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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00700583
First received: June 16, 2008
Last updated: May 9, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition Intervention
Nocturia
 Drug: combination therapy of terazosin and hydrochlorothiazide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men With LUTS: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 3-day frequency-volume chart [ Time Frame: at baseline and at the end of the 4-week therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • International Prostate Symptom Score (IPSS) question 7 [ Time Frame: at baseline and at the end of the 4-week therapy ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: May 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: combination therapy of terazosin and hydrochlorothiazide
25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks

Detailed Description:

Because nocturia may result in sleep disturbances, daytime fatigue, a lower level of general well-being, and an increased risk of falling at night, it is among the most bothersome of the lower urinary tract symptoms (LUTS). Nocturia is related to a variety of conditions such as aging, overactive bladder (OAB), benign prostatic hyperplasia (BPH)/LUTS, medications, diabetes mellitus, diabetes insipidus, anorexia nervosa, and sleep disturbance. In a previous study, we suggested that treatment with terazosin can reduce episodes of nocturia, both subjectively and objectively, in some men with LUTS. Other study showed that in men with nocturnal polyuria, furosemide resulted in a significant reduction in night-time frequency and percentage of the voided volume.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700583

Locations
Korea, Republic of
Department of Urology, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Min Chul Cho, M.D. Master Department of Urology, Seoul National University College of Medicine
  More Information

Publications:

Responsible Party: Jae-Seung Paick/M.D.,Ph.D., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00700583     History of Changes
Other Study ID Numbers: mccho
Study First Received: June 16, 2008
Last Updated: May 9, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
nocturia
bladder
urination disorders
hydrochlorothiazide
terazosin

Additional relevant MeSH terms:
Nocturia
Urological Manifestations
Signs and Symptoms
Adrenergic alpha-Antagonists
Terazosin
Diuretics
Hydrochlorothiazide
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013