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

Yuzuncu Yıl University

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder Syndrome; Obstructive Sleep Apnea; Overactive Bladder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05250245

065

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

CPAP only group

Active Comparator group

Description:

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

Treatment:

Other: Continuous positive airway pressure therapy (CPAP)

Combined use of CPAP and tolterodine

Active Comparator group

Description:

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

Treatment:

Other: Continuous positive airway pressure therapy (CPAP)

Drug: Tolterodine Tartrate 4 MG