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CompletedNCT05250245Updated Feb 22, 2022

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

A Phase 4 interventional study of Tolterodine Tartrate 4 MG and Continuous positive airway pressure therapy (CPAP) in Overactive Bladder, Obstructive Sleep Apnea and Overactive Bladder Syndrome, sponsored by Yuzuncu Yil University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-02-22.

Sponsored by Yuzuncu Yil University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Jun 2020, registered Feb 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Overactive Bladder
  • Obstructive Sleep Apnea
  • Overactive Bladder Syndrome
03

In context

Urinary Bladder, Overactive

864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Yuzuncu Yil University is the lead sponsor of 75 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    CPAP only group

    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)

  • Active comparator
    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

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

Interventions

  • DrugTolterodine Tartrate 4 MG

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

  • OtherContinuous positive airway pressure therapy (CPAP)

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

06

What researchers measure

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

    Time frame: 3 months

07

Study locations

1 site
  • Yuzuncu Yıl University
    Van, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05250245
Lead sponsor
Yuzuncu Yil University
Responsible party
Kasım Ertas (Assistant Professor, Yuzuncu Yil University) — Principal investigator
First posted
Feb 22, 2022
Start date
Jun 1, 2020
Primary completion
Dec 30, 2021
Completion
Jan 1, 2022
Last update
Feb 22, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tolterodine

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