Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study

Comparison of efficacy and safety of the secondary treatment with increased fesoterodine and with mirabegron combination with 4mg fesoterodine for those who still have moderate or more overactive bladder symptoms after the initial treatment with 4mg fesoterodine: preliminary study - Comparison of efficacy and safety between increased fesoterodine and mirabegron combination for the overactive bladder resistant to the initial fesoterodine treatment.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011677

Enrollment

Registered

2013-09-17

Start date

2013-09-09

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

For 8 weeks 8mg fesoterodine will be orally administered once a day after breakfast to the patients who have still moderate or more overactive bladder symptoms after 4mg fesoterodine treatment for mor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Obtaining of written informed consent 2) Male and female, more than 20 years old 3) After 4 week or more administration of fesoterodine 4mg, more than 6 points of total IPSS, and more than 2 points of OABSS 3rd question 4) Patients who have not seen side effects 5) In case of the male patients who are suitable for the enrollment of this study but have any of the following symptoms; more than 7 points of total IPSS, less than 15ml/s of maximum urinary flow rate, and more than 50ml of residual urine volume, they need preceding BPH treatment with alpha 1 blocker for more than 4 weeks or dutasteride for more than 24 weeks or anti-androgenic agent for more than 16 weeks.

Exclusion criteria

Exclusion criteria: 1) Patients with the practice of catheterization past or present. 2) Residual urine volume is more than 100ml. 3) Patients who can`t urine voluntarily. 4) Neurogenic bladder, urethral stricture, urinary tract infection, urinary tract calculi, interstitial cystitis, chronic prostatitis, prostate cancer, bladder cancer 5) Patients who are contraindicated for fesoterodine administration. 6) Patients who are contraindicated for mirabegron administration. 7) Patients who have the history of the administration of contraindicated agents within 2 weeks.

Design outcomes

Primary

Measure	Time frame
Change of total overactive bladder symptom score.	—

Secondary

Measure	Time frame
1) Changes of parameters of questonnairs 2) Changes of parameters of urodynamic studies 3) Safety	—

Countries

Japan

Contacts

Public ContactKimihiko Masui

Otsu Minicipal Hospital Urology

k_m36@hotmail.com077-522-4607

Outcome results

None listed

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