Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 30, 2021
Interventions
- Drug: Tolterodine Tartrate 4 MG
- Tolterodine is actively being used in the treatment of over active bladder symptoms today
- Other: Continuous positive airway pressure therapy (CPAP)
- The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy
Arms, Groups and Cohorts
- Active Comparator: CPAP only group
- Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS)
- Active Comparator: Combined use of CPAP and tolterodine
- Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS
Clinical Trial Outcome Measures
Primary Measures
- 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
Participating in This Clinical Trial
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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Yuzuncu Yıl University
- Provider of Information About this Clinical Study
- Principal Investigator: Kasım Ertas, Assistant Professor – Yuzuncu Yıl University
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