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