Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men

NCT00700583 | Completed

• 1 other identifier: mccho
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to determine whether the combined administration of a diuretic agent, hydrochlorothiazide, at night would improve the frequency of nocturia unresponsive to alpha-blocker monotherapy in men with LUTS.

Conditions

Nocturia

Keywords

nocturia; bladder; urination disorders; hydrochlorothiazide; terazosin

Outcome Measures

Primary Outcomes (1)

• 3-day frequency-volume chart

  at baseline and at the end of the 4-week therapy

Secondary Outcomes (1)

• International Prostate Symptom Score (IPSS) question 7

  at baseline and at the end of the 4-week therapy

Study Arms (1)

1

EXPERIMENTAL

Drug: combination therapy of terazosin and hydrochlorothiazide

Interventions

combination therapy of terazosin and hydrochlorothiazide DRUG

25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks

1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• no response or \< 25% reduction in subjective nocturia by the IPSS question 7 after 4-weeks of treatment with terazosin
• no response or \< 25% reduction in objective nocturia by the FVC after 4-weeks of treatment with terazosin
• nocturia on average two times or more per night (according to the FVC) after 4-weeks of terazosin therapy

You may not qualify if:

• use of medications for the control of bladder symptoms
• use of sedatives or tranquillisers for treating sleep disturbances
• bladder tumours
• bladder stones
• urethral strictures
• neurogenic bladder dysfunction
• restricted mobility
• working primarily at night
• a documented history or clinical symptoms of prostatitis, prostate cancer, or prostatic intraepithelial neoplasia on biopsy
• serum PSA levels of \>20 ng/mL
• a history of prostate surgery or radiotherapy, acute urinary retention or an indwelling catheter
• evidence of acute urinary infection (pyuria and bacteriuria)on urine analysis

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Urology, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Cho MC, Ku JH, Paick JS. Alpha-blocker plus diuretic combination therapy as second-line treatment for nocturia in men with LUTS: a pilot study. Urology. 2009 Mar;73(3):549-53; discussion 554-5. doi: 10.1016/j.urology.2008.08.517. Epub 2008 Dec 18.

  PMID: 19100605 RESULT

MeSH Terms

Conditions

Nocturia; Urination Disorders

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Min Chul Cho, M.D. Master

  Department of Urology, Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: May 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

KR (1)