Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Overactive Bladder, Obstructive Sleep Apnea, Overactive Bladder Syndrome

Intervention / Treatment
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* Drug: Tolterodine Tartrate 4 MG
* Other: Continuous positive airway pressure therapy (CPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP only group<br>Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS) | Other: Continuous positive airway pressure therapy (CPAP)<br>* The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy<br>|
| Active Comparator: Combined use of CPAP and tolterodine<br>Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS | Drug: Tolterodine Tartrate 4 MG<br>* Tolterodine is actively being used in the treatment of over active bladder symptoms today<br>Other: Continuous positive airway pressure therapy (CPAP)<br>* The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB-V8 questionnarie score improvement | comparison of the groups in terms of improvements of symptom score questionnaires related to OAB at third month | 3 months |