Management of OAB in Female Patients .

NCT ID: NCT06184334

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A : patients will receive mirabegron

patients will receive mirabegron

Group Type ACTIVE_COMPARATOR

Mirabegron

Intervention Type DRUG

pills taken once day

Group B: patients will receive tadalafil 5mg

patients will receive tadalafil 5mg

Group Type ACTIVE_COMPARATOR

Tadalafil 5mg

Intervention Type DRUG

pills taken once day

Group C: patients will receive solfenacin

patients will receive solfenacin

Group Type ACTIVE_COMPARATOR

Solfenacin

Intervention Type DRUG

pills taken once day

Interventions

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Solfenacin

pills taken once day

Intervention Type DRUG

Mirabegron

pills taken once day

Intervention Type DRUG

Tadalafil 5mg

pills taken once day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Elsayed Abdelhalim Elsayed

OTHER

Sponsor Role lead

Responsible Party

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Elsayed Abdelhalim Elsayed

assistant lecturer, urology department, Kafrelsheikh university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kafrelsheikh University hospital

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OAB

Identifier Type: -

Identifier Source: org_study_id

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