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NCT Number: NCT07114640

The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial

The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Its primary objectives were to answer the following questions:

Which medication is most effective for women with nocturia? Which medication has the least effect on heart rate variability in women with nocturia?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital,

Banqiao District, New Taipei, 22050, Taiwan

Location contact

Sheng-Mou Hsiao, M.D.

CONTACT

[email protected]

+886-2-89667000 ext. 1818

About this study

We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the questionnaires and before taking the drug and four weeks and twelve weeks after taking the medication. In addition, measurement of heart rate variability will be performed before and twelve weeks after taking the medication. All enrolled women will be randomized to receive nighttime mirabegron, solifenacin, tolterodine or oxybutynin for 12 weeks.

The aims of this study is to obtain the impact of nighttime dosing of mirabegron, solifenacin, tolterodine or oxybutynin versus combined therapy on nocturia, psychologic distress, sexual function, cognition, heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old.
  • female patients with overactive bladder syndrome

Exclusion criteria

  • Clinically significant dysuria (inability to urinate, difficulty urinating).
  • Severe stress urinary incontinence (urinary incontinence caused by coughing).
  • Mixed urinary incontinence mainly caused by stress urinary incontinence (urinary incontinence caused by coughing as the main symptom).
  • Contraindications to antimuscarinic drugs or adrenergic receptor agonists.

Treatment and study plan

Mirabegron 25mg

Drug

Taking 25 mg mirabegron in the nighttime

Solifenacin 5 mg

Drug

Taking 5 mg solifenacin in the nighttime

Tolterodine 4 mg

Drug

Taking 5 mg tolterodine in the nighttime

Oxybutynin ER 5 mg

Drug

Taking 5 mg oxybutynin ER in the nighttime

Primary outcomes

  1. Improvement of overactive bladder symptoms

    Time frame: 12 weeks

    Comparisons of the changes of overactive bladder symptom score between groups

Secondary outcomes

  1. Change of heart rate variability

    Time frame: 12 weeks

    Comparisons of the changes of heart rate variability between groups

  2. Change of bladder blood perfusion

    Time frame: 12 weeks

    Comparisons of the changes of bladder blood perfusion between groups

Other outcomes

  1. Change of quality of life

    Time frame: 12 weeks

    Comparisons of the change of King's Health Questionnaire score between groups

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

Far Eastern Memorial Hospital

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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