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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05250245
• Other study ID #: 065
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: February 2022
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Overactive Bladder
• Overactive Bladder Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome
• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University	Van

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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