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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