Actively Recruiting

Phase 4
Age: 18Years - 75Years
FEMALE
NCT07416968

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

Led by Mansoura University · Updated on 2026-02-18

480

Participants Needed

14

Research Sites

65 weeks

Total Duration

On this page

Sponsors

M

Mansoura University

Lead Sponsor

C

Cairo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 75 years
  • Overactive bladder symptoms lasting at least 3 months
  • Overactive Bladder Symptom Score (OABSS) greater than 5 with urgency sub-score of 2 or more
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Active urinary tract infection
  • Primary diagnosis of stress urinary incontinence or mixed urinary incontinence with predominant stress urinary incontinence
  • Pelvic organ prolapse stage II or higher according to POP-Q system
  • History of pelvic radiation or neurosurgical interventions
  • Pregnancy or breastfeeding
  • Neuropathic diseases affecting the lower urinary tract
  • History of genitourinary malignancy
  • Post-void residual urine greater than 150 ml
  • Presence of vesical or lower ureteric stones
  • Uncontrolled diabetes mellitus (HbA1c greater than 7)
  • Any psychological or psychiatric disorders
  • Allergy or contraindications to the study medications
  • History of surgeries in the urinary bladder
  • History of pelvic surgeries within the last 6 months
  • Voiding dysfunctions

AI-Screening

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Trial Site Locations

Total: 14 locations

1

Faculty of medicine, Menofia Univeristy

Shibīn al Kawm, Al-Minūfiyyah, Egypt

Actively Recruiting

2

Faculty of medicine, Zagazig University

Zagazig, Al-Sharqia, Egypt

Actively Recruiting

3

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt, 35516

Actively Recruiting

4

Faculty of medicine, Tanta University

Tanta, Gharbia Governorate, Egypt

Actively Recruiting

5

faulty of medicine, Tanta Univeristy

Tanta, Gharbia Governorate, Egypt

Actively Recruiting

6

Faculty of medicine, minia university

Al Minyā, Egypt

Actively Recruiting

7

Faculty of medicine, Alexandria University

Alexandria, Egypt

Actively Recruiting

8

Faculty of medicine, Aswan university

Aswān, Egypt

Actively Recruiting

9

Faculty of Medicine - Assiut University

Asyut, Egypt

Actively Recruiting

10

Faculty of Medicine - Banī Suwayf University

Banī Suwayf, Egypt

Actively Recruiting

11

Faculty of medicine, Ain Shams University

Cairo, Egypt, 1181

Actively Recruiting

12

Cairo University, faculty of medicine

Cairo, Egypt, 1211

Actively Recruiting

13

Faculty of Medicine, South Valley University

Qina, Egypt

Actively Recruiting

14

Faculty of medicine, Sohag Univeristy

Sohag, Egypt

Actively Recruiting

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Research Team

M

Mohammed Hegazy, M.D of Urology

CONTACT

Y

Yahya H ElMorsy, MSc of Urology

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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