Voiding DisordersPhase 3NCT05490082
Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation
A Phase 3 study testing Mirabegron, Propevirine, Solifenacin in people with Voiding Disorders, run by Mansoura University at 1 site in Egypt.
Trial summary
A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Voiding Disorders
- What is being tested?
- Mirabegron, Propevirine, Solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to Oct 2023
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than age 18 years.
- Able to provide an informed consent.
- Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
- Persistent LUTS after intravesical BCG induction.
Who cannot join
- International Prostate symptom score (IPSS) greater than 20.
- Post-void residual (PVR) volume greater than 50 ml.
- Use of medications for overactive bladder.
- Pelvic surgery within the previous 6 months.
- Hypersensitivity for BCG or any of the above mentioned drugs.
- Tumor recurrence during follow up period.
- Other medical conditions that would be adversely affected by anticholinergics such as history of urinary retention due to BPH(Benign prostatic hyperplasia), constipation and history of narrow angle glaucoma.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Urology and Nephrology Center, Mansoura University
Al Mansurah, 35516
Bassem Wadie, MD, 0020502202222, unc@mans.edu.eg
About this study
Official title: Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial
A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation
- Conditions
- Voiding Disorders
- Being tested
- Mirabegron, Propevirine, Solifenacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron, Propevirine, SolifenacinDrug
Efficacy comparison
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron arm | Active comparator | 50 mg PO once daily Receives: Drug: Mirabegron, Propevirine, Solifenacin |
| Propevirine arm | Active comparator | 15 mg PO twice daily Receives: Drug: Mirabegron, Propevirine, Solifenacin |
| Solifenacin arm | Active comparator | 10 mg PO once daily Receives: Drug: Mirabegron, Propevirine, Solifenacin |
| Placebo arm | Placebo comparator | starch tablet once daily Receives: Drug: Mirabegron, Propevirine, Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysuria
Compare the percentage of reduction of dysuria as measured by Pain Visual Analouge Score at 3 month follow up after using propiverine, mirabegron and solifenacin versus placebo.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DisordersStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Elmenair, Mansoura University
- Investigators
- Ahmed Elhefnawy, MD, Study director, urology and nephrology center mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490082
- Sponsor's protocol ID
- MD.21.12.576
- Status last verified
- Aug 2022
- First submitted
- 30 Jun 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05490082
- Acronym / sponsor ID
- MD.21.12.576
- Conditions
- Voiding Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
A randomized controlled study to compare the efficacy of mirabegron, solifenacin and propevirine for treatment of Lower urinary tract symptoms during intravesical BCG installation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mirabegron arm | Active comparator | Drug: Mirabegron, Propevirine, Solifenacin50 mg PO once daily |
| Propevirine arm | Active comparator | Drug: Mirabegron, Propevirine, Solifenacin15 mg PO twice daily |
| Solifenacin arm | Active comparator | Drug: Mirabegron, Propevirine, Solifenacin10 mg PO once daily |
| Placebo arm | Placebo comparator | Drug: Mirabegron, Propevirine, Solifenacinstarch tablet once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than age 18 years.
- Able to provide an informed consent.
- Denovo or recurrent cases with intermediate and high risk NMIBC eligible for intravesical BCG immunotherapy.
- Persistent LUTS after intravesical BCG induction.
Key exclusion criteria (7 listed)
- International Prostate symptom score (IPSS) greater than 20.
- Post-void residual (PVR) volume greater than 50 ml.
- Use of medications for overactive bladder.
- Pelvic surgery within the previous 6 months.
- Hypersensitivity for BCG or any of the above mentioned drugs.
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 |
|---|---|---|
| Mirabegron, Propevirine, SolifenacinEfficacy comparison | Drug | Mirabegron arm, Placebo arm, Propevirine arm, Solifenacin arm |
Primary outcome
Dysuria
Time frame: 3 months
Compare the percentage of reduction of dysuria as measured by Pain Visual Analouge Score at 3 month follow up after using propiverine, mirabegron and solifenacin versus placebo.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Ahmed Elhefnawy, MD study director
urology and nephrology center mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirabegron, Propevirine, Solifenacin in people with Voiding Disorders, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 7 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 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ali Abed, MSc (002001068896788, ali.elmenair.abed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysuria (time frame: 3 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 5 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.