NCT07114640

Brief Summary

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?

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
32mo left

Started Aug 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Aug 2025Dec 2028

First Submitted

Initial submission to the registry

August 4, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 7, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3.4 years

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

Urinary Bladder, Overactive

Keywords

autonomic nerve system, nocturia, psychologic distress, sexual function, bladder blood perfusion, heart rate variability, overactive bladder syndrome

Outcome Measures

Primary Outcomes (1)

  • Improvement of overactive bladder symptoms

    Comparisons of the changes of overactive bladder symptom score between groups

    12 weeks

Secondary Outcomes (2)

  • Change of heart rate variability

    12 weeks

  • Change of bladder blood perfusion

    12 weeks

Other Outcomes (1)

  • Change of quality of life

    12 weeks

Study Arms (4)

mirabegron

ACTIVE COMPARATOR

mirabegron 25 mg

Drug: Mirabegron 25mg

Solifenacin

ACTIVE COMPARATOR

Solifenacin 5mg

Drug: Solifenacin 5 mg

Tolterodine

ACTIVE COMPARATOR

Tolterodine 4mg

Drug: Tolterodine 4 mg

Oxybutynin ER

ACTIVE COMPARATOR

Oxybutynin ER 5mg

Drug: Oxybutynin ER 5 mg

Interventions

Mirabegron 25mgDRUG

Taking 25 mg mirabegron in the nighttime

mirabegron
Solifenacin 5 mgDRUG

Taking 5 mg solifenacin in the nighttime

Solifenacin
Tolterodine 4 mgDRUG

Taking 5 mg tolterodine in the nighttime

Tolterodine
Oxybutynin ER 5 mgDRUG

Taking 5 mg oxybutynin ER in the nighttime

Oxybutynin ER

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital,

Banqiao District, New Taipei, 22050, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, OveractiveNocturia

Interventions

mirabegronSolifenacin SuccinateTolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief and Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

August 7, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)