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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05250245
Other study ID # 065
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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