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

Asan Medical Center

Status: Unknown

Conditions: Prostatic Neoplasms, Prostatectomy

Treatments: Drug: tamsulosin 0.4mg; Other: No medication

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01209988

AMC_UR_010

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups, including a placebo group

Tamsulosin 0.4mg

Experimental group

Description:

Perioperative tamsulosin 0.4mg daily

Treatment:

Drug: tamsulosin 0.4mg

Control

Placebo Comparator group

Description:

No medication

Treatment:

Other: No medication