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Tracking Information | |||||
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First Received Date † | January 22, 2009 | ||||
Last Updated Date | May 5, 2009 | ||||
Start Date † | June 2006 | ||||
Current Primary Outcome Measures † |
Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW) [ Time Frame: Baseline and 6 months of dutasteride treatment ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00827814 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction | ||||
Official Title † | Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction: A 24-Week Open-Label, Single-Arm Pilot Study | ||||
Brief Summary | Treatment of lower urinary tract symptoms due to benign prostate hyperplasia aims at improving patient quality of life by reducing symptom-related bother. Treatment of bladder outlet obstruction aims at relieving benign prostate hyperplasia complications, such as chronic renal failure, hydronephrosis, bladder diverticula, and acute and chronic retention of urine, but also aims at relieving lower urinary tract symptoms associated with detrusor dysfunction. 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. |
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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:
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
Micturition diary efficacy parameters: From baseline to 6 months of treatment
Prostate volume parameters:
Quality of life parameters:
LUTS Symptom parameters:
LUTS outcome score (LOS)
Patient perceptions:
Safety parameters:
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. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † | Benign Prostatic Hyperplasia | ||||
Intervention † | Drug: Dutasteride | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 36 | ||||
Completion Date | April 2009 | ||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 50 Years to 79 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Korea, Republic of | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00827814 | ||||
Responsible Party | Kyu-Sung Lee/Professor, Samsung Medical Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | Samsung Medical Center | ||||
Collaborators †† | GlaxoSmithKline | ||||
Investigators † |
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Information Provided By | Samsung Medical Center | ||||
Verification Date | May 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |