Functional Changes of Urogenital System After Holmium Laser Prostatectomy

Prostatic Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02033785
• Other study ID #: L201401N1
• Secondary ID: VC13OISI0222
• Status: Not yet recruiting
• Phase: N/A
• First received: January 7, 2014
• Last updated: January 9, 2014
• Start date: February 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2014
• Source: The Catholic University of Korea
• Contact: Seung-Ju Lee, MD, PhD
• Phone: 82-31-249-8305
• Email: lee.seungju[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital, The Catholic University of Korea	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	international index of erectile function		3 months	No
Other	international index of erectile function		12 months	No
Other	normalized rigidity activity unit in penile tip	This parameter can be obtained from nocturnal penile tumescence test.	3 months	No
Other	normalized rigidity activity unit in penile tip	This parameter can be obtained from nocturnal penile tumescence test.	12 months	No
Other	normalized rigidity activity unit in penile base	This parameter can be obtained from nocturnal penile tumescence test.	3 months	No
Other	Estimated glomerular filtration rate		3 months	No
Other	Estimated glomerular filtration rate		12 months	No
Other	Urinary protein to creatinine ratio		3 months	No
Other	Urinary protein to creatinine ratio		12 months	No
Other	International prostate symptom score		3 months	No
Other	International prostate symptom score		12 months	No
Other	Pittsburgh Sleep Quality Index		3 months	No
Other	Pittsburgh Sleep Quality Index		12 months	No
Other	Health-related quality of life, short form 36 score		3 months	No
Other	Health-related quality of life, short form 36 score		12 months	No
Primary	Maximal flow rate	This parameter can be obtained from urodynamic study.	3 months	No
Primary	Maximal detrusor pressure	This parameter can be obtained from urodynamic study.	3 months	No
Primary	Bladder outlet obstruction index	This parameter can be obtained from urodynamic study.	3 months	No
Primary	schäfer grade	This parameter can be obtained from urodynamic study.	3 months	No
Primary	Compliance	This parameter can be obtained from urodynamic study.	3 months	No
Secondary	Maximal flow rate	This parameter can be obtained from urodynamic study.	12 months	No
Secondary	Maximal detrusor pressure	This parameter can be obtained from urodynamic study.	12 months	No
Secondary	Bladder outlet obstruction index	This parameter can be obtained from urodynamic study.	12 months	No
Secondary	schäfer grade	This parameter can be obtained from urodynamic study.	12 months	No
Secondary	Compliance	This parameter can be obtained from urodynamic study.	12 months	No