Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

Benign Prostatic Hyperplasia Clinical Trial

Official title:

The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877669
• Other study ID #: 2008-10-038
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: December 2016

Study information

• Verified date: November 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 313
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 50 yrs or greater

• International prostatic symptom score >= 12

• Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)

• Able to give fully informed consent

Exclusion Criteria:

• Patients with urologic malignancies such as prostate cancer and bladder cancer

• Patients underwent urethral, prostate surgery

• Patients with urethral stricture or bladder diverticulum or bladder neck contracture

• Patients with histories of bacterial prostatitis within 1 year

• seems not to be appropriate to this study by the decision of investigators because of any other reasons

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Procedure:
• Transurethral resection of the prostate
Standard transurethral resection of the prostate using electrocautery loop
• Holmium Laser Enucleation of the Prostate
HoLEP using 100W Ho:YAG laser

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation		6 months
Secondary	The changes of Quality of Life (QoL) parameters		6 months
Secondary	The changes of IPSS and QoL parameters		1 month and 3months after operation
Secondary	The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters		2 weeks and 3 and 6 months after operation
Secondary	Postoperative hospital stay days and postoperative catheterization days		immediate postoperative period
Secondary	The changes of the hemoglobin and the serum sodium		0 and 1 day after operation
Secondary	Operative time and Resected tissue weight		0 day after operation
Secondary	The changes of ICS male questionnaire (short form) parameters		3 and 6 months after operation
Secondary	The changes of international index of erectile function (IIEF)-15 parameters		6 months after operation
Secondary	The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters		3 and 6 months after operation
Secondary	The changes of voiding frequencies and urgency parameters in Frequency volume chart		3 and 6 months after operation
Secondary	Ejaculation parameter		6 months after operation
Secondary	Complications		During all study periods