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Recruiting NCT07416968

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

Phase IV Interventional Overactive Bladder (OAB) Overactive Bladder Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tadalafil 5 mg, Solifenacin 5mg.
Who it may be relevant to
Registry conditions: Overactive Bladder (OAB), Overactive Bladder Syndrome. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Tadalafil 5 mg
    Tadalafil 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

Primary outcome measures

  • Overactive Bladder Symptom Score percentage reduction [Time frame: from enrollment to 12 weeks]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Egypt · 14 centers
  • Faculty of medicine, Menofia Univeristy — Shibīn al Kawm
  • Faculty of medicine, Zagazig University — Zagazig
  • Urology and Nephrology Center, Mansoura University — Al Mansurah
  • Faculty of medicine, Tanta University — Tanta
  • faulty of medicine, Tanta Univeristy — Tanta
  • Faculty of medicine, minia university — Al Minyā
  • Faculty of medicine, Alexandria University — Alexandria
  • Faculty of medicine, Aswan university — Aswān
  • … and 6 more centers

Identifiers

NCT: NCT07416968 · R.25.08.3317

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗