Urinary Incontinence Clinical Trials

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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Urology and Nephrology Center, Mansoura University
RECRUITING
Al Mansurah
Faculty of medicine, minia university
RECRUITING
Al Minyā
Faculty of medicine, Alexandria University
RECRUITING
Alexandria
Faculty of medicine, Aswan university
RECRUITING
Aswān
Faculty of Medicine - Assiut University
RECRUITING
Asyut
Faculty of Medicine - Banī Suwayf University
RECRUITING
Banī Suwayf
Cairo University, faculty of medicine
RECRUITING
Cairo
Faculty of medicine, Ain Shams University
RECRUITING
Cairo
Faculty of Medicine, South Valley University
RECRUITING
Qina
Faculty of medicine, Menofia Univeristy
RECRUITING
Shibīn Al Kawm
Faculty of medicine, Sohag Univeristy
RECRUITING
Sohag
Faculty of medicine, Tanta University
RECRUITING
Tanta
faulty of medicine, Tanta Univeristy
RECRUITING
Tanta
Faculty of medicine, Zagazig University
RECRUITING
Zagazig
Contact Information
Primary
Mohammed Hegazy, M.D of Urology
mhalem88@yahoo.com
+201028299216
Backup
Yahya H ElMorsy, MSc of Urology
hossam.yahya@yahoo.com
+201100311999
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 480
Treatments
Experimental: Group 1, Low dose Tadalafil group
Participants will receive 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
Related Therapeutic Areas
Sponsors
Collaborators: Beni-Suef University, Aswan University, Cairo University, Sohag University, Menoufia University, Ain Shams University, Zagazig University, Assiut University, Tanta University, Alexandria University, Minia University, South Valley University
Leads: Mansoura University

This content was sourced from clinicaltrials.gov