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NCT Number: NCT07416968

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

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.

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Key information

Conditions

Overactive Bladder (OAB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil 5 mg

Drug

Tadalafil 5 mg orally once daily for the duration of 12 weeks

Solifenacin 5mg

Drug

solifenacin succinate 5 mg orally once daily for the duration of 12 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Hegazy, M.D of Urology

CONTACT

[email protected]

+201028299216

Yahya H ElMorsy, MSc of Urology

CONTACT

[email protected]

+201100311999

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: WoMEN'S

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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