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Management of OAB in Female Patients .

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06184334
Enrollment
300
Registered
2023-12-28
Start date
2022-09-14
Completion date
2023-12-01
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

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.

Interventions

pills taken once day

DRUGMirabegron

pills taken once day

pills taken once day

Sponsors

Elsayed Abdelhalim Elsayed
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
overactive bladder symptoms score (OABSS)three monthsOABSS 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026