Clinical trial NCT02033785: Functional Changes of Urogenital System After Holmium Laser Prostatectomy
Official title: Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Hyperplasia
Keywords: Prostatic hyperplasia
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 86
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal flow rate
timeFrame: 3 months
measure: Maximal detrusor pressure
timeFrame: 3 months
measure: Bladder outlet obstruction index
timeFrame: 3 months
measure: schäfer grade
timeFrame: 3 months
measure: Compliance
timeFrame: 3 months
Secondary outcomes:
measure: Maximal flow rate
timeFrame: 12 months
measure: Maximal detrusor pressure
timeFrame: 12 months
measure: Bladder outlet obstruction index
timeFrame: 12 months
measure: schäfer grade
timeFrame: 12 months
measure: Compliance
timeFrame: 12 months
Other outcomes:
measure: international index of erectile function
timeFrame: 3 months
measure: international index of erectile function
timeFrame: 12 months
measure: normalized rigidity activity unit in penile tip
timeFrame: 3 months
measure: normalized rigidity activity unit in penile tip
timeFrame: 12 months
measure: normalized rigidity activity unit in penile base
timeFrame: 3 months
measure: Estimated glomerular filtration rate
timeFrame: 3 months
measure: Estimated glomerular filtration rate
timeFrame: 12 months
measure: Urinary protein to creatinine ratio
timeFrame: 3 months
measure: Urinary protein to creatinine ratio
timeFrame: 12 months
measure: International prostate symptom score
timeFrame: 3 months
measure: International prostate symptom score
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 3 months
measure: Pittsburgh Sleep Quality Index
timeFrame: 12 months
measure: Health-related quality of life, short form 36 score
timeFrame: 3 months
measure: Health-related quality of life, short form 36 score
timeFrame: 12 months
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital, The Catholic University of Korea
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea
name: Seung-Ju Lee
role: STUDY_CHAIR
affiliation: The Catholic University of Korea
name: Dong Sup Lee
role: PRINCIPAL_INVESTIGATOR
References: