Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary IncontinencePhase 1NCT04500860
Low Dose Tadalafil for Treatment of Female OAB Syndrome: Short Term Follow up.
A Phase 1 study testing Low dose tadalafil 5 mg and Tolterodine 4 Mg Oral Capsule, Extended Release in people with Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence
- What is being tested?
- Low dose tadalafil 5 mg and Tolterodine 4 Mg Oral Capsule, Extended Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Jul 2022
- Phase
- Phase 1
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence
Who cannot join
- Active Urinary tract infection
- neurologic abnormality
- Pure Stress urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up
Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome
Read the detailed description
90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up
- Being tested
- Low dose tadalafil 5 mg, Tolterodine 4 Mg Oral Capsule, Extended Release, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose tadalafil 5 mgDrug
Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence
Tolterodine 4 Mg Oral Capsule, Extended ReleaseDrug
To compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder
PlaceboDrug
Placebo drugs
| Study group | Role | What they receive |
|---|---|---|
| Group A Tadalafil 5 mg | Active comparator | 30 patients subjected to Daily dose of tadalafil 5mg Receives: Drug: Low dose tadalafil 5 mg |
| Group B Tolterodine | Active comparator | 30 patients subjected to tolterodine 4 mg daily Receives: Drug: Tolterodine 4 Mg Oral Capsule, Extended Release |
| Group C placebo | Placebo comparator | 30 patients subjected to placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up
Evaluation of efficacy of tadalafil 5 mg
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 posted5 Aug 2020
- Study start1 Dec 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
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
- NCT04500860
- Sponsor's protocol ID
- Cairo University
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2020
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Tadalafil 5mg for Treatment of Female Overactive Bladder Syndrome :6 Months Follow up
- ClinicalTrials.gov ID
- NCT04500860
- Acronym / sponsor ID
- Cairo University
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 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.
Evaluation of use of low dose tadalafil 5 mg daily for treatment of female OAB syndrome
Detailed description
90 female patients with overactive bladder syndrome divided into 3 groups group A subjected to daily low dose tadalafil 5 mg ,group B subjected to tolterodine and group C to placebo. They are evaluated as using OAB symptoms score for 6 months follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A Tadalafil 5 mg | Active comparator | Drug: Low dose tadalafil 5 mg30 patients subjected to Daily dose of tadalafil 5mg |
| Group B Tolterodine | Active comparator | Drug: Tolterodine 4 Mg Oral Capsule, Extended Release30 patients subjected to tolterodine 4 mg daily |
| Group C placebo | Placebo comparator | Drug: Placebo30 patients subjected to placebo daily |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any female with overactive bladder syndrome, urgency with or without urgency urinary incontinence
Key exclusion criteria (3 listed)
- Active Urinary tract infection
- neurologic abnormality
- Pure 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 |
|---|---|---|
| Low dose tadalafil 5 mgEfficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence | Drug | Group A Tadalafil 5 mg |
| Tolterodine 4 Mg Oral Capsule, Extended ReleaseTo compare efficacy of low dose tadalafil 5 mg to tolterodine 4 mg extended release in treatment of female overactive bladder | Drug | Group B Tolterodine |
| PlaceboPlacebo drugs | Drug | Group C placebo |
Primary outcome
Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up
Time frame: 6 months
Evaluation of efficacy of tadalafil 5 mg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose tadalafil 5 mg and Tolterodine 4 Mg Oral Capsule, Extended Release in people with Female Patients With Overactive Bladder Syndrome or Female Patients With Urgency or Urgency Urinary Incontinence, run by Kasr El Aini Hospital 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 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: finished, as of the sponsor's last update on 15 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of daily low dose tadalafil 5mg in treatment of female overactive bladder syndrome: 6 months follow up (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 15 Aug 2022.