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CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY)

CLSS-based assessment of alfa-adrenoceptor blockers for male LUTS (CLAM-STUDY) - CLAM-STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003125
Enrollment
600
Registered
2010-02-01
Start date
2010-02-01
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

male lower urinary tract symptoms, mLUTS

Interventions

Silodosin 8 mg dairy Tamsulosis 0.2 mg dairy

Sponsors

Department of Urology, The University of Tokyo Hospital
Lead Sponsor
Kamijyo Clinic, Meirikai Chuo General Hospital, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo Kyosai Hospital, Toshiba Hospital, etc.
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male patients with newly diagnosed LUTS according to the treatment algorithm of the Clinical Practice Guidelines for Male Lower Urinary Tract Symptoms

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are excluded: 1) Patients taking anticholinergic agents, antidepressants, or antianxiety agents 2) Patients with a history of urinary retention, urinary tract infections, macroscopic haematuria, lower urinary tract surgery, radiotherapy for the pelvic organs, or neurologic disease 3) Patients with pyuria, renal impairment, calculus bladder, or who are urine cytology positive 4) Patients with elevated PSA levels (4.0 ng/mL or over) 5) Patients whose 9th CLSS score is 2 or higher 6) Patients who are not willing to receive drug treatment 7) Patients who cannot answer the questionnaire by themselves 8) Patients classified as ineligible by the investigator

Design outcomes

Primary

MeasureTime frame
Results of treatment with silodosin or tamsulosin hydrochloride evaluated by variations in the new CLSS evaluation index (total score and category-specific score).

Secondary

MeasureTime frame
I-PSS, OABSS, Uroflowmetry, Residual urine volume, Prostate volume

Countries

Japan

Contacts

Public ContactMotofumi Suzuki

The University of Tokyo Hospital Department of Urology

SUZUKIM-URO@h.u-tokyo.ac.jp+81-3-5800-8662

Outcome results

None listed

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