Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men
Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturia
Intervention: combination therapy of terazosin and hydrochlorothiazide (Drug)
Phase: N/A
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s):
Min Chul Cho, M.D. Master, Principal Investigator, Affiliation: Department of Urology, Seoul National University College of Medicine
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.
Clinical Details
Official title: Alpha-Blocker Plus Diuretic Combination Therapy as Second-Line Treatment for Nocturia in Men With LUTS: a Pilot Study
Study design: Treatment, Uncontrolled, Single Group Assignment
Primary outcome: 3-day frequency-volume chart
Secondary outcome: International Prostate Symptom Score (IPSS) question 7
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Department of Urology, Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information
Starting date: May 2008
Ending date: June 2008
Last updated: June 16, 2008
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