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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00700583
Enrollment
72
Registered
2008-06-18
Start date
2008-05-31
Completion date
2008-06-30
Last updated
2011-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia

Keywords

nocturia, bladder, urination disorders, hydrochlorothiazide, terazosin

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.

Interventions

DRUGcombination therapy of terazosin and hydrochlorothiazide

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Healthy volunteers
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

Design outcomes

Primary

MeasureTime frame
3-day frequency-volume chartat baseline and at the end of the 4-week therapy

Secondary

MeasureTime frame
International Prostate Symptom Score (IPSS) question 7at baseline and at the end of the 4-week therapy

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026