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

NCT07416968 | Recruiting Phase 4

• 1 other identifier: R.25.08.3317
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 14

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 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

Overactive Bladder (OAB); Overactive Bladder Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in frequnecy episodes in three-day voiding 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

  from enrollment to follow up visits at 4,8 and 12 weeks

• changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)

  All follow up visits at 4, 8, and 12 weeks

• Changes in number of nocturia episodes on three-day urinary diary

  from enrollment to follow up visits at 4,8 and 12 weeks

• Changes in number of urgency episodes on three-day urinary diary

  from enrollment to follow up visits at 4,8 and 12 weeks

Study Arms (2)

Group 1, Low dose Tadalafil group

EXPERIMENTAL

Participants will receive tadalafil 5 mg orally once daily for the duration of 12 weeks

Drug: Tadalafil 5 mg

Group 2: Solifenacin Group

ACTIVE COMPARATOR

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

Drug: Solifenacin 5mg

Interventions

Tadalafil 5 mg DRUG

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

Group 1, Low dose Tadalafil group

Solifenacin 5mg DRUG

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

Group 2: Solifenacin Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (14)

Faculty of medicine, Menofia Univeristy

Shibīn al Kawm, Al-Minūfiyyah, Egypt

RECRUITING

Faculty of medicine, Zagazig University

Zagazig, Al-Sharqia, Egypt

RECRUITING

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Faculty of medicine, Tanta University

Tanta, Gharbia Governorate, Egypt

RECRUITING

faulty of medicine, Tanta Univeristy

Tanta, Gharbia Governorate, Egypt

RECRUITING

Faculty of medicine, minia university

Al Minyā, Egypt

RECRUITING

Faculty of medicine, Alexandria University

Alexandria, Egypt

RECRUITING

Faculty of medicine, Aswan university

Aswān, Egypt

RECRUITING

Faculty of Medicine - Assiut University

Asyut, Egypt

RECRUITING

Faculty of Medicine - Banī Suwayf University

Banī Suwayf, Egypt

RECRUITING

Faculty of medicine, Ain Shams University

Cairo, 1181, Egypt

RECRUITING

Cairo University, faculty of medicine

Cairo, 1211, Egypt

RECRUITING

Faculty of Medicine, South Valley University

Qina, Egypt

RECRUITING

Faculty of medicine, Sohag Univeristy

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Tadalafil; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Tetrahydroisoquinolines; Isoquinolines

Study Officials

• Ahmed A Shokeir, professor of urology

  Urology & Nephrology Center, Masnoura university, Egypt

  STUDY DIRECTOR

• Sherif Mourad, Professor of Urology

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Mohammed Hegazy, M.D of Urology

CONTACT

+201028299216; mhalem88@yahoo.com

Yahya H ElMorsy, MSc of Urology

CONTACT

+201100311999; hossam.yahya@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: February 18, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-12

Locations

EG (14)