Management of OAB in Female Patients .

NCT06184334 | Completed

• 1 other identifier: OAB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group A : patients will receive mirabegron

ACTIVE COMPARATOR

patients will receive mirabegron

Drug: Mirabegron

Group B: patients will receive tadalafil 5mg

ACTIVE COMPARATOR

patients will receive tadalafil 5mg

Drug: Tadalafil 5mg

Group C: patients will receive solfenacin

ACTIVE COMPARATOR

patients will receive solfenacin

Drug: Solfenacin

Interventions

Solfenacin DRUG

pills taken once day

Group C: patients will receive solfenacin

Mirabegron DRUG

pills taken once day

Group A : patients will receive mirabegron

Tadalafil 5mg DRUG

pills taken once day

Group B: patients will receive tadalafil 5mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 18 to 65 years of age with LUTs due to OAB

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsayed Abdelhalim Elsayed: lead

Study Sites (1)

Kafrelsheikh University hospital

Kafr ash Shaykh, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

mirabegron; Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer, urology department, Kafrelsheikh university

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: September 14, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

EG (1)