Does Mirabegron Have a Positive Impact on Sexual Function... | NCT04511273

Studies
Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder

NCT04511273

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Aug 13, 2020Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence

Interventions

Follow up of female sexual function

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Estimated

Primary Completion Date

Oct 1, 2020Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Aug 8, 2020

First Submission Date that Met QC Criteria

Aug 10, 2020

First Posted Date

Aug 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2020

Last Update Posted Date

Aug 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Detailed Description

80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow up of female sexual function	Drug	Mirabegron 50mg once daily for treatment of overactive bladder symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sexual function evaluation after 6 months	Sexual function evaluation using female sexual function index FSFI	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any female with overactive bladder symptoms, urgency and urgency incontinence

Exclusion Criteria:

neurologic abnormalities
Weak bladder contractility
Diabetics

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Females with overactive bladder symptoms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samer Morsy	Contact	01000908851		Samermorsy1@gmail.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053202	Urinary Incontinence, Urge

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided