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NCT06184334 Clinical Trial

Management of OAB in Female Patients .

Overactive Bladder Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06184334
Other study ID # OAB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date December 1, 2023

Study information
Verified date March 2024
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Solfenacin
pills taken once day
• Mirabegron
pills taken once day
• Tadalafil 5mg
pills taken once day

Locations
Country Name City State
Egypt Kafrelsheikh University hospital Kafr Ash Shaykh

Sponsors (1)
Lead Sponsor Collaborator
Elsayed Abdelhalim Elsayed

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary overactive bladder symptoms score (OABSS) 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. three months
See also
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Completed NCT02667470 - Reproducibility Study of OABSS and Its Response to Treatment Phase 4