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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFar Eastern Memorial Hospital

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>18 years old.

female patients with overactive bladder syndrome

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

220 Participants
are divided into 4 treatment groups
Group A: mirabegronActive comparator 1 intervention
Group B: SolifenacinActive comparator 1 intervention
Group C: TolterodineActive comparator 1 intervention
Group D: Oxybutynin ERActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Improvement of overactive bladder symptoms

Comparisons of the changes of overactive bladder symptom score between groups

Time frame
12 weeks

Secondary outcomes

1

Change of heart rate variability

Comparisons of the changes of heart rate variability between groups

Time frame
12 weeks
2

Change of bladder blood perfusion

Comparisons of the changes of bladder blood perfusion between groups

Time frame
12 weeks

Other outcomes

1

Change of quality of life

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

Time frame
12 weeks

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: