Lower Urinary Tract SymptomsPhase 3NCT06114979
Silodosin vs Placebo in the Treatment of Female LUTS
A Phase 3 study testing Silodosin in people with Lower Urinary Tract Symptoms, run by Mansoura University.
Trial summary
This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Silodosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Dec 2024
- 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 21 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females complaining of lower urinary tract symptoms
- IPSS ≥ 8 or OAB - V8 score ≥ 8
Who cannot join
- Patients with documented hypersensitivity to Silodosin.
- Patients receiving alpha blockers or anticholinergic medications for any other reason.
- Patients with history of orthostatic hypotension.
- Pregnant or breastfeeding females.
- Patients with stress urinary incontinence.
- Patients with active urinary tract infection.
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- History of previous pelvic surgery or radiation.
- Patient with diabetes mellitus.
- Patients diagnosed with bladder cancer.
- Patients with hepatic impairment (Child-Pugh score >9).
- Patients with severe renal impairment with creatinine clearance of less than 10 mL/min.
- Patients planned to undergo any ophthalmic procedure.
- Patients with history of urinary retention or gastric retention.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial
This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.
Read the detailed description
The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Silodosin, Placebo
- Keywords
- Silodosin, LUTS, Female
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Each patient will receive 8 mg of silodosin tablet once daily.
PlaceboDrug
Each patient will receive placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Silodosin | Active comparator | Patients will receive 8 mg of Silodosin tablet once daily. Receives: Drug: Silodosin |
| Placebo | Placebo comparator | Patients will receive placebo pill once daily, Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score
International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome.
Measured: 8 weeks
Overactive Bladder Validated 8-question
Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome.
Measured: 8 weeks
Secondary outcomes (2)
Uroflometry
Voided volume , Maximum flow, Voiding time, Post void residual
Measured: 8 weeks
Adverse events
Side effects of the treatment will be recorded
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Amiri Hospital
- Responsible party
- Sponsor
- Investigators
- Tariq F AL-Shaiji, MD, Principal investigator, Amiri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114979
- Sponsor's protocol ID
- Silodosin for female LUTS
- Other IDs
- 937/2018
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silodosin vs Placebo in the Treatment of Female Lower Urinary Tract Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06114979
- Acronym / sponsor ID
- Silodosin for female LUTS
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Silodosin, LUTS, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Amiri Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Nov 2023 (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.
This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.
Detailed description
The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silodosin | Active comparator | Drug: SilodosinPatients will receive 8 mg of Silodosin tablet once daily. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive placebo pill once daily, |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females complaining of lower urinary tract symptoms
- IPSS ≥ 8 or OAB - V8 score ≥ 8
Key exclusion criteria (13 listed)
- Patients with documented hypersensitivity to Silodosin.
- Patients receiving alpha blockers or anticholinergic medications for any other reason.
- Patients with history of orthostatic hypotension.
- Pregnant or breastfeeding females.
- Patients with stress urinary incontinence.
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 |
|---|---|---|
| SilodosinEach patient will receive 8 mg of silodosin tablet once daily. | Drug | Silodosin |
| PlaceboEach patient will receive placebo tablet. | Drug | Placebo |
Primary outcome
International Prostate Symptom Score
Time frame: 8 weeks
International Prostate Symptom Score will be recorded for each patient. The score ranged between 7 and 35. Higher scores means worse outcome.
Overactive Bladder Validated 8-question
Time frame: 8 weeks
Overactive Bladder Validated 8-question will be recorded for each patient. The score ranged between 2 and 42. Higher scores means worse outcome.
2 secondary outcomes
Uroflometry
Time frame: 8 weeks
Adverse events
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- 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.
Tariq F AL-Shaiji, MD principal investigator
Amiri Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silodosin in people with Lower Urinary Tract Symptoms, run by Mansoura University.
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 2 inclusion and 13 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 2 Nov 2023. 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. 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 Majd Alkabbani, MD (0097450322671, majd.qabbani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 2 Nov 2023.