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

Study Overview
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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.

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.

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

Conditions
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Nocturia

Intervention / Treatment
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* Drug: combination therapy of terazosin and hydrochlorothiazide


Participation Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: combination therapy of terazosin and hydrochlorothiazide<br>* 25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-day frequency-volume chart |  | at baseline and at the end of the 4-week therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) question 7 |  | at baseline and at the end of the 4-week therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nocturia, bladder, urination disorders, hydrochlorothiazide, terazosin