Functional Changes of Urogenital System After Holmium Laser Prostatectomy

Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients

Holmium laser prostatectomy will enhance voiding function.

Holmium laser prostatectomy will enhance sleep quality.

Holmium laser prostatectomy will enhance renal function.

Holmium laser prostatectomy will enhance erectile function.

Holmium laser prostatectomy will enhance the health-related quality of life.

Study Overview

• Status: Unknown
• Conditions: Prostatic Hyperplasia

Detailed Description

Check urodynamic parameters for voiding function evaluation Check low urinary tract symptoms (IPSS: international prostate symptom score) for voiding function evaluation Check Pittsburgh Sleep Quality Index for sleep quality evaluation Check estimated glomerular filtration rate and urine protein/creatinine ratio for renal function evaluation Check International Index of Erectile Function score (IIEF-5) for erectile function evaluation Check nocturnal penile tumescence parameters for erectile function evaluation Check 36-Item Short- Form Health Survey (SF-36) for evaluation of the health-related quality of life.

• Study Type: Observational
• Enrollment (Anticipated): 86

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
      • St. Vincent's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

• Prostate size over 30 cc by transrectal ultrasonography
• prostate-specific antigen level less than 10 ng/ml
• International prostate symptom score more than 7
• At least one of followings: Bladder outlet obstruction index > 40, maximal flow rate < 10 cc/sec, postvoid residual urine >100cc or schäfer grade II or more

Exclusion Criteria:

• Patients who do not want surgery
• Evidence of prostate cancer or bladder cancer during evaluation or treatment
• All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
• Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
• History of pelvic radiation therapy
• Poorly controlled diabetes mellitus or hypertension

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal flow rate	This parameter can be obtained from urodynamic study.	3 months
Maximal detrusor pressure	This parameter can be obtained from urodynamic study.	3 months
Bladder outlet obstruction index	This parameter can be obtained from urodynamic study.	3 months
schäfer grade	This parameter can be obtained from urodynamic study.	3 months
Compliance	This parameter can be obtained from urodynamic study.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal flow rate	This parameter can be obtained from urodynamic study.	12 months
Maximal detrusor pressure	This parameter can be obtained from urodynamic study.	12 months
Bladder outlet obstruction index	This parameter can be obtained from urodynamic study.	12 months
schäfer grade	This parameter can be obtained from urodynamic study.	12 months
Compliance	This parameter can be obtained from urodynamic study.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated glomerular filtration rate		3 months
international index of erectile function		3 months
international index of erectile function		12 months
normalized rigidity activity unit in penile tip	This parameter can be obtained from nocturnal penile tumescence test.	3 months
normalized rigidity activity unit in penile tip	This parameter can be obtained from nocturnal penile tumescence test.	12 months
normalized rigidity activity unit in penile base	This parameter can be obtained from nocturnal penile tumescence test.	3 months
Estimated glomerular filtration rate		12 months
Urinary protein to creatinine ratio		3 months
Urinary protein to creatinine ratio		12 months
International prostate symptom score		3 months
International prostate symptom score		12 months
Pittsburgh Sleep Quality Index		3 months
Pittsburgh Sleep Quality Index		12 months
Health-related quality of life, short form 36 score		3 months
Health-related quality of life, short form 36 score		12 months

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Study Chair: Seung-Ju Lee, The Catholic University of Korea; Principal Investigator: Dong Sup Lee, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 13, 2014

Study Record Updates

• Last Update Posted (Estimate): January 13, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Prostatic hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: L201401N1; VC13OISI0222 (Other Identifier: IRB of St. Vincent's Hospital)