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

Primary Purpose

Nocturia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
combination therapy of terazosin and hydrochlorothiazide
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring nocturia, bladder, urination disorders, hydrochlorothiazide, terazosin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Urology, Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

3-day frequency-volume chart

Secondary Outcome Measures

International Prostate Symptom Score (IPSS) question 7

Full Information

First Posted
June 16, 2008
Last Updated
May 9, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00700583
Brief Title
Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men
Official Title
Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men With LUTS: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia
Keywords
nocturia, bladder, urination disorders, hydrochlorothiazide, terazosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
combination therapy of terazosin and hydrochlorothiazide
Intervention Description
25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks
Primary Outcome Measure Information:
Title
3-day frequency-volume chart
Time Frame
at baseline and at the end of the 4-week therapy
Secondary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) question 7
Time Frame
at baseline and at the end of the 4-week therapy

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Chul Cho, M.D. Master
Organizational Affiliation
Department of Urology, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19100605
Citation
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. doi: 10.1016/j.urology.2008.08.517. Epub 2008 Dec 18.
Results Reference
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Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men

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