Full Text View
Tabular View
No Study Results Posted
Related Studies
Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men
This study has been completed.
Study NCT00700583   Information provided by Seoul National University Hospital
First Received: June 16, 2008   Last Updated: March 12, 2009   History of Changes

June 16, 2008
March 12, 2009
May 2008
June 2008   (final data collection date for primary outcome measure)
3-day frequency-volume chart [ Time Frame: at baseline and at the end of the 4-week therapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00700583 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men
Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men With LUTS: a Pilot Study

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.

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.

 
Interventional
Treatment, Uncontrolled, Single Group Assignment
Nocturia
Drug: combination therapy of terazosin and hydrochlorothiazide
 
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. Epub 2008 Dec 18.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
72
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Male
 
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00700583
 
mccho
Seoul National University Hospital
 
Principal Investigator: Min Chul Cho, M.D. Master Department of Urology, Seoul National University College of Medicine
Seoul National University Hospital
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP