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Nocturia QOL evaluation in OAB patients treated with Oxybutinin & Mirabegron study

Nocturia QOL evaluation in OAB patients treated with Oxybutinin & Mirabegron study - NEOXY study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024234
Enrollment
120
Registered
2016-10-01
Start date
2016-10-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

overactive bladder

Interventions

Arm of oxybutynin tape 73.5mg per one day for 8 weeks. Arm of mirabegron 50mg per one day for 8 weeks.

Sponsors

Department of Urology, school of medicine, Shinshu university
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 20 years of age or older of overactive bladder female patients with nocturia symptoms.

Exclusion criteria

Exclusion criteria: (1) Patients in the study drug administration proposed site with a skin disease and skin abnormalities. (2) Patients with residual urine volume greater than 100mL. (3) Patients with a difficulty in going to the bathroom without the assistance. (4) Patients with a history of hypersensitivity of Oxybutynin hydrochloride or Mirabegron. (5) Patients receiving flecainide acetate or propafenone hydrochloride. (6) Patients with severe blood, liver, kidney disease and severe arrhythmia, suffering from cardiovascular diseases such as congestive heart failure. (7) Patients with hypokalemia (less than 3.5mEq / L). (8) Patients with paralytic ileus, ulcerative colitis, stomach atony, patients suffering from gastrointestinal diseases, such as bowel atony. (9) Patients with Parkinson's syndrome, dementia, suffering from psychiatric and neurological disorders or cerebrovascular disorders such as myasthenia gravis. (10) Patients with a glaucoma. (11) Patients with a hyperthyroidism. (12) Patients with malignant tumors. (13) Pregnant patients, patients in lactating, and patients want to become pregnant during test period. (14) Patients who participated in the other interventions tested within 16 weeks prior to study drug administration. (15) Other, patient that investigators or test sharing doctor was ineligible as a subject of the present study.

Design outcomes

Primary

MeasureTime frame
N-QOL score

Countries

Japan

Contacts

Public ContactToshiro Suzuki

Department of Urology, school of medicine, Shinshu university Urology

yokoso1046@shinshu-u.ac.jp+81263-35-4600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026