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OpenTrials
Completed

NCT Number: NCT06184334

Management of OAB in Female Patients .

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University hospital

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solfenacin

Drug

pills taken once day

Mirabegron

Drug

pills taken once day

Tadalafil 5mg

Drug

pills taken once day

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Elsayed Abdelhalim Elsayed

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 28, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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