Clinical trial NCT00700583: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nocturia
Keywords: nocturia
bladder
urination disorders
hydrochlorothiazide
terazosin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 72
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3-day frequency-volume chart
timeFrame: at baseline and at the end of the 4-week therapy
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS) question 7
timeFrame: at baseline and at the end of the 4-week therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Seoul National University Hospital
Study officials:
affiliation: Department of Urology, Seoul National University College of Medicine
name: Min Chul Cho, M.D. Master
role: PRINCIPAL_INVESTIGATOR
References:
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.