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Completed

NCT Number: NCT05250245

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

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.

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Key information

Conditions

Overactive Bladder Apnea Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Obstructive Sleep Apnea Overactive Bladder Syndrome Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Yuzuncu Yıl University

Van, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tolterodine Tartrate 4 MG

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 22, 2022
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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