Functional Changes of Urogenital System After Holmium Laser Prostatectomy

NCT ID: NCT02033785

Last Updated: 2014-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Seung-Ju Lee

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung-Ju Lee

Role: STUDY_CHAIR

The Catholic University of Korea

Dong Sup Lee

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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St. Vincent's Hospital, The Catholic University of Korea

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Seung-Ju Lee, MD, PhD

Role: CONTACT

82-31-249-8305

Dong Sup Lee, MD, PhD

Role: CONTACT

82-31-249-8276

Other Identifiers

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VC13OISI0222

Identifier Type: OTHER

Identifier Source: secondary_id

L201401N1

Identifier Type: -

Identifier Source: org_study_id

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