Functional Changes of Urogenital System After Holmium Laser Prostatectomy

• Conditions: Prostatic Hyperplasia

• Registration Number: NCT02033785
• Lead Sponsor: The Catholic University of Korea

Brief Summary

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.

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 Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-13
• Last Update Posted: 2014-01-13
• Study Start: 2014-02
• Primary Completion: 2016-02
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Vincent's Hospital, The Catholic University of Korea; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of