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

Nocturia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700583
• Other study ID #: mccho
• Status: Completed
• Phase: N/A
• First received: June 16, 2008
• Last updated: May 9, 2011
• Start date: May 2008
• Est. completion date: June 2008

Study information

• Verified date: May 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• combination therapy of terazosin and hydrochlorothiazide
25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-day frequency-volume chart		at baseline and at the end of the 4-week therapy	Yes
Secondary	International Prostate Symptom Score (IPSS) question 7		at baseline and at the end of the 4-week therapy	No