NocturiaNCT00700583
Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men
A study testing combination therapy of terazosin and hydrochlorothiazide in people with Nocturia, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Nocturia
- What is being tested?
- combination therapy of terazosin and hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men With LUTS: a Pilot Study
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.
Read the 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.
- Conditions
- Nocturia
- Being tested
- combination therapy of terazosin and hydrochlorothiazide
- Keywords
- nocturia, bladder, urination disorders, hydrochlorothiazide, terazosin
- Medical subject headings
- Nocturia, Urination Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination therapy of terazosin and hydrochlorothiazideDrug
25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: combination therapy of terazosin and hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-day frequency-volume chart
Measured: at baseline and at the end of the 4-week therapy
Secondary outcomes (1)
International Prostate Symptom Score (IPSS) question 7
Measured: at baseline and at the end of the 4-week therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Min Chul Cho, M.D. Master, Principal investigator, Department of Urology, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700583
- Sponsor's protocol ID
- mccho
- Status last verified
- May 2011
- First submitted
- 16 Jun 2008
- Last updated
- 10 May 2011
- Results posted
- No
Publications
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.
PubMed 19100605
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-blocker Plus Diuretic Combination Therapy as Second-line Treatment for Nocturia in Men With LUTS: a Pilot Study
- ClinicalTrials.gov ID
- NCT00700583
- Acronym / sponsor ID
- mccho
- Conditions
- Nocturia
- Keywords
- nocturia, bladder, urination disorders, hydrochlorothiazide, terazosin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: combination therapy of terazosin and hydrochlorothiazide |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- use of medications for the control of bladder symptoms
- use of sedatives or tranquillisers for treating sleep disturbances
- bladder tumours
- bladder stones
- urethral strictures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination therapy of terazosin and hydrochlorothiazide25 mg of hydrochlorothiazide eight hours before bedtime and 4 mg of terazosin at bedtime for 4 weeks | Drug | 1 |
Primary outcome
3-day frequency-volume chart
Time frame: at baseline and at the end of the 4-week therapy
1 secondary outcome
International Prostate Symptom Score (IPSS) question 7
Time frame: at baseline and at the end of the 4-week therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
- Results publication: PubMed 19100605Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Chul Cho, M.D. Master principal investigator
Department of Urology, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination therapy of terazosin and hydrochlorothiazide in people with Nocturia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-day frequency-volume chart (time frame: at baseline and at the end of the 4-week therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00700583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.