Overactive Bladder (OAB), Overactive Bladder Syndrome
Conditions
Keywords
Overactive Bladder, OAB, Tadalafil, Solifenacin, Low dose tadalafil, Urgency, frequency, Urge Urinary Incontinence
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.
Interventions
DRUGTadalafil 5 mg
Tadalafil 5 mg orally once daily for the duration of 12 weeks
DRUGSolifenacin 5mg
solifenacin succinate 5 mg orally once daily for the duration of 12 weeks
Sponsors
Mansoura University
Cairo University
Ain Shams University
Alexandria University
Zagazig University
Tanta University
Menoufia University
Assiut University
Sohag University
South Valley University
Beni-Suef University
Minia University
Aswan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Voiding dysfunctions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive Bladder Symptom Score percentage reduction | from enrollment to 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in frequnecy episodes in three-day voiding diary | from enrollment to follow up visits at 4,8 and 12 weeks | 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 | from enrollment to follow up visits at 4,8 and 12 weeks | 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) | All follow up visits at 4, 8, and 12 weeks | 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 | from enrollment to follow up visits at 4,8 and 12 weeks | 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 |
| Changes in number of urgency episodes on three-day urinary diary | from enrollment to follow up visits at 4,8 and 12 weeks | 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 |
| Changes in number of incontinence episodes on three-day voiding diary | from enrollment to follow up visits at 4,8 and 12 weeks | Changes in number of incontinence episodes per day (involuntary leakage of urine) as measured by a self administered three-day urinary diary |
Countries
Egypt
Contacts
CONTACTMohammed Hegazy, M.D of Urology
CONTACTYahya H ElMorsy, MSc of Urology
STUDY_DIRECTORAhmed A Shokeir, professor of urology
Urology & Nephrology Center, Masnoura university, Egypt
STUDY_CHAIRSherif Mourad, Professor of Urology
Ain Shams University
Outcome results
None listed