Impact of Tamsulosin on Voiding Patterns Following Early Catheter Removal After Robot-assisted Laparoscopic Radical Prostatectomy

NCT ID: NCT01209988

Last Updated: 2010-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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To date, there is a lack of consensus concerning the optimal timing for removal of the urethral catheter, its related complications, the effectiveness in prophylactic drug use to reduce complication, and the patient reported outcomes (quality of life) after robot-assisted laparoscopic prostatectomy (RALP). The purpose of this study is to determine the impact of tamsulosin on voiding patterns following early urethral catheter removal after RALP for prostate cancer.

Detailed Description

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Conditions

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Prostatic Neoplasms, Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Tamsulosin 0.4mg

Perioperative tamsulosin 0.4mg daily

Group Type EXPERIMENTAL

tamsulosin 0.4mg

Intervention Type DRUG

perioperative tamsulosin 0.4mg daily for three weeks

Control

No medication

Group Type PLACEBO_COMPARATOR

No medication

Intervention Type OTHER

No medication

Interventions

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tamsulosin 0.4mg

perioperative tamsulosin 0.4mg daily for three weeks

Intervention Type DRUG

No medication

No medication

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must have localized or locally advanced prostate cancer
* Patients must receive robot assisted laparoscopic radical prostatectomy
* Patients must be able to provide written informed consent

Exclusion Criteria

* Patients must not have a history of treatment with alpha blockers within 4 weeks
* Patients must not have previously undergone transurethral resection, laser therapy, or other surgery of the prostate
* Patients must not have previously been diagnosed with neurogenic bladder
* Patients must not have hypersensitivity to trial drug or other alpha-blockers
* Patients must not have the participation of other clinical trial within the past 3 months
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Asan Medical Center

Principal Investigators

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Choung-Soo Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Asan Medical Center, Seoul, Korea

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Choung-Soo Kim, M.D.

Role: CONTACT

82-2-3010-3734

Facility Contacts

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Choung-Soo Kim, M.D.

Role: primary

Other Identifiers

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AMC_UR_010

Identifier Type: -

Identifier Source: org_study_id