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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Nocturia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

combination therapy of terazosin and hydrochlorothiazide

Intervention Type DRUG

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

Interventions

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combination therapy of terazosin and hydrochlorothiazide

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

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

MALE

Accepts Healthy Volunteers

No