Status:

COMPLETED

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

Lead Sponsor:

Seoul National University Hospital

Conditions:

Nocturia

Eligibility:

MALE

Phase:

NA

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-block...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2008

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT00700583

Start Date

May 1 2008

End Date

June 1 2008

Last Update

May 10 2011

Active Locations (1)

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1

Department of Urology, Seoul National University Hospital

Seoul, South Korea, 110-744