NCT04511273

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1 month

First QC Date

August 8, 2020

Last Update Submit

August 10, 2020

Conditions

Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence

Outcome Measures

Primary Outcomes (1)

  • Sexual function evaluation after 6 months

    Sexual function evaluation using female sexual function index FSFI

    6 months

Interventions

Follow up of female sexual functionDRUG

Mirabegron 50mg once daily for treatment of overactive bladder symptoms

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females with overactive bladder symptoms

You may qualify if:

  • any female with overactive bladder symptoms, urgency and urgency incontinence

You may not qualify if:

  • neurologic abnormalities
  • Weak bladder contractility
  • Diabetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Samer Morsy

CONTACT

01000908851Samermorsy1@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology Consultant

Study Record Dates

First Submitted

August 8, 2020

First Posted

August 13, 2020

Study Start

September 1, 2020

Primary Completion

October 1, 2020

Study Completion

April 1, 2021

Last Updated

August 13, 2020

Record last verified: 2020-08