Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00827814
First received: January 22, 2009
Last updated: June 8, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: Dutasteride
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction: A 24-Week Open-Label, Single-Arm Pilot Study

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

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 ]

Secondary Outcome Measures:
  • Urodynamic parameters [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • Micturition diary efficacy parameters [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • Prostate volume parameters [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • Quality of life parameters [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • LUTS Symptom parameters [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • LUTS outcome score [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • Patient perceptions [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]
  • Safety parameters [ Time Frame: Baseline and 3 and/or 6 months of dutasteride treatment ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: June 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dutasteride Drug: Dutasteride
Dutasteride 0.5 mg od.
Other Name: Avodart

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age≥50 and <80 years old
  2. Presence of LUTS for at least 3 months
  3. IPSS≥15
  4. Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
  5. Prostate volume measured by TRUS ≥ 30ml and < 100ml
  6. Able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

  1. Patients with neurogenic voiding disorders
  2. Patients with prostate or bladder cancer
  3. Patients underwent urethral, prostate or bladder neck surgery
  4. Patients with urethral stricture or bladder neck contracture
  5. Serum PSA≥4ng/ml (if the patient confirmed as no malignancy by prostate biopsy can be included).
  6. Patients who medicated with 5ARI within 6 months
  7. Patients who do not agree with the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827814

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00827814     History of Changes
Other Study ID Numbers: 2006-06-022
Study First Received: January 22, 2009
Last Updated: June 8, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Pathological Conditions, Anatomical
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014