The efficacy and safety of silodosin on nocturia for patients with benign prostatic hyperplasia

A multi-center, prospective, open-label, single-arm, 12-weeks, phase IV trial to evaluate the efficacy and safety of silodosin on nocturia for patients with benign prostatic hyperplasia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003797

Enrollment

126

Registered

2019-04-16

Start date

2014-01-02

Completion date

Unknown

Last updated

2019-04-23

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

Conditions

None listed

Interventions

Drug : 8 mg silodosin once daily for 12 weeks

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: nocturia (=2 events/night) on 3-day voiding diary, an International Prostate Symptom Score (IPSS) =8, and a quality of life score =3

Exclusion criteria

Exclusion criteria: prostate specific antigen >10 ng/ml, neurogenic bladder, bladder cancer, bladder stones, urethral stricture, acute urinary retention, urinary tract infection within one month, prostate cancer, a history of prostate surgery, use of an a-blocker or antimuscarinic agents within 2 weeks, or use of 5-a-reductase inhibitors within 6 months

Design outcomes

Primary

Measure	Time frame
the change in the mean number of nocturia episodes in a voiding diary from the baseline to the final assessment	—

Secondary

Measure	Time frame
changes in IPSS total score;changes in IPSS quality of life score;changes in overactive bladder symptom score;changes in International Consultation on Incontinence Questionnaire-Nocturia score;percentage of patients with 25% or more IPSS reduction rate after 12 weeks of treatment;percentage of patients with 25% or more nocturia reduction after 12 weeks of treatment	—

Countries

Korea, Republic of

Contacts

Public ContactKang Jun Cho

The Catholic University of Korea, Bucheon St. Mary's Hospital

Outcome results