Back to resultsTolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome
Primary Purpose
Overactive Bladder, Obstructive Sleep Apnea, Overactive Bladder Syndrome
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Tolterodine Tartrate 4 MG
Continuous positive airway pressure therapy (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
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.
Sites / Locations
- Yuzuncu Yıl University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CPAP only group
Combined use of CPAP and tolterodine
Arm Description
Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS)
Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS
Outcomes
Primary Outcome Measures
OAB-V8 questionnarie score improvement
comparison of the groups in terms of improvements of symptom score questionnaires related to OAB at third month
Secondary Outcome Measures
Full Information
NCT ID
NCT05250245
First Posted
February 10, 2022
Last Updated
February 10, 2022
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05250245
Brief Title
Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Obstructive Sleep Apnea, Overactive Bladder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP only group
Arm Type
Active Comparator
Arm Description
Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS)
Arm Title
Combined use of CPAP and tolterodine
Arm Type
Active Comparator
Arm Description
Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS
Intervention Type
Drug
Intervention Name(s)
Tolterodine Tartrate 4 MG
Intervention Description
Tolterodine is actively being used in the treatment of over active bladder symptoms today
Intervention Type
Other
Intervention Name(s)
Continuous positive airway pressure therapy (CPAP)
Intervention Description
The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy
Primary Outcome Measure Information:
Title
OAB-V8 questionnarie score improvement
Description
comparison of the groups in terms of improvements of symptom score questionnaires related to OAB at third month
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Yuzuncu Yıl University
City
Van
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tolterodine Relieves Overactive Bladder Symptoms in Women With Moderate-to-severe Obstructive Sleep Apnea Syndrome
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