Benign Prostatic HyperplasiaPhase 4NCT00827814
Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction
A Phase 4 study testing Dutasteride in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and patients, and relief of bladder outlet obstruction reverses an increased bladder mass. Read more about this study
- Who is it for?
- Ages 50 to 79 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Dutasteride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Apr 2009
- Phase
- Phase 4
- 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 50 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥50 and <80 years old
- Presence of LUTS for at least 3 months
- IPSS≥15
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- Prostate volume measured by TRUS ≥ 30ml and < 100ml
- Able to comply with the prescribed treatment protocol and evaluations.
Who cannot join
- Patients with neurogenic voiding disorders
- Patients with prostate or bladder cancer
- Patients underwent urethral, prostate or bladder neck surgery
- Patients with urethral stricture or bladder neck contracture
- Serum PSA≥4ng/ml (if the patient confirmed as no malignancy by prostate biopsy can be included).
- Patients who medicated with 5ARI within 6 months
- Patients who do not agree with the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction: A 24-Week Open-Label, Single-Arm Pilot Study
Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and patients, and relief of bladder outlet obstruction reverses an increased bladder mass. Whether increased bladder mass is not only a consequence of bladder outlet obstruction but also a relevant risk factor for the progression of lower urinary tract symptoms associated with benign prostate hyperplasia cannot be decided due to a lack of appropriate data, most likely because bladder wall thickness is not routinely measured in clinical studies and/or routine clinical practice. Despite this lack of data, many urologists feel that increased bladder mass should be prevented or decreased to reduce the occurrence of serious complications.
The possibility of using bladder wall thickness data as criteria for benign prostate hyperplasia intervention and as outcome criteria for benign prostate hyperplasia treatment has been proposed. Detrusor hypertrophy associated with bladder outlet obstruction can be imaged on suprapubic ultrasound, and bladder mass can be quantified from the evaluation of bladder wall thickness and bladder volume. Bladder wall hypertrophy has been found to be correlated with detrusor function.
Read more
Independent studies have shown that surgical treatment of benign prostatic obstruction results in a significant decrease of bladder mass. Preliminary data suggest the possibility that medical treatment with alpha-adrenergic antagonists might also produce a reduction of bladder wall hypertrophy.
The investigators assume that the prevention of benign prostate hyperplasia progression by alpha-adrenergic antagonists and 5 alpha reductase inhibitors may be result of bladder function protection. To our knowledge there have been no studies that evaluated the effects of a 5 alpha reductase inhibitors on bladder function. Therefore, the investigators plan to conduct a prospective trial evaluating the effects of 5 alpha reductase inhibitors on bladder function by the evaluation of bladder wall thickness and lower urinary tract symptoms.
Read the detailed description
1 Objective
1.1 Primary Objective: To explore the efficacy of Dutasteride in reducing bladder wall hypertrophy from baseline to 6 months of treatment in male patients with benign prostatic obstruction.
1.2 Secondary Objective:
- To explore the efficacy of Dutasteride in reducing the LUTS symptoms, number of micturitions, and number of urgency episodes from baseline to 6 months of treatment
- To explore the efficacy of Dutasteride on the urodynamic parameters from baseline to 6 months of treatment.
- To explore the efficacy of Dutasteride on the tolerability, safety, patient perception and quality of life from baseline to 6 months of treatment.
2 Endpoints
2.1 Primary Endpoint: Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW) from baseline to 6 months of treatment
2.2 Secondary Endpoint:
Urodynamic parameters: From baseline to 6 months of treatment
- Percentage and numeric changes of the
- Maximum flow rate (mL/s)
- Average flow rate (mL/s)
- Post-void residual urine volume (mL)
Micturition diary efficacy parameters: From baseline to 6 months of treatment
- Percentage and numeric changes in micturition frequency/24 hours
- Percentage and numeric changes in mean volume voided per micturition
- Percentage and numeric changes in mean number and severity of urgency per micturition
Prostate volume parameters:
- Change in prostate volume by TRUS from baseline to after 6 months of treatment.
- Change in serum PSA from baseline to after 6 months of treatment.
Quality of life parameters:
- Change in Bother Score of IPSS score from baseline to 6 months of treatment
LUTS Symptom parameters:
- Change in IPSS score from baseline to 6 months of treatment
- total score: sum of all 7 questions
- storage score: sum of questions 2, 4 and 7
- voiding score: sum of questions 1, 3, 5 and 6
LUTS outcome score (LOS)
- Change in LOS from baseline to 6 months of treatment
Patient perceptions:
- Patient perception of treatment benefit after 3 and 6 months of treatment
- Change in patient perception of urgency from baseline to 3 and 6 month of treatment
Safety parameters:
- Incidence and severity of adverse events
- Incidence and reason of withdrawals
- STUDY DESIGN AND METHODS
Study Design: This is a 6-month prospective Phase IV study to explore the effect on the bladder function of Dutasteride in male patients with benign prostatic obstruction.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Dutasteride
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Also called Avodart
Dutasteride 0.5 mg od.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Experimental | Not described Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW)
Measured: Baseline and 6 months of dutasteride treatment
Secondary outcomes (8)
Urodynamic parameters
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
Micturition diary efficacy parameters
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
Prostate volume parameters
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
Quality of life parameters
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
LUTS Symptom parameters
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
LUTS outcome score
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
Patient perceptions
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
Safety parameters
Measured: Baseline and 3 and/or 6 months of dutasteride treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJun 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827814
- Sponsor's protocol ID
- 2006-06-022
- Status last verified
- Jun 2009
- First submitted
- 22 Jan 2009
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction: A 24-Week Open-Label, Single-Arm Pilot Study
- ClinicalTrials.gov ID
- NCT00827814
- Acronym / sponsor ID
- 2006-06-022
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Jan 2009 (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.
Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and patients, and relief of bladder outlet obstruction reverses an increased bladder mass. Whether increased bladder mass is not only a consequence of bladder outlet obstruction but also a relevant risk factor for the progression of lower urinary tract symptoms associated with benign prostate hyperplasia cannot be decided due to a lack of appropriate data, most likely because bladder wall thickness is not routinely measured in clinical studies and/or routine clinical practice. Despite this lack of data, many urologists feel that increased bladder mass should be prevented or decreased to reduce the occurrence of serious complications.
The possibility of using bladder wall thickness data as criteria for benign prostate hyperplasia intervention and as outcome criteria for benign prostate hyperplasia treatment has been proposed. Detrusor hypertrophy associated with bladder outlet obstruction can be imaged on suprapubic ultrasound, and bladder mass can be quantified from the evaluation of bladder wall thickness and bladder volume. Bladder wall hypertrophy has been found to be correlated with detrusor function.
Independent studies have shown that surgical treatment of benign prostatic obstruction results in a significant decrease of bladder mass. Preliminary data suggest the possibility that medical treatment with alpha-adrenergic antagonists might also produce a reduction of bladder wall hypertrophy.
The investigators assume that the prevention of benign prostate hyperplasia progression by alpha-adrenergic antagonists and 5 alpha reductase inhibitors may be result of bladder function protection. To our knowledge there have been no studies that evaluated the effects of a 5 alpha reductase inhibitors on bladder function. Therefore, the investigators plan to conduct a prospective trial evaluating the effects of 5 alpha reductase inhibitors on bladder function by the evaluation of bladder wall thickness and lower urinary tract symptoms.
Detailed description
1 Objective
1.1 Primary Objective: To explore the efficacy of Dutasteride in reducing bladder wall hypertrophy from baseline to 6 months of treatment in male patients with benign prostatic obstruction.
1.2 Secondary Objective:
- To explore the efficacy of Dutasteride in reducing the LUTS symptoms, number of micturitions, and number of urgency episodes from baseline to 6 months of treatment
- To explore the efficacy of Dutasteride on the urodynamic parameters from baseline to 6 months of treatment.
- To explore the efficacy of Dutasteride on the tolerability, safety, patient perception and quality of life from baseline to 6 months of treatment.
2 Endpoints
2.1 Primary Endpoint: Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW) from baseline to 6 months of treatment
2.2 Secondary Endpoint:
Urodynamic parameters: From baseline to 6 months of treatment
- Percentage and numeric changes of the
- Maximum flow rate (mL/s)
- Average flow rate (mL/s)
- Post-void residual urine volume (mL)
Micturition diary efficacy parameters: From baseline to 6 months of treatment
- Percentage and numeric changes in micturition frequency/24 hours
- Percentage and numeric changes in mean volume voided per micturition
- Percentage and numeric changes in mean number and severity of urgency per micturition
Prostate volume parameters:
- Change in prostate volume by TRUS from baseline to after 6 months of treatment.
- Change in serum PSA from baseline to after 6 months of treatment.
Quality of life parameters:
- Change in Bother Score of IPSS score from baseline to 6 months of treatment
LUTS Symptom parameters:
- Change in IPSS score from baseline to 6 months of treatment
- total score: sum of all 7 questions
- storage score: sum of questions 2, 4 and 7
- voiding score: sum of questions 1, 3, 5 and 6
LUTS outcome score (LOS)
- Change in LOS from baseline to 6 months of treatment
Patient perceptions:
- Patient perception of treatment benefit after 3 and 6 months of treatment
- Change in patient perception of urgency from baseline to 3 and 6 month of treatment
Safety parameters:
- Incidence and severity of adverse events
- Incidence and reason of withdrawals
- STUDY DESIGN AND METHODS
Study Design: This is a 6-month prospective Phase IV study to explore the effect on the bladder function of Dutasteride in male patients with benign prostatic obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | Experimental | Drug: Dutasteride |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥50 and <80 years old
- Presence of LUTS for at least 3 months
- IPSS≥15
- Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
- Prostate volume measured by TRUS ≥ 30ml and < 100ml
Key exclusion criteria (7 listed)
- Patients with neurogenic voiding disorders
- Patients with prostate or bladder cancer
- Patients underwent urethral, prostate or bladder neck surgery
- Patients with urethral stricture or bladder neck contracture
- Serum PSA≥4ng/ml (if the patient confirmed as no malignancy by prostate biopsy can be included).
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 |
|---|---|---|
| DutasterideAlso: AvodartDutasteride 0.5 mg od. | Drug | Dutasteride |
Primary outcome
Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW)
Time frame: Baseline and 6 months of dutasteride treatment
8 secondary outcomes
Urodynamic parameters
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
Micturition diary efficacy parameters
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
Prostate volume parameters
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
Quality of life parameters
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
LUTS Symptom parameters
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
LUTS outcome score
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
Patient perceptions
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
Safety parameters
Time frame: Baseline and 3 and/or 6 months of dutasteride treatment
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 11 Jun 2009.
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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.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dutasteride in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center 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 6 inclusion and 7 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 11 Jun 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW) (time frame: Baseline and 6 months of dutasteride treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2009.