Females With Overactive Bladder Symptoms, Urgency & Urge IncontinenceNCT04511273
Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder
An observational study of Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence, run by Kasr El Aini Hospital.
Trial summary
80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence
- What is being tested?
- Follow up of female sexual function
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Females with overactive bladder symptoms
Who may be able to join
- any female with overactive bladder symptoms, urgency and urgency incontinence
Who cannot join
- neurologic abnormalities
- Weak bladder contractility
- Diabetics
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder ?
80 female patients evaluated for sexual function after receiving Mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms
Read the 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
- Being tested
- Follow up of female sexual function
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up of female sexual functionDrug
Mirabegron 50mg once daily for treatment of overactive bladder symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function evaluation after 6 months
Sexual function evaluation using female sexual function index FSFI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Females With Overactive Bladder Symptoms, Urgency & Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer Morsy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511273
- Sponsor's protocol ID
- Cairo University Hospitals
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Mirabegron Have a Positive Impact on Sexual Function in Females With Overactive Bladder ?
- ClinicalTrials.gov ID
- NCT04511273
- Acronym / sponsor ID
- Cairo University Hospitals
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Females with overactive bladder symptoms
Key inclusion criteria (1 listed)
- any female with overactive bladder symptoms, urgency and urgency incontinence
Key exclusion criteria (3 listed)
- neurologic abnormalities
- Weak bladder contractility
- Diabetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up of female sexual functionMirabegron 50mg once daily for treatment of overactive bladder symptoms | Drug | – |
Primary outcome
Sexual function evaluation after 6 months
Time frame: 6 months
Sexual function evaluation using female sexual function index FSFI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence, run by Kasr El Aini Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samer Morsy (01000908851, Samermorsy1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual function evaluation after 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020; AzTrials last refreshed its copy on 26 Oct 2026.