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Clinical Trials/NCT06184334
NCT06184334CompletedNot Applicable

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

Elsayed Abdelhalim Elsayed1 site in 1 country300 target enrollmentStarted: September 14, 2022Last updated:
Conditions
Interventions

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

Active Comparator

patients will receive mirabegron

Intervention: Mirabegron (Drug)

Group B: patients will receive tadalafil 5mg

Active Comparator

patients will receive tadalafil 5mg

Intervention: Tadalafil 5mg (Drug)

Group C: patients will receive solfenacin

Active Comparator

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

Sponsor
Elsayed Abdelhalim Elsayed
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Elsayed Abdelhalim Elsayed

assistant lecturer, urology department, Kafrelsheikh university

Kafrelsheikh University

Study Sites (1)

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