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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
Tadalafil 5 mg orally once daily for the duration of 12 weeks
solifenacin succinate 5 mg orally once daily for the duration of 12 weeks
Faculty of medicine, Menofia Univeristy
Shibīn al Kawm, Al-Minūfiyyah, Egypt
RECRUITINGFaculty of medicine, Zagazig University
Zagazig, Al-Sharqia, Egypt
RECRUITINGUrology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGFaculty of medicine, Tanta University
Tanta, Gharbia Governorate, Egypt
RECRUITINGfaulty of medicine, Tanta Univeristy
Tanta, Gharbia Governorate, Egypt
RECRUITINGFaculty of medicine, minia university
Al Minyā, Egypt
RECRUITINGFaculty of medicine, Alexandria University
Alexandria, Egypt
RECRUITINGFaculty of medicine, Aswan university
Aswān, Egypt
RECRUITINGFaculty of Medicine - Assiut University
Asyut, Egypt
RECRUITINGFaculty of Medicine - Banī Suwayf University
Banī Suwayf, Egypt
RECRUITING...and 4 more locations
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
Time frame: from enrollment to 12 weeks
Changes in frequnecy episodes in three-day voiding diary
Changes in the mean number of voiding episodes per days as measure by a self administered three-day urinary 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
self administered questionnaire with minimum score of 0 and maximum score of 21, the higher score, the worse the symptoms
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
changes in Overactive bladder quality of life questionnaire (ICIQ-OABqol)
elf administered questionnaire with minimum score of 25 and maximum score of 160 , higher score indicated worse effect on the quality of life
Time frame: All follow up visits at 4, 8, and 12 weeks
Changes in number of nocturia episodes on three-day urinary diary
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
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
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
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
Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary
Time frame: from enrollment to follow up visits at 4,8 and 12 weeks
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