governorate, Egypt

Mohammed Medhat Elkhashab, Contact, 00201093131911, [email protected]

Recruiting

Faculty of medicine, minia university, Al Minyā, Egypt

Mohammed Hussein Qassem, Contact, 00201033131812, [email protected]

Recruiting

Faculty of medicine, Alexandria University, Alexandria, Egypt

Wally Mahfouz, Contact, 00201119671666, [email protected]

Wally Mahfouz, Principal Investigator

Recruiting

Faculty of medicine, Aswan university, Aswān, Egypt

Ahmed Salaheldein, Contact, 00201100299002, [email protected]

Recruiting

Faculty of Medicine - Assiut University, Asyut, Egypt

Hassan A Aboullela, Professor of Urology, Contact, 00201063010777, [email protected]

Recruiting

Faculty of Medicine - Banī Suwayf University, Banī Suwayf, Egypt

AlMoatasem Adel Albadawy, Contact, 00201148019617, [email protected]

Recruiting

Faculty of medicine, Ain Shams University, Cairo, 1181, Egypt

Sheirf Mourad, Professor of Urology, Contact, 00201005355353, [email protected]

Sherif Mourad, professor of urology, Principal Investigator

Abdelrahman nazmy Hatata, Sub-Investigator

Recruiting

Cairo University, faculty of medicine, Cairo, 1211, Egypt

Hussein Aly Hussein, Professor of Urology, Contact, 00201001422396, [email protected]

Recruiting

Faculty of Medicine, South Valley University, Qina, Egypt

Mostafa Abdelrazek, Principal Investigator

Recruiting

Faculty of medicine, Sohag Univeristy, Sohag, Egypt

Ahmed Mamdouh Abdelhamed, Contact, 00201068056074, [email protected]

Recruiting

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S) Phase 4 480 Randomized

Inclusion Criteria

Exclusion Criteria