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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 16, 2008 | ||||
| Last Updated Date | March 12, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
3-day frequency-volume chart [ Time Frame: at baseline and at the end of the 4-week therapy ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00700583 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men | ||||
| Official Title ICMJE | Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men With LUTS: a Pilot Study | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Uncontrolled, Single Group Assignment | ||||
| Condition ICMJE | Nocturia | ||||
| Intervention ICMJE | Drug: combination therapy of terazosin and hydrochlorothiazide | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 72 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00700583 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | mccho | ||||
| Study Sponsor ICMJE | Seoul National University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Seoul National University Hospital | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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