Overactive BladderPhase 4NCT05250245
Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome
A Phase 4 study testing Tolterodine Tartrate 4 MG and Continuous positive airway pressure therapy (CPAP) in people with Overactive Bladder and Obstructive Sleep Apnea, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aim to determine whether combined tolterodine and CPAP therapy is a more effective treatment for patients with OSAS than CPAP treatment only. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Overactive Bladder, Obstructive Sleep Apnea, Overactive Bladder Syndrome
- What is being tested?
- Tolterodine Tartrate 4 MG and Continuous positive airway pressure therapy (CPAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jan 2022
- Phase
- Phase 4
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women older than 18 who underwent polysomnography test with suspicion of OSAS between 01.06.2020-01.01.2022 were enrolled in the study
- Patients with AHI ≥15 (moderate or severe) and OAB-V8≥8 were considered eligible for the study and randomized in two groups to receive either CPAP treatment only or CPAP treatment with tolterodine tartrate
Who cannot join
- Patients diagnosed with neurological diseases, diabetes mellitus, congestive heart failure, infection, hematuria, urolithiasis, urinary tumors, and urinary retention were excluded from the study. Also, a history of lower urinary tract surgery and medication due to lower urinary tract symptoms were the exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Combined Use of Tolterodine and Continuous Positive Airway Pressure vs Continuous Positive Airway Pressure Only Treatment on Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial
In this study, we aim to determine whether combined tolterodine and CPAP therapy is a more effective treatment for patients with OSAS than CPAP treatment only.
- Being tested
- Tolterodine Tartrate 4 MG, Continuous positive airway pressure therapy (CPAP)
- Medical subject headings
- Urinary Bladder, Overactive, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolterodine Tartrate 4 MGDrug
Tolterodine is actively being used in the treatment of over active bladder symptoms today
Continuous positive airway pressure therapy (CPAP)Other
The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy
| Study group | Role | What they receive |
|---|---|---|
| CPAP only group | Active comparator | Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS) Receives: Other: Continuous positive airway pressure therapy (CPAP) |
| Combined use of CPAP and tolterodine | Active comparator | Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS Receives: Drug: Tolterodine Tartrate 4 MG; Other: Continuous positive airway pressure therapy (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OAB-V8 questionnarie score improvement
comparison of the groups in terms of improvements of symptom score questionnaires related to OAB at third month
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 posted22 Feb 2022
- Study start1 Jun 2020
- Primary completion30 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasım Ertas, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250245
- Sponsor's protocol ID
- 065
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 22 Feb 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 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Use of Tolterodine and Continuous Positive Airway Pressure vs Continuous Positive Airway Pressure Only Treatment on Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05250245
- Acronym / sponsor ID
- 065
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 22 Feb 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.
In this study, we aim to determine whether combined tolterodine and CPAP therapy is a more effective treatment for patients with OSAS than CPAP treatment only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP only group | Active comparator | Other: Continuous positive airway pressure therapy (CPAP)Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS) |
| Combined use of CPAP and tolterodine | Active comparator | Drug: Tolterodine Tartrate 4 MG, Other: Continuous positive airway pressure therapy (CPAP)Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women older than 18 who underwent polysomnography test with suspicion of OSAS between 01.06.2020-01.01.2022 were enrolled in the study
- Patients with AHI ≥15 (moderate or severe) and OAB-V8≥8 were considered eligible for the study and randomized in two groups to receive either CPAP treatment only or CPAP treatment with tolterodine tartrate
Key exclusion criteria (1 listed)
- Patients diagnosed with neurological diseases, diabetes mellitus, congestive heart failure, infection, hematuria, urolithiasis, urinary tumors, and urinary retention were excluded from the study. Also, a history of lower urinary tract surgery and medication due to lower urinary tract symptoms were the exclusion criteria.
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 |
|---|---|---|
| Tolterodine Tartrate 4 MGTolterodine is actively being used in the treatment of over active bladder symptoms today | Drug | Combined use of CPAP and tolterodine |
| Continuous positive airway pressure therapy (CPAP)The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy | Other | CPAP only group, Combined use of CPAP and tolterodine |
Primary outcome
OAB-V8 questionnarie score improvement
Time frame: 3 months
comparison of the groups in terms of improvements of symptom score questionnaires related to OAB at third month
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 22 Feb 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.
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 4 study testing Tolterodine Tartrate 4 MG and Continuous positive airway pressure therapy (CPAP) in people with Overactive Bladder and Obstructive Sleep Apnea, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 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 22 Feb 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 Turkey (Türkiye). 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
OAB-V8 questionnarie score improvement (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 22 Feb 2022.