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

Phase 4

Completed

• Conditions: Overactive Bladder; Obstructive Sleep Apnea; Overactive Bladder Syndrome
• Interventions: Other: Continuous positive airway pressure therapy (CPAP); Drug: Tolterodine Tartrate 4 MG

• Registration Number: NCT05250245
• Lead Sponsor: Yuzuncu Yıl University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-10
• Last Update Submitted: 2022-02-10
• Study First Posted: 2022-02-22
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP only group	Continuous positive airway pressure therapy (CPAP)	Patients who are going to receive only CPAP treatment for their moderate-to-severe obstructive sleep apnea syndrome (OSAS)
Combined use of CPAP and tolterodine	Tolterodine Tartrate 4 MG	Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS
Combined use of CPAP and tolterodine	Continuous positive airway pressure therapy (CPAP)	Patients who are going to receive combined use of CPAP and tolterodine 4mg a day treatment for their OSAS

Primary Outcome Measures

Name	Time	Method
OAB-V8 questionnarie score improvement	3 months	comparison of the groups in terms of improvements of symptom score questionnaires related to OAB at third month

Trial Locations

Locations (1)

Yuzuncu Yıl University; 🇹🇷 Van, Turkey