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

February 17, 2026 updated by: Mansoura University

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:

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohammed Hegazy, M.D of Urology
  • Phone Number: +201028299216
  • Email: mhalem88@yahoo.com

Study Locations

  • Egypt
      • Al Minyā, Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of medicine, Alexandria University
        • Contact:
        • Principal Investigator:
          • Wally Mahfouz
      • Aswān, Egypt
      • Asyut, Egypt
        • Recruiting
        • Faculty of Medicine - Assiut University
        • Contact:
      • Banī Suwayf, Egypt
        • Recruiting
        • Faculty of Medicine - Banī Suwayf University
        • Contact:
      • Cairo, Egypt, 1181
        • Recruiting
        • Faculty of Medicine, Ain Shams University
        • Contact:
        • Principal Investigator:
          • Sherif Mourad, professor of urology
        • Sub-Investigator:
          • Abdelrahman nazmy Hatata
      • Cairo, Egypt, 1211
        • Recruiting
        • Cairo University, faculty of medicine
        • Contact:
      • Qina, Egypt
        • Recruiting
        • Faculty of Medicine, South Valley University
        • Principal Investigator:
          • Mostafa Abdelrazek
      • Sohag, Egypt
        • Recruiting
        • Faculty of medicine, Sohag Univeristy
        • Contact:
    • Al-Minūfiyyah
      • Shibīn al Kawm, Al-Minūfiyyah, Egypt
    • Al-Sharqia
      • Zagazig, Al-Sharqia, Egypt
        • Recruiting
        • Faculty of Medicine, Zagazig University
        • Contact:
        • Principal Investigator:
          • Kareem M Taha
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt, 35516
        • Recruiting
        • Urology and Nephrology center, Mansoura University
        • Principal Investigator:
          • Mohammed Hegazy, MD of urology
        • Sub-Investigator:
          • Yahya H Elmorsy, MSc of Urology
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt
        • Recruiting
        • Faculty of medicine, Tanta University
        • Contact:
        • Principal Investigator:
          • Mohammed Elkhashab
      • Tanta, Gharbia Governorate, Egypt
        • Recruiting
        • faulty of medicine, Tanta Univeristy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Collaborators

Zagazig University
Alexandria University
Cairo University
Assiut University
Ain Shams University
Sohag University
Menoufia University
Beni-Suef University
Tanta University
South Valley University
Minia University
Aswan University

Investigators

  • Study Director: Ahmed A Shokeir, professor of urology, Urology & Nephrology Center, Masnoura university, Egypt
  • Study Chair: Sherif Mourad, Professor of Urology, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.25.08.3317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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