Assessment of Efficacy of Mirabegron, Solifenacin, Tadalafil 5mg and Combination Therapy in Female Patients With Overactive Bladder: A Double Blinded Prospective Randomized Placebo -Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- overactive bladder symptoms score (OABSS)
Study Overview
Brief Summary
The objective of this study is to compare the effectiveness of mirabegron, solifenacin, tadalafil (5mg), and their combination in relieving symptoms of overactive bladder (OAB) in a double-blinded prospective randomized placebo-controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women from 18 to 65 years of age with LUTs due to OAB
Exclusion Criteria
- •Severe cardiovascular disorders. \
- •Severe neurogenic dysfunction.
- •Drug administration which interfere with bladder function .
- •Abnormal bleeding profile.
- •A verified urinary tract infection as determined by urinalysis and/or urine culture during screening
Arms & Interventions
Group A : patients will receive mirabegron
patients will receive mirabegron
Intervention: Mirabegron (Drug)
Group B: patients will receive tadalafil 5mg
patients will receive tadalafil 5mg
Intervention: Tadalafil 5mg (Drug)
Group C: patients will receive solfenacin
patients will receive solfenacin
Intervention: Solfenacin (Drug)
Outcomes
Primary Outcomes
overactive bladder symptoms score (OABSS)
Time Frame: three months
OABSS is a symptom assessment questionnaire designed to quantify OAB symptoms into a single score The questionnaire consists of 4 questions on OAB symptoms with maximum scores ranging from 2 to 5: daytime frequency (2 points), night-time frequency (3 points), urgency (5 points), and UUI (5 points). The total score ranges from 0 to 15 points, with higher scores indicating higher symptom severity.
Secondary Outcomes
No secondary outcomes reported
Investigators
Elsayed Abdelhalim Elsayed
assistant lecturer, urology department, Kafrelsheikh university
Kafrelsheikh University