Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Uncontrolled, Single Group Assignment

Study Primary Completion Date: June 2008

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.

Intervention(s) in this Clinical Trial

• Drug: combination therapy of terazosin and hydrochlorothiazide
  • 25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• 3-day frequency-volume chart
  • Time Frame: at baseline and at the end of the 4-week therapy
    Safety Issue?: Yes

Secondary Measures

• International Prostate Symptom Score (IPSS) question 7
  • Time Frame: at baseline and at the end of the 4-week therapy
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Seoul National University Hospital

Overall Clinical Trial Officials and Contacts

Min Chul Cho, M.D. Master Principal Investigator Department of Urology, Seoul National University College of Medicine  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00700583

Study ID Number: mccho

ClinicalTrials.gov Identifier: NCT00700583

Health Authority: Korea: Food and Drug Administration