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.
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.
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.
Parallel
Tadalafil 5 mg
DrugTadalafil 5 mg orally once daily for the duration of 12 weeks
Solifenacin 5mg
Drugsolifenacin succinate 5 mg orally once daily for the duration of 12 weeks
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
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
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
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
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
Click on the lead sponsor to view all of their trials.
Mansoura University
Lead sponsor
Cairo University
Collaborator
Ain Shams University
Collaborator
Alexandria University
Collaborator
Zagazig University
Collaborator
Tanta University
Collaborator
Menoufia University
Collaborator
Assiut University
Collaborator
Sohag University
Collaborator
South Valley University
Collaborator
Beni-Suef University
Collaborator
Minia University
Collaborator
Aswan University
Collaborator
