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

NCT00827814 | Completed Phase 4

• 1 other identifier: 2006-06-022
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Percent (numeric) changes in ultrasound-estimated bladder weight (UEBW)

  Baseline and 6 months of dutasteride treatment

Secondary Outcomes (8)

• Urodynamic parameters

  Baseline and 3 and/or 6 months of dutasteride treatment

• Micturition diary efficacy parameters

  Baseline and 3 and/or 6 months of dutasteride treatment

• Prostate volume parameters

  Baseline and 3 and/or 6 months of dutasteride treatment

• Quality of life parameters

  Baseline and 3 and/or 6 months of dutasteride treatment

• LUTS Symptom parameters

  Baseline and 3 and/or 6 months of dutasteride treatment

Study Arms (1)

Dutasteride

EXPERIMENTAL

Drug: Dutasteride

Interventions

Dutasteride DRUG

Dutasteride 0.5 mg od.

Also known as: Avodart

Dutasteride

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2009
• First Posted: January 23, 2009
• Study Start: June 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 11, 2009

Record last verified: 2009-06

Locations

KR (1)