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

NCT ID: NCT05250245

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder Obstructive Sleep Apnea Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP only group

Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS)

Group Type ACTIVE_COMPARATOR

Continuous positive airway pressure therapy (CPAP)

Intervention Type OTHER

The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy

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

Group Type ACTIVE_COMPARATOR

Tolterodine Tartrate 4 MG

Intervention Type DRUG

Tolterodine is actively being used in the treatment of over active bladder symptoms today

Continuous positive airway pressure therapy (CPAP)

Intervention Type OTHER

The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy

Interventions

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Tolterodine Tartrate 4 MG

Tolterodine is actively being used in the treatment of over active bladder symptoms today

Intervention Type DRUG

Continuous positive airway pressure therapy (CPAP)

The gold standard for the treatment of confirmed OSAS is continuous positive airway pressure (CPAP) therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Kasım Ertas

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yuzuncu Yıl University

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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065

Identifier Type: -

Identifier Source: org_study_id

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