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Completed

NCT Number: NCT00700583

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

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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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combination therapy of terazosin and hydrochlorothiazide

Drug

25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks

Primary outcomes

  1. 3-day frequency-volume chart

    Time frame: at baseline and at the end of the 4-week therapy

Secondary outcomes

  1. International Prostate Symptom Score (IPSS) question 7

    Time frame: at baseline and at the end of the 4-week therapy

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men With LUTS: a Pilot Study

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 18, 2008
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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