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

NCT05250245 | Completed Phase 4

• 1 other identifier: 065
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder; Obstructive Sleep Apnea; Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CPAP only group

ACTIVE COMPARATOR

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

Other: Continuous positive airway pressure therapy (CPAP)

Combined use of CPAP and tolterodine

ACTIVE COMPARATOR

Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS

Drug: Tolterodine Tartrate 4 MG; Other: Continuous positive airway pressure therapy (CPAP)

Interventions

Tolterodine Tartrate 4 MG DRUG

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

Combined use of CPAP and tolterodine

Continuous positive airway pressure therapy (CPAP) OTHER

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

CPAP only group; Combined use of CPAP and tolterodine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yıl University

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Sleep Apnea, Obstructive

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 22, 2022
• Study Start: June 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: January 1, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)